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We are grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy).

Response:

1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review and other scientific publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”

2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central.

NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties.

For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.

In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.

1) Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2) For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3) Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central 4) Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5) Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central 6) Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law

• Regarding Patent Rights: Has NIH fully considered the public-access requirements’ impact on patent rights? Articles may be jointly authored by NIH-supported and privately supported researchers – indeed, some industry researchers also receive NIH grants. Posting of accepted manuscripts to PubMedCentral may well be considered publication, imposing time limits on commercial collaborators’ ability to file patents on their inventions. Unless authors are fully aware of these implications, public-access posting could jeopardize researchers’ ability to patent and commercialize their inventions. These requirements could, moreover, jeopardize NIH-funded researchers’ access to non-NIH-funded collaborations. This would be have a negative impact on innovation and commercially exploitable scientific knowledge.

The Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition have prepared and submitted a thorough list of the information and communications related to the NIH Public Access Policy that would be helpful to publishers. We agree that these questions should be fully and publicly addressed by NIH.

Informa supports the Association of American Publishers’ request for information and communications, which are as follows:

1) Regarding Consultation with Publishers, Societies and Authors

• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? • What is NIH’s timeline for amending this policy moving forward? • What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright

• Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy

• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? • Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? • How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. • How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? • How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? • If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation

• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? • The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope

• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? • Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? • The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? • What will the repercussions be for investigators and journals that do not follow the process? • NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access

• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? • Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? • For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? • How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? • How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost

• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? • Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness

• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? • What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? • What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While we appreciate NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, we are troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and we welcome the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.

These are incredible wastes of the greatest resources this country has, our human capital, as is increasingly common with the enormous amount of NIH mandates. The collective hours of cost is not really worth the repetition of the same effort. You have the power to make this happen and dumping the task on individuals is just setting up people for failure. Where is the thinking about translational science?

We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers’ web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a free, digital and permanent stable archive of biomedical and life sciences journal literature. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues. We can say emphatically that a dark archive that links to publishers’ web sites is an unacceptable alternative to PMC that NIH has consistently and wisely rejected. Arizona State University fully supports the NIH Public Access Policy in its current form, and commends the NIH’s extensive efforts to seek input from the full range of stakeholders. ASU also supports the efforts of all to move to implement this congressionally approved policy. This policy is supportive of our institution’s and higher education’s commitment to making the results of scientific inquiry available as well as enabling the building on the discoveries of others to enhance understanding. Simply put, the public, as the funding source of this research, is entitled to have free access to the discoveries. One of ASU’s faculty members commented, “I think NIH’s recent policy of open-access to research results is long overdue.”

Several parts of ASU worked together to insure our ability to comply with this mandate. The Office of the Vice President for Research and Economic Affairs communicated multiple times with faculty members already receiving support and has established a mechanism for timely reminders to researchers of the requirement to deposit. This office worked with the University Libraries to develop useful web pages. Both of these units encouraged researchers to become familiar with the requirements of the mandate and a webinar on the topic was well-attended. The Office of General Counsel advised all of us on the issues of copyright management.

There is mixed opinion at ASU regarding a six month or one-year embargo. However, it is the case that journals would not be cancelled at ASU for the reason that articles are available in open access repositories. The pace of science renders ASU faculty members less competitive when subscriptions are canceled. It was further noted by a faculty member that publisher archives are “more tidy” than the current PUBMED Central.

It would be useful if NIH would maintain a list of publishers whose author publishing agreements are consistent with deposit to PMC, without additional copyright addendums. This enables faculty members to “do science” and not be troubled by bureaucracy.

Recognize that it is difficult for institutions to monitor compliance with this policy. Manuscripts and articles are written and submitted by the principal investigator. The sponsored projects office does not get involved in this process. A potential way to monitor compliance is to have NIH ensure that all NIH grant application forms or electronic submission sites include a prompt or field for inclusion of the PMCID on the PI’s cited references that fall within the policy. Perhaps a routine communication process with campus offices of research could be established to ensure compliance.

We recommend advice for researchers who encounter one-click copyright agreements during article submission.

Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in a local repository to link to research generated at our institution-specific, searchable record of compliance and success in publishing research results.

Advice for researchers who encounter one-click copyright agreements during article submission should be made available.

PMC should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.

Update and maintain lists of journals that comply with NIH policy and that do not charge a fee.

Advice directed to publishers.

Admittedly, The NIH is working within a publishing environment that is not of their making and the NIH has no easy way to compel publishers to participate themselves. However, it would benefit all parties if NIH would work with publishers to increase the number who automatically submit manuscripts for funded authors. Researchers can help drive this by requesting publisher participation, but the leverage of a large funding agency reaching out to publishers will help ease the transition.

Ultimately, to have the greatest impact, NIH support should take advantage of the scientific skills of researchers rather than requiring even modest bureaucracies.

Other disciplines have a long history of sharing research results through pre-prints without having a negative impact on publishers’ ability to maintain a sufficient revenue stream and viable business models. There is no reason to expect a different result here.

Rather, this policy is an important step towards improved public access to publicly funded research. It is essential for NIH to work out practicable processes as similar policies are adopted by other government funding agencies.

Dr Zerhouni National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892

30th May 2008

Dear Dr Zerhouni, Re: National Institutes of Health (NIH) Mandatory Public Access Policy I am writing on behalf of the Federation of European Biochemistry Societies (FEBS) in response to a request for information (RFI) in the Federal Register, seeking public comment on the NIH Mandatory Public Access Policy. FEBS provides dedicated focal points for its vast network of members in molecular biology and promotes excellence in the molecular life sciences in Europe, through an extended programme of activities, ranging from fellowships, courses and workshops, conferences and scientific publications. FEBS is a not-for-profit scientific organization. Whilst our organization supports the principle of public access to government-funded research and efforts made to enhance public access to science, we have significant concerns about the impact of the public access policy. The policy will affect all stakeholders in the scientific research community but it is likely to have a particularly severe impact on societies such as ourselves, who rely on subscription revenue derived from our journal operations to fund the activities outlined above. We believe that the NIH policy must be implemented in a way that maximizes its effectiveness to the public and the scientific research community, whilst maintaining our journals and Societies. Importance of peer review Our organization believes strongly in high-quality journals as a means of ‘sorting the wheat from the chaff’, where readers can be sure that only the best studies have been accepted for publication. Our editorial boards consist of scientists who have demonstrated experimental insight and expertise in their own field and offer a fair and thorough peer-review of submitted manuscripts. In fields of research heavily dependent on experimental findings the quality of the data and the understanding of the limitations that need to be applied to its interpretation require review by scientists who are themselves intimately involved with these same techniques and are crucial to having the findings widely accepted by those in the field. In short, journals add considerable value by performing peer review. The effort and expense of this process is supported entirely by journals and not the NIH. It is a vital service for science and it is imperative that such a system of expert filtering continues. As subscription revenues decline alongside the free availability of these peer-reviewed manuscripts on PMC there is a real risk that the funds supporting the editorial costs of peer-review (funding the electronic editorial office and financial support of editors) will disappear. Infrastructure In the same way that learned societies act as experts in peer review, it is the active collaboration of our publishers which has aided the efficient transmission of the findings of research to others. This collaboration between experts in science and experts in communication is the principle element in making experimental data, interpretation and analysis available to other researchers world-wide. Just as our Societies’ income derived from our journal operations is fed back into science, publisher profits fund online developments. Once such example is Cross Ref where publishers have collaborated on this initiative bringing about great value to researchers. The notion that secure archiving and continued evolution can be delivered without the involvement of professional publishers who have developed this system seems to defy reason. In an ‘open access’ environment will repositories provide the infrastructure currently offered and continue the evolution of this scientific information process? Quality control In addition to undertaking the marketing, distribution and preservation of our journals, our publishers ensure that copyright protections are maintained, take action against piracy and protect authors’ copyright interests. How will the NIH ensure that the policy respects the integrity of the copyrighted content? We feel that subscription-based publishing has succeeded in providing quality assurance, and it important that the journal sites maintain the final published version which authors should cite. As such, NIH should link the accepted manuscript versions on PMC to the definitive published version on the journal sites (via the DOI) as a version of record.

On a final note, how is NIH planning to continue the dialogue with stakeholders? We would be keen to learn further how the policy develops and to see if our concerns might be addressed. Yours sincerely, Prof. Félix M. Goñi, Chairman, Publications Committee, FEBS

You now have created such a tedious, laborious process for publication that I will never submit a grant proposal to NIH again. You have ascertained that original, creative, productive ideas such as pathtoreading.com are funded elsewhere.

It would also be helpful if NIH could publish a list of publishers whose publishing agreements with authors provide for deposit with PubMed Central in a way that is consistent with copyright law. I call it a “NIH seal of approval” list!

Finally, it would be helpful if the NIH grant application form/e-submission included a field requiring citation to all previously required PubMed Central deposits as part of ensuring that an application was complete.

I currently work with our Chemistry faculty in particular. This faculty actively engages in research, securing grants for their work, and contributing new knowledge to their disciplines. This policy now provides unprecedented access to published research and as time passes, that access will grow exponentially. As our campus is not rich, this will foster and support the work in which they engage. It will improve not only their research, but their teaching. Our students participate in faculty research projects as well as engaging in their own research projects. In addition, the availability of information formerly difficult to access will allow faculty to bring new ideas and research successes into their classrooms. This is our core mission and the NIH policy contributes directly to that mission.

As the person responsible for “spreading the word” on campus, I have provided our faculty with a campus web site that includes instructions on how to comply and how to help publishers of their articles meet the NIH requirements. This is available at http://www.library.csueastbay.edu/copyright/nih.htm, which is our current site, but is also available at http://libwiki.csueastbay.edu/wordpress/using-the-libraries/services/copyright/nih-requirements/, which will be the new site as of Summer quarter 2008. I have also worked closely with our Office of Research and Sponsored Programs, which has directed our current NIH grant holders to the page. Between us, we are working to ensure that these grantees and potential future grantees in our College of Science are aware of and informed about this program and related compliance issues. With this policy, we have a wonderful opportunity to collaborate across campus to ensure broad distribution and exposure for our institution research findings.

We want and need this program to work.

I am aware that there is opposition to this policy on the grounds that this may have a detrimental financial effect on publishers of science journals; however, that would only happen if libraries canceled subscriptions in a wholesale manner. As a library faculty member and practicing librarian, I do not foresee this. There are safeguards in the form of the embargo period and the demands that the requirements for author manuscripts require.

There are also concerns that the policy conflicts with current copyright law; however, I have worked with copyright for decades and I fail to see how this is the case. It is reasonable for the public to expect the availability of information that they sponsor through their governmental taxes.

I have made several suggestions in the question boxes above. In the meantime, as we go through this shakedown and adjustment phase for the new policy, I wish to re-iterate my appreciation for this policy and the gifts it is providing to our faculty and students. It is an important step forward in the sharing of new knowledge.

It has come to my attention that there is a proposal that the NIH policy be implemented through a dark archive that links to publishers' web sites. This is not an appropriate alternative. The requirement is for “public” access. There's nothing public about directing the public to sites where it has to pay for information that has already been paid for through public funds. An important goal is to make public the information discovered or created through NIH-funded endeavors.

Another major goal is to provide a permanent, stable archive. This requires that the material be centralized (not scattered among publishers' web sites and in various forms). A central repository ensures that the information will be curated, preserved, and used on a regular basis. As a librarian, I can assure you that a dark archive does not achieve appropriate archiving and preservation needs. NIH has consistently and sensibly rejected this alternative in the past and I urge NIH to continue to reject this idea in favor of promoting the public dissemination of information through the access of PubMed Central.

To ensure NIH-funded researchers' awareness of and compliance with the public access policy, staff from the Office of Intellectual Property – Industry Sponsored Research, the Office of the Vice Chancellor for Research, and the UCLA Library have collaborated on designing a multi-pronged approach involving both education and assistance. This coordinated effort targeted at faculty, librarians, and staff aims to inform, educate, and assist researchers and to support the broadest possible dissemination of their work. Staff from all three of these organizations participated in a webinar organized by the University of California Office of the President. At UCLA, the Library has taken the lead in providing individual assistance to authors who have questions about the submission process.

We support the NIH Public Access Policy as a very strong step taken toward ensuring that the results of publicly funded research are widely disseminated and available in a permanent, stable archive, though we are aware that some problems must still be overcome. The submission process must be simplified, by persuading all publishers either to join those who submit papers to PubMed on behalf of their authors or to permit authors to deposit papers without additional charges or difficult contract negotiations. In addition, a clearer explanation is needed to clarify the difference between the PubMed Central identification number and the PubMed identification number and about whether either can be used in submitting the paper to PubMed Central.

Thank you for the opportunity to comment. Roberto Peccei UCLA Vice Chancellor for Research

Kathryn Atchison UCLA Vice Provost of Intellectual Property and Industrial Relations; Associate Vice Chancellor for Research

Gary E. Strong UCLA University Librarian

o How to deposit, including how to use the deposit tools provided by NIH, and clarification of the respective responsibilities of the author(s) and the Principal Investigators.

o What to deposit, including more expansive information about which version of the work to deposit, and clarification of the applicability of the policy with respect to the funding year for the supporting grant. In this regard, we note that NIH's own documents conflict with one another: the Policy says that it applies to all articles arising from NIH funding that are accepted for publication on or after 4/7/08, but the FAQ has a further limitation to articles that arise from FY08 funding.

o How to identify, control and manage the multiple versions of works; we continue to hear continued expressions of concern and uncertainty about the existence of multiple versions

UC therefore strongly recommends that NIH address this problem by establishing a systematic program, working with publishers and institutions, to define a single, simple model that facilitates and supports deposit of NIH-sponsored works in PMC. The submission of Anthony De Crappeo, on behalf of the Council on Governmental Relations, on May 28, 2008, expresses concerns similar to those of UC and reaches a similar conclusion. The University of California has extensive relationships with most major biomedical publishers, both as a purchaser of journal publications, and, through its faculty, as a supplier of the work that they publish. UC is willing to work with NIH and like-minded peer institutions to plan and implement such a program.

We think that journals should not have the sole right to reproduction of our work, and that maintenance of this copyright is fundamental to our careers in science. From a political standpoint, we think that no government organization should provide support for research that is not accessible to the public for free through a service like this.

As future researchers having spent the majority of our academic lives with the aid of the internet, we recognize that a change to open-access is coming. In previous generations, part of the service provided by journals was dissemination of knowledge, and maintenance of copyright was necessary to this service. In the age of the internet, this is an already obsoleted role, as a simple pub-med search will show. We are routinely surprised that publishing involves a transfer of copyright, and we no longer accept this as a necessity of the dissemination of information.

To the creators of the NIH Public Access Policy: Please stand by your change. Complaints about being unable to cope with the "huge inconveniences" imposed by the plan are overstated, and complying with additional requirements by funding agencies is part of the job as far as we are concerned. We look forward to putting our papers in a Caltech repository in the not-too-distant future, and, those of us supported by NIH grants jump at the chance to put them here.

The Offices of the Vice Provost for Research, Sponsored Research, Library, and General Counsel at Caltech undertook the following for successful implementation of the NIH Public Access Policy: 1) Crafted text for authors to include in their manuscript submission letters to address copyright in a manner consistent with the law. 2) Individually notified every NIH grantee of the steps to undertake. 3) Met with research groups to address compliance needs. 4) Created and added a number of web pages announcing, explaining, and providing compliance steps to the Caltech community. 5) Consulted and advised one-on-one in labs and offices, as well as electronically, regarding the policy and related PubMed Central manuscript submission process

The NIH should continue to urge publishers to automatically deposit papers in the PMC and find appropriate ways to recognize those who do. In addition, with incentives from funding agencies such as the NIH and given today's available technologies, universities and publishers need to establish effective new mechanisms for handling peer-review certification and optimizing world-wide research paper distribution. New more collaborative approaches borne of the network are needed.

Also, Caltech has no intention of canceling journal subscriptions due to the NIH policy. However, like all organizations, it must operate within a budget. Regrettably, it does occur that some publisher prices exceed our ability to pay. Therein rests the source of any journal cancellations, not public access mandates. Therefore the limits on an embargo could easily be shortened to 6 months without changing the decision-making process we undertake.

University based research is fundamentally driven by the desire for public benefit. Caltech welcomes the leadership of the NIH in creating change and dialog so that publicly funded research can realize the full potential made possible by the global network.

Simplified procedures are essential to identify compliance policies by journal title. For the future we look forward to publisher’s submission on behalf of their authors and urge NIH to collaborate with publishers in this regard. In the interim we strongly encourage NIH to partner publishers to produce a searchable index by journal title. The limited list by publisher is of little value to authors who do not know publishers nor does it include the majority of journal titles.

One way to increase incentives for compliance is for NIH to collaborate closely with campus research officers, who have more direct contact with researchers. Whenever an article from any institution is successfully deposited in PubMed Central or the NIHMS, the appropriate campus research office should be notified.

We commend NIH for the materials currently available on the NIH website– they have been helpful in our outreach efforts to authors and in work with the research office and for rapid response to questions about the policy. Below is a summary of activities to date at the University of California, San Francisco (UCSF) and those planned for the near future: o Development of a prominent page about the NIH Public Access Policy on the Library’s web site: http://library.ucsf.edu/research/scholcomm/nih.html; o Targeted outreach to faculty, in coordination with the UCSF Office of Research; o In-service trainings for Library staff members to become familiar with the basics of the policy. These trainings rely upon the “Public Access Training” presentation developed by NIH; o Collaboration on educational and advocacy activities across the ten 10 University of California campuses; o External trainings for UCSF faculty and staff about the policy; and, o Establishment of an email address that UCSF researchers or administrative assistants can use to submit questions about the policy

Given the significant commitment of local resources allocated to support compliance with the NIH Public Access Policy, and the stated aims of the policy, we feel that the policy should remain stable for the next year at least. (However, as stated above, a shortening of the embargo period to 6 months would be preferable.) This policy is the first of its kind in the United States, and it would be distressing to see it scaled back significantly so soon after it was enacted.

The NIH Public Access Policy balances the legitimate interests of publishers with wide dissemination of the results of taxpayer-funded research. Deposit of the final peer-reviewed manuscript in a respected archive such as PubMed Central—with its easy linkages to sources of genomic, clinical, and chemical information—will facilitate scientific research and improve public health. I fully support the goals of the NIH Public Access Policy.

I have spoken to many individuals regarding the new policy and it is still not clear if NIH support means any author in a multi-author article or whether all of the authors. Several years ago when one of the NIH funded authors objected to copyright of an article, the New England Journal of medicine removed the author from the article in order to publish and used the other authors.

As I interpret US copyright law, the intent was to protect the public from inappropriate ownership of publicly funded projects which now would include research grant results. Would the policy therefore also include articles written in publications that are not traditional medical journals such as textbooks, educational items supported by promotional companies but which include work performed by NIH funded investigators, PowerPoint presentations at scientific meetings etc. clarification of exactly what this policy covers is critical.

I would argue that the TRIPS agreement is applicable to publication of articles just as it is applicable to patented drugs. It makes no sense that generic drugs can be manufactured in countries one life-threatening health situations exist but the articles which tell us how to use the drugs are still under intellectual property control. As the HIV epidemic moves more and more into resource poor countries, the physicians who perform the studies, the patients who are participants in the study, and the health care professionals who are responsible for health care require that the information be provided to them in a timely manner. A12 month delay is just too long.

The UC Merced Library provides access to some 20,000 full-text journals but carries no print-format journals. We believe it is only a matter of time until this strategy becomes the norm rather than the exception. Clearly, the NIH Public Access Policy enhances this emerging way of managing a research-library journal collection.

Even more important is the long-term impact the NIH Public Access Policy, in conjunction with similar policies, will have on the future UC Merced School of Medicine. Designed to bring medical education and improved medical care to California’s Central Valley, our state’s most medically underserved region, the UC Merced School of Medicine will follow a distributed model in which students and faculty are spread up and down the Central Valley rather than being clustered around a single teaching hospital. Unimpeded access to online medical research of the sort made possible by the NIH Public Access Policy will be vital under such an educational model, with the ultimate beneficiaries being the residents of California’s Central Valley.

The University of California, Merced commends the NIH for moving access to medical research into the Twenty-First Century and encourages NIH to stand by, and eventually expand, its Public Access Policy.

The PMC (NIH Portfolio) Archive Program has the following terms: The participating project provides NIH with final articles representing NIH-funded research. NIH has internal use of the articles during participating journals’ embargo period, which can be no longer than 12 months. During the embargo period, NIH can link to the journal web sites to provide access to NIH-funded research articles; following the embargo period, NIH can provide links to the journal, but can also distribute articles directly from its PMC web site (NIH’s view of an article includes a page banner that identifies the corresponding journal and provides a link to the journal’s own web site). ASH volunteered to have Blood be the first participant in the program and agreed to provide articles going back to the original May 2005 implementation date of the original NIH Public Access Policy.

ASH has implemented the PMC (NIH Portfolio) Archive Program for almost two years, and the Society strongly believes that this option meets the NIH Public Access Policy goals while providing a better alternative for journals and authors than the newly mandated policy. Consequently, ASH’s comments below focus on the importance of maintaining this option and promoting participation in it to other nonprofit publishers. ASH strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program.

Section B-Scope of the Policy - The information provided in response to question 2 states, “The Policy applies to all peer-reviewed journal articles, including research reports and reviews. The Policy does not apply to non-peer-reviewed materials such as correspondence, book chapters, and editorials.” It has come to the Society’s attention, however, that several non-peer-reviewed materials have been submitted and posted to PMC. Therefore, ASH urges NIH to make sure implementation of the Policy is consistent with this response.

The information provided in response to question 4 concerns whether submission is required for research funded by a grant or cooperative agreement that expired before FY 2008. ASH recommends that NIH include in this response that the author should check with the journal to make sure the submission is not duplicative, if he or she decides to submit.

Section C-How to Comply With the Policy – ASH is pleased that NIH has included in the response to question 1 that some publishers have agreed to make the final published article of every NIH-funded article publicly available in PubMed Central within 12 months of publication and for these journals, authors do not need to do anything to fulfill the submission requirement. The Society recommends, however, that this language also be included prominently upfront in the General Information section as well in order to make sure authors are aware of this option and to prevent duplication of submission or incorrect submission by well-intended authors.

ASH is also pleased that NIH notes in response to question 2 that authors should work with the publisher before any rights are transferred to ensure that all conditions of the NIH Public Access Policy can be met. It is critical that authors be encouraged to work with their publishers in order to meet the requirements of the NIH Public Access Policy and also the requirements of the publisher. Similarly, ASH recommends that in response to question 3 concerning language for the copyright agreement, NIH should refer authors back to their publishers to ensure that the authors adhere to the publishers’ requirements and legal counsel. On this point, ASH is particularly concerned that NIH intramural investigators recently were instructed to only use the NIH publishing agreement, not accept a publisher’s copyright transfer agreement, and to submit their manuscript (not final article) to PubMed Central upon acceptance. Further, the recent instructions to intramural researchers state that if the journal rejects the NIH Publishing Agreement or wants to change it, the author must recall the manuscript and submit it to another journal. These instructions are not only inconsistent with the Public Access FAQ, but they undermine the terms of the PMC (NIH Portfolio) Archive Program. ASH believes that if an article is based on NIH-funded research by a NIH intramural researcher the information is in the public domain. Legally, therefore, the intramural researcher author cannot assign copyright to ASH or to the NIH. ASH would like to discuss this more thoroughly with NIH to resolve issues raised in these instructions following the Request for Information comment period.

The members of the Professional & Scholarly Publishing Division of the Association of American Publishers appreciate NIH’s vision for “an interconnected world of science” and continue to support efforts to enhance public access to scientific research with many of our own innovative online tools. However, we are troubled both by NIH’s unwillingness to acknowledge the Public Access Policy’s flawed legislative process to date and by the lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for this major shift in policy. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, the public) and for science itself, and these implications should be fully considered and addressed as soon as possible. Our key policy and implementation concerns include: Copyright. Blanket requirements in grant contracts would effectively deny authors and publishers the benefits of their copyrights—the most fundamental of which is the ability to decide how and in what form their works may be distributed—in conflict with fundamental copyright principles and without compensation for the value added by publishers and editors. In effect, the application of the NIH policy is an imposition of an extraordinary and unprecedented exception or burden to the copyright works—and thus diminishes their value for any journal business model that relies on exclusivity to drive traffic, advertising and subscriptions. The NIH policy essentially mandates a business model that can accommodate this “burdened” copyright, a model that must be based on up-front submission or publication charges, rather than the current models of the vast majority of journal publishers. This does not seem to us to be consistent with the legislative mandate to implement the NIH policy consistent with copyright. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. Quality Control and Compliance with Publisher Policies. Many manuscripts currently appear on PubMed Central (PMC) in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? For publishers submitting directly, how will NIH ensure that articles will not be accepted from individuals or entities other than the publisher? Scope. The revised mandatory public access policy now calls for submission of review articles. This is of concern to publishers especially since NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only. Repurposing. Changes made by NIH or authors that will result in variations from the original manuscript are of considerable concern for a number of reasons, not least of which is the potential introduction of errors. NIH needs to ensure that no changes, such as substantive editorial changes, are made to the manuscripts other than obvious errors in NIH production process or perhaps improved graphics for related illustrations. Links to other databases also raise concerns about changing an article’s principal context and focus. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the editorial integrity of the underlying work.

Patient education. Although we understand that the principal motivation of the legislative mandate to be patient information and education, the NIH policy implementation does not address this need directly (focusing instead on building researcher infrastructure). Publishers have been working actively with voluntary health organizations (VHOs), and we believe that more should be done in this area by NIH – hopefully, working with publishers and VHOs. Piracy. Third parties could commercially exploit content that appears on PMC without the consent of the publisher. What safeguards will NIH put in place to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose?

These represent only a few of our many practical concerns related to implementation of the mandatory policy. Below is a more expansive “checklist” of publisher questions.

We hope it is clear that publisher concerns reflect not only critical issues related to the spirit and protection of copyright but those aspects affecting day-to-day management of the policy and how effectively it achieves its stated objectives. We believe that we can work with NIH to arrive at practical solutions to these concerns, but that will require regular, ongoing consultation and discussion. In light of the substantial nature of these questions and NIH’s commitment to the advancement of science, we believe it is important that NIH fully address these questions. We look forward to a positive and constructive interaction with NIH that will result in balanced implementation of the new public access mandate in a way that addresses our concerns, advances science and benefits the public.

· Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals?

· What is NIH’s timeline for amending this policy moving forward?

· What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed? Overview: Copyright Concerns Journals add considerable value to published papers by managing peer review and providing copyediting and design revisions to improve the validity of the published product, benefiting researchers, the public, and the scientific community. The expense and effort of this process is supported entirely by the journals, not by NIH. Under the mandatory policy, significant copyright interests are being taken from publishers, without compensation for their investments. Other related responsibilities undertaken by publishers that bolster the scientific enterprise and thereby add value to individual scholarly works include: editorial selection of manuscripts to be published, marketing, distribution, and preservation. Publisher business models involving subscriptions, transactional paid access to individual articles, and advertising support within traditional publishing and on publisher web sites driven by the distribution of “new” articles, all of which depend on traditional copyright protection, will be impacted by the policy as announced. · Shouldn’t NIH support the full value of copyright and their use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central? Brand Protection, Repurposing and Piracy It is critical that NIH implement the Public Access Policy in a manner consistent with intellectual property protection and the intent of the related Congressional mandate, and work with publishers in ensuring such implementation. · What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers?

· Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) Would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus?

· How will NIH ensure proper protection of publisher or society trademarks and branding? Not only has there been no affirmation of these markers of quality, but all too often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain.

· It is critical that NIH respect the rights of copyright holders to stipulate what NIH will or will not allow related to third-party use of its works. Will NIH ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher?

· How will NIH prevent piracy of the articles from PubMed Central? Third parties could commercially exploit content that appears on PMC without the consent of the publisher. Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers?

· If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites? Compensation While taxpayers pay for the scientific research on which journal articles are based, non-profit and commercial publishers expend hundreds of millions of dollars a year in the peer-review of manuscripts and in preparing journal articles for publication and timely dissemination in print and online. The cutting-edge research that the many societies publish is rarely obsolete within a year, and may have a shelf life of five to ten years. It is imperative that NIH provide reasonable compensation to publishers for their investments and the well-recognized value that they provide to peer-reviewed manuscripts based on NIH-funded research.

· What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done?

· The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years? Scope The statutory language of the mandatory Public Access Policy applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. · If there are other funders, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central?

· Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based?

· The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision?

· What will the repercussions be for investigators and journals that do not follow the process?

· Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does NOT apply to literature reviews?

Integrity of Research, Quality Control and Meaningful Public Access The NIH posting of peer-reviewed manuscripts accepted for publication compromises the quality of scientific publishing by ultimately making available two different versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version. Given the new policy requiring deposit of NIH-funded manuscripts in PubMed Central upon acceptance, there are some procedural issues that are unclear. In addition, the benefit of access to manuscripts by patients and the general public has never been fully assessed and alternatives such as lay summaries may be far more useful. NIH should ensure that the implementation of the policy is truly beneficial to the public and does not displace other useful models. · How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal?

· Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted?

· For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher?

· How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? One possibility is for NIH to develop a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to VHOs, Patient Inform, publisher sites.

· How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

Cost The mandatory public access policy will not change the cost of scientific publishing, but will shift the burden of that cost away from scientific publishers and onto authors and the government, in other words, onto taxpayers. · NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy?

· Does this cost detract from funds to grantees actually conducting the innovative research that advances science? Measuring Impact and Effectiveness The policy will affect all stakeholders in the scientific research community and may have a particularly severe impact on small society publishers as subscription revenue will likely decline with increased free access on PubMed Central. It is important for NIH to ensure that content on PMC will not displace the definitive published version and that publishers brands are not diminished. NIH needs to ensure that PMC does not undermine the viability of journals whose economic stability varies widely. · Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions?

· What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)?

· What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

The two documents submitted for the RFI record are, respectively:

A letter addressed to me by Jon A. Baumgarten of Proskauer Rose LLP, dated May 30, 2008, in response to my request for an analysis of the relationship between the NIH Final Policy on Public Access and certain aspects of U.S. and international copyright law; and,

A letter addressed to Dr. Elias Zerhouni by the Chair and Vice Chair of the Executive Council of the Professional & Scholarly Publishing Division of the Association of American Publishers, dated March 17, 2008, which originally was timely submitted to NIH in response to its request for comments on the implementation of the NIH Public Access Policy pursuant to NOT-OD-08-057 (March 7, 2008).

Both of these documents raise important issues regarding compliance with the statutory proviso that Congress included in Division G, Title II, Section 218 of the Consolidated Appropriations Act, 2008 (Public Law 110-161) to make sure that “the NIH shall implement the public access policy in a manner consistent with copyright law.”

We appreciate the opportunity to provide these additional materials to NIH and thank you for ensuring that they will also become part of the record in response to the RFI.

AAU, on behalf of its member university presidents and chancellors, has repeatedly endorsed NIH’s efforts to increase public access to the results of NIH-funded research through the implementation of its Public Access Policy. Most recently, as the FY08 House Labor/HHS Appropriations Act was about to be debated on the House floor last summer, AAU President Robert M. Berdahl wrote to Subcommittee Chairman David Obey endorsing the Section 217 language that prompted NIH’s new guidelines. We welcome this additional opportunity to offer our support for the appropriations language and NIH’s progress in implementing it. Indeed, NIH’s effort to assure that everyone who has a view is heard has been much appreciated in the research university community.

Our member institutions have responded to NIH by developing policies and procedures to alert, educate and assist faculty in complying with the new requirements. Generally speaking, our administrators appreciate the effort that NIH has put into the complex exercise of developing and communicating the new requirements.

• We seek NIH’s help in negotiating a blanket permissions agreement with the publishers that will greatly ease the transaction costs that are currently borne not only by individual authors and, by extension their institutions, but also by publishers. What is needed is a modified standard copyright agreement acknowledging that the author retains the right to provide a copy of the final manuscript to NIH for posting by NIH on PubMed Central within 12 months of publication by a given journal. We request that NIH work to encourage publishers to adopt such agreements.

• If, as we hope, more publishers adopt such agreements over time, it would be helpful if NIH maintained and posted an easily accessible and authoritative list of publishers whose author agreements provide blanket permissions for authors to comply with the NIH Public Access Policy.

• NIH might also consider an automatic notification system for designated campus entities (an institution’s Office of Sponsored Research, for example) when a faculty member from that institution has deposited an article in PubMed Central. If the relevant institutional office is also notified when a faculty member receives electronic confirmation that his or her paper has been deposited, institutions would not have to go to additional and unnecessary effort to confirm the transaction.

• As institutions have put significant effort into establishing policies for the submission of articles to PubMed Central, educating and providing technical assistance to faculty, and requiring faculty to certify that they have complied, we would request that NIH develop a “safe harbor” for institutions that have met their responsibilities. If grantee institutions which have made good faith efforts to assure compliance of faculty, we believe such institutions should be shielded from the consequences of non-compliance, especially when that non-compliance arises from circumstances beyond the institution’s control.

• NIH should monitor (or perhaps have a third party such as the National Academies of Science analyze) the impact of the implementation of its Public Access Policy on scholarly publishing and trends in faculty publishing decisions as well as the costs associated with compliance under the new policy.

In March 2007, the legal firm Morrison & Foerster LLC (www.mofo.com) generously agreed to provide pro bono legal assistance to BioOne in drafting a Model Publication Agreement. Ms. Pamela Pasti, Of Counsel in the Technology Transactions Group of Morrison & Foerster’s San Francisco office, was assigned to the project. Over the course of the following year, Ms. Pasti worked with BioOne to review existing publication agreements, notable author’s addenda, and articles describing emerging trends in copyright law as it relates to academic publishing.

The resulting agreement allows author(s) to retain copyright, while granting the publisher both a temporally limited and exclusive right to first publish, and a perpetual, non-exclusive right to publish, distribute, and sublicense. In response to NIH’s Public Access Policy (passed by Congress in December 2007) and other institutional and subject repository deposit mandates, the Agreement allows authors to deposit their work in digital repositories directly, or permits the publisher to deposit to the National Library of Medicine on their behalf.

The BioOne Model Author Agreement reflects over a year of work for all involved in this important project. From the onset, we felt strongly that BioOne was in a unique position as a collaborative publishing endeavor to draft an equitable agreement, which would not have been possible without the legal guidance of Morrison & Foerster, and the invaluable feedback garnered from the publisher and library community.

The final Agreement is freely available on the BioOne website at www.bioone.org. An accompanying “roadmap” is also available to provide publishers adopting the Agreement with guidance on specific author and publisher rights and amendable sections.

CED most recently issued a report entitled Harnessing Openness to Transform American Health Care (February 2008). The report (available at http://www.ced.org/docs/report/report_healthcare2007dcc.pdf) made the following recommendations regarding openness, publishing and disclosure of research results: • The explicit policy of the federal government should be to promote the broadest possible access to research results in the healthcare arena, particularly government-supported research. • Those federal agencies supporting research should positively respond to requests for funding to pay for publication/disclosure of sponsored research. • In evaluating applicants for research funding, federal agencies supporting research should recognize the scientific value of database science and scholarly work that may be validated by means other than traditional scholarly publication. • Federal agencies supporting research should require that sponsored researchers disclose potential conflicts of interest in any publications/disclosure of the sponsored research. • Federal agencies supporting research should target efforts to reduce the interval between publication/disclosure of research and its implementation in accepted treatment regimes.

The report took a favorable view of the National Institutes of Health’s leadership on these issues critical to accelerating the pace of research, promoting new discoveries and stimulating innovation.

CED, consistent with these principles, supports the NIH public access policy as articulated. If any changes were to be made, CED would favor a shorter embargo.

As an alternative, journals could agree to deposit the final published article in PubMed Central. In this case, a significant portion of the burden on the grantee institution and its investigators is relieved and the public has timely access to the results of federally supported research. We recognize that the business models for many of the professional society-based journals do not anticipate this approach. Nonetheless, the society members are the very investigators that will be unable to meet their grant obligations and, as a consequence, jeopardize future federal funding.

Conversely, NIH can assist the research community by reconsidering its strategy for meeting its obligations under the Consolidated Appropriations Act of 2008. The language in the statute does not preclude NIH from providing links to journal websites as a way to make research results publicly available. There is no apparent expectation for a permanent archive of publications, per se, or a prescribed format for the publicly available electronic versions. A link to journal websites can meet NIH’s obligations under Consolidated Appropriations Act.

The near-term problem will be how to address the compliance question with investigators who inadvertently fail to reserve their rights to submit to PubMed Central. We hope that NIH will recognize that this transition will take some time before it is complete. Institutions and investigators will not want to be forced into a position to violate signed copyright agreements

As NIH has moved forward with this policy, investigators have discovered the significant costs of providing public access. Journal charges for public access for a single article have reached, in some cases, $3,000. NIH has reminded the community that publication charges are an allowable expense against a grant. However, charging these publication costs to a grant will result in a considerable reduction in funds available to conduct research.

Moreover, we expect that in many cases publications will be accepted after a grant has closed. As a result, research institutions will be expected to assist investigators in meeting these unexpected costs, putting greater strain on institutions that currently provide more than 20 percent of the funds to conduct research in the US. Combined with increasing unfunded compliance costs for the institutions and reductions in NIH’s budget, in general, this policy will contribute to a real reduction in funds available to conduct biomedical research.

We remain concerned for investigators – particularly junior investigators – whose career advancement may be jeopardized if some journals refuse to accept the reservation of rights or the investigator lacks access to sufficient resources to pay the price for public access. We hope that NIH will continue to engage the publishing community in discussions that seek a resolution of outstanding issues including cooperation in the reservation of rights to submit to PMC and fees associated with providing public access.

A copy of these comments in letter format will be forwarded by USPS.

Accordingly, APA strongly supports efforts to enhance public access to scientific publications that advance science and benefit the public, while safeguarding the copyright interests of publishers. Our overriding concern with the new mandatory NIH public access policy is that it uses public taxpayer funds to duplicate services that are currently provided by publishers. Moreover, when peer-reviewed manuscripts are made widely and freely available on line, the commercial value of the finished, published work is likely to be seriously diminished, with resulting declines in subscriptions and licensing agreements. This loss of income, which will be particularly acute for non-profit scientific society publishers like APA, is likely to lead to less science publishing, and thereby, less public access to research findings. A compelling alternative way to accomplish the goals of the NIH policy would be for publishers to provide NIH with immediate access to journal articles for internal portfolio management and archiving of publications arising from NIH-funded research and for NIH to provide public access to the final published articles through existing PubMed Central (PMC) links to journal Web sites.

In response to the NIH Request for Information, we would like to raise a number of specific concerns about the NIH procedures currently in effect to implement the new mandatory public access policy and suggest ways that they might be addressed:

a) Preserving Copyright Interests

It is essential to realize that publishers add immense value to the scientific enterprise through such functions as editorial selection, peer review, copyediting, and design production. Underlying the new public access policy is the faulty presumption that publishers will not experience significant financial hardship due to the 12-month lag between date of publication and posting of the peer-reviewed manuscript in PMC. While this may be true for a handful of publishers, it hardly applies to the industry as a whole, and certainly not to our association. This is due to the fact that the cutting-edge research that APA publishes is rarely obsolete within a year, and may have a shelf life of five to ten years. Moreover, only 15 percent of the eventual “lifetime” usage of our journal articles -- in the form of downloads -- occurs within the first year after publication. In clear violation of copyright principles, the NIH public access policy requires publishers for the first time ever to essentially forego their copyright interests without just compensation for their investments.

As a means to address this concern, the NIH policy does allow for the use of grant funds for the payment of publication fees for NIH-funded authors provided that certain stipulated conditions are met. This approach could work provided that NIH grant reviewers approve publication costs included in biomedical, behavioral, and social science research grants. Alternatively, NIH could set aside funds to enter into direct licensing arrangements with publishers to deposit copyrighted work on behalf of authors as some other non-governmental funding agencies have done, such as the Wellcome Trust and the Howard Hughes Medical Institute.

b) Maintaining Quality of Scientific Publishing

The public access policy by its very nature compromises the quality of scientific publishing by ultimately making available two versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version.

To distinguish between these two versions and increase accessibility to the published version, the following changes should be made to PMC to: 1) ensure that the NIHPA author manuscript bar or some other watermark appears on the printed version of manuscripts as it does on the on-line and PDF versions; 2) make the “Author Manuscript” label larger and more obvious on abstract and html pages; 3) make the link to the published version at least as large as to the manuscript version on the abstract landing page; 4) change the title of the link to the published version, e.g., from “APA Full Text” to “APA Published Version;” 5) ensure that the links to the journal citation on the publisher sites are functional; and 6) ensure that the html and publisher sites are fully branded. c) Narrowing Scope of Policy Coverage

The relevant statutory provision in the Consolidated Appropriations Act applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. But what if these other sources oppose the posting of their funded work on PMC? To address these concerns, NIH should stipulate that its requirement for the deposit of peer-reviewed manuscripts in PMC only applies when NIH funding represents the majority of funding for the scholarly work.

It is also of concern that NIH has expanded its claimed domain of manuscripts required for PMC deposit from reports of NIH grant-supported empirical research to include literature reviews. This is a significant expansion without a statutory basis. Literature reviews can arise from various contexts, which may or may not be directly related to a funded NIH grant. It is essential to clarify which review articles must be deposited. Accordingly, the language in the FAQ should be modified to explain that only those review articles that are anticipated by, and described in, an NIH-funded grant proposal are subject to the PMC deposit requirement. The guidelines should be further modified to stipulate that the policy does not apply to any grants issued before its effective date of April 7, 2008. The guidelines currently apply to NIH grants or cooperative agreements “active” in FY 2008 (which began on October 1, 2007). This sets in place an unfair, retroactive imposition of grant terms and conditions that could extend back for years prior to the official implementation date.

a) Undue Burden on Authors and Institutions

According to the relevant statutory provision, it is the responsibility of NIH, not the institutions or investigators as NIH contends, to “implement the public access policy in a manner consistent with copyright law.” Yet the policy states that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” This even includes the submission of manuscripts that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure that these other authors are “aware of and comply with” the NIH policy. This provision should be removed, because authors cannot reasonably be expected to comply with it.

b) Needed Procedural Changes

As a means to help protect the copyright interests of publishers, the following procedural issues need to be addressed. First, highly visible links need to be put in place in PMC to publishers’ copyright and disclaimer documents, not just to those developed by NIH. Second, any NIH revisions to the publisher-submitted, peer-reviewed manuscript need to be approved by the publisher, as well by as the author, prior to PMC posting, including links to databases and other resources. And third, when there is a publisher agreement in force, the author should not be able to designate an embargo date in PMC and thereby potentially alter an embargo date already agreed upon with the publisher; rather NIH should defer to the embargo policy of that particular publisher.

c) Needed Protections

Also, there needs to be a process in place to determine and monitor whether peer-reviewed manuscripts are and will be appropriately posted in PMC, and if improperly placed by authors, that manuscripts are promptly removed from PMC. In this regard, APA has identified close to 100 peer-reviewed manuscripts of articles published in our journals that have been improperly placed by authors in PMC in violation of copyright (prior to the implementation of the mandatory policy). Furthermore, protections need to be put in place to ensure that third parties cannot exploit PMC-posted content for commercial purposes and that publisher and society trademarks and branding are safeguarded.

"Does your institution wish to develop or amend a standard copyright transfer agreement for all institutional authors?"

"Does your institution wish to designate an individual or department to help investigators submit their own manuscripts?"

In addition to this one Web site and the explanatory page linked from the citation sites, it would be helpful to have some guidance on the actual pages that provide links to the peer-reviewed manuscripts and final published journal articles to help inform both the scientific community and the lay public about the difference between the two and how the latter can be obtained from the publishers.

Furthermore, NIH’s instructions to authors about the PMC manuscript deposit process should include language directing authors, when preparing their grant proposals, to check on the deposit fees and charges required by the journal(s) to which they intend to submit their work for publication. NIH also needs to change the wording of its FAQ about publication costs to clarify that publication fees, page charges, and NIH deposit fees are authorized for payment with NIH grant funds.

However, this reflects a woeful miscalculation of the potential impact of this policy on our economy and international trade. Journals published by U.S. scientific, technical, and medical (STM) publishers represent about $3 billion in annual revenue, and North America-based STM publishers account for 45% of all peer-reviewed research papers published annually worldwide. The mandatory NIH public access policy would provide free, world-wide access to U.S. scientific research to countries that are competing with American business and industry, undermining the intent of the America Competes Act.

Therefore, NIH would be well advised to carefully consider the input that it receives from publishers and other key stakeholders and amend the policy to effectively address their compelling concerns. Such a deliberative approach would be in keeping with the guidance provided by the U.S. Senate in report language that accompanied the omnibus appropriations bill. Specifically, the Senate requested that NIH “seek the advice of journal publishers on the implementation of the mandate to ensure that publishers’ copyright protections are maintained.” The scientific publishing community is dedicated to the widespread dissemination of scientific research and welcomes the opportunity to work closely with NIH to ensure that the goals of the public access policy are achieved and that the scientific publishing industry is preserved in the process.

ARL commends NIH for soliciting additional comments on the revised Policy while at the same time, implementing the congressionally approved change in policy. Because the NIH Policy is integrally tied to the mission of higher education, research libraries are collaborating with others across the academic enterprise to ensure effective compliance with the revised Policy. This entails assisting individual researchers, working with campus research offices, developing or extending existing policies to ensure effective compliance, creating informational websites and more. Copyright management and access have been the focus of ARL libraries for quite some time. This involves helping authors make informed decisions so that they exercise their rights and interests in the ownership and use of copyrighted works in a manner that promotes the greatest possible scholarship and public use of their work. As a result, implementation of the NIH Policy builds on existing policies and initiatives and is seen as one more opportunity to support the interests of the academy.

When applying for grant renewals, researchers cite the papers that resulted from the last iteration of that grant. Kind of a track record proving that the grant generated real advances in the field and thereby making a case for continuing to fund that grant. If researchers were compelled to cite only their public access papers they would fall all over themselves to do so.

It would be easy to ask NIH funded researchers to provide a brief synopsis of drug developments that immediately stem from their work. 2-3 sentences per paper per year would be sufficient and that blurb could be used to track publicly funded drugs and treatments.

A dark archive is no archive; it is a temporary measure which will eventually be scuttled. NIH needs to mandate an open archive, with open access.

D Van Kampen

>>>April 28, 2008

Dear Members of the NIH Research Community:

I am writing to remind you that the mandatory NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) applies to final peer-reviewed manuscripts accepted for publication on or after April 7, 2008. Making published research funded by NIH accessible to everyone, including health care providers, patients, educators and scientists, helps advance science and improve human health. We all have a role to play in achieving this goal, and I appreciate your efforts to make the NIH Public Access Policy successful.

The NIH Public Access Policy implements Division G, Title II, Section 218 of PL 110-161 (see http://publicaccess.nih.gov/policy.htm), which was signed into law late last year. Compliance with this Policy is a legal requirement and a term and condition for all active grants and contracts awarded as of April 7, 2008. Failure to comply may trigger one or more enforcement actions, depending on the severity and duration of the non-compliance.

Please see the Public Access Web site for the tools you need to comply with the Policy. The Web site houses Frequently Asked Questions (FAQs), training information, and other resources.

To ensure compliance with the Policy, please remember to:

Address Copyright - Make sure that any copyright transfer or other publication agreements allow your paper to be submitted to NIH in accordance with the Policy.

Submit Papers upon Acceptance for Publication

1. Some journals will submit the final published article on your behalf, without your involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals.

2. For any journal other than those on this list, please:

a. When submitting a paper for publication, inform the journal that the final peer-reviewed manuscript is subject to the NIH Public Access Policy.

b. Make sure that any copyright transfer or other publication agreement allows the final peer-reviewed manuscript to be submitted to NIH in accordance with the Policy. For more information, see the FAQ Whose approval do I need to submit my article to PubMed Central? and consult with your Institution.

c. Submit the final peer-reviewed manuscript to NIH upon acceptance for publication at http://www.nihms.nih.gov/. See the Submission Process for more information.

Cite Papers

§ When citing your NIH-funded papers in NIH applications, proposals or progress reports, please include the PubMed Central reference number (PMCID) for each paper.

§ NIH will monitor compliance through citations. Effective May 25, 2008, when your NIH Program Officer reviews your progress report or application, he or she will be expecting a PMCID in the citation of every applicable paper that arose out of your NIH funding, or a manuscript submission system reference number (NIHMSID) if the PMCID has not been issued. See Section C of our FAQ for examples.

§ If you publish through a journal listed under http://publicaccess.nih.gov/submit_process_journals.htm, there might be a slight delay in assignment of a PMCID. That is okay. We have signed agreements with these journals that allow NIH to resolve submission with them without your involvement. To facilitate your Program Officer’s job, we ask that you indicate ‘PMC Journal- In Process’ until the PMCID is available.

The NIH Public Access Policy is a legal requirement and represents an important opportunity for science and medicine. We are very interested in your feedback on the Policy and are soliciting input through a request for information from March 31, 2008 to May 31, 2008. Please send any comments or suggestions to http://publicaccess.nih.gov/comments.htm.

Sincerely,

Norka Ruiz Bravo, PhD NIH Deputy Director for Extramural Research

For the latest in NIH grants policies and initiatives, subscribe to the NIH Extramural Nexus

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Thieme is grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy). Our written comments follow.

1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”

2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central.

NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties.

For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.

In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.

1)Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2)For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3)Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central 4)Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5)Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central 6)Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law

The information and communications requested are as follows:

1) Regarding Consultation with Publishers, Societies and Authors

•Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? •What is NIH’s timeline for amending this policy moving forward? •What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright •Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy •What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? •Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? •How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. •How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? •How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? •If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation •What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? •The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope •If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? •Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? •The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? •What will the repercussions be for investigators and journals that do not follow the process? •NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access •How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? •Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? •For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? •How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? •How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost •NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? •Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness •Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? •What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? •What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While Thieme appreciates NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, Thieme is troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and Thieme welcomes the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.

I'm glad to see the NIH making the publications that they sponsor available freely to the public.

UIC is also are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

These comments are submitted on behalf of UIC Vice Chancellor for Academic Affairs and Provost Michael Tanner, Interim Vice Chancellor for Research Larry Danziger, and Mary Case, University Librarian.

ACRL reiterates its support for the policy as it stands. Public access to publicly funded biomedical research will advance research and education at the nation's colleges and universities, helping undergraduates, graduate students, faculty, and researchers remain competitive with their peers elsewhere in the world. Research in the biomedical sciences advances rapidly, and 12 months, as stipulated in the current policy, is the longest period for which this research should be embargoed if the benefits of public access for education and research are to be realized and our colleges and universities remain globally competitive.

Evidence continues to build that the cost of validating, packaging, and disseminating research results can be met through a variety of business models that are consistent with public access. Public access to selected articles is not the primary determinant for most libraries in making subscription decisions -- relevance, quality, and affordable pricing are the key factors. Indeed, a shorter embargo period (6 months) would bring US policy into greater alignment with policies already in place in Canada, the UK, and the European Union, and would better reflect the rapid pace of research in the biomedical fields. We encourage the NIH to consider shortening the embargo period as the U.S. and other countries gain experience with public-access science.

Moreover, we understand that the current policy operates within and in accordance with U.S. copyright law and international copyright conventions, and is consistent with the authors' rights in their original manuscripts. Implementation of this policy on member campuses is providing an important opportunity for those communities to discuss intellectual property law and compliance. ACRL has supported member education in this area by, for example, co-hosting (with ARL and SPARC) a special one-hour Webcast for librarians called “Understanding Author Rights.”

Academic and research libraries across the country have already invested significant time in helping their campuses prepare for and implement the new policy, through outreach, copyright education, technical support, and other means. ACRL, guided in part by its Scholarly Communication Committee, will continue to assist its members with implementation of the policy by, for example, documenting and sharing best practices, promulgating model publication agreements, and providing education about the rapidly changing scholarly publishing environment in which this policy fits. The ARL-ACRL Institute on Scholarly Communication and a new shorter workshop on scholarly communication, currently in development, both cover the NIH policy.

Alternative arrangements, such as links to publishers' web sites, would not serve the public well or achieve the NIH goal of assuring a permanent, stable public archive of the research it has funded. Over the long term, as publishers and journals change ownership, links would inevitably break and more work would be required of NIH staff to maintain the links than would be needed to maintain a central repository. Advanced researchers will still rely on the published record for citation and other purposes. NIH has wisely rejected the model of a dark archive in the past, and should continue to do so.

First, establishing routine communication with campus offices of research. These are the campus entities best positioned to ensure consistent, timely communication with investigators who might be planning an NIH grant application. Increasingly, campus offices of research are collaborating with their university libraries to help investigators understand the policy and comply with it, and NIH might consider encouraging such collaboration where appropriate.

Second, collaborating with the institutional repository community -- and with individual campuses that maintain open repositories of the scholarship of their faculty and students -- to identify ways to coordinate manuscript deposit between PubMed Central and institutional repositories, possibly in batch uploads or downloads.

An advantage I can see to this proposal is that the reader would truly have access to the absolute final, published version of the paper, as opposed to, in some cases, just the penultimate version of the paper. But I think studies currently underway will show that this is not a huge problem, and thus do not override the guaranteed availability of the research findings.

I appreciate the verbiage that NIH has provided. But they could also point folks to the Sherpa/Romeo site <http://www.sherpa.ac.uk/romeo.php>, where authors can see if their publisher, de facto, is "NIH compliant".

Additionally, we are offering to do third-party submissions for our authors. And we are using the NIH Public Access mandate conversation as an opening for suggesting that our researchers also put their manuscripts in our institutional repository, IDEALS.

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

http://www2.kumc.edu/comptraining/events.html

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

It would be helpful if NIH would work with academic institutions on coordinated manuscript deposit between PubMed Central and institutional repositories.

A possible avenue for compliance may exist by having authors submit to their academic institution's repository, then export those records and items to NIH. A researcher's local institution may be able to provide assistance with compliance, although this does raise some technical concerns about importing items from various repository platforms.

It makes little sense to require accepted manuscripts to be posted if it does not come through the journal. You are going to end up with someone submitting a manuscript as submitted that isn't and then this will get used as an example of how scientists can not be trusted.

• Announced and explained the policy to our NIH Principle Investigators and research administrators campus-wide; • Prepared two web pages for authors: an overview, and a step-by-step guide for compliance; • Created a submission letter and revised MIT amendment to publisher agreements for authors’ use; • Presented to research administrators about the policy and compliance with it; • Modified our internal grant application process to flag the new policy; • Worked with the NIH on search strategies to properly identify MIT-authored works via PubMed and PubMed Central; • Consulted with colleagues and NIH on possible third-party submission support that might be offered to MIT authors; • Investigated key publisher policies for NIH-funded research and documented them for MIT authors; • Communicated about the policy with many publishers, and received responses from some of them. We have been working with individual authors on preparing appropriate publisher agreement amendments so that they can comply with the new policy without coming into conflict with any publisher copyright policy. This activity forms part of our overall author support program that assists MIT authors in considering how to manage the rights to their work.

If reducing the embargo period quickly or suddenly is politically impossible, then the NIH could reduce it gradually. For example, it could announce that a year from now it will reduce the maximum embargo to six months, giving stakeholders time to prepare. Or it could first reduce it to nine months, then six, and then three, over a period of years with ample notice to all.

The NIH mission is to advance medical research and healthcare, not to protect the revenue of publishers. The current embargo period is much too long and inverts these priorities.

(B) PubMed Central should develop the means to harvest copies of the full-text papers it needs from institutional repositories at universities, if it doesn't already have this capability. Then NIH should allow grantees (optionally) to deposit in their local repository and send PMC the URL. This change should not affect the timing of deposits within PMC, the completeness of the PMC collection, or the ability of the NIH to monitor compliance. But it might make compliance easier for authors, by enlisting local help with the initial deposits. It would also build up institutional repositories nationwide, giving them a critical mass and helping them to change expectations in every discipline.

Conversely, PMC should also allow institutional repositories to harvest copies of full-text papers in PMC. When grantees choose to deposit directly into PMC rather than their institutional repository, this would allow the author's institution to maintain a complete, open-access portfolio of its own research output.

(C) NIH already maintains a list of journals willing to submit articles directly to PMC on behalf of authors, http://publicaccess.nih.gov/submit_process_journals.htm

It should also maintain a list of journals whose standard copyright transfer agreements are already consistent with the NIH policy, requiring no negotiation or "author addendum" by authors. This list will overlap with the first, but would very likely be larger.

(D) Some subscription-based journals plan to charge NIH-funded authors a fee for the right to comply with the NIH policy. Some "hybrid" journals may force NIH-authors to "choose" the free-access option and pay the accompanying fee. NIH-funded authors needn't publish in those journals, of course, but some may sincerely believe that every other publisher would also charge such a fee and some may feel other pressures to acquiesce. The NIH cannot directly stop journals from charging such fees, but it should look for creative, indirect ways to deter the practice. For example, NIH could list journals engaged in the practice and inform its grantees that this is not the norm and not required by the NIH policy. In addition, it could decide that it would *not* allow grantees to use grant funds to pay publication fees or color charges at journals engaged in the practice. (To use jargon common in the open access movement, the NIH would still allow grantees to use grant funds to pay for gold OA at full OA journals; but it would not allow the use of grant funds to pay for green OA or to pay for gold OA at hybrid journals which force NIH-funded authors to select the fee-based free-access option.)

Congress asked for a mandatory policy in 2004, but the NIH adopted a voluntary policy instead. The compliance rate for the voluntary policy ranged from 4% to 15%, and failed to meet the objectives of Congress and the agency. It's no exaggeration to say that we've waited more than three years for the strengthened policy to take effect and exert its beneficial effects on medical research and healthcare. Further delay would further delay those benefits.

Since the strengthened policy was announced in January, and took effect in April, researchers and their institutions throughout the United States have geared up to comply with it. Here's a list of some of the institutions with web pages devoted to their efforts to educate their faculty about the policy and assist them in compliance. http://www.earlham.edu/~peters/fos/newsletter/04-02-08.htm#nih

The policy has been thoroughly vetted. The NIH released its first draft policy for a 60 day period of public comments, ending on November 2, 2004, and later extended the period by two weeks. The agency received more than 6,000 comments, which Director Elias Zerhouni described as "overwhelmingly supportive." The NIH solicited a second set of public comments as recently as March 2008 (the comment period ended March 17, 2008). The current round of public comments is the third. Publishers have been heard. As SPARC documented in its public comment (May 30, 2008), "the Office of the NIH Director has met with publishers to discuss the policy 29 times between 2003 and March 2008, versus 20 meetings with all other stakeholders."

I submitted a shorter version of this comment in the second round of public comments, on March 14, 2008. http://publicaccess.nih.gov/comments/comments_via_email.htm

Publishers are mistaken to say that the policy violates copyright. Indeed, the policy uses a simple, effective method to avoid any question of copyright infringement. When NIH grantees publish articles based on NIH-funded research, they must now retain the right to comply with the public access policy, even if they transfer all their other rights to publishers. As a result, public access by the NIH is expressly authorized by the copyright holders.

The public access policy is badly needed to insure that the large volume of high-quality medical research produced by the NIH is made available to everyone who can make use of it: researchers whose universities cannot afford access to the full range of biomedical journals, practicing physicians without university or large-hospital affiliations, non-profit disease advocacy organizations, and patients and their families.

It's not true that all who need access already have it. The best evidence that free online access to peer-reviewed research meets a large unmet need is that open-access articles are cited 50-250% more often than non-open-access articles published in the same issues of the same journals. For the empirical evidence underlying this claim, see the empirical studies collected in the Hitchcock bibliography, http://opcit.eprints.org/oacitation-biblio.html

It's not true that the rise of free online access to peer-reviewed literature will jeopardize peer review itself. Publishers who make that argument cite no evidence and ignore abundant counter-evidence. For a detailed analysis of the question, see my article from September 2007, http://www.earlham.edu/~peters/fos/newsletter/09-02-07.htm#peerreview

Some publishers have proposed an alternative under which PMC would be a "dark archive" and merely link to the articles at publisher web sites. This proposal is very far from adequate. It does not satisfy the terms laid down Congress and the President, which require that PMC make articles "publicly available". It makes public access depend on publishers, when publishers might change their access policies or go out of business. Publisher delays and omissions would be inevitable; and even when inadvertent, either NIH would spend time and money on monitoring and enforcement, or some valuable NIH-funded research would not be publicly available. Long-term preservation would suffer because libraries and other third-party curators would have to seek permission from many different publishers to make copies for storage and to migrate those copies to new formats to keep them readable as technology changed. Finally, users would fail to get the benefit of the enhancements PMC makes to submitted articles, including XML markup, OAI-interperability, and links to relevant content in the many public NIH databases. Users would be stuck with the publishers' PDFs, which are not readable in bandwidth-poor parts of the world, which frequently lack working links, and which impede text processing by users, text mining and automated translation by software, handicapped access, and mark-up by third parties.

I thank the NIH for its repeatedly demonstrated willingness to take comments from stakeholders.

It is also ambiguous. You seem to equate "peer reviewed publication" with "journal article". This is wrong, since in some fields funded by NIH peer-reviewed conferences have equal or higher prestige and impact. If you mean "journal", say "journal". IF you mean something else, you need to say that.

There is often no feasible way for an investigator to force compliance with a journal that does not routinely (and almost exclusively) publish NIH-funded research. First off, the relevant person to contact is not routinely and easily available. Second, the delay involved may cause publication deadlines to be missed. The situation with conferences is even worse.

The net effect is likely to be to DETER publication, thus delaying or even preventing dissemination of NIH-funded research results.

It would help immensely if NIH can pro-actively enter into agreements with the major engineering and medical societies. Within engineering, key would include IEEE (publishes many biomed engineering, medical imaging, and other pertinent journals), ASME, MICCAI, CARS/CAS. There are any number of medical societies as well.

You should delay enforcement of this rule until these agreements are in place.

Some description of what efforts NIH staff are taking to ease implementation of this policy. E.g., see answer to question #2. You might say whom you are approaching and give a contact email address for investigators to query status or suggest additional journals or societies to contact.

On May 15, 2008, the Johns Hopkins University Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. Having retained rights to permit submission to PubMed, JHU faculty members must then submit their articles in a timely fashion. To retain rights, the Council of Deans recommended two alternate addenda and a notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf, allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum.

The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1.

We appreciate the opportunity to express our support for the NIH Public Access Policy and its implementation as currently stated, and supplement our expressions of support as submitted March 17. The continued engagement of NIH with its stakeholders is both wise and productive.

On May 15, 2008, the Johns Hopkins Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. To do so, there are two alternate addenda and a recommended notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf , allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum. The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1. At Johns Hopkins University, the University Libraries Council strongly supports the NIH Public Access Policy. The new NIH reporting requirement will benefit Hopkins authors as well as the public. The requirement provides an important opportunity to make published research funded by NIH and written by Hopkins authors accessible to all - the public, health care providers, educators and scientists, among others. This improved access will help advance science and, ultimately, improve human health.

Deposit in PubMed Central ensures that research results will be preserved in a state-of- the-art digital repository. Free access within a 12-month period will maximize the visibility of Hopkins’ research and ensure that researchers and students around the world will be able to read and build on Hopkins’ work, regardless of their ability to subscribe to the journal in which the research is published. Preliminary research suggests that articles freely available are cited more often and have a greater impact than articles locked away behind subscription walls. NIH public access will foster development of new research tools, open doors to new research avenues, and advance scientific discovery. At Johns Hopkins University, we have taken the following steps in response to the NIH Public Access Policy:

1. The Dean of University Libraries, Winston Tabb, the Director of the Welch Medical Library, Nancy Roderer, and the Vice Provost for Research met to explore how the University and its Libraries can assist its authors in meeting the NIH mandate and support open access to the scholarly output of the University. 2. From that meeting came a recommendation from the Provost to the Deans that the University adopt an authors’ addendum to publication agreements, enabling Hopkins faculty to make their research results freely available through PubMed Central. 3. Created a scholarly communications website (openaccess.jhu.edu) with an FAQ on the NIH policy, including the Johns Hopkins’ authors’ addendum. The FAQ also directs authors to the SCAE, a tool to customize addenda and designed to enable authors to reserve their rights in support of peer exchange, teaching, and public access. The FAQ includes contact information for two members of the Scholarly Communications Group of the University Libraries Council, who will respond to questions from our authors. 4. Advised our Vice Deans for Research in the Schools of Medicine, Public Health and Nursing of the FAQ; remain in close contact with the Office of the General Counsel, sharing the Carroll White Paper and other relevant analysis of implications of the Policy for the University and its authors. 5. Broadcast emails from the Deans and the Provost alerting faculty to their responsibilities under the new mandate have been sent. The emails direct authors to an FAQ on the NIH Policy developed by the University’s Scholarly Communications Group. The School of Public Health and the School of Medicine have linked to the resource from their research administration sites. 6. Initiated discussions on how we might develop an interface between our repository and PubMed Central in collaboration with other institutions and software developers. At our request, the Association of Research Libraries has agreed to play a leadership role in bringing interested parties into the discussion, including the National Library of Medicine. 7. Joined fellow members of the American Association of Health Science Libraries in strong support of the NIH Public Access Policy. 8. Have conducted educational sessions on the policy and how to comply with faculty and staff across the University, and are working with our authors to ensure copyright compliance through the use of addenda to publication agreements, directing them to the NIH Public Access Policy FAQ as needed. 9. JScholarship, the Johns Hopkins institutional repository, is taking an active role in promoting open access publishing activities. The Graduate Board for the University has mandated submission of all theses and dissertations into JScholarship beginning in 2009. JScholarship personnel are currently putting in place a submission workflow to enable students to self-submit their theses into the repository. In addition, we are developing a process by which an author may make his or her work available under a Creative Commons license. We plan to promote the use of these licenses to enable the widest possible use our research materials. Finally, we have devoted a section of our JScholarship "help" pages to copyright issues. This page http://library.jhu.edu/collections/institutionalrepository/irhelppage.html offers advice to authors about copyright issues in the repository, and contains information about the SHERPA/RoMEO database. 10. In sum, the policy has created a valuable opportunity to collaborate across campus, involving faculty, libraries and academic administrators to ensure the broadest level of compliance and exposure of our research results. 11. Finally, the University Libraries Council values the services provided by publishers, and does not believe that we can cancel journals and still provide our faculty, students and researchers the current information necessary for their work.

NIH should also provide assistance to investigators by working with publishers to create a database of journal embargo dates. How can an investigator publishing in multiple journals remember the policies of all of them. Just as one can search by journal in PubMed, the manuscript submission site for PMC should include a journal search capacity that would allow for the release period to be populated by default from the NIH created database.

The release date of 12 months should be defined as 12 months after final publication, not 12 months after the journal's posting of the accepted manuscript on a journal website two to three months in advance of final publication.

It is also strongly recommended that NIH only accept researh related mansucripts and/or papers into PMC, not the review articles, editorials, and commentaries commissioned by editors to scientific journals. In advance of the voluntary plan, NIH and Dr. Zerhouni encouraged editors to enhance the value of their subscription based journals by inviting reviews, editorials and commentaries. To now require that such peer-reviewed material be depositied in PMC is inappropriate and not reflective of the earlier policy.

2. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months. NIH should consider the costs that could be saved by simply linking to the publisher's sites and not duplicating existing services already provided by publishers.

ASN supports the principle of public access to science and voluntarily has taken the following significant steps to accomplish this: • The abstracts of ASN journals are indexed in MedLine, which is accessible over the Internet from NIH’s PubMed website. • In 2000, ASN began offering free public access to articles 12 months after publication. • By 2006, the ASN put its entire journal collection, including over 110 years of archival content, online through Stanford University’s High Wire Press. Approximately 98% of online journal content is freely accessible to both subscribers and non-subscribers. • Since 1997, the Society has included free access to the online journal collection as a membership benefit.

ASN is part of a group of more than 59 scholarly publishers who jointly developed the D.C. Principles for Free Access to Science. The DC Principles include a commitment to these forms of free access: • Selected articles of public interest are free from the time of publication • The full text of articles is made freely available either immediately or within months of publication, depending upon what is economically feasible for the journal • Journals are freely available to scientists in many low-income nations • Relevant articles are freely available to individuals in case of compassionate need, i.e. to those seeking information about their own health or that of a family member • Public access to content is facilitated through indexing agreements with Internet search engines

ASN, like many non-profit scholarly publishers, reinvests the revenues from our journals in direct support of science through scientific meetings, research grants, educational outreach, advocacy, dissemination of information to the public, and improvements in scientific publishing. We believe our efforts constitute a sustainable approach to public access.

Notwithstanding our commitment to public access, ASN has serious concerns about the Public Access Policy currently being implemented by NIH. Our concerns are outlined below.

Administrative Burden The new policy places a significant administrative burden on authors, institutions and publishers. The low compliance with the voluntary policy (five percent of NIH funded articles in 2006 were deposited by the author) suggests this is the case. The fact that someone, be it the publisher or the scientist, must deposit the manuscript represents time and money. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months.

Review Articles The inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications.

Copyright The inclusion of blanket requirements in grant contracts has the potential to deny authors and publishers the benefits of their copyrights, among those being the freedom to decide how and in what form their works may be distributed. Moreover, the policy as proposed by NIH may conflict with fundamental copyright principles and does not take into account the value added by publishers and editors. The NIH policy as currently proposed is not, in our opinion, consistent with the legislative mandate to implement said policy in a manner that is consistent with copyright.

Impact on not-for-profit publishers and scientific societies The NIH has not given appropriate consideration to the potential economic impacts of its proposal on publishers and the fundamental roles and services scientific societies provide to their membership and the scientific community at-large. These impacts may be especially severe for scholarly societies and not-for-profit publishers. NIH has stated in past notices that economic and business implications of any policy changes should be taken into account, and the danger that mandated access will interfere with the ability of journals to recover costs still exists. As ASN has implemented policies to improve public access to the research it publishes, the economic impact of these new policies was carefully considered. Certain considerations influence how soon free public access is economically feasible for a particular journal. These include revenue sources, production costs, utilization patterns, time needed for cost recovery, and frequency of publication. For example, it costs on average $3,500 to publish an article in AJCN or JN. NIH should have the same consideration for these factors. Ironically, it is possible that the NIH plan may have the greatest deleterious impact on not-for-profit publishers who already provide some form of free access.

Societies such as ASN derive the bulk of their revenue from journal operations. The membership of these societies – the very scientists who are also NIH-funded investigators – derive important benefits from membership in these societies. Such benefits include access to scientific meetings, organization and review of abstracts, provision of continuing medical education programs, mentorship programs for young scientists, and many more. It is clear that hobbling these societies is a major unintended consequence of the current proposal, and one that is not in the interests of researchers, NIH, or the American public.

Impact on researchers This proposal initially was intended to benefit researchers by broadening access to the scientific literature, but since the NIH policy would affect approximately 10 percent of that literature, it is not clear how helpful it would be. At the same time, journals that publish large amounts on NIH-funded research would suffer the greatest negative repercussions. If the NIH plan indeed undermines journal operations, ASN may have to scale back its publications programs or curtail the activities it supports to advance nutritional science. This could mean fewer opportunities for scientists to share research findings in a timely manner, expand collaborate projects, and train junior scientists. Should journals like ours seek to recover lost production costs by increasing fees charged to authors, research funding also would be affected. Regardless of where the money to pay fees originates—taken from existing grant funds or charged to the research institution or funding agency—the net result is less money for research.

Conclusion We respectfully request that NIH address the concerns as outlined above, and we urge you to fully involve publishers in the implementation of this policy. We look forward to continued dialogue on this important issue. If you have any questions, please contact John Courtney, ASN’s Executive Officer, at (301) 634-7050 or jcourtney@nutrition.org.

NIH previously encouraged publishers to add review articles to journals as a way to sustain our subscription base under the voluntary policy. The revised mandatory public access policy now calls for the submission of review articles to PMC. Journal editors commission review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants.

We request that NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews. NIH might consider review articles as ?low-hanging fruit? in regard to possible changes in the public access policy. It is a simple change that the scientific publishing community would appreciate.

Compensation for value added

The research published in our journals is rarely obsolete within a year; it generally has a shelf life well beyond the 12-month public access window. When copyrighted articles are freely available online, their commercial value is significantly eroded. While NIH may pay for the actual research, it is the journal publisher who bears the expense of creating the publication?from peer review to copyediting, layout, production, distribution, and archiving both digitally and in print.

When publishers are no longer able to recoup these costs through subscription revenues (i.e., from the readers), they will have to recoup them at the front end from the authors. We note that the NIH policy allows reimbursement of publication costs if they are ?actual, allowable, and reasonable to advance the objectives of the award.? We ask that NIH be more explicit about what is considered ?allowable? and ?reasonable? and make it very clear to grantees that funds may be used to cover open access fees. In addition, we would like to know how such funds will be identified in a grant and how much NIH has budgeted per year for publication costs.

AAA?s scientific research journals?The Anatomical Record and Developmental Dynamics?are now fully compliant with the NIH?s current public access policy, as mandated by Congress. Upon publication of each issue, our publisher will deposit the final peer-reviewed version of all NIH-funded articles to PubMed Central (PMC) and authorize public availability 12 months after publication. Although we object to the mandate, we are abiding by it.

However, this compliance apparently does not make us compliant enough for NIH. Only journals that make the final published version of NIH-funded articles available to PMC within 12 months will appear on the NIH list of compliant journals, the list that researchers are encouraged to check prior to submitting a manuscript for publication.

Why doesn?t actual compliance with the law entitle a journal to appear on this list? Why is NIH misleading our prospective authors by not acknowledging that we are, indeed, compliant? Isn?t it NIH that is out of compliance for seeking to go beyond the law and penalizing those who are actually fulfilling the terms of the congressional mandate?

While we are not experts on congressional intent, we find it difficult to believe that ?in a manner consistent with copyright law? was meant to be the congressional equivalent of ?make copyright someone else?s problem.? Nonetheless, that is precisely what NIH has done. Researchers are told by NIH that the first step in complying with the public access policy is to ?Address Copyright. Before you sign a publication agreement or similar copyright transfer agreement, make sure that the agreement allows the paper to be submitted to NIH in accordance with the Public Access Policy.?

With that brief instruction, NIH appears to think that the congressional intent has been followed. Copyright protection is intended to give the copyright holder the right to determine who can adapt the work to other forms. In reality, NIH has simply redefined the term ?copyright? to suit its PMC model, forcing authors to comply because of their dependence on NIH grant support.

The copyright issues raised by implementation of this policy have been addressed in lengthy documents submitted to NIH by both commercial and non-profit publishers. We list just some of these issues here: a. PMC is reformatting and altering submitted author manuscripts. Why is this preferable to linking to the originally published document? b. NIH is exceeding its legal mandate by distributing copies of the PMC version to Web sites hosted outside the U.S., depositing manuscripts on an international mirror site with plans for additional such sites. How do these sites serve the needs of U.S. taxpayers? c. How will international copyright considerations be addressed to protect rights holders?

These issues raise important questions and concerns regarding copyright protections that would prevail both within and outside U.S. borders. By appropriating and redefining copyright in this manner, NIH has clearly gone beyond congressional intent in regard to making manuscripts publicly available and has disregarded congressional intent related to consistency with copyright law.

FASEB and member societies collectively publish approximately 50 journals using a range of publishing models. They will be affected differently by the policy, and some of them will raise additional issues. All believe that the NIH public access policy does not represent the best method of achieving NIH’s goals of public access, portfolio management, and archiving of manuscripts reporting on NIH-funded research. In addition; we believe the policy will duplicate private publishers’ services using public funds, undermine the integrity of the scientific literature, and impose an unnecessary burden on investigators and institutions.

The NIH approach is inferior to innovations that publishers currently offer and continue to invest in improving. Most of our member society journals make their entire content available freely after 12 months or sooner, offer content at low subscription and pay-per-article fees, and provide enhanced functionality including integrated links to research databases. FASEB is proud that its member societies are in the forefront of electronic publishing and archiving. We believe that NIH should work collaboratively with publishers to encourage and promote these efforts, not attempt to duplicate or compete with them.

The RFI asks for recommendations for alternative implementation approaches. We continue to believe that a partnership between NIH and journal publishers would better achieve NIH’s goals while also addressing our community’s concerns about the policy as outlined above. Instead of NIH undertaking a whole new publishing venture that involves formatting and publishing unfinished manuscripts of authors, NIH should use existing links from NIH’s highly respected PubMed to journals’ websites for reader access to final, published articles. To address NIH’s desire to create an archive of manuscripts reporting NIH-funded research, journals would provide to NIH immediate access to journal content for internal use. This mechanism has several advantages to the current implementation plan. It would relieve the administrative burden on NIH-funded scientists because they would not have to take any additional steps to comply. They would simply continue submitting manuscripts to journals, as they always have. The integrity of the scientific literature would be ensured because only the final, published version of the article would be publicly available and archived by NIH. Articles would be available at significantly lower cost since publishers are already publishing, editing, and posting articles at no additional charge to the public. The database of articles would be more comprehensive and accurate for NIH portfolio analysis and strategic planning. This proposal was put forward by 56 organizations and publishers on October 15, 2005, and we urge NIH to reconsider it. This proposal would fulfill the public access policy as enacted by the Consolidated Appropriations Act of 2008 and would also specifically address copyright law concerns expressed by Congress.

It is FASEB’s recommendation that NIH efforts should focus on ways to work with publishers to achieve common goals, and we stand ready to work with NIH on this effort.

The revised mandatory public access policy now calls for submission of review articles. NIH previously encouraged publishers to add review articles to journals as a way to sustain the subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only.

The policy imposes an unnecessary administrative burden on researchers and their institutions. We question if this is the best use of investigators’ time and public funds. Given the magnitude of the policy, we remain concerned about the lack of rigorous analysis and public discussion of the cost involved. We request that NIH examine and publish the cost of this policy. We are concerned that the NIH publication policy will draw resources from other areas of critical research investment, particularly in this time of constrained budgets.

We are aware that there are calls for NIH to reduce the time of manuscript release to six months or less. This would seriously compromise the ability of most of the FASEB member society journals to provide quality peer review, editing, and publishing of NIH funded research results. We urge NIH to maintain the 12-month upper limit.

The reliance on authors to deposit articles is problematic. Publishers want to perform this action on behalf of their authors, but the NIH implementation requirements make this unnecessarily difficult. NIH should form a working group that includes publishers and the NIH representatives to work out the details of implementation.

AIP as publisher retains copyright but grants authors rights to deposit their manuscripts into Pub Med Central (PMC). That permission does not grant NIH the right to provide the manuscripts to other entities, domestic or international, unless agreed to by the publisher. The public law that had created the mandate said nothing about NIH sharing the deposited works with other entities. AIP will consider such actions to be a violation of its copyright and take action to protect its interest. In addition, we ask that NIH ensure all possible measures are taken to eliminate article piracy. Should a piracy occur, publishers are to be notified and provided with any information NIH may have about the infringer.

Furthermore, it should be stated for the record that Congress recently addressed the research-access issue in Title VII of the America COMPETES Act by establishing an access policy to research funded by the National Science Foundation (NSF). In the National Science Foundation Authorization Act, which was signed into law by the President in August 2007 as Title VII of the America COMPETES Act (P.L.110-69), Congress addressed the issue of ensuring public access to the results of government-funded research. The Act directed NSF to make all “final project reports and citations of published research documents” resulting from NSF funded research available to the public in a timely manner and in electronic form through the NSF’s Web site. The Conference agreement (House Report 110-289) further clarified that NSF is required “to provide the public a readily accessible summary of the outcomes of NSF-sponsored projects,” along with “citations to journal publications,” in which funded researchers have published articles regarding such research.

Since the NSF research-access policy was developed by Congress and is now public law, and since NSF funds research for all disciplines (and 20% of all basic research), other Federal research-funding agencies should follow this model in making their research widely available to the public. The NSF research-access model helps meet the important objective of widespread dissemination of research findings without undermining the important intellectual property and copyright protections that help sustain the scientific publishing community.

Who pays for the value-added after an author submits his/her manuscript to a publisher or institutional online platform is an important question that needs to be addressed. Should institutional platforms—such as PMC—be using government funds to reproduce what is already effectively supplied by the private sector? Publishers (both for-profit and nonprofit) invest considerable resources in the editorial and production processes that underlie high-quality journals. The result is high-quality articles that have been peer reviewed, copyedited, and properly referenced to the world’s scientific literature. The articles are then made available in online versions on highly reliable, digital platforms that constantly evolve to meet the changing needs of their readers. They are also published and distributed in print versions—the only form accepted by some archivists and librarians as archival. Publishers who provide this value-added to the submitted manuscripts are compensated for this service under several business models. The models typically involve the reader paying (through institutional or individual subscriptions) or the author paying (through open-access fees or page charges) or a combination of the two. If the NIH public-access policy is implemented without real engagement of the publishing community, the viability of the journal publishing enterprise—a significant asset to the scientific community and valuable means of distribution to the international scientific community—could be adversely affected.

Scientific journals help assure the integrity of science by organizing and managing peer review of scientific manuscripts to guarantee their accuracy as well as publishing, archiving and disseminating the articles. Publishers invest hundreds of millions of dollars each year in the peer-review process that ensures all research articles are rigorously reviewed by experts in specialized fields before they are published. Federal agency research-access policies that would undermine our nation’s scientific enterprise must be avoided.

Nevertheless, we have grave reservations about the announced NIH implementation of the Public Access Policy, because we fear that this implementation runs the risk of unnecessarily damaging the economic viability of scientific-society publishers and the integrity of the scientific literature, while at the same time costing the taxpayers significantly more than is needed to achieve the central goals of the congressional public access mandate.

The announced implementation effectively establishes NIH as a duplicate publisher for an unknown fraction of the literature (all papers not directly submitted by publishers) and provides no compensation to publishers for their significant investment in peer-review, scientific editing, composition, copyediting, and electronic hosting and archiving (for example, APS maintains three geographically distributed, continuously updated mirrors of all its content). Furthermore, we are concerned that the final XML files produced by PMC will not be as accurate as those produced by scientific-society publishers, with close scientific oversight (e.g., APS employs approximately 50 full-time Ph.D. editors).

We believe that NIH should immediately begin serious and substantive consultations with publishers to explore a variety of cost-effective alternatives that show more appreciation for the service to the scientific community provided by nonprofit society publishers, and that avoid producing variant archival copies of the same paper. The latter seems a near-certain result of PMC’s plans to perform independent and duplicative composition and copyediting, at taxpayer expense. For example, it would be completely consistent with the public-access legislation for PMC to simply operate a well-indexed repository of publisher-prepared PDFs of all NIH supported articles, including links to publishers’ websites. Nothing in the legislation requires PMC to host full XML files of articles, let alone to spend public funds on the production of its own XML versions.

APS is particularly concerned by the plans of NIH to provide its archive to other entities, including repositories outside of the United States. We see nothing in the legislation that supports the right of NIH to do this, and we believe that it is in clear violation of our copyright agreement and those of other publishers. We urge NIH to abandon these plans voluntarily and immediately.

We are profoundly committed to the dissemination of scientific knowledge. This is central to the APS mission “to advance and diffuse the knowledge of physics.” However, we are equally committed to guaranteeing the accuracy of the public record of the collective scientific literature. We believe that these two objectives are best achieved by nonprofit scientific societies that combine the highest standards of the academy, long-term stability, and the ingenuity and expertise of private enterprise.

A policy without consequences for noncompliance (reward for compliance) is useless.

The issue here is comprehensiveness: If even a small portion of the full-text data is missing, users must fear missing something during literature searches, and are therefore pushed to use fee-based options rather than free ones.

NIH Public Access Staff National Institutes of Health Transmitted via http://publicaccess.nih.gove/comments2/comments.htm

Re: Request for Information: NIH Public Access Policy: NOT-OD-08-060 (March 28, 2008) ARVO, the Association for Research in Vision and Ophthalmology, is grateful for the opportunity to respond to the above mentioned NIH Public Access Policy. As stated in previous correspondence, ARVO has over 12,000 members worldwide and publishes two of the top five peer-reviewed journals in ophthalmology, as demonstrated by the Institute of Scientific Information’s Impact and Immediacy Factors. Investigative Ophthalmology & Visual Science (IOVS) receives over 1,600 submissions and publishes over 750 peer-reviewed articles annually; all articles are freely available online to everyone within twelve months after publication. The Journal of Vision includes 300 articles online only, all of which are freely accessible as they are published. Our concerns continue to be as follows.

Intramural Researchers: Policy Interpretation • ARVO recognizes that US-government funded research is in the public domain but does not recognize NIH’s redistribution or claim of ownership of public domain content. • ARVO does not support NIH’s stated practice of depositing US taxpayer-funded articles and/or selected content in non-US sponsored or controlled databases. • ARVO supports the practice of deep archives of scientific articles and is willing to work with NIH to establish a perpetual, deep archive. • The Policy is confusing for authors and PIs; it states that the PI is responsible for submission of accepted articles whether or not they are authors of the articles. In addition, publishers do not have information regarding who is the PI for every grant. • NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press. • ARVO explicitly states in its Copyright Form for government employees that NIH-funded authors may submit final, accepted electronic files to PubMed Central. Additional forms are redundant and potentially confusing to authors, institutions, and publishers.

Overall Policy Concerns • NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press. • Many associations, including ARVO, have free online access to all back issue content published since the inception of the journal (volume 1, issue 1).

Suite 250 • 12300 Twinbrook Parkway • Rockville, MD 20852–1606 • TEL (240) 221-2900 • FAX (240) 221-0370 • www.arvo.org • This policy severely inhibits publishers’ oversight and control of the use and potential misuse of its intellectual property. • The fundamental financial models of subscriptions and advertising supporting the peer-review process as well as the ongoing educational opportunities and member support provided by Associations’ publications are threatened. The Policy is forcing model changes but does not support publisher charges if an article is accepted and published after the grant has expired, regardless of funding included in the grant. • The Policy and NIH submission process impose the additional burden of proofing and verification activities on Principal Investigators (PIs), affecting research in the short- and long-term. • There are no procedures at the NLM and PubMed Central (PMC) for ensuring that only those articles funded by NIH are made publically available. Currently publishers must monitor PMC and request removal of articles that do not meet NIH’s stated criteria.

ARVO looks forward to working with NIH’s Public Access and NLM staff to resolve these significant issues.

Sincerely yours,

Sally Atherton, PhD Executive Vice President

Nicholas Delamere, PhD Chair, Publications Committee

Joanne Angle Executive Director

Clearly a far more desirable option would be for publishers to have an understanding that allows public access to the final, published version, of NIH-funded manuscripts that satisfies the desire for public access to these manuscripts. Perhaps a read-only repository could be established? Or a way for download of temporary files? Either way, the current system, requiring either the creation of an imperfect parallel track of manuscripts or the payment of rather large sums of money by the investigator seems subpar.

All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)

The transmission of knowledge is central to the mission of Washington University in St. Louis as is research and the creation of new knowledge. The underlying principle of the NIH Public Access Policy is to disseminate scientific knowledge generated by NIH funded research for the public good. We are confident that WU can meet its obligations to fulfill the requirements of the NIH Public Access Policy.” Speaking as University Librarian, I can assure publishers that the NIH policy will not result in mass cancellation of journal subscriptions at Washington University. The delay of 12 months ensures that taxpayer-funded research ultimately becomes publically available; however our University researchers must have access to the journals without a 12 month delay. Even if the delay were only six months, we would still continue our subscriptions. The University has made the necessary arrangements to support compliance with the NIH Public Access Policy. We are revising our grant application submission form to remind investigators of their need to comply and to certify that they have met that obligation. We have also educated the research administrators so that they can help faculty comply.

In addition, librarians are meeting with faculty from all departments engaged in NIH-supported research and providing them with the assistance needed to comply with the law. At the same time, we are engaging in discussions with faculty around copyright issues, to foster an understanding of faculty rights and their obligations. The NIH Public Access Policy has provided a welcome opportunity to engage in these discussions and to encourage broad distribution of Washington University research results. Our work with faculty would be facilitated by NIH’s publishing a list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law.

1. This policy is an extreme waste of time and should be rescinded, or journals, not PIs, should be required to take care of it. Why is it crucial that articles be made public a few months before publication, when people can wait and get the publication in other ways? How much money is this costing, and for what gain? It's a prime example of wasteful governmental bureaucracy.

2. One problem with implementation is that PIs are responsible for ensuring articles are submitted and cited, but papers are written by authors that may not include the PI. So, there is a disconnect between who knows about the acceptance for publication and who is held responsible.

The NIH public access policy directs welcomed attention to the issue of author rights. Our University encourages faculty and students to exercise their interests in ownership and use of their copyrighted works in a manner that provides the greatest possible scholarly and public access to their work. We have worked over the past year on a number of initiatives to support this goal including conducting an educational campaign on author rights (http://www.lib.umn.edu/scholcom/au-rights.phtml) and the creation of an institutional repository (http://conservancy.umn.edu/). The University of Minnesota, as a member of the Committee on Institutional Cooperation (Big 10 schools plus Chicago) has endorsed an “addendum to publication agreements” for authors to use with their publishers to retain rights for use of their work in their teaching, for posting on their personal websites, or depositing to institutional or subject repositories, such as PubMed Central.

University Libraries have invested significant resources ensuring that our staff are informed about the policy and are prepared to assist authors with the submission process. We have developed a successful partnership with the Office of the Vice President for Research to implement the policy. We have created a website to centralize all information and institutional advisories about the policy (http://www.lib.umn.edu/scholcom/NIHaccess.phtml); met with faculty and administrative committees to discuss the policy and plan its implementation; provided notice to Principal Investigators about their responsibilities; and created a letter to publishers from the Vice President for Research for use by authors in the first submission of a manuscript that informs publishers of University of Minnesota intent to comply with the NIH policy and requests their support in permitting deposit of manuscripts. Finally, we have shared best practice experiences with colleagues at other institutions.

We encourage NIH to work toward reducing the maximum embargo period from 12 months to 6 months, which would be more in sync with other funding agencies in the UK and Canada, and the Howard Hughes Medical Institute. A 6 month embargo maximum would also be consistent with the CIC addendum mentioned above, creating less confusion for our authors.

A 6 month embargo provides a sufficient safeguard for publishers. The faculty and students at the University of Minnesota require the most current information for their research and study – a delay of 6 months for access to critical information is not acceptable. The journals to which we subscribe are based on faculty needs, quality and use of the journals in our setting, and our budget situation which changes from year to year. The NIH Public Access Policy is NOT a factor in our cancellation decisions. However, it COULD be a factor in our assessment of journals to subscribe to in the future – favoring those journals which comply with the NIH Policy and are supportive of our authors in facilitating that compliance.

The submission process would be facilitated by the availability of a comprehensive, up-to-date location for recording individual publisher policies. NIH could work with SHERPA and others to create and maintain this and integrate it with the submission system. NIH should work to influence additional publishers to participate as “fully compliant” partners.

In addition, NIH should ensure that all NIH grant application forms or electronic submission sites include a prompt or a field for inclusion of the PMCID on the PI’s cited references that fall within the policy.

PubMed Central should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.

NIH could clarify in the FAQs that authors need not pay OA fees to publishers to comply with the NIH mandate.

The new NIH Public Access Policy is a great opportunity to get NIH funded research out to my faculty and researchers to accelerate the rate of research on my campus. As a Librarian supporting those faculty and researchers, I have spent a great deal of time creating a resource to help educate the faculty on this new policy. Please see: http://libguides.library.umkc.edu/content.php?pid=5230

I understand that the largest concern with the policy from the publishers is that libraries would cancel their subscription to a journal title based on this policy. For my perspective, this is ungrounded. We do not cancel titles for this reason. The embargo alone would require we have access to the most recent journals to support our faculty. If copyright issues are a concern – though I am not sure how! – I am working to educate my faculty on their rights as copyright holders.

My only suggestion is to please consider making the embargo 6 months. Again, as a professional librarian supporting the faculty, I would not be canceling a journal because of this policy.

Shirley K. Baker Vice Chancellor for Scholarly Resources and Dean of Libraries Washington University in St. Louis

UNC is also developing an institutional repository and would welcome a means to coordinate manuscript deposit between PubMed Central and the repository. We would eagerly participate in, facilitate, test, or otherwise help to advance such an arrangement.

We take the position that open access to federally funded research is not simply an educational or economic issue, but also a moral one that will place vital information into the hands of the very public whose taxes support the advance of science.

--Sarah C. Michalak, University Librarian and Associate Provost for Libraries, on behalf also of Tony Waldrop, Vice Chancellor for Research and Economic Development, and Carol Jenkins, Director of the Health Sciences Library

UNC is also developing an institutional repository and would welcome a means to coordinate manuscript deposit between PubMed Central and the repository. We would eagerly participate in, facilitate, test, or otherwise help to advance such an arrangement.

We take the position that open access to federally funded research is not simply an educational or economic issue, but also a moral one that will place vital information into the hands of the very public whose taxes support the advance of science.

--Sarah C. Michalak, University Librarian and Associate Provost for Libraries, on behalf also of Tony Waldrop, Vice Chancellor for Research and Economic Development, and Carol Jenkins, Director of the Health Sciences Library

A student preparing a published work such as a masters’ paper, a doctoral thesis or a journal article should read and cite the final edited paper whenever possible. In order for students (and other researchers) to distinguish the author manuscripts from the final articles in PubMed Central, they need to look very different. The information on the author manuscript that a final edited version is available elsewhere needs to be made much more prominent (perhaps enclosed in a box.) The appearance of the author manuscripts should be quite distinctive from the final articles in PubMed Central (perhaps with a different color header.) It would also be helpful to add information about how to cite an author manuscript as an author manuscript on both the web version and the PDF version of the author manuscript.

Look at the following two citations in PubMed, and the two articles in PubMed Central to see how difficult it is to distinguish between final articles and author manuscripts:

Cruz GD, Salazar CR, Morse DE. Oral and pharyngeal cancer incidence and mortality among Hispanics, 1996-2002:the need for ethnoregional studies in cancer research. Am J Public Health. 2006 Dec;96(12):2194-200. Epub 2006 Oct 31. PMID: 17077408 [PubMed - indexed for MEDLINE]

Ramirez A, Farmer GC, Grant D, Papachristou T. Disability and preventive cancer screening: results from the 2001 California Health Interview Survey. Am J Public Health. 2005 Nov;95(11):2057-64. Epub 2005 Sep 29. PMID: 16195509 [PubMed - indexed for MEDLINE]

Because we believe that there is both an advantage to our researchers and to the general public in having a stable and permanent archive of taxpayer-funded research, we must view the suggestion sometimes heard for a “dark archive” of articles with links to publisher websites as an unacceptable alternative. This suggestion would not achieve the goals articulated by the NIH, nor would it provide the benefits which are the reason for the support of so many institutions of higher education and research. This alternative was wisely rejected by NIH in its initial consideration and should not be reconsidered at this time. Our institution, like many others, has already invested substantial resources in compliance with the policy as now written, and a substantial change, particularly one that would undermine the benefits we see in the policy, would be a serious problem.

The internet and the WWW have changed the options for publication tremendously. Understandably, the publishers who have provided a valuable service to the scientific community, while simultaneously building a very successful and profitable business, do not want that to change.

However, just as the digital camera changed the field of photography by making it cheaper and more accessible, the WWW is doing the same thing for publishing. Many successful photographers who had built their business using the constraints of the pre-digital era had a hard time transitioning to the digital era. In this same way, some publishers will not make the transition, but there will be many opportunities for those publishers who embrace the digital age and think innovatively.

My suggestion to overcome this would be the publishing of a PDF formatted manuscript supplied by the author(s). If PubMed Central would like to make these 'uniform', perhaps simply making a uniform title page would suffice. The submission of a PDF document by the author would ensure that no typesetting errors/changes will detract from the manuscript, and obliviate the need for the 'proofing' and revisions stages.

1. PMC now offers publishers various types of Participation Agreements, and under these publishers may submit NIH-funded articles to PMC on behalf of authors. The current file submission guidelines state: A journal must provide PubMed Central the full text of articles in an XML or SGML format that conforms to an acceptable journal article DTD (Document Type Definition). The original high-resolution, digital image files must also be provided for all figures. A PDF may be submitted in addition to the XML/SGML version of an article, but not as the primary (or only) form. and A journal that does not currently produce XML or SGML versions of its articles would have to add this process to its production stream or contract with a vendor to create XML from the article source files. Most university presses do not now operate production processes that would support production of these XML files. To suggest that they "add this process to the production stream," is not reasonable, when one considers that a press might only have a small number of NIH-funded articles to handle. We recommend that PMC alter the requirement and accept PDFs from publishers, just as PMC now does accept PDFs from authors. This would reduce the burden on many university presses and increase both required and voluntary participation.

2. The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal articles, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal's publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal's and publisher's editorial policies, peer-review standards, and funding sources.

First, inside the university, implementation of the policy has created an opportunity for several offices and many scientists to work together to address an important development in the law and to devise new policies and procedures that may ultimately increase accessibility of research results. The effort has been an important occasion to review existing positions on related matters and to share ideas within the university on critical issues related to research, publishing, and funding.

Most notably, implementation at Columbia has involved a cooperative interaction among many diverse offices, such as the University Library, the Office of Research Administration, the Office of Research Compliance and Training, the Office of General Counsel, and the Copyright Advisory Office, as well as a many research programs and academic disciplines. One outcome of the process has been a website specifically developed to guide faculty members and others seeking to comply with the NIH policy (http://scholcomm.columbia.edu/nih-public-access-policy/). The website includes explanations of the law and tools and documents for compliance.

Second, we are seeing numerous examples of publishers revising their policies and often implementing standards that are supportive of the public interest beyond the requirements of the law. Scientists at Columbia have appreciated those publishers that have offered to undertake the submission procedures, and those publishers that have chosen to make their works available in final form or on an earlier schedule.

These unexpected benefits of the NIH policy underscore the policy’s fundamental importance to the creation and dissemination of research results. The NIH policy is much more than legal mechanics; it is proving to be an invaluable motivation for universities, scientists, government agencies, and publishers to reevaluate their polices and to implement standards that can more effectively reflect the public interest and the needs of diverse stakeholders. Thank you for this opportunity to submit comments.

I also do much research online using the NIH and pubmed facilities. I, too, have also been frustrated by the requirement to purchase research articles published by third party outfits which profit using this publicly funded research as a means to sell their publications. If the public funds the research then the public should have access to the results.

I suggest the following minor modifications to the proposal. 1) mandatory publication of research data at the time of acceptance for publication. If the subsequently published article has changed for any reason then the later published article should also be entered into the pubmed facility. The original submission (prior to publishing) should then be archived at pubmed, thus allowing access to the later published article from the original pubmed submission and vice versa. Such a mechanism would be very useful, I believe, in terms of later auditing for the purpose of establishing how many articles had been changed between the time of research completion/initial-pubmed-submission and the time of journal publication. Such changes of article content may thus shed light later on any differences between the two articles and help to establish a historical chain of information which may prove useful for several different reasons. The more transparency the better...

In the event an article changes between the time of original pubmed submission (publication acceptance time) then the updated/changed article should be required for submission to pubmed no later than 2 weeks after original article publication (and hopefully even sooner).

1.) Was any of the research encompassed by your article funded using NIH or other public funds?

The aforementioned question should be answered in writing by *all* authors/co-authors listed on all published articles along with that author's/co-author's signature.

In the event that any author or co-author answers 'yes' to the question then the publication (publishing entity) should then be required to submit a copy of that paperwork to the NIH (or pubmed facility). In the event an author/co-author answers the question untruthfully then sanctions should be applied that individual. In the event the document is not properly procured by the publishing entity and/or not submitted to NIH (or pubmed) prior to publication then the sanctions should be attendant upon the publishing entity.

It should also be mandatory for all authors having answered 'yes' to the question to retain a copy of the signed disclosure form so as to indemnify themselves against sanction in such cases as the publishing entity neglected to submit the disclosure form to the NIH.

Ensuring timely and unfettered public access to research data supported by public funds is an extremely valuable and laudable pursuit.

It has been suggested that this policy would harm journal publishers and lead to the cancelation of STM journals. This is a misunderstanding of the decision process in libraries for journal selection. Scholarly journals are typically subscribed within packages, and it is not possible to establish a correlation between individual NIH-funded articles in open access repositories such as PMC and journal cost. Furthermore, libraries are unable to predict which journals will publish NIH-funded articles, so this factor would be a specious one on which to base journal acquisition. Finally, even if the embargo period were reduced to six months, this period would be too long to make the unavailability of the journal a palatable option. We have never used public access availability as a criterion for journal cancelation.

We believe the rate of compliance would benefit from two developments: 1) having the final PMC version of an article sent for verification to both the principle investigator and the lead author listed on the article and accepting verification from one or the other, and 2) developing a strategy for working with publishers which use click through licenses that allow no negotiation.

We require that submission to our institutional repository include actual content -- not links -- because that is the function of the repository. By analogy, NIH/PMC should have the same requirement. Mere citations with links to the actual content on the publisher’s website, or a “dark archive,” will not fulfill the purpose of the policy. Furthermore, it assigns part of the responsibility for access to publicly-funded research to a private entity. Additionally, to further the wide availability of this valuable content, we urge development of methods of interoperability for exchange of content between PMC and institutional repositories.

These comments are submitted on behalf of the Rutgers University Libraries by Rhonda Marker, Jim Neissen, and Jeanne Boyle.

An alternative for NIH could be to adopt a SCOAP3 model (Sponsoring Consortium for Open Access Publishing in Particle Physics) for supporting NIH-funded research. Like SCOAP3, NIH would reimburse publishers for the cost of making NIH-funded research publicly available, in lieu of an author payment. IEEE recently expressed an interest in working with CERN and SCOAP3 to experiment in this area.

Another alternative would be to have the NIH contract with one or more publisher to host all published NIH-funded research on existing digital archives such as the IEEE’s Xplore platform. Such an arrangement would give readers access to existing specialized search tools (like Scitopia) as well as to cross linking with other STM literature.

We urge the NIH to consider these alternatives to ensure that it will not unnecessarily waste taxpayer funds building an article repository and web delivery system that duplicates what already exists in the operations of scholarly publishers.

The IEEE sees significant complications in this second issue that will make ensuring compliance difficult. Although the NIH requires that NIH-funded investigators submit an electronic version of the author’s final manuscript resulting from the peer review process, this nuance is likely to cause a difference in the version posted to PMC and the final publisher’s version of the article. In addition, it is our experience that it is challenging to capture the attention of the author to review the copyedited version of the manuscript before it is finally published. Thus, the NIH’s practice of converting the article to XML and then requiring authors to again review the NIH version, after it’s been converted to XML, is redundant and will ultimately cause even a greater difference between the PMC and publisher’s own version of the manuscript. Experienced publishers are aware that conversion to XML needs to be done very carefully in order to avoid introducing errors. How will NIH monitor conversions that it undertakes, and how will it ensure that only errors introduced in the XML conversion process are corrected, while maintaining the integrity of the content itself?

If PMC linked metadata, in lieu of the full manuscript, to the publisher’s web site (for the final version of the manuscript), it will have accomplished its goal of ensuring compliance and meeting the directive to implement the public access policy in a manner consistent with copyright law. Moreover, it will ensure that the production qualities of the manuscripts to which it provides public access are as high as possible.

Among the publishing principles IEEE has adopted are:

• Society benefits from an objective and intellectually free scholarly publishing environment that is unfettered by censorship or bias based on personal, commercial, or government agenda. • In order to perpetuate itself, scholarly publishing requires financial support from self-sustaining business models. • Copyright and intellectual property rights of authors and publishers must be protected in any publishing activity, including those that involve government-mandated policies on access to government sponsored research.

We urge NIH to consider using IEEE’s well-established and proven online content delivery platform, IEEE Xplore, to serve the needs of the NIH and the public instead of allocating potential grant funds to duplicate publishers’ activities.

Many publications are accompanied by data, and indeed for many of these (e.g. about sequences and structures of biomolecules) the data are often more important than the fulltext. Although the STM publishers have urged their members to regard data as facts and therefore free of copyright, several publishers label data as copyright, thus effectively barring the legitimate re-use of data. It is important that the NIH challenges this and forbids it on PMC.

Many data are embedded in the full text and can be extracted by machines (”text-mining”). This process is made more tractable if the text is available in XML form (including XHTML) and I support the use of these formats.

Text-mining” and “data-mining” are hardly mentioned - if at all - in the NIH’s description and requirements. I would therefore wish to see positive indication that the NIH supports the re-use of the material, in high-throughput mode.

I would urge that the NIH make clear what their policy on data- and text-mining is, using those terms. I would also suggest that the NIH add machine-readable versions of licences or similar documents so that robots are aware of what they may and not do.

This submission will only comment on those questions which we consider relevant to the ALPSP membership.

Many journal publishers, and most of those publishing in the biomedical sciences, make the final ‘version of record’ journal article freely available on the Internet a maximum of 12 months after publication. We believe that it would be highly preferable if NIH linked PubMed and/or PubMed Central to final published journal articles on publishers’ website and adapted PubMed and PubMed Central to allow for full-text searching across the publishers’ websites.

This approach does not constitute a “dark archive” as some have suggested since articles appearing in journals operating a delayed open access publishing model are available freely on the Internet in compliance with the NIH public access requirement. We would suggest that the policy mandating deposit of peer-reviewed manuscripts in PubMed Central should be reserved for only those articles published in journals that do not make content freely available on the publishers website after 12 months or less.

There are numerous advantages to this approach: * It would provide a more comprehensive ‘one-stop-shop’ for searching the biomedical literature which would include vastly more than the 10% of articles that arise from NIH funded research * It would assist with version control and enable readers to access the trustworthy version of record with corrections, links to corrigenda and errata and thus maintain the integrity of the corpus of literature * Journals would be able to determine their own access policies within a 12 month timeframe based upon the requirements of their business models * It would eliminate needless and expensive duplication of the storage, curation and preservation of a large number of research articles

We therefore urge NIH to reconsider this proposal.

We note the confusion that has arisen from the use of the term “journal articles” in the Public Access Frequently Asked Questions (FAQs) posted on January 11, 2008 and the continued use of the terms “journal manuscripts” and “journal papers” used in the amended version of the FAQs (http://publicaccess.nih.gov/FAQ.htm) as updated on May 2, 2008. We believe that NIH should be clear and unambiguous in referring to the final peer-reviewed manuscript in order to avoid confusion with the final journal version of record.

We would draw your attention to the NISO / ALPSP project on Journal Article Versions (see http://www.niso.org/workrooms/jav) which will shortly produce a standard nomenclature for versions of journal articles. We urge NIH to utilize these definitions once the standard has been formally announced by NISO.

We note that Congress directed the NIH to ensure copyright agreements and rights were preserved and it seems onerous, unfair and an avoidance of this responsibility to transfer that obligation to researchers. At the very least the NIH should implement procedures during the process of uploading manuscripts to PubMed Central to check that the version of the article uploaded is consistent with copyright law and that institutions and investigators are complying with their obligation to ensure that “any publishing or copyright agreements concerning submitted articles fully comply with this Policy”.

The Revised Policy now calls for the deposit of review articles. Review articles are commissioned by Publishers and Editors and are written based on the scientific expertise of the author; they are not based on the specific research projects supported by NIH grants and we therefore respectfully suggest that review articles should not be subject to the mandatory Revised Policy.

To assist with version control, adherence to copyright law and to minimize duplication of costs, NIH should implement measures to ensure that where manuscripts are deposited by journals on behalf of their authors the submission of duplicate copies or different versions are not accepted for ingress into PubMed Central.

We believe that NIH should implement measures to detect inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central and should immediately alert the publisher of any articles so abused. NIH should also implement specific safeguards to prevent copyrighted material available on PubMed Central from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose.

Questions / comments raised by Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition

1) Regarding Consultation with Publishers, Societies and Authors

• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? • What is NIH’s timeline for amending this policy moving forward? • What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright

• Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy

• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? • Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? • How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. • How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? • How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? • If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation

• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? • The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope

• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? • Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? • The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? • What will the repercussions be for investigators and journals that do not follow the process? • NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access

• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? • Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? • For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? • How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH develop, for example, a special section within PMC for members of the general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? • How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost

• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? • Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness

• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? • What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? • What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

We believe that by implementing the Revised Policy on April 7, 2008 - before completing a thorough consultation - the approach taken by NIH regarding the Revised Policy does not adhere to the Administrative Procedure Act. We also note the short timescales between the announcement on March 7, 2008 of a public meeting regarding the Revised Policy, the meeting taking place on March 20, 2008 and the Revised Policy coming into effect on April 7, 2008.

We therefore respectfully request that the NIH suspend the Revised Policy and undertake a formal rulemaking according to the provisions of the Administrative Procedure Act. A Rulemaking would allow all interested stakeholders the opportunity to comment with adequate deadlines and offer a formal procedure via which the NIH could address the issues raised.

In addition, we are aware of calls for the NIH to reduce the upper limit of the Revised Policy’s embargo period from 12 months to six months or less. Research (see for example Self-Archiving and Journal Subscriptions: Co-existence or Competition? (Beckett and Inger 2007; www.publishingresearch.net/documents/Self-archiving_summary2.pdf) and ALPSP Survey of Librarians on Factors in Journal Cancellation (Ware 2006; www.alpsp.org)) has indicated that the upper limit of 12 months is the minimum required for publishers of biomedical journals supported by subscription revenues to have a chance of recovering their costs. We therefore urge NIH to commit retaining the upper limit at 12 months and allow journals to choose a shorter embargo period if it is compatible with their business model.

I see two ways this could happen. One, NIH could just require that researchers submit NIH-funded research to journals that allow the published version to be available through NIH. There would be no copyright or ownership issues associated with this, since journals that will not allow the published version to be distributed by NIH would be off limits to NIH researchers.

Alternatively, NIH could encourage the use of paid Open Access publishing alternatives. Researchers here are reluctant, however, to use existing grant funds to pay the Open Access charges of major publishers. While grantees recognize that their existing grant funds can be used to pay open access fee, the grant funds they receive are never enough to pay for the work that needs to be done under the grant. Most are therefore reluctant to divert any of the funding to publication costs. Grantees are also worried that including publication costs in proposed grants would make their grants appear to be expensive and less competitive.

A solution would be for NIH to implement a separate fund upon which PIs can draw to pay open access fees from publishers. Such a fund would also save NIH money in the long run since institutions would not be claiming Facilities and Administrative (F&A) costs on grant funds devoted to publication.