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

As an indicator of our overwhelming support for the Public Access Policy, we proactively held a symposium on March 10 on policy implementation and compliance. This meeting brought together librarians, medical school personnel, university research administrators and faculty to ensure that GWLA-member institutions were on schedule to meet the April 7th compliance deadline.

The consensus of the symposium attendees:

1. GWLA-member libraries unanimously support this policy. 2. We are confident the policy will not harm the peer review process. 3. We believe the policy will increase the use and usefulness of the research conducted on our campuses. 4. We advocate for the shortest possible embargo period. 5. We urge NIH to keep the policy deadline firm at April 7, 2008. Administrators at GWLA-member institutions are working out the compliance workflows and communications infrastructure issues at each campus, and are confident they will be prepared for the deadline. 6. We urge the expansion of this policy beyond NIH to all federally-funded research. One faculty member in attendance said he “can’t wait until this policy applies to my discipline.”

The Kabuki Syndrome Network, an entirely volunteer group of parents, has been a lifesaver for so many of us, providing information and advice as we face the many challenges of life with our children. So 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, 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.

Stacey

On behalf of our 25,000 members, NEAVS, a national animal protection organization, strongly supports the NIH Public Access Policy. As a not-for-profit organization, we have an on-going and important need for information regarding current research. Such information is necessary to fulfill program needs that are consistent with our mission -- a mission that is funded by our members' donations (the vast majority of whom are tax paying U.S. citizens). Having to pay for access to publications that result from biomedical research that was already paid for by public tax dollars is not only costly and a burden on our budget, but is an unfair double expense for our supporters. Further, the current process to access such information is not only costly but lengthy and cumbersome. To effectively do our work and maintain our fiduciary responsibility to our supporters, we need to be able to access publications even sooner than the current allowance of 12 months. Science moves quickly and obtaining current information is critical to fulfilling our mission. Additionally, we believe that through FOIA, the American public should have access to all information regarding animals in NIH funded research, even if such research is being done on animals housed in private institutions. The loophole that has allowed institutions that receive private and public funds to side step FOIA as well as state sunshine laws, has prevented proper monitoring, evaluation, or other critical thinking regarding what is and is not resulting from the billions of dollars of tax payer money that are spent each year on research. Further, the American public reluctantly supports animal research only when there are no alternatives, and only if they are assured humane treatment and freedom from pain and suffering. All Americans, including publicly supported not-for-profits who work on their behalf, should have free access to research publications. Thank you.

The Kabuki Syndrome Network, an entirely volunteer group of parents, has been a lifesave for so many of us, providing information and advice as we face the many challenges of life with our children. So 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, 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.

A nation subjected to ever increasing healthcare costs cannot ignore any longer the positive national financial impact of OA self-archiving as is required under the Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research.

As is amply clear in so many of the comments made in the last few days, patients suffering from cancer and of rare diseases have already understood that knowledge is power. For those suffering from rare diseases, the higher the level of functional health literacy, the more they are able to truly partner with the few specialists in their condition and obtain optimal care. Access to full text peer-reviewed publications representing the current state-of-the-art knowledge can easily make the difference between life and death. That fact alone is sufficient to strongly support OA policies.

We just hope that, after an initial period to pilot the implementation of the new policy, the next step will be a reduction of the 12-months period to a 6-months period and then to a 3-months period.

Stephen R. Sprague Staten Island, NY

Such access is particularly important to cancer community leaders and patients with advanced cases, like me. I have attended about a half dozen FDA hearings and have delivered oral statements at several. I have also attended four national conventions on prostate cancer, have been a Scientist-Survivor Program participant in 2005 and 2006 in the program sponsored by the American Association for Cancer Research, have been a consumer reviewer for peer reviews by the Prostate Cancer Research Program of the Congressionally Directed Medical Research Program in 2006 and 2007, and am a director of the Virginia Prostate Cancer Coalition. I am on the web and internet daily with other patients and caregivers.

I make great use of PubMed, but I find that access to complete papers often adds great value to understanding and follow-up communication. Studying complete papers also enables survivors to participate meaningfully in current medical issues. Online access means I won't have to put off research until the next time I can fit in a trip to a medical library, and it will also be less time consuming. These are important benefits.

Withholding access for a year, as proposed, should not be a significant hindrance to cancer community leaders like me, but it should preserve the subscription base for medical publishers. To me, that makes the proposal a win-win proposition. Providing access to the public as proposed will also have the important benefit of increasing the salience of Federally funded medical research. This is very important. As a prostate cancer community leader, I find that most survivors, let alone the general public, and most politicians have a grossly inadequate concept of the important role played by Federal funding. Among other benefits, having online access will let us quote and refer key parties directly to important research.

Please provide public access.

bottom line: cancer patients can't afford to wait a year or more to gain access to results that could impact the decisions we are currently faced with.

due to the limited availablilty of current study results.... i would not have survived my bladder cancer battle without the knowledgeable support of the members of the awesome acor.org bladder cancer cafe.

while I am exceedingly grateful to have found this group, it is a sad commentary that individuals cannot access study results that could very well end upsaving their life

We applaud the Congress in its wisdom for enacting the policy expressed in Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008and National Institutes of Health (NIH) for implementing this mandatory open access policy.

Consumers must be empowered to make medical decisions about their health and that of their loved ones. Especially for those with rare diseases, the cutting edge research performed at NIH provides insight as to the nature of these conditions and can provide medical professionals with further insight on possible treatments and interventions.

However, access to these vital research findings has been limited to the elite few who may have costly subscriptions to journals containing published research results. As a result, consumers have been forced to add to their suffering, beyond their disease and need for knowledge, to financial struggles as well, in an effort to access these findings.

The consumer community was heartened with NIH’s voluntary policy two years ago to deposit research findings into a free, online database. However, less than 5% of individual researchers elected to submit their findings. As a result, public access to research findings was impeded. Quite obviously, this is not an area that will thrive with voluntary submission.

The mandatory policy directed by Congress in recent fiscal year 2008 appropriations legislation is a necessary step to ensuring that NIH tracks its investments and corresponding results in federally funded research, has a complete archive of this research, and enhances public access to these assets. Genetic Alliance supports resource sharing, community commons and strengthening of the broad networks empowered by information. This is a strong step in a direction that will enable novel partnership to accelerate translation of biomedical research into better health.

American taxpayers are entitled to open access. Widespread access to the information contained in these articles is an essential, inseparable component of our nation's investment in science.

Genetic Alliance’s network includes hundreds of disease-specific advocacy organizations, in partnership with universities, companies, government agencies and policy organizations. The network is an open space for thousands of shared resources, creative tools, and dozens of focused programs.

The organizations we represent have varied needs: technical assistance, building and maintenance of robust information systems, and public policies that promote the translation of basic research into therapies and treatments. In particular, Genetic Alliance identifies solutions to emerging problems and works to reduce obstacles to rapid and effective translation of research into accessible technologies and services that improve human health.

Advocacy organizations such as those we represent lead entire research endeavors, and so spend countless hours building research consortium, developing registries, managing blood and tissue banks and initiating and managing clinical trials. Despite our nation's significant spending on biomedical research through NIH, these organizations face numerous hurdles in accessing articles that report the results of this taxpayer-funded research. We uniformly pay $30 ad more per single article.

We should not spend hundreds of extra dollars each year to simply access the results of research funded by our tax dollars. Open access policy is a necessary step in the right direction. In fact, we believe that 12 months is too long. Information as critical as this should be available immediately. Understanding that there are logistical issues and also acquiescing to the need for a transition period, we support a 6 month period at this point, and look to the day when we can access these results immediately upon publication.

We applaud Congress for mandating deposit of NIH-funded research findings into a free, online database.

Publishers' profits should not take precedence over free access to valuable health research data, assuming the research wasn't done only for the the investigators' need to publish. The 12 month period is too long; New England Journal of Medicine is only 6 months.

We do have concerns about some of the challenges to implementation raised by the submission and compliance process as currently in place. Our authors, as is true throughout the academy, submit directly to journals without going through any university office, making tracking full and complete compliance difficult. Foremost among logistical concerns is with the required author approval of the XML-tagged version before the author can obtain a PMCID number. We look forward to working with NIH and the research community to resolving these challenges and developing an increasingly smooth process for implementation of this policy.

By having this available, it keeps me informed of what is happening out in the world of cancer research so I as a care giver can asset the medical care available.

Needless to say that all medical costs are extreme and to add another fee on top of this for valuable information would be another financial burden. Thank You.

1. Since PMC will compete with publishers’ own websites as more PMC content overlaps with content on publishers’ sites, how will NIH maintain the primacy of the publishers’ websites and ensure that the manuscript on PMC does not displace or act as a substitute for the final published journal article, i.e., the authoritative version of record, which resides on a publisher’s site? Will NIH work with publishers to ensure that readers know and are directed to where the final published versions can be obtained?

2. Many publishers provide free access to authors’ manuscripts or final published articles twelve months after publication or even sooner. NIH does not consider this access compliant with the NIH policy. Would NIH consider including author manuscripts only in its administrative database and archive, while providing public access via display only through publisher sites? If not, what is the rationale for maintaining an unedited manuscript for public consumption if the final, authoritative version has been made available for free access on the publisher’s site?

3. What will NIH do in cases of noncompliance with its policy guidelines? What action will be taken when a grantee’s article is published, but NIH is not provided with the peer-reviewed manuscript? What actions will be taken against noncompliant grantees when they apply for future NIH grants?

4. How does NIH anticipate securing and sustaining a source of funding to maintain the database of articles that will accumulate over time, including costs to migrate to new platforms? Under the new policy, US taxpayers will be funding public access to science to any person anywhere in the world with Internet access. Has the NIH considered the ramifications of providing such international access, and how this might affect national security or other US government trade regulations?

We look forward to the public meeting at NIH on March 20 and the upcoming RFI proceedings, but considering the far-reaching implications of the substantial change in the NIH public access policy, we urge HHS and NIH to do a full Notice and Comment Rulemaking. We believe that the public and the publishing community should be given an opportunity to comment on the content of the new policy before it goes into effect. We urge HHS and NIH to hold off on implementing the policy until after the Notice and Comment proceedings have been completed.

We also look forward to a more formal process for working closely with NIH to implement the new public access policy.

1. How will NIH ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking, or otherwise changing the articles do not undermine the rights, added value and interests referred to above?

2. How will the policy protect against distribution of copyrighted materials to other sites around the world besides PubMed Central?

3. How will NIH address possible objections or concerns from copyright owners who do not assent to the public posting of their material on PubMed Central and its related international sites, or who have concerns about the enforcement of copyright located on and delivered from those sites?

4. Publishers recoup the expense of peer review, production, and distribution by several means, including commercial sales. When copyrighted articles are freely available online, their commercial value can be eroded. How will NIH ensure that the policy will protect publishers’ intellectual property assets, retaining the commercial value of the copyrighted articles?

5. Recognizing publishers' copyright and investments in peer review and publishing, does NIH plan to supplement its grant funds to sponsor public access to the manuscripts? If yes, how will such funds be identified in the grant, and what has NIH budgeted per year for such incremental costs?

6. How will NIH ensure that the articles on PubMed Central meet with publisher requirements, such as the access-control period, and that the policy actually applies to the articles that NIH is posting?

7. How will NIH prevent piracy of the articles from PubMed? Will NIH monitor for mass downloading of posted articles by single users? How will NIH work with publishers in the event that copyrighted articles are pirated from PubMed Central? If NIH finds that articles have been subject to piracy, how will NIH notify the publisher and provide any information NIH may have about the infringer? Will NIH provide for review and revision of the public access policy if piracy occurs from PubMed Central or the other international repositories connected with PMC?

8. How will NIH ensure that the articles on PMC maintain the publisher’s branding, and if applicable, the corresponding disclaimers and notices so that publishers can preserve their brand assets and manage their liability appropriately?

Such information can be essential to people seeking information about illnesses that they have recently been diagnosed with. They often need the latest and most up to date research information to have a chance to save their lives.

1. How has the policy that NIH announced on January 11, 2008, only weeks after the legislation was signed into law, incorporated publisher input, and how will NIH incorporate the concerns of publishers as it moves forward?

2. We would like to work with NIH toward an effective and fair implementation of this policy. We propose that a task force or advisory group, co-chaired by NIH and publisher-designated representatives, be vested with the requisite authority and responsibility to propose procedures for implementation of the policy mandate.

3. In the NIH Notice of Jan 11, NIH notes that “institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.” Why would NIH place grantees in the position of negotiating with publishers in the complex world of copyright law? Why not reach agreements with publishers regarding payment for their journal articles, so as to remove from authors the administrative or financial burden of compliance with the policy?

4. The policy will have a negative impact on publishers, many of whom are small professional societies, because with their copyrighted material freely available on PubMed Central, subscription or other article-related revenues may well decline. What is NIH’s plan to track possible harm to publishers, especially small societies? If harm is found, how does NIH plan to remedy it? Does NIH understand the basis for publishers’ concern about such possible harm and its impact on publishers’ willingness to invest in promoting the integrity and widespread availability of the scientific literature?

5. What are NIH expectations of its grantees with regard to ensuring that PMC postings of material will not diminish the rights that are acquired by publishers in that material, the value of the publishers’ added contributions, and the interests of authors?

6. Will NIH provide publishers with detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? It is not clear from current NIH policies and procedures how publishers may obtain detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage on their own web traffic and subscription or other article-related income.

I fully support the policy that implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which 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 madepublicly 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."

I fully support the policy that implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which 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."

Sincerely, Shanon M. Burke

Government funded research is extraordinarily important. But tell your researchers that they don't have to publish in the NEJM, Science, or other journals that are fighting to make a buck here.

PLEASE MAKE ALL ARTICLES RESULTING FROM NIH FUNDED RESEARCH AVAILABLE IMMEDIATELY AND ALSO MAKE IT MANDATORY THAT IT BE EASY FOR PARENTS OR PATIENTS DOING INTERNET RESEARCH TO FIND THE FREE VERSIONS RATHER THAN BE SUCKERED INTO PAYING.

THANKS

By having this available, it keeps me informed of the latest information so I can be a patient who is an asset in my medical care.

Medical care costs are extreme...to add a fee for this valuable information is unreasonable in my estimation. Thank you for the opportunity to comment.

As the Associate Director of the National Network of Libraries of Medicine, Middle Atlantic Region, I am working in collaboration with one of our resource libraries in offering online courses in the NIH Public Access policy and demonstration of how the policy has been implemented at one library. The course will be available to librarians and researchers throughout four states: New York, New Jersey, Delaware and Pennsylvania. We will promote the availability of tutorials and training materials on the NIH Public Access site.

Thank you for the opportunity to comment on the NIH Public Access policy.

Since I am a taxpayer, I would like to have access to the information we Americans have funded.

Thank you,

Bruce

WHY THE LEEWAY OF ONE FULL YEAR??

The published results should be FREELY ACCESSIBLE IMMEDIATELY!

Others have mentioned the fact that closing access to this research is in essence causing double payment for citizens. Additionally, the research that is funded by taxpayers has a very concrete benefit - it often relates to improving health. An educated society also tends to allow better decision-making, which in this case could save lives. Please continue to focus on citizens' rights and health by supporting this legislation.

Medical libraries are increasingly e-based. Hard copies of recent research are increasingly difficult to find. For the US government to aid in any way in the current ransom system is indefensible.

12 months is well too long. Government funded research should be available to the patient community immediately.

Yes. I'd like to see complete public access to all NIH funded research articles and studies. I belive it's in the public interest.

Thanks.

HW

Please do it.

Regards, Dan Martin

One cannot react without knowing what is going on, In the world of rare disease, it is vital that we know what and when things are happening. Time is not on our side.

Thank you for this opportunity,

Muriel Finkel President Amyloidosis Support Groups Inc. ASG www.amyloidosissupport.com Toll Free 866-404-7539 Organization Member of NORD www.rarediseases.org

Respectfully, Douglas Jardine, Ph.D, MFT (prostate cancer survivor) Sandy Jardine, M.S. LPC (wife) We are both relationship therapists who counsel individuals and couples with life-threatening illnesses.

It is clearly in our interest, in the interest of scientists and the public at large that access be granted access to the full articles reporting on taxpayer supported studies at the earliest possible date. What conceivable public purpose is served by withholding this information?

Please make it easy for those of us trying to make a difference.

But Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) is flawed:

". . . made publicly available no later than 12 months after the official date of publication . . . ."

1. There should not be a "no later than 12 months" time period. The articles should be available when published, not only in abstract as they are now on PubMed. The articles are available for a fee at that time now. Our tax dollars have paid for the research and it is illogical under this Act to not make it available as soon as it is published; it is ours. When confronted with any disease time is of the essence.

2. Since there are other taxpayer funding sources for research than NIH, the Act should apply to all taxpayer funded research.

Once more politician have acceded to the pressure of lobbyists.

The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which 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.

1. Authors, in particular publicly funded researchers, are not mandatorily required to (a)express their conclusions in layman's language, and (b) explain the PRACTICAL medical significance of their findings (its context).

2. Whilst publishers should be free to list, collate and monopolize (copyright) their interpretive analysis/commentary on medical research, they should not be free to monopolize distribution of the raw content - unless they fund that research themselves. Appropriating/monopolizing raw, PUBLICLY funded research is a form of theft - particularly whilst there are free, public data distribution networks in place.

3. Publicly funded research is wasteful in the extreme because it is (a) not adequately expressed in laymen's terms (b) it is often not provided in any context (c) it is not adequately analysed and interpreted by another publicly funded umbrella organisation prior to publication (d) it is not adequately distributed to physicians in a manner akin to that of (say) drug companies.

4. Sponsored research that is favorable to the sponsor is published and vigorously promoted, whilst research that is unfavorable is selectively excluded from being published.

5. Very poor integration between US and non-US-based research in regards distribution of knowledge.

All in all, the dissemination of medical research is hopelessly inadequate. The Internet is an ideal medium for this role, however it requires publishers and preferably Government agencies to collate, interpret and distribute the various data in an open-minded and progressive manner - with less of the pessimistic conservatism that currently prevails. Monopolization of raw content by publishers is just part of the problem. Removing the monopoly will force publishers to add REAL value to that content.

Pete Granger

I think that open access and commercial publishing are compatible (no one would contend that up-to-one-year delay in opening access significantly will impact sales of journals and articles in the science-technology-medicine fields. In fact many publishers currently provide such open access after one year through High Wire based at Stanford University.

We have paid for such reports once by funding the NIH with our tax Dollars. We should not be asked to pay for them twice.

Thank You !

The submissions should be made public (on line) within 12 months.

I am willing to get out the medical dictionary and "translate" these articles on my own if only I could get a copy of them. Looking into a subscription for even one of these journals, I was told it was in the range of $10,000 a year. Why is the public virtually denied the opportunity to read published peer reviewed studies? Why is this so difficult for families with affected children? The doctors don't have time to look up the articles and send to the family but that is the route we are forced to take.

The FDA is highly politicized and does not always make decisions purely in the patients' interest.

The more informed the public is, the more we can push forward to overcome maddening bureaucratic obstacles.

We have already paid for this research through our taxes, we should not have to pay again to see the results of the previously paid for research.

12 months is a long time to have exclusive rights to something that was free initially. I don't begrudge the publications that period to generate additional revenue but their primary income should be from subscriptions and advertising, not the exclusive right to public documents in perpetuity.

All grants from NIH should come with the stipulation that final reports will be published for the public to view. If the researchers do not like the strictures placed on publishing, they can pay for it themselves or find other methods to pay the research.

I have no problems with copyright restrictions placed on other uses of the material, but the public still has the right to view the reposrts.

How can we have an intellectual discussion with our physician if only one of us has access to the latest research.

Free access can be accomplished from simply posting a link on the NIH site pointing to the latest research paper connected to each project. This would require the NIH grant recipient to by simply post a copies of their reports on a public accessible web site.

Those researchers who don't accept this stipulation are free to apply for research grants elsewhere.

Those who violate this stipulation should not be eligible to apply for further grants for one year after discovery of non-compliance with publishing policy. I prefer this penalty rather than prematurely ending the current research grant (assuming the research is meeting its original objectives), because often this is academic research where mainly graduate students academic careers would be adversely affected just because their professor did not ensure that grant requirements were fulfilled.

It will take a few years to implement this policy, so NIH should be lenient in the initial stages, as some researchers are not web-savvy. Often there are many people in the organization, especially if it is a university, who are very web-savvy.

It may take a few cases of enforcement a year after implementation of the guideline before everyone accepting funds gets the idea.

...Tom

P.S. I have never applied for an NIH grant.

NIH is a publically funded institution and all intellectual property rights should vest in the US Government at the time the agreement funding the research is executed.

Any deviation from this policy should be on a case by case basis and individally negotiated. The intellectual property rights policy of the NIH should be consistent with that of other US government contracting agencies and protect the rights of natural citizens.

Any delay in full intellectual property rights received on behalf of the citizens on the US unjustly enriches the research entity.

Permitting the entity receiving government funding to retain intellectual property rights is contrary to good business practices and I believe is not the norm in commercial, arms length transactions unless individually negotiated by the parties.

Alternatively, NIH should advance or advocate for a change to the copyright laws of the US exempting intellectual property rights resulting from US government funded research.

Again this policy would only impact government funded research and should be a quid pro quo for such funding. A researcher that does not agree to share their intellectual property rights has the alternative to seek private funding.

Hugh

Personally, my son's treatment was changed, based on information I found doing research on pub med. That change is now the standard for children with his type of cancer, but he would not have received it if it werent for my access to articles.

The costs of his treatment have nearly put our family in bankruptcy, I dont believe families facing such financial hardships for medical care should have the extra burden of paying for research articles.

As a taxpaying citizen, I believe the pub med articles should all be available for free.

thank you.

As a research oriented patient advocate, I struggle daily to access full articles, both new and old. I am not associated with a university, so I have to scramble and find someone who will provide the article to me.

I would like to see a mandate that any research funded in full or part by NIH or any tax-funded entity, be required to provide a detailed research results article within 6 months of the completion of that research. There should be no waiting period while the journal decides to publish or not, and certainly no waiting period after journal publication. We as the funders of that research, should have access to it first.

The quickest possible free access to articles referring to research and new breakthroughs is of vital importance to those of us suffering from diseases for which there are no cure, or can carry with them unusual risks for other diseases. It was only because a physician friend was able to access articles which I couldn't that I learned that people diagnosed with Chronic Lymphocytic Leukemia are more prone to skin cancer. My personal physician never mentioned this because she said she wasn't aware of that fact. At my request she referred me to a dermatologist who found two cancerous moles. Even he was shocked because I am not fair skinned, have brown eyes and have lived most of my life in WA state where there is not an overabundance of sunshine. Members of the CLL ACOR group can tell numerous similar stories. Information regarding publicly funded research should be made available without charge as quickly as is reasonably possible.

Thank you, Mary Ann Klutenkamper survivor renal cell carcinoma 5/2001 survivor Lung cancer 11/2007

It is entirely reasonable to assume that very few patients would volunteer for clinical trials if the result of those trials were to be withheld from them and their fellow patients.

JR

Thanks.

John Peterson

The proposal to allow private publishers the exclusive right to sell articles for one year after publication seems to me to offer reasonable protection for the publishers involved. The proposal does not completely disregard the publishers, but it does recognize that the public has a right to see the results that they paid to produce.

I believe that there is also a compelling public interest in providing more and better access to medical research. The purpose of this research, and the reason that the government funds it, is to advance medical knowledge for the entire community. Providing free access to this research will benefit all of those who have the knowledge to read it. It will benefit private citizens, students, and doctors in the U.S. who have limited or no access to medical journals. It will also benefit large numbers of students, doctors, and researchers around the world who do not have the hard cash needed to pay for journal subscriptions.

Specifically, currently the information that comes easily online to patients is through Pharma supported organizations ( Medscape, POZ, ViralED, Urotoday etc) and has an inherent bias.

Ten years ago I was diagnosed with a rare autoimmune condition. It took me six months to find the NLM PubMed database, and then I could only view abstracts.

It might help if the NIH/NLM would make it clear to the public that most hospitals have a medical library where full text articles can be obtained free or at nominal cost.

Taxpayers already paid for the research, and should receive easy access to the findings.

I feel the relationship between the doctor and the patient is a trusted partnership. How can we as patients ask relevant questions about treatments when information is withheld from us unless we pay. I appeal to your humanitarian spirit that all helpful information by made available to everyone as soon as it is published. I want to know what treatments are viable and what ones are not before we commit to a treatment route.

Time is one of our enemies...we need information as it becomes available...sooner, not later!

I strongly support making all publicly funded research freely available to the public. Publishers may have an economic interest in restricting such use, but that should not weigh more heavily than the public's need to know the results of publicly funded research.

2. As a speech pathologist research that would benefit my treatment of patient should be available.

3. As a tax payer I would want my money to support the free access of research that would help in the above situations.

as a cancer patient, i should not have to pay for access to valuable, government-funded information that may help me proactively partner with my healthcare professionals in an effort to save my life.

Now imagine that all of this work is not just available to scientists in well-placed academic institutions that can afford to pay for it, but to anyone with an interest and an idea. We would multiply the potential for innovation tremendously. Anyone suitably motivated could learn something new and push the process. The few thousand scientists simply don't have time to do everything. But someone dying of cancer might find something that others missed, because of his situation. Such personal discovery is the kind of thing that made, and makes, America great. It's the American dream.

In short, I fully support open publication. Innovation is driven by information, and innovation is the heart of America.

John Jobe PhD Atomic & Molecular Physics

Shirley K. Baker Vice Chancellor for Scholarly Resources Washington University

Patients who gain an education about their disease which is based on NIH studies will no doubt be more committed to their treatments. They also may be willing participate in clinical trials or genetic studies, all of which will have a general positive effect on the general public. Without such legitimate information, patients will be limited to less trustworthy sources.

Please do make such information readily and freely available to the public.

Peggy Zuckerman 2 El Portal Palos Verdes Estates, CA 90274

Please support this access to vital information!

Patients have to have a free access to vital and timely info, if their government paid for the research.

Joseph Shmulovich

As a cancer survivor, I require access to this information. Not only have we paid taxes to support the research, but many of us have participated in the clinical trials on which these published articles report. We should not be expected to pay for access.

I found it absolutely necessary to educate myself about both of my cancers, but especially about my aggressive and rare uterine cancer. By reading articles that I found myself or articles that were made available to me through members of my online group for uterine carcinosarcoma, I have learned alot about my disease and treatment options. My uterine cancer is so rare that there are oncologists in this country who have never treated a patient with this diagnosis. I think that it is imperative that a patient have free access to research articles so that she or he can be confident that treatment being proposed or given is the best choice. We will never become as knowledgeable as our doctors but having free access to research articles would help us to become better informed members of our own treatment teams. Let's face reality; many of us will do our research online. It is extremely important that accurate and up to date information is available to us from reliable, accountable sources. And if our tax dollars are funding that research, then we deserve to have free access to the results. Synopsis reveal so little that they are often of no use, and few of us cancer patients can afford paying for numerous articles. Thank you.

If the proper information is available to them, these people can move from medical naivete to a high level of understanding in just a few weeks. I have seen it happen countless times on our mailing list where we discuss these cancers and treatments for them. But we need more! We need free access to research results so patients can get accurate information and up-to-date treatment in a field that is changing daily.

Medical professionals also benefit from having research results freely available to the public. Highly-motivated patients and caregivers sieve out the most promising and important information and pass it along to professionals and others. Many oncologists have been able to use patient-provided research materials to everyone's benefit.

Since we the public fund NIH research, it is only right that we all have access to the written results. Please make this life-saving resource available to all of us.

I believe that if more information had been accessible without the associated high cost we may have been in a better situation regarding her treatment and the outcome.

Strongly believe that free access to publications should be made available and in a much shorter time frame than 12 months!!

Our member libraries are recognized as leaders on our campuses in addressing policy issues related to authors rights. We have encouraged our faculty to retain rights to use their work in teaching, for posting on their personal websites, or depositing to institutional or subject repositories. This new policy directs increased attention to the issue of authors rights, a matter of high importance to the advancement of scholarship.

Our libraries are partnering with research administrators and faculty on a number of activities to meet the April 7, 2008 implementation deadline. Many have taken steps to assist with the submission process. We are sharing “best practice” experiences with each other through our strong network, our website and a Toolkit. Our president is serving as a moderator for an online chat session on March 27 to discuss implementation strategies with libraries throughout the country. As preparation for the policy, AAHSL held a session at its annual meeting in November 2007 that included a presentation on authors rights. We are planning a session on the policy at the Medical Library Association annual meeting in May 2008 to continue the dialog with the larger medical library community.

Special mention is due to those publishers who facilitate the public access policy implementation by either participating fully in PubMed Central already, or submitting final manuscripts on behalf of the their authors. We look forward to an ever-expanding list of “fully compliant” journals that can ease the article submission process for our faculty. We recommend that NIH actively seek out partnerships with other publishers and work with other national associations to urge publishers to join the growing list of compliant journals. And we urge NIH to continue its work to streamline the deposit system and the timely updating of its website.

Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information for our faculty, students and the academic medical centers that we serve. Our member libraries lend strong support to their institutions’ efforts to comply with the policy.

We have been supporting the Public Access Policy since its inception and are gratified to see the Policy take the form of a mandate. We are optimistic that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health.

The Library is partnering with research administrators and faculty at the many educational and clinical institutions in the Texas Medical Center to implement the policy by April 7, 2008. We have been recognized as leaders in addressing the issues surrounding the Public Access Policy and institutional repositories in general. This leadership role includes educating faculty about retaining more of their authorship rights when signing publication agreements with their publishers and encouraging faculty to retain rights for using their work in their teaching, for posting on their personal websites, or depositing to institutional repositories. This new mandated public access policy affects so many of our researchers and focuses increased attention on the issue of author rights. We believe this is a very positive and important outcome.

We are developing methods to assist with the actual submission process. The NIH Submission System is easy to use once the author rights issues have been addressed, but when researchers need assistance, we are available to help. Many publishers have already worked to facilitate the implementation of the policy either by participating fully in PubMed Central or by submitting final manuscripts on behalf of the authors who wish to publish in their journals. These publishers are an important part of this process, and we look forward to an ever-expanding list of “fully compliant” journals that can ease the article submission process for our faculty. We recommend that NIH continue to actively seek out partnerships with publishers and work with other national associations to urge publishers to join the growing list of compliant journals.

Thank you for your efforts to ensure a smooth implementation of the Public Access Policy. This policy will result in significant improvement in access to health information, in research collaboration, and in supporting educational programs in the health sciences.

The Houston Academy of Medicine – Texas Medical Center Library is the library for Baylor College of Medicine and The University of Texas Health Science Center at Houston. You can learn more about us at http://resource.library.tmc.edu.

As noted in a September letter to California’s senators from Wyatt Hume, UC Provost and Executive Vice President of Academic and Health Affairs, the new policy will maximize both the impact of research and the dissemination of new knowledge. The policy also appropriately recognizes and preserves the integrity of peer-reviewed journals, which play a vital role in the conduct of science, by providing a twelve-month embargo period that protects publishers’ subscription revenue.

Equally important, the NIH Revised Policy on Enhancing Public Access to Archived Publications promises to achieve the goals of expanding the use of NIH research findings in the advancement of science and public health; enhancing the management of NIH's invaluable research portfolio; and providing for a timely, sustainable, and openly accessible archive of research results arising from the substantial investments of U.S. taxpayers. These NIH goals are strongly endorsed by University of California scientists and librarians, along with their academic colleagues throughout the nation. Brian E.C. Schottlaender University Librarian University of California, San Diego

The NIH Public Access Policy will greatly expand the availability of the more than 80,000 articles that result each year from NIH funding. At the most fundamental level, of course, taxpayers have a right to see the results of research they have funded without paying an additional fee. But beyond basic rights, the policy’s impact will be far reaching and deeply felt. Two profound implications stand out.

1 Impact on Public Health. Currently, the general public does not have unrestricted access to rigorous, peer reviewed, high quality research. There are numberless examples of citizens seeking health information online, only to be denied the access for which they have essentially already paid.

Similarly, due to the high cost of medical journals, many physicians can’t afford to keep up with the latest research in their own fields. And health policymakers, who formulate influential public policy, are likewise barred from reading the full text of the latest research. In all of these cases, people are forced to rely on abstracts alone, which are sorely inadequate as the basis for critical clinical and health policy decisions.

In fact, there are several recent studies that suggest that abstracts often inaccurately represent the content of the research they purport to summarize. A recent editorial in no less an authority than The Lancet concluded that “abstracts are known to be fickle representations of an article.”

2 The Internet Unleashed. The internet has enormous power to not only disseminate information, but also to bring to bear computational tools to find, share and combine that information into virtual, interlinked libraries that will spark new ideas and spur scientific discovery.

The Wellcome Trust, Great Britain’s largest private funder of medical research, has noted that “as the tools for mining become more sophisticated, we will see new knowledge being created by the linking of research papers that previously had not been seen as relevant to each other. For this to happen, however, papers must be held in an open access repository and not remain hidden behind publishers’ authentication systems.”

The NIH’s seminal Open Access Policy will not only encourage others to follow suit with their own open access mandates, it will itself help unlock the power of scientific data and enable scientists to pioneer new kinds of computational research that can only occur in the open environment.

I recently attend an all-day seminar of information specialists and the consensus of that group was that the new standards were much needed, and if anything could be more stringent. Its encouraging to see this policy being implemented.

The Libraries are working with the Office of Sponsored Programs to provide UConn faculty, and specifically NIH researchers, the information and resources they need to comply with the NIH Public Access Policy.

Furthermore is states that for peer-reviewed publications of CIHR funded research output "grant recipients are now required to make every effort to ensure that their publications are freely accessible through the Publisher's website (Option #1) or an online repository as soon as possible and in any event within six months of publication (Option #2). Under the second option, grant recipients must archive the final peer-reviewed full-text manuscripts immediately upon publication in a digital archive, such as PubMed Central or the grantees institutional repository. Publications must be freely accessible within six months of publication, where allowable and in accordance with publisher policies."

The NIH should emulate such a clear policy.

Thank you for your time and consideration.

The information that NIH has provided on the policy, including its FAQ and tutorials, is excellent; it has greatly aided our educational efforts. The responsiveness of the public access office to our questions about the policy implementation has also been fantastic. No initial implementation is perfect, however, and so we are separately submitting six suggestions for its improvement.

For authors, deposit in PubMed Central (PMC) will maximize the visibility of their NIH-funded research. Preliminary research suggests that articles that are freely available are cited more often and have a greater impact rating than articles that are locked away behind subscription walls. This works to the benefit of our authors and the journals in which they publish. In addition, the availability of the article in a subject repository addresses one of the most widely-requested author demands in their publishing contracts. In 2005, the Cornell University Faculty Senate strongly urged “all faculty to deposit preprint or postprint copies of articles in an open access repository such as the Cornell University DSpace Repository or discipline-specific repositories such as arXiv.org.” PubMed Central is such a repository. NIH has crafted the implementation in such a way that it imposes relatively small burdens on the faculty, and we anticipate few problems in implementing it.

From the perspective of the Library, the implementation has also been very good. Deposit in PubMed Central ensures that the research results will be preserved in a state-of-the-art digital repository, thus addressing one of our major concerns: the long-term preservation of electronic journal literature. (See the Cornell report E-Journal Archiving Metes and Bounds: A Survey of the Landscape by Anne R. Kenney, Richard Entlich, Peter B. Hirtle, Nancy Y. McGovern, and Ellie L. Buckley, September, 2006, published by CLIR.) Unfortunately for our budget, we do not anticipate that the new policy will allow us to cancel any journal subscriptions. Our researchers demand ready access to the most current literature and can’t wait even six months for access to published literature. Furthermore, no journal consists solely of NIH-funded research.

For the rest of the world, free access after twelve months will ensure that researchers and students around the world will be able to read and build on the work, regardless of their (or their library's) ability to subscribe to the journal in which the research is published. Public access to publicly funded research contributes directly to the mission of higher education.

When we allocate public funds, it is not so that institutions and journals can make money. It is to fund helpful research. The results of such research should be freely made available to those whose tax dollars have helped fund that research.

Cancer patients need to self-educate on their diseases and potential treatments, but the cost of doing so can be prohibitive. Patients and medical professionals should be entitled to the results of studies funded by our taxes. It is only right! Thank you.

For those of us with aggressive disease, access to current research is critical as we attempt to plan toward and choose treatment options.

Thank you.

Neurofibromatosis, Inc.-Mid-Atlantic supports NIH requiring all NIH-funded investigators to submit to the National Library of Medicine their final, peer-reviewed manuscripts upon accceptance for publication be made publicly available no later than 12 months after the official date of publication.

The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which 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.

The Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central ( http://www.pubmedcentral.nih.gov/). The Policy requires that these articles be accessible to the public on PubMed Central to help advance science and improve human health.

Ann Osterling

When first diagnosed, I was astounded to find that I had to pay to access current journal articles reporting the results of research funded with Federal funds-- i.e. my tax dollars. In a 35 + year career with the U.S. Geological Survey, one of the aspects of "Federal Science" that I appreciated was that all our information was made available at no cost to the public.

As a cancer patient actively monitoring my cancer and trying to stay current on potential treatment alternatives, I find it unreasonable and unconscionable that I have to pay to obtain research results funded with my taxes. For patients such as myself, even a 12 month delay in access to research may be too long. There needs to be a public respository for current Federally-funded medical research that can be accessed with reasonable charges-- just enough to offset costs of maintaining the appropriate databases and servers.

I will be following the results of the public access debate with great personal interest.

Sincerely,

Jon Nowlin

Research conducted over the last few years shows that Americans joining medical online communities do so first and foremost to obtain accurate, current and complete information regarding every aspect of their disease, including accuracy of diagnosis, available treatments, including all clinical trials, side effects of the treatments and any other short and long term impact the disease may have on their life.

The NIH proposed policy could only further enhance the availability of current, accurate and until now hard to find medical information. We should all support such policy since it can easily save lives. The ongoing democratization of medical knowledge (started with the PDQ Statements and followed by PubMed and the growing number of high quality open access scientific publications) may be the single most important tool at our disposal to retool the malfunctioning portions of the healthcare system. Informed patients can easily become empowered patients and empowered patients are quietly leading the transformation of the American healthcare system by demonstrating the real benefits of participatory medicine.

I just wish that the proposed guidance was even more oriented to the good of the American public and required open access after 6 months instead of a year. A number of peer-reviewed publications have already adopted the 6-months timeframe. It should become the new national standard for a nation facing dire consequences if we do not promote constant and ubiquitous innovation in the healthcare system.

Publication of any research paper funded by US Taxpayers should be openly and freely accessible to the public. It is an absolute no-brainer.

Gilles Frydman Founder ACOR.org

As the public are ultimately providing funding for this research it seems only fair that we should have access to it without having to subscribe to expensive research periodicals. Many of us face health issues in our lives that such articles have a bearing on, and often times doctors are so over worked that it takes patients own research to bring their doctors' attention to the latest findings.

Please help us to help our medical teams take care of us and provide us access to NIH funded research free of charge.

Thanks for your consideration.

Thank you for the opportunity to comment on this inportant issue.

Robert B. Miller

As a researcher, both for the government and for a contractor, I found that many funded studies never saw the light of day. That is wrong. Every government-funded study should be reported to the public, even if a total failure.

I have experienced the difference between reading abstracts and reading the full text articles. Full text is so much better. We need public access to NIH-funded research articles to better participate in helping our doctors help our children beat this disease and to surmount the late effects caused by its treatment.

The ASU Libraries created an e-mail address where users may submit any NIH-related questions. Experts in the Libraries will promptly answer all queries and/or seek referrals as necessary.

The ASU Libraries and ORSPA hosted group viewings and discussions of the webcast: Institutional Compliance with the NIH Public Access Policy. The ASU Libraries, Office of the Vice President for Research and Economic Affairs (OVPREA), ORSPA, and OGC are collectively branding the user guide, and remain committed to continue its collaboration and assistance to the ASU community.

Positively contributes to the advancement of science;

Serves the public health by enabling discovery, speeding treatment and cures;

Provides a direct return for public investment in the NIH;

Keeps the USA in step with other countries who have recently enacted similar polices;

Democratizes teaching and learning by providing new resources for scientists and teachers to use in new and innovative ways.

As one researcher (who is also the editor of a journal in the life sciences) noted, this is free advertising for the journals. She also expressed some puzzlement about why, especially given the huge success of Google and similar new models of information access, some academic publishers seem so resistant to innovation.

There is, of course, some concern about implementation. Many authors are confused about what the terms of copyright transfer agreements allow, and about the potential for liability if they make an error. Some are concerned that the optional embargo period may imply very long delays from article acceptance to publication to eventual availability of public access. In medical research in particular, long delays may imply that members of the general public will still not have access to current research results that are crucial to informed medical decisions. On the other hand, I have heard very little concern about the actual mechanics of submitting final author manuscript to PMC.

As a university publisher, the RUP represents the middle of the road in the ongoing dialogue about public access to published data – firmly in between the advocates for complete open access and those publishers who hold most or all of their content behind access controls.

The content of all three RUP journals is released on our own websites six months after the date of publication. More recently, we worked with the National Library of Medicine to post the full, final, copy edited, and formatted text of all of our content on PubMed Central to be made available to the public six months after publication. We thus already comply with the NIH Public Access Policy.

Two of the RUP’s three journals have been free to the public, six months after the publication date, since January, 2001. Even though our content is only under access control for a short time period, our subscription revenues have continued to rise over the last seven years. The RUP is thus in the unique situation of demonstrating that it is financially feasible for publishers to permit the release of all of their content in accordance with the NIH Public Access Policy.

At the RUP we strongly believe that scientific publishers have an obligation to release their content to the public, who provide much of the funding to generate that content and to buy subscriptions. In an ideal world, all publishers would fulfill and facilitate this obligation on their own. Although many publishers are doing so, there are still many who are not. We thus strongly support the NIH mandate for deposition of NIH-funded research in PubMed Central.

I do not know of a single publisher that has publicly declared, in a forum available to their readers, opposition to the NIH mandate. This is probably because they fear alienating the readers on whom they depend for content and subscriptions. In contrast, many publishers have publicly declared support for the NIH mandate.

Publishers who oppose this policy may present various arguments, but the bottom line is that they fear losing subscription revenue. In a sense they have a financial conflict of interest with respect to this debate that should be declared up front, just as we require authors and reviewers to do with regard to submitted manuscripts.

With tax-payers money, the NIH funds the research. NIH funded researchers perform and review the research. And thus, the data from any resulting publications can and should be made available to the public. To this there should be no argument.

We urge you to implement the mandate as soon as possible.

Generally, it is abstracts that are available. It is not unusual to there to be a request for a fee to view the full text of an article. On occasion I have recommended that members of the brain tumor community seek access to the article for which there is a fee through the interlibrary loan department of their local library. How much easier it would be to have access through the National Library of Medicine website.

For brain tumor survivors, as well as for many disease specific patient groups, the information that comes from rigorous research can literally mean the difference between life and death. It is not unusual for patients to discuss the most recent reaserch results with their treating physicians to determine if they may be a candidate for a particular treatment.

Our ability to access medical research articles online is one way in which we can have some semblance of control. "Knowledge is power" is more than a cliche to those whose lives are challenged by life threatening orphan diseases. Many of us want to be informed consumers and an active part of our treatment team. Additionatlly, directly or indirectly it is our dollars that support medical research.

As patients it is unacceptable that we be denied access to potentially life saving research results for want of a fee.

I fully support the NIH public access policy and would hope that articles are available online well in advance of the 12 month period after publication deadline.

Thank you for your consideration.

Having more reliable, reviewed research available, that was funded with public funds, is to the benefit of patients, researchers and the NIH.

Free and open access will enhance the advancement of basic science and health care.

Clark Grundler

Dale Beasley, Member of ACOR list serve

The mandate neither provides compensation for the added-value of services that these manuscripts have received from publishers nor does it earmark funds to ensure the economic sustainability of the broad and systematic archiving this sort of project requires. It also undermines a key intellectual property right known as copyright – long a cornerstone used to foster creativity and innovation.

STM believes that this legislation establishes an unfunded government mandate with an unknown impact on the advancement of science and puts at risk a system which has enabled more research to be available to more scientists in more countries than at any point in the history of science.

Other governmental bodies, such as the European Commission, have recognized the unique role and extensive investments made by scientific publishers in the organization of peer review, the management of publication processes, the production, access, distribution, preservation and digitization of scientific knowledge. They have called for an evidence-based approach toward questions like the broad and systematic archiving of scientific manuscripts to ensure that the current system of scientific publishing is not destabilized without reason. Regrettably, neither the acknowledgement of the key role that publishers play in the advancement of science, nor the commitment toward an evidence-based approach, nor the funding to support this broad mandate seems present in the current U.S. legislation.

STM publishers will, of course, comply with the laws of the nations in which they operate. At the same time, in order to fulfill their primary mission of maximizing the dissemination of knowledge through economically self-sustaining business models, they will continue a vigorous engagement with appropriate stakeholders on issues such as this where legislative change seems necessary or desirable.

Public access to research publications will accelerate research by allowing any scientist to read, use and build on the work of others. Deposition of the articles in PubMed Central will also allow better integration of research literature with the data that underpins research, bringing further benefits to the research process. Beyond the research community, the NIH policy will also enable any interested reader - physicians, educators, students, journalists, patients and so on - to access research literature, bringing further benefits for education and health. With the provision of an embargo of up to 12 months, the policy also balances the needs of publishers who rely on subscriptions to cover their costs.

Tissue repositories linked to informative clinical datasets generated during the conduct of prospective clinical research projects are an invaluable perhaps unique resource. They are under utilised - perhaps in large part because their existence is not adequately or effectively communicated. This clearly leads to enormous redundnacy and repetition. Mechanisms should be developed to ensure effective and efficient communication of tissue repositories (existence, inventories, mechanisms of access) arising from public sector funding to research groups.

As a genome annotation database provider, I particularly support the move to open access as it offers the chance to discover links between publications and database symbols such as gene names, via text mining and to build web links to the point within the document where this is discussed.

I believe that this and other web based integration around open access text will improve the efficiency of science by creating a new competitive market of processing, sumarizing and presenting textual information to scientists. This will ensure they learn about relevant discoveries sooner and avoid duplicating existing research needlessly etc.

Best wishes,

Tim Hubbard Head of Informatics PI, NIH ENCODE annotation scale up project Wellcome Trust Sanger Institute

I believe strongly that it is the best interest of the public health to have a clear and unbiased picture of the results of all clinical trials. If investigators can pick and choose what to publish, they will certainly be tempted to find reasons not to publish negative results.

But we need to know the bad news as well as the good news. As US taxpayers, we deserve the right to know the fruits of our investment, even if the "fruit" is not as sweet as what we had imagined.

Otherwise, we will be living in a polyannish world in which the only results that get disseminated are ones that fulfilled the investigator's hope.

When negative studies don't get published, future investigators may embark on the very same study, not knowing that they may be investing their time and additional government money into a blind alley.

David Nalin, MD

I am fully supportive of the new regulations that research paid for by the US public should be available to the US public. I am somewhat surprised to hear that certain groups with a clear self-interest (e.g. publishers) are trying to block the regulations. Whatever the reasons they give for this must surely be a smokescreen: it is ridiculous to think that science or the public interest could best be served by blocking access to research findings.

best

Andrew Vickers

But most importantly, the NIH has a responsibility to the taxpayer that funds its research; it is unacceptable for members of the public to have to pay to access the results of research they funded.

However, it should be realized that OA publishing will, in the final count, cost more to the academic community than the current system (because, for example, industry is a relatively larger consumer of than contributor to the scientific literature). OA publishing will only be sustainable if funded researchers obtain additional funds to defray publication costs and simultaneously a just mechanism is put in place to ascertain that unfunded researchers will still have the possibility to publish their results. Without the latter, much original research would get lost to the community, to the detriment of these researchers and, in the end, scientific progress.

A final concern is that under the OA model, it is in a publisher's interest to publish as many manuscripts as possible. In the classical publishing model, editors are constrained by their page-budget, leading to a heavy selection of articles for publication. In OA publishing, thresholds are definitely lower. Whether this will lead to lower scientific standards in the future is something that is difficult to predict at this point, but the dangers are clear.

But my most serious concern is the lack of access to health-related research by physicians and patients. I can walk over to Harvard's Countway Library and for $35 a day have excellent access. That is no solution, and certainly an impossible one for someone in a rural area of the US, far from any source of medical information, but suffering from a life-threatening medical condition.

In conclusion, for the health and well-being of our nation, it is important to make taxpayer-funded research on Biology and Medicine freely available to our citizens.

Thank you

In this way it serves the public health—by enabling discovery, speeding treatment, and cures of diseased people.

It makes the USA as a front runner compared with a number of other countries who have not yet enacted similar polices - but it must come to all.

I strongly suggest that the policy apply to all documents which have been published over X months ago, not just documents published after the policy goes into effect.

I realize that legally, legacy documents are a somewhat different issue than newly-published documents. But, certainly this can be worked out with the copyright holders as part of the overall plan.

NIH is in the driver's seat here; they can always prohibit publishing of any future NIH-funded manuscripts by copyright holders who do not agree to reasonable terms on the legacy documents.

Without such terms for legacy documents, NIH is relegating Public Access to a database that starts in 2008. Can any researcher reasonably use such a database in the course of their work with confidence that they have knowledge of all the relevant literature? Of course not.

Thirdly, abandon this absurd, redundant publication of research results burden. The NIH obviates the requirement to deal with existing copyright law by pitting the researchers against the journals. The fundamental problems in biomedicine at the moment have nothing to do with availability of published articles. They have to do with (1) non-publication by funded studies, and (2) lack of access to raw data.

We should try to find a way to divert resources from plausible but useless programs to disseminate information, into actual disseminations of actual information, where it will do some good.

* positively contributes to the advancement of science * serves the public--enabling discovery, speeding treatment, and cures * leverages the public investment in the NIH to deliver better public health * keeps us in step with other countries who have recently enacted similar polices * democratizes teaching and learning--providing new resources forscientists to use in new and innovative ways.

Rebuttal 1: If the assertion is valid then ALL research output including books, patents and discoveries should be made available for free. Publishers add value, and should be entitled to do so, in the same way that countless other individuals and organizations are able to build businesses around Government funded research. The taxpayer funds many activities and services that are not provided to the public for free.

Assertion 2: In the Internet age the marginal cost of delivering content is almost zero, so scholarly manuscripts should be disseminated for free.

Rebuttal 2: Controlling access to content acts as a proxy for access control for value added capabilities (e.g. specialized search engines, discovery tools, branding etc) provided by publishers. Free access, undermines this revenue recovery mechanism and will drive out innovation from publishing.

Assertion 3: Authors and scientists work for “free”, so the content should be free.

Rebuttal 3: Just because the raw ingredients of a product are extremely low cost, does not entitle the Government to mandate free distribution. The cost of the ingredients used to make Coke are negligible (water and sugar), does that mean that Coke has to be provided to the public for free? In fact, publishers invest heavily in branding and marketing that helps to connect appropriate readers with appropriate content. Without a financial incentive this important work of branding and marketing will disappear.

Optimize the NIH Mandate Now: Deposit Institutionally, Harvest Centrally http://eprints.ecs.soton.ac.uk/15002/

It should be clarified whether the policy applies only strictly to journal articles, or whether it also extends to peer-reviewed conference papers.

In the latter case, it needs to be further clarified under what circumstances a conference paper is considered peer reviewed. Does this cover only papers that were reviewed in full, or also papers for which only an (extended) abstract was reviewed, but not the final paper as such (example: annual SPIE Medical Imaging conference).

Instead requiring direct deposit in PubMed Central greatly restricts the benefits of the NIH mandate, and complicates instead of facilitating university mandates for self-archiving for all the rest of research output. It makes incomparably more sense to deposit institutionally and harvest centrally, whenever/wherever desired, rather than mandating that researchers deposit willy-nilly in repository after repository. Institutional deposit mandates systematically converge; central deposit mandates diverge and even get in one another's way.

Se:How To Integrate University and Funder Open Access Mandates http://openaccess.eprints.org/index.php?/archives/369-guid.html

The range of policy options have been thoroughly discussed and weighed since at least 2004 in Congress, at NIH, in the scientific community, and in public fora. Support for public access has been broad and opposition has been limited to a relative handful of prosperous publishers. NIH has taken a thoughtful, conservative approach, embracing a mandatory policy only after the failure of a voluntary approach. It has gone to great lengths to consult with the range of interested parties and the resulting policy fairly balances their preferences with the public interest.

Vested interests must not be allowed to further stall NIH public access.Prompt NIH action to implement the newly announced policy will ensure that NIH-funded research findings are available to all. Any delay will only hold back scientific advancement and impede the public’s access to high-quality health information. The April 7, 2008 implementation date announced by NIH must not be held up.

Particularly in the current, difficult economic climate, taxpayers have a right to expect that they are getting their money’s worth from the federal investment in research. Universal access to NIH research will unlock the full health, economic, and social benefits that motivate NIH appropriations. Any delay will reduce the return on public investment.