In its present form, I believe the Policy is somewhat limited in its approach. While access to published studies is very important to many, access to NIH funded study protocols is equally important. Important for two reasons: first, unlike a published study which may detail research conducted as much as two years previously, NIH funded studies currently underway detail cutting edge research. Unfortunately, unless enrolled in the particular study, obtaining a trial protocol is not an easy task.

Second, NIH funded studies typically build off of the published literature and, in doing so the written trial/study protocols provide an excellent summary of the research conducted to date and how the current study will advance the understanding of a treatment process. This is the kind of information extremely important for those seeking potential solutions that support, or go beyond, conventional approaches.

While the NIH ponders the issue of making published studies freely accessible, as an interim measure I suggest the NIH make the study protocols from all NIH funded clinical trials accessible so those in need of alternative solutions will have the ability to obtain this information.

To quote Margret Fuller, “If you have knowledge, let others light their candles at it”. Please, let us light our candles.

We at the University of Michigan believe that ARL's comments accurately reflect the beliefs of its membership and the interests of research universities. ARL points out that the U.S. Government funds research with the expectation that new ideas and discoveries from the research will further scientific discovery, stimulate the economy, and improve the lives and welfare of Americans. When American taxpayers are funding research, it makes perfect sense that they should also have free, unfettered access to the fruits of that research. The access required by the revised NIH Public Access Policy will advance science, enhance U.S. competitiveness, and promote the public good, and the University of Michigan Library strongly supports its prompt implementation.

To address these concerns, we believe that the NIH should undertake a formal Administrative Procedure Act Rulemaking. A Rulemaking would provide the public and all interested stakeholders with a formal mechanism for comment with adequate lead times and a formal procedure for NIH to address the concerns. All publishers, from the corporate publishing houses to the small professional societies, have questions not addressed in the NIH Frequently Asked Questions section of the NIH Public Access Website. Significant copyright concerns remain. To implement a policy by issuing a Notice just sixteen days after being signed into law, then seeking public input with an open meeting just eighteen days prior to the implementation date (with one week to prepare), will never be used as a case study in effective public policy with open communication from all stakeholders.

Should the NIH undertake a Rulemaking, the final NIH Public Access Policy, taking into serious consideration comments from all stakeholders, would be greatly improved for the betterment of science, clinicians and the public.

University of Utah researchers publish cutting-edge medical research, much of it funded by NIH. Our research will earn greater returns if it can be read and used by medical practitioners and researchers everywhere. Pubmed Central complements our institutional repository that contains research articles and other sholarly works from many disciplines.

We are actively working on compliance and welcome the opportunity to contribute our research to Pubmed Central. The Eccles Health Sciences Library has established a web site to assist our researchers and the Office of Sponsored Programs is organizing compliance activities.

Even with this unsurpassed record of commitment to open access, we nevertheless rely on our traditional journals to supply core financial support to our many other services to our community, which include significant efforts in science education for K-12 students and outreach to minority programs in science on all grade levels. As important, OSA’s journals offer common ground for our highly unified sector of physics. OSA is small by the standards of the large “general” scientific societies, which makes our journals all the more valuable in sharing research. No other publisher—commercial or nonprofit—is as dedicated to publishing peer-reviewed research in optics, and the loss of any of our journals would damage the free flow of information in one of the oldest branches of physics.

Throughout OSA’s 90-year history, optical scientists have time and again broken new ground by bridging the apparent gap between traditional optics and other scientific fields. Authors in our journals have been responsible for the technology behind lasers, fiber optics, Polaroid photography, and an array of other breakthroughs with impact throughout the physical sciences. Most recently, we have allied ourselves with well-respected scientists in biomedicine to explore the many ways that optics can offer significant advances in medical imaging. Our efforts in consolidating research in fields like biomedical optics need careful nurturing.

We are not certain that NIH has fully weighed the repercussions of mandated open access within small, highly respected scientific societies. We’re aware that our “big sisters” in physics and chemistry have clearly voiced their concerns in this matter. Yet as we hope we have made clear above, societies like OSA operate at even less margin than organizations that are household names. Our delicate margin and promising alliances for cross-disciplinary research may be impaired by NIH’s recent open access policy.

We would very much like to state our case more fully as part of NIH’s decision-making policy. We agree with AIP, APS and others that a more “open access” rulemaking process would be helpful to all concerned—public, government, and scientific societies. We at OSA support more freely available research in our field, but we feel, along with AIP and APS, that scientists and the public would be better served by a process developed jointly by NIH and scientific society publishers.

The Journal of Dental Research supports the DC Principles of Open Access, and content is free of access controls, no matter the funding source, 12 months after publication. We have digitized our entire Journal content back to volume 1, issue 1, published in March of 1919. Scientists, dental practitioners, students, and the public can access all of our content from March 1919 to March 2007. The Journal of Dental Research complies with the current voluntary NIH public access policy and even submits to PubMed Central (PMC) accepted manuscripts on behalf of NIH-funded authors, with an embargo period of 12 months from publication.

While we support Open Access, we strongly object to the NIH’s interpretation and planned implementation of the mandatory language contained in Division G, Title II, Section 218 of the Consolidated Appropriations Act, 2008. Specifically and most importantly, we do not believe that NIH has adequately addressed Congress’ proviso that “the NIH shall implement the public access policy in a manner consistent with copyright law.”

For a small professional association, we have invested significant resources to establish an effective peer-review system, to develop in-house copyediting and production systems, to launch our Journal online in 2002, and to digitize all of our volumes back to 1919. The only way for the Associations to recoup this investment – not make a profit, just recoup our investment – is to retain the copyrighted material and to offer individual and institutional subscriptions. Once a significant proportion of our “copyrighted” Journal content – in the form of accepted manuscripts – is available free on PMC and then onto PMC-International – we forecast a decline in our subscriptions, which will undermine and threaten the sustained viability of the number one journal in the dental sciences.

Furthermore, the IADR and AADR, as publishers of the Journal of Dental Research, are willing to provide PMC with a link to the final authoritative version of the published article, with the same embargo period. As you may know, significant value is added by publishers in the copyediting process. Yet, the proposed implementation of the public access policy would retain the earlier non-authoritative version of the accepted manuscript on the PMC site. Surely, the interest of the public is better served by having access to the final authoritative publication rather than to an unedited manuscript.

Due to space limitations, we will propose a solution in the next comment window.

The NIH public access policy directs welcomed attention to the issue of authors 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 authors rights http://www.lib.umn.edu/scholcom/au-rights.phtml. 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 faculty 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.

At the University of Minnesota, the University Libraries have partnered with the Office of the Vice President for Research to implement the policy by April 7, 2008. 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; prepared to assist authors with the submission process; developed plans to provide effective notice to Principal Investigators about their responsibilities; drafted 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; and, finally, we have shared best practice experiences with colleagues at other institutions.

We urge the NIH to work with all stakeholders to reduce the administrative burden of compliance on institutions and authors, and to streamline the process wherever possible. Work to influence additional publishers to participate as “fully compliant” partners. Consider providing a master list of journals and their policies to guide author choice, and incorporate those lists into the NIH submission system.

Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. We think the policy will result in a significant improvement in access to health information that will benefit both our university and the publics it serves.

We are pleased that legislation was passed to make this policy mandatory. To help our members and their institutions with implementing the NIH Policy, ACRL is providing education, networking, and tools around the NIH Public Access Policy itself and the related issue of maximizing the use and impact of research and scholarship. For example:

1. Convening a live chat in late March so librarians can discuss how institutions are implementing the NIH Public Access Policy and how libraries could leverage this opportunity on campus. 2. Developed a short video, together with the Association of Research Libraries (ARL) and the Scholarly Publishing and Academic Resources Coalition (SPARC), to help librarians effectively engage disciplinary faculty and researchers on maximizing the use and impact of their scholarship. 3. Presented special joint one hour Webcasts for librarians, together with ARL and SPARC, called “Understanding Author Rights.” 4. Co-sponsoring with SPARC a regular twice yearly forum at the meetings of the ALA with topics including federal policy for public access and author control of copyrights. 5. Publishing a regular column in College and Research Libraries News on topics related to the changing system of scholarly communication, including federal policy and copyright.

In summary, ACRL applauds the NIH on the Public Access Policy and is taking steps to support our members as they work within their institutions to implement this policy effectively.

Sincerely, Julie B. Todaro President, ACRL

Many SPARC members have established robust author rights management campaigns. These are now being deployed to specifically address questions related to the NIH policy and how authors may comply. Many universities are also providing explicit language to their authors to ensure proper copyright compliance. (See: http://www.mclibrary.duke.edu/nihpolicy for just one of many examples.)

While these libraries are playing central roles in facilitating communication and compliance programs, they are by no means acting alone. On many campuses, these efforts have involved close collaboration among librarians, researchers, research administrators, and university counsel. SPARC’s members view the NIH policy as a welcome opportunity to work in concert with their campus colleagues and contribute directly to the mission of the institution – to promote and advance knowledge.

SPARC commends the National Institutes of Health for issuing implementation guidelines in a timely manner and for being consistently responsive to queries about the process from our member organizations.

SPARC applauds the National Institutes of Health for advancing this important policy, which will provide a rich and innovative suite of new resources – as well as access to critical biomedical research findings – to researchers on our campuses and beyond. Prompt implementation of this policy will accelerate the pace of research and discovery, fuel innovation, and serve the public good.

SPARC looks forward to continuing to work with both its member libraries and the broader American academic community to ensure the policy’s success.

[Part 2 of 2]

2.What do I do about publishers that charge authors to make NIH funded manuscripts publicly accessible via PubMedCentral? 3. What do I do about the considerable staff time required to upload my publications to PubMedCentral? 4. Why does the list of journals which automatically upload to PubMedCentral not include many of the journals (Health Care Policy) that faculty members routinely submit to?

As an organization of more than 220 academic and research libraries on campuses across the U.S., SPARC and its members are committed to the promotion of programs and policies that expand the dissemination of research results, reduce barriers to the use of those results, and leverage the networked digital environment in an efficient, cost-effective manner. We believe that the NIH Public Access Policy provides an important opportunity to further these aims. It is a major development that enhances our member institutions’ ability to fulfill their commitment to the advancement of scientific knowledge.

SPARC has been strongly supportive of this policy since it was first proposed in 2004 and, along with many of our institutional members, has created several programs to help to pave the way for the smooth implementation of the revised policy. The variety of educational initiatives and practical tools we have prepared are specifically designed to help the higher education community leverage this groundbreaking new opportunity. For example:

SPARC has deployed a comprehensive educational initiative to inform authors of their rights and responsibilities as copyright holders. This campaign emphasizes that authors must be aware of the rights they need to retain in order to comply with the NIH Public Access Policy, and features the SPARC Author Addendum as one tool authors may deploy to ensure they have retained the rights they need. (See http://www.arl.org/sparc/author for details.)

Recently, SPARC (along with the Association of Research Libraries and Science Commons) also published a white paper outlining six alternative copyright management strategies that campuses may consider adopting to guarantee that the institution and its researchers meet the policy’s requirement for compliance with current copyright law. (See http://www.arl.org/sparc/advocacy/nih/copyright.html.)

Author rights, copyright policies, and the NIH policy are the focus of SPARC’s recent and ongoing campus presentations, Web casts, and meetings with university administrators – including vice provosts for research.

[Part 1 of 2]

The U.S. Government funds research with the expectation that new ideas and discoveries from the research will further scientific discovery, stimulate the economy, and improve the lives and welfare of Americans. These strategies, such as the revised NIH Public Access Policy, advance science, enhance U.S. competitiveness, improve access to the fruits of our collective investment, and provide better accountability of our Nation's research investments. For these reasons, ARL is a strong supporter of the NIH Public Access Policy. NIH is to be commended for engaging the research, education, scholarly publishing, and biomedical communities in designing,refining, and implementing this important policy. ARL's complete filing is available at PublicAccessComments@NIH.gov.

2. Amend applications considered as “new” – omitting rebuttals of criticism. The reviewer supports this recommendation.

3. Rate all applications by specific criteria and rank to reduce ambiguity. The reviewer supports this recommendation.

4. Shorter applications with focus on impact and innovation, less on methods and preliminary results. The reviewer supports the recommendation that less focus should be on methods that are standard in research and can be referenced in published literature. However, novel methods and altered disease models should be discussed if the information necessary to conduct the experiments is not available in published literature. The researcher also feels that focus should be kept on preliminary data that begins to support a hypothesis. However, large sample sizes and statistically significant data may not be necessary for all data presented. Also, addressing each specific aim in preliminary data should not be a requirement since many subsequent experimental designs may depend on the results from the previous specific aims.

5. Require at least 20% of effort to go to grant, to limit investigators with multiple grants. The reviewer supports this recommendation.

6. Consider separate review for new investigators. The reviewer supports this recommendation and would like to suggest that R21 grant proposals also be reviewed in separate study sections since the current protocol lumps R21 grants and R01 grants together in a single review process, which inadvertently creates a situation where the R21 is being compared to R01 grants.

The policy supports the mission of the UCLA Library in many ways. It provides broader access to and dissemination and preservation of scholarly research, both that conducted at UCLA and elsewhere. This enhances the free flow of information, which has untold benefits such as stimulating further ground-breaking research and giving the public access to articles about research and treatment options that may save lives. It respects the important role played by peer-reviewed journals, while at the same time making research conducted at UCLA – a public university supported by both U.S. and California tax dollars – freely available to the public whose tax dollars pay for that research.

I strongly encourage you to keep the policy as it is currently written. It clearly supports Article I of the U.S. Constitution – "The Congress shall have Power…To promote the Progress of Science and the useful Arts..." – which established the purpose of copyright under U.S. law as to promote learning and the creation of knowledge. Thank you for your consideration.

Non-profit independent research institutes are stand-alone academic-style centers that offer scientists a focused research environment to conduct innovative science. Therefore, despite the fact that AIRI member researchers may not have an institutional repository to assist authors with depositing their manuscripts into PubMed Central, we stand ready, willing and able to comply with the requirement. Our Board has not expressed any concerns with this policy and actually believes that this requirement may enhance overall support for science once the public is able to view first hand the benefits that result from federally funded research.

AIRI applauds NIH for undertaking the effort to implement the intent of Congress, and we believe the requirements are clear, easy to follow and do not constitute an excessive burden on our researchers or research institutes. We also enthusiastically support making our research available to all who can benefit from it.

We thank you for the opportunity to express our views. We hope that you will continue to look upon AIRI as a resource on this and other issues. Should you require additional information, please do not hesitate to contact me at (405) 271-7410 (Chip-Morgan@omrf.ouhsc.edu) or Jon Retzlaff in the AIRI Washington office at (202) 289-7475 (jretzlaff@lewis-burke.com).

At the UCSF Library, we have been engaged in efforts to educate our researchers about options for increasing access to their scholarly work through publication in open access journals and managing their copyrights to enable self-archiving in PubMed Central and the UC repository, eScholarship. For the past several years, many of our faculty have taken an interest in the issues of scientific publishing.

At UCSF, we have been able to build upon existing initiatives in the area of scholarly communication in order to assist our campus with responding to the new NIH policy. We have coordinated communication with the campus office of contracts and grants to notify our researchers about the policy. The Library put up an informational website and questions regarding copyright compliance are being directed to our staff.

Members of our faculty senate committees have identified an interest in understanding the copyright policies of the top journals where our researchers publish. We are in the process of developing a list of journals and determining their policies. The list of PMC participating journals provided by NIH is extremely helpful. However, faculty also want an easy way to know about the other publishers who will submit to PMC on behalf of authors.

At the University of California, a letter signed by the Executive Director, Office of Technology Transfer and Research Administration, University of California, Office of the President is being sent to publishers notifying them that UC faculty will be posting their articles to PubMed Central. We are instructing investigators to enclose this letter with any articles submitted to publishers for possible publication or to append it to any copyright agreement with publishers. This letter significantly facilitates the process of compliance for our researchers. Our researchers are expected to handle their compliance with the mandate using their own staff and resources.

The Library would also like to commend NIH for developing thorough and useful instructions and training materials. In particular, the slide presentations explaining the policy are very useful, as well as the tutorials that explain how to use the manuscript submissions system. As UCSF researchers begin the process of complying with the mandate, we will gain more knowledge about the effectiveness of the FAQ and other help materials provided by NIH. We will forward any comments for improvements at that time.

The current practice of requiring a subscription or charging a fee for each article quickly goes beyond my ability to pay.

In preparation for the April 7 and May 25 implementation dates, the Libraries have been working with the Office of Research (WFU Health Sciences, Bowman Gray Campus) and Office of Research and Sponsored Programs (WFU, Reynolda Campus) to educate faculty researchers and research administration staff on the steps necessary to ensure compliance, specifically advocating the joint use of cover letters and copyright contract addenda to retain rights necessary for compliance. The Coy C. Carpenter Medical Library has featured articles and announcements about the policy in its quarterly newsletter and weblog, will offer scheduled classes on the policy throughout the spring and summer, and maintains a resources webpage on the NIH Public Access Policy (http://www.wfubmc.edu/library/nih). The Z. Smith Reynolds Library recently hosted a scholarly communications workshop, organized by the Committee, for staff from all three WFU Libraries to provide education on scholarly communications issues and author rights management, and to discuss strategies being developed by the Committee to address issues important to the University community, of which the NIH Public Access Policy is a key priority.

As an institution that last year received 53% of all extramural research funding from the NIH, and with a Health Sciences division that received close to 70% of its total funding from the NIH during the past five fiscal years, we are dedicated to ensuring successful compliance by all WFU investigators as a means of guaranteeing that the vital research being conducted by our scholars continues unimpeded and is disseminated as broadly as possible.

Molly Keener, Chair - Scholarly Communications Committee, Wake Forest University

Although implementing the policy will create short term challenges for MIT and its investigators, we do not view those challenges as a reason to delay implementation. In the short term, without a broader, institutional approach in place, compliance necessarily falls to individual authors who will need to ensure they retain sufficient rights to comply with the terms of their research funding. There is a tension inherent in this situation, which will at times leave authors and their institutions struggling with the need to execute hundreds of individual appropriate legal contracts with publishers in order to achieve compliance. MIT’s approach to implementation assumes that over time, all players in the scholarly communication chain – research institutions, authors, funding agencies, and publishers – will need to work together to find efficient procedures and policies so that publicly funded research is shared as widely as possible, for the benefit of taxpayers and the betterment of society.

CONTINUED IN PARTS TWO AND THREE

Our team has focused so far on written communications and face-to-face discussions meant to convey the basic requirements of the policy and to inform authors of what resources MIT has to assist them in compliance. The documents we’ve prepared include a web page to guide authors in complying with the policy, a draft journal submission letter, and a draft one-page overview of the key aspects of the policy. We have begun drafting a letter to be sent to each NIH Principal Investigator, and an article for the faculty newsletter is in the planning stages.

We are prepared to handle the inquiries we expect as of the April 7 implementation date, since MIT already makes available to its authors an amendment to publisher agreements that was developed in support of voluntary deposit in PubMed Central. MIT additionally support authors in compliance through a staff position in the Libraries devoted to supporting authors in retaining rights to their work.

CONTINUED IN PART THREE

Some cancer center libraries have already taken action to create centralized support services for mandate compliance. As such, they post articles on behalf of their institution’s authors and provide additional support by interpreting copyright agreements and locating PMCID numbers. Other smaller research libraries are creating web pages of information and working with grants offices to ensure compliance. One concern is that a number of major publishers have not clearly indicated that their copyright agreements will allow authors to retain the right to comply with the mandate. Librarians and research administrators are consulting with legal counsel and approaching publisher representatives in order to ascertain the best approach to these situations. Also, the NIH Public Access FAQs do not address an exact deadline or specific number of days after publication acceptance that submission to PMC is expected to occur. It would be helpful to clarify this point and to provide FAQ information on how to post to the NIH Manuscript System on behalf of authors via an NCBI account. Finally, emailing the PMCID numbers to the author as well as the poster (librarian) following completion of the submission process would also help in retention of these numbers for future citing purposes in grant applications. Submitted by: Karen Albert, MLS, AHIP, Chair, Medical Library Association Committee for Advocating Scholarly Communication, and Library Services Director, Talbot Research Library, Fox Chase Cancer Center, Philadelphia

The Kabuki Syndrome Network is an entirely volunteer group of parents and has been a lifesaver for so many of us, providing information and advice as we face the many challenges of life with our children. Much of this information comes from medical articles that are available free of charge. We do not have the money to pay fees for these articles, but we are the people that need to see them the most.

Please go forward with this proposal to make all research articles that receive your funding available at no charge. You are doing such an incredible service to parents of disabled children everywhere.

Thank you.

Linda Lukowski

The NIH missed an opportunity to make its May 2005 voluntary public access policy a success by not proactively including scientific journal publishers as it developed its voluntary Public Access Policy. Consultation with publishers is critical in 2008 to prevent the agency from embarking on a similar collision course as it proceeds to implement the new mandate. Key to success will be NIH taking an active role, one based on openness and inclusiveness, to resolve the outstanding copyright and intellectual property issues that cut across a very broad and deep swath of the scientific journal publishing community.

The ACS publishes annually approximately 4,000 articles that acknowledge NIH as a research funding source. Ever since NIH directed ACS to halt article deposition into PubMed Central in December 2005, ACS has tried unsuccessfully to resolve outstanding copyright and intellectual property issues with NIH. At present, ACS has more than 3,000 manuscripts awaiting deposition.

During the 2005-2008 time period, NIH PubMed Central has accepted unauthorized postings of ACS copyrighted material, and repurposed and openly displayed such postings without adhering either to NIH’s own policy guidelines, or terms and conditions as set forth to NIH by ACS as rights holder. Issues of concern to ACS remain unresolved and will continue to be problematic and exacerbated under the new mandatory policy as outlined in NIH’s implementation plan issued on January 11, 2008.

ACS hastens to point out that the vast majority, if not all, the Society’s copyright and intellectual property concerns could be resolved if NIH would abide the original intent of the Public Access policy and post without alteration or modification the unedited author versions of peer-reviewed manuscripts on PubMed Central—without any reformatting, repurposing or modification or any mirroring of content to third-party websites—and simply link back to the final published article as the authoritative version for readers on the Society’s own website.

ACS commends the NIH for announcing a public comment process on its planned mandatory policy implementation through a Request For Information notice but questions the logic of proceeding with the announced implementation of the mandate on April 7, 2008 when the timeline for public comment submittal and the NIH’s response and possible amendment of the policy may not be complete until sometime in August 2008.

ACS has submitted much more detailed comments for NIH’s consideration at its designated website -- PublicAccessComments@NIH.gov

The Alliance -- a coalition of more than 80 research organizations, libraries, patient groups and consumer advocates -- believes that the NIH Public Access Policy will facilitate the ability of researchers, physicians, clinicians, health care professionals and other members of the public to access, share, and use the results of this research. Faster and wider sharing of NIH-funded research will enable scientists to build upon it more quickly, accelerating the pace of discovery and speeding the translation of this knowledge into public benefits. This will have a profound effect on the advancement of scientific research and the improvement of public health.

The Alliance is pleased that the NIH has published implementation guidelines in a timely fashion, and our member organizations are actively working to raise awareness of the policy to ensure effective compliance within the communities we represent. Our organizations have also been developing and promoting mechanisms to help researchers prepare for manuscript deposit as well as to ensure they retain the necessary rights to comply with the policy, in accordance with current copyright law.

We are particularly pleased to note the growing list of over 300 journals (listed on the PubMed Central Web site) that have indicated their willingness to support the policy by facilitating the deposit of manuscripts -- and, in some cases, final published articles -- on behalf of NIH-funded researchers.

We believe the terms of the new NIH Public Access Policy reflect a reasonable balance of stakeholder interests with one exception: the Alliance urges the NIH to shorten the maximum time frame for this material to be embargoed from 12 months to six. A six-month embargo -- which has already been adopted by biomedical funders in Canada, the U.K., and the European Union -- better reflects the rapid pace of discovery in biomedical science and more effectively addresses the public’s pressing need for access to this publicly funded information.

MLA is pleased that implementation of the newly revised policy is on schedule and is working with members of the medical library community to support implementation of the new policy.

MLA is a nonprofit, educational organization with more than 4,500 health sciences information professional members worldwide. Founded in 1898, MLA provides lifelong educational opportunities, supports a knowledge base of health information research, and works with a global network of partners to promote the importance of quality information for improved health to the health care community and the public.

Mark E.Funk,AHIP,President,Medical Library Association,Weill Cornell Medical College, Samuel J. Wood Library, NY, NY

Therefore, NIH would be well advised to proceed very carefully prior to implementing this new policy to ensure sufficient time to obtain and review input from key stakeholders. 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.”

Rather than take precipitous action, NIH should delay implementation of the public access policy for six months consistent with its own stated time frame to review comments arising from the RFI (i.e., March posting of RFI with 60-day comment period followed by 120 days for NIH to respond to comments and announce any amendments of the policy). It truly makes no sense and is highly questionable process-wise to seek informal input from the public at the end of March, implement the policy effective April 7, review the public comments, and then announce possible amendments to the policy six months later. Furthermore, if the policy were still to go into effect on April 7th, it should not apply to any grants issued before that date, counter to the current NIH guidelines that apply to NIH grants or cooperative agreements “active” in FY 2008 (which began on October 1, 2007). Otherwise, this policy would involve an unfair, retroactive imposition of grant terms and conditions that could extend back for years prior to the official April 7, 2008, implementation date.

To address these concerns, NIH should stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents the sole funding for the scholarly work. NIH should also 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.

The NIH policy does allow for the use of grant funds for the payment of publication fees for NIH-funded authors. Yet, it is not clear whether this refers to page charges or a more comprehensive fee per article payment. In this context, it should be noted that behavioral science publishers, unlike their colleagues who publish in the biomedical sciences, do not currently receive page charges for published articles, which can be quite substantial (e.g., as much as $850 per page), from authors through their designated grant funds. Thus, NIH needs to either set aside funds to make direct payment to publishers or to include publishing costs in behavioral and social science research grants (which NIH does not do at the present time).

With respect to the first option, would it be possible for publishers to undertake direct licensing arrangements with NIH to deposit copyrighted work on behalf of authors? Would NIH be able to negotiate the terms of these licensing agreements like other non-government funding agencies have done, such as the Wellcome Trust and the Howard Hughes Medical Institute?

How does NIH propose to ensure that the postings in PubMed Central will not devastate the copyright interests of publishers, the value that they add to the research, and the interests of the public in maintaining the quality of scientific publishing?

Over the past 25 years I’ve collected over 200 articles on PJS by traveling many miles to medical center libraries. While the photocopy/printout costs are reasonable – this is time consuming and taxing for someone who is seriously ill. The alternative, to print out articles from a computer, is prohibitively expensive. It’s difficult to judge the value of an article from a PubMed abstract. Spending a dollar or two for copy/print costs is one thing, spending over $30 is another.

Public Access will help physicians as well as patients. Easy access to recent journal articles will help them keep up to date on research and treatment options – an invaluable aid whether treating patients with rare or common illnesses.

Thank you for considering my comment, Stephanie Sugars

NIH research is publicly-funded and taxpayer-supported and yields important and timely scientific information. Open access will ensure that NIH-funded research is readily accessible to the research community, faculty, students, and the general public. Students and faculty will use PubMed Central to bolster their engagement in scientific learning. Researchers will continue to benefit from the peer review of their research and the prestige of journal publication while their research receives broader exposure to scholars and citizens alike.

We support this important national initiative.

William Sharp - Director, Research Integrity, Office of Research and Graduate Studies; Deborah Ludwig - Interim Assistant Dean, KU Libraries; Holly Mercer - Coordinator for Scholar Services, KU Libraries

The Prader-Willi Syndrome Association (USA) supported the legislation that became Division G, Title II, Section 218 of PL 110-161. As because Prader-Willi syndrome (PWS) is a rare disease, families of those with PWS have an avid need for relevant health information. NIH plays a significant part in funding the creation of such knowledge, and the Public Access Policy will therefore help thousands of families including those with PWS.

Clearly it will be desirable for relevant journals to assume responsibility for submitting covered articles (or, ideally, all their articles regardless of source of funding) to PubMed Central to remove this burden from individual researchers. To the extent that NIH can ease the submission process or provide incentives to publishers to submit these articles directly, those would be positive additions to the current policy.

Also, NIH should take steps to ensure that if publishers impose costs upon NIH-funded researchers to comply with this policy, these costs do not unduly diminish NIH or other funds available to researchers for their funded research.

Craig

***************************************** Craig Polhemus Executive Director Prader-Willi Syndrome Association (USA) 8588 Potter Park Drive, Suite 500 Sarasota, FL 34238 Voice (800) 926-4797 ext. 720 Direct line (941) 487-6720 Fax (941) 312-0142 www.pwsausa.org cpolhemus@pwsausa.org *****************************************

I want to be a smart consumer of health care. To do that I need access to all available research. Make it public!

Familial Periodic Paralysis is often misdiagnosed and difficult to understand. Patients appear healthy until their muscles fail to contract and they become paralyzed. This paralysis attack can happen anywhere, at anytime, and can be quite dangerous.

In the beginning there were three known variants of Familial Periodic Paralysis. Now researchers are working to identify many more variants and mutations.

We need free access to NIH funded research because of the financial barrier that prevents ordinary people like me from reading important ion channel research. My reading and deciphering of abstracts and literature has helped hundreds of patients worldwide. All of my work as a patient advocate has been completely voluntary.

With free access, it would allow more patients and their advocacy groups to help open communication with their doctors. It will allow more interaction between patient, doctor, and researcher. Patients and doctors would be better informed about the most recent research. Overworked healthcare worker currently do not have time to research each specific disorder their patients suffer from. Free access opens communication between the three most important groups: patient, research, and physician. Currently, the conduit of information from research group to physician is quite long. Allowing access to NIH funded research shortens that conduit from years to weeks. Please consider the disabled, hurting patients who will gain the most. Financial gain is not always the greatest reward. For me, personally, my research has kept me out of a wheelchair. I no longer use a cane. My last ER visit, via ambulance, was three years ago. I can keep up with my 11-year-old daughter. All of this happened because I was able to find answers hidden deep in NIH and MDA funded research.

Familial Periodic Paralysis is often misdiagnosed and difficult to understand. Patients appear healthy until their muscles fail to contract and they become paralyzed. This paralysis attack can happen anywhere, at anytime, and can be quite dangerous.

In the beginning there were three known variants of Familial Periodic Paralysis. Now researchers are working to identify many more variants and mutations.

We need free access to NIH funded research because of the financial barrier that prevents ordinary people like me from reading important ion channel research. My reading and deciphering of abstracts and literature has helped hundreds of patients worldwide. All of my work as a patient advocate has been completely voluntary.

With free access, it would allow more patients and their advocacy groups to help open communication with their doctors. It will allow more interaction between patient, doctor, and researcher. Patients and doctors would be better informed about the most recent research. Overworked healthcare worker currently do not have time to research each specific disorder their patients suffer from. Free access opens communication between the three most important groups: patient, research, and physician. Currently, the conduit of information from research group to physician is quite long. Allowing access to NIH funded research shortens that conduit from years to weeks. Please consider the disabled, hurting patients who will gain the most. Financial gain is not always the greatest reward. For me, personally, my research has kept me out of a wheelchair. I no longer use a cane. My last ER visit, via ambulance, was three years ago. I can keep up with my 11-year-old daughter. All of this happened because I was able to find answers hidden deep in NIH and MDA funded research.

It is sad that cancer patients are often the LAST ONES to be able to access results that could very well serve to save their lives.

I daresay, those who are opposed to free access would very quickly change their minds if THEY were struggling with a life threatening cancer!

The Library of the University of California at Berkeley is strongly supportive of the NIH mandate as both good public policy and a research-friendly regulation. Berkeley-based research contributes to solving national and global health problems. And Berkeley libraries are a key conduit for information flows.

To cite one example, our Public Health Library serves roughly 750 active users of health research, including California state government agencies such as the Department of Public Health, Department of Health Care Services, Department of Toxic Substances (Cal/EPA), and Office of Environmental Health Hazard Assessment (Cal/EPA). (On a personal note, the mission here is exemplified by the career of Berkeley’s distinguished Public Health graduate, Dr. Julie Louise Gerberding, Director of the Centers for Disease Control and Prevention.) Some 15,500 requests for materials are received per annum in the Public Health Library from researchers. Opening up access to even somewhat dated research from NIH-funded projects will aid immensely in the health-related study in the interest of public health that goes on at campus and government agencies in California.

We see no problem in ensuring that our researchers with NIH funds meet the requirements of the new law. Modern librarians prize assignments to make scholarly communication more available in the society that funds research. The Library is currently working with our Sponsored Projects Office and Office of Research to ensure that all NIH grant recipients are aware of the new rules. As part of this coordinated strategy, the Library has developed an informational webpage with key dates and requirements at http://www.lib.berkeley.edu/scholarlycommunication/nih_mandate.html

We also note that the University of California’s Office of President has issued a "Compliance Memo" to all UC campus research administration officers, including our Office of Sponsored Projects, outlining steps to be taken ensuring a consistent approach across the ten campuses of the University of California.

Thomas C. Leonard University Librarian Professor in the Graduate School of Journalism University of California, Berkeley

The American Society of Plant Biologists (ASPB) is a non-profit society of 5,000 scientists. ASPB publishes the two most frequently cited journals in plant science: Plant Physiology and The Plant Cell.

ASPB is concerned that the published policy of the National Institutes of Health (NIH) on submissions to PubMed Central is not consistent with the provision on access passed by the Congress.

The relevant provision of the law passed by Congress is found in Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008). This provision of the law states:

SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

Copyright law

The law clearly states the importance of protecting publisher’s copyright ownership. The law says, “Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law." Implementation of the access policy is contingent upon this provision. It is not consistent with copyright law for NIH to mandate submission of copyright-protected articles to a federal publisher website, PubMed Central, without the agreement of publishers’ who hold copyright to the articles. NIH needs to revise its policy to remove mandatory submission of publisher’s articles to PubMed Central.

Congress Addressed “Manuscripts” – not “Articles”

Despite the reference to “manuscripts” in the law, NIH policy refers to scientists submitting “journal articles” to PubMed Central.

NIH needs to amend its policy to include the language used by Congress in the Consolidated Appropriations Act. Congress clearly used the word “manuscripts” and at no time used the word “article.” The term “article” refers to the finished, completely edited document that is submitted for copyright. In comparison, a “manuscript” is not a fully edited document. The NIH Policy is out of compliance with the law by calling for submission of “articles” instead of “manuscripts.”

This NIH Policy will threaten the viability of some publishers. Readers will soon learn they can read the publisher’s articles for free on PubMed Central instead of paying for them in a publishers’ subscription. Some readers will decide not to renew subscriptions, because they can read the articles for free on PubMed Central.

Thank you for the opportunity to provide these comments. Please let us know if we could provide further information.

Sincerely, Gary Stacey, Chair ASPB Committee on Public Affairs