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

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.

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.

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.

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.

I want to thank the NIH for their openness to comments from those of us who have a primary interest in the availability of scientific research. We support the Public Access Policy (NOT-OD-05-022) as currently articulated, because it will expand access by our faculty and students to NIH-funded research, accelerate research on our campus, contribute to our core mission as a research-based undergraduate institution, improve access for other institutions with fewer financial resources to important research, and ensure that citizens of this nation are able to get and use the results of the research their tax dollars have paid for.

Those who have opposed the legislation that led to this policy and who have demanded that an additional period for comments be opened have made false claims that the policy will result in the cancellation of journal subscriptions en masse. As the person responsible for purchasing these subscriptions, I can assure you that this is not the case. The fact that public access is not required for 6-12 months after publication means that we will continue to subscribe in order to obtain the results of research as soon as it is available. We know full well that crippling the scholarly publishing industry would not be in our interest, our faculty’s, or our students’.

As implemented, it's horrific, arguably a violation of the law (poorly written in any case, and - even where NOT a direct violation of the law - ham-handed, counterproductive, and set to waste massive amounts of very scarce NIH $$$ to achieve the portion of the underlying objective that is laudable.

Rec #1 -- Work more constructively than you have with the many scientific societies whose journals provide open access to the information after a reasonable period (6-12 mo) post-publication. For instance, accept their offer of invisible autolinking from High-Wire (or their own WWW sites, autolinked already from NLM PubMed) to PMC (sneakily named PubMedCentral - distinct from PubMed). In addition, just program an autodownload conversion from PubMed entries (and their active journal links) to PMC, which don't become activated until investigator performs one simple click within 12 mo of publication date (or earlier, specifying a length of Embargo period).

Apart from those that already are on the NIH list of journals taking care of PMC transmission of papers on behalf of investigators, there remain two classes of journal: a. those that already make the information openly available to all with WWW access within 6 or 12 mo of publication, and therefore achieve your present objective, versus

b. those that do not, and may be almost impossible to drag into doing so because of their unique branding and (over)weighting in the cultural consciousness of medicine or science [i.e., NEJM, Nature and baby natures, Cell and baby cell press journals].

If you work constructively, instead of the current obstinate obstructionism, to bring journals of group a into the fold, the mass of high-value content will increase the pressure on the hold-outs.

2. Provide a clear path whereby scientists can use a PMID and embedded link {rather than a PMCID; heuristic point = PubMed and PubMedCentral are different units} in those instances where the open access need is already met as a matter of course. [Didn't Congress' appropriation include a specific point to the effect that "open access, as long as it does not violate copyright law"? So, NIH wants to implement things about like Mafiosi or the like (with the metaphorical gun to the head): don't publish in journals with concerns about PMC, too bad if your paper was under review at a journal with "non-compliant" copyright policy and got accepted April 10, and it's all your problem - we'll just make you certify that you were compliant.

Similarly, grant applications, progress reports, and other forms of reporting should allow ANY open access link that Congress, staff, NIH officials, other govt officials, reviewers, and the public can all use. [Is it not true that under current Federal Law, the simplest and lowest cost means of achieving compliance with the requirement incorporated into the appropriation is MANDATED?]

3. Better clarity, simpler path to compliance, and acceptance with no further action on the part of the investigator.

I previewed the site, having just had a paper accepted into a journal that apparently will take care of the upload within 6 months of publication, but I see no reason to spend an extra $700 of scarce and precious taxpayer money to select their "Open Access Option", and in the meantime (nest 8-9 mo), what's the PMCID? Am I supposed to sit around deemed 'non-compliant' even though I am or will be compliant?

First, honestly consider and implement ways of using PubMed / PMID with autouploads to PMC as a mechanism - the simpler things are, the less the time, and the more transparent (and less high-handed) NIH behaves, the better the compliance will be).

Second, as noted above, monitor whether the NIH-funded investigator’s work becomes publicly accessible (free of charge other than internet access) within a year of publication date (or, in cases when journals use an e-publication date that is earlier than the print date, set the clock going at the ePub date.

Third, minimize the loss of precious $$$ that will be wasted on pig-headed insistence on imperfect, cost-wasteful means of implementing the policy by using accepted principles of statistical sampling (auditing) for purposes of reporting to Congress on the progress each year from 4% compliance (NIH Open Access voluntary) to xy % compliance (Open Access mandatory).

Fourth, during at least the first two years, monitor and ensure compliance in line with principles used for monitoring and accepting compliance with laws such as the speed limit on interstate highways (speed kills, short-term shortfalls in public access do not).

If the NIH and Congress are really serious about enhancing research, and making taxpayer $$$ be used in the most effective ways possible, it should direct its effort more toward effective enforcement of the mandate that unique reagents (mouse lines, plasmids, etc) be shared in a timely and effective manner, in line with written investigator assurances that they will do so [and, for that matter, better screening for overlap in funding between R01’s and PPG’s, etc] than toward the flawed NIH choice of system for achieving Open Access.

a. how much the chosen mechanism will cost to implement (as opposed to incorporation of alternative approaches), including not just the servers and the I.T. support but also the direct and indirect costs charged in the cases where desirable journals (e.g., those that impress grant reviewers) start charging several thousand $$$ for the alternative of having author own copyright – see testimony already logged in response to this RFI) AND a reasonable estimate of the increases in page charges that publishers inevitably will start charging to defray the shift in revenue away from subscriptions – extra page charges that will be shouldered by NIH funds and subtract from the real goals, which are getting and disseminating new data and insights, followed by flow of those insights into better health.

b. how many aggregate NIH $$$ will be spent to cover the direct and indirect cost component of having this dumped on investigators and covered as a direct cost to the grant (as opposed inclusion of an automated system at NIH that is based on PI’s submitting PMID and an NLM computer program pulling the open access text in instances where it was already available, and simply requiring that the PMID be submitted between time of publication and 12 mo thereafter) (number of papers per year x $75 / hr (a low-end estimate of direct + indirect cost of PI time) x at least 60 min / paper -- US government estimates of how little time things take are always ludicrously on low side because of legal mandate that policies be cost-effective; uploading takes longer than 15 min, and then there’s the follow-up emails, the inevitable screw-ups of conversions, etc) [10,000 papers per year would mean at least 2 R01’s gone, which these days means 2 scientists gone; probably 4 gone is more realistic as, after queries and re-edits, this may take 2 hr per paper on average]

c. how many R01’s of average size will not be funded per year because of this form of implementation and construction of PMC (after y’all presumably asked Congress specifically to name PMC as the mechanism for achieving the goal of allowing public to view the fruits of research they funded)?

2. Send an email to all NIH grantees with each of the information links embedded in text, and with each of the instruction presentations attached (slide show on public access policy, 15 slides; NIHMS System Slide Show).

Among hidden costs – 1. more NIH-funded scientists just saying ‘screw it’ (international competition for scientists) 2. one more bit of bureaucratic creep and reason to advise talented young folks to steer clear of scientific career 3. probably large amounts of money diverted away from actually doing science. 4. Top-quality peer-review (and other aspects of NIH) depend on mutuality with the PI community, and constantly dumping on us or taking such high-handed approaches is not likely to foster the spirit that enhances other NIH needs. And more . .. .

that said, if it were implemented better A reasonable general notion – that the taxpaying public (and congressional staff, etc) should, within a reasonable period of time, have access to articles representing the fruits of the support. A reasonable general notion, that building access with some database characteristics might help NIH get a better handle on its own portfolio and help its program and scientific review officers a bit.

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.

I can not find out what a "PMCID" number [NIH info] is versus the "PMID" I see associated with my articles in PubMed - is there a difference?

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.

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?

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.

>>>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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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.

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.

What do you recommend? How can we comply with the law for adding the PMCID # to articles in grants that were published after April if we don't have a PMCID for the article and can't add it to the system to get a number?

2) Find some way to establish greater access to NIH-funded articles that pre-date the April 8, 2008 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.

Is the version of record going to be the PMCID HTML file, the PMCID PDF version, or the publisher's version? Will having three versions out there affect the way authors cite the resources within their papers?

If, after an article is published on PMC or in a journal, a mistake is found, how are corrections (or retractions) handled?