1. Access to Research Data: NIH Public Access and PMC Special Libraries Association Baltimore, MD 13 June 2006 David Gillikin Head, MEDLARS Management Section National Library of Medicine National Library of Medicine National Institutes of Health/DHHS

2. Access to Research Data Background Background PubMed Central (PMC) PubMed Central (PMC) NIH Public Access Policy NIH Public Access Policy Current Issues Current Issues

3. Background - NLM National Library of Medicine (NLM) and Public Access to information National Library of Medicine (NLM) and Public Access to information –MEDLINE database  Cost recover basis, 1971 – 1997  Web-based search access free to the public 1997 –MedlinePlus: Health Care and Drug Information, 1998 –Health Services Research databases –Specialized Information Services: Environmental Health & Toxicology information and databases

4. Background National Institutes of Health (NIH) NIH-supported research is essential to improving human health NIH-supported research is essential to improving human health Public Access to information resulting from this research is vital Public Access to information resulting from this research is vital –Results should be made available to the public –It demonstrates output resulting from taxpayer funded research

5. Recommended Priorities for New Emphasis Health Information for the Public Health Information for the Public Molecular Biology Information Systems Molecular Biology Information Systems Training for Computational Biology Training for Computational Biology Definition of the Research Publication of the Future Definition of the Research Publication of the Future Permanent Access to Electronic Information Permanent Access to Electronic Information Fundamental Informatics Research Fundamental Informatics Research Global Health Partnerships Global Health Partnerships

6. NIH PRIORITY A repository of freely accessible life sciences journal articles and supporting research data, including multimedia data: A repository of freely accessible life sciences journal articles and supporting research data, including multimedia data: –a permanent archive –a platform for enriched linking, analysis, and use of research reports and data –one of many sources of full-text articles linked to PubMed/MEDLINE citations

7. PubMed Central (PMC) Goals Journals provide the most immediate access to significant new and historical research PMC Goals Freely Accessible Data Freely Accessible Data Archival Documents Archival Documents Participating Publishers Participating Publishers Back Issue Scanning Project Back Issue Scanning Project

8. Back Issue Scanning Project May 2006 Data Complete backruns (including predecessor titles) of 24 journals that also deposit current content in PMC Complete backruns (including predecessor titles) of 24 journals that also deposit current content in PMC 68 more journals in production 68 more journals in production Over 300,000 articles deposited Over 300,000 articles deposited Include Table of Contents, Full Text Summary, HTML view, Images, PDF Include Table of Contents, Full Text Summary, HTML view, Images, PDF

9. PMC in May 2006 249 journals 249 journals Over 675,000 articles (> 65% from digitized back issues) Over 675,000 articles (> 65% from digitized back issues) Users: Users: –2,000,000 unique IP addresses –Actual users estimated to be 2.5 times this number Article Sources: Participating Publishers, Manuscript Deposit System Article Sources: Participating Publishers, Manuscript Deposit System

10. Public Access Policy Background US Congress, House Appropriations Language, FY2004: US Congress, House Appropriations Language, FY2004: “The Committee is very concerned that there is insufficient public access to reports and data resulting from NIH-funded research. This situation, which has been exacerbated by the dramatic rise in scientific journal subscription prices, is contrary to the best interests of the U.S. taxpayers who paid for this research.” (July 8, 2003)

11. Public Access Policy Background US Congress, House Appropriations Language, FY 2005: US Congress, House Appropriations Language, FY 2005: “The Committee is aware of a proposal to make the complete text of articles and supplemental materials generated by NIH-funded research available on PubMed Central (PMC)… The Committee supports this proposal and recommends that NIH develop a policy, to apply from FY 2005 forward, requiring that a complete electronic copy of any manuscript reporting work supported by NIH grants or contracts be provided to PMC upon acceptance of the manuscript for publication in any scientific journal listed in the NLM's PubMed directory.” (Sept. 7,2004)

12. Public Access Policy Background Congressional Recommendation: Congressional Recommendation: Develop a policy about depositing manuscripts reporting on NIH grant supported work into PubMed Central

13. Policy Goals ACCESS: Provide electronic access to NIH-funded research publications for patients, families, health professionals, teachers, and students. ACCESS: Provide electronic access to NIH-funded research publications for patients, families, health professionals, teachers, and students. ARCHIVE: Keep a central archive of NIH-funded research publications—for now and in the future, preserving vital medical research results and information for years to come. ARCHIVE: Keep a central archive of NIH-funded research publications—for now and in the future, preserving vital medical research results and information for years to come. ADVANCE SCIENCE: Advance science by creating an information resource that will make it easier for scientists to mine medical research publications, and for NIH to better manage its entire research investment. ADVANCE SCIENCE: Advance science by creating an information resource that will make it easier for scientists to mine medical research publications, and for NIH to better manage its entire research investment.

14. Policy Development Proposed Policy (September 2004), to enhance public access to archived publications resulting from NIH-funded research. Proposed Policy (September 2004), to enhance public access to archived publications resulting from NIH-funded research. Public Comments Public Comments –Public meetings: Publishers and Associations (July 2004), Investigators (August 2004) –Disease advocacy groups (August 2004) –Notice in NIH Guide for Grants and Contracts (September 3, 2004) –Notice in Federal Register (September 17, 2004) –Talks, visits, interviews, letters 6,249 comments received 6,249 comments received

15. Final Policy February 3, 2005: Final policy published in the NIH Guide and Federal Register February 3, 2005: Final policy published in the NIH Guide and Federal Register Emphasize the voluntary nature of authors’ submissions Emphasize the voluntary nature of authors’ submissions

16. Final Policy Policy applies to: Policy applies to: –Peer-reviewed publications resulting from research supported in whole or in part with direct costs from NIH –All research and career development award mechanisms, cooperative agreements, contracts, NRSA grants, and NIH intramural research studies Author’s final manuscript Author’s final manuscript –Final version accepted for journal publication and includes all modifications from the peer review process Policy does not apply to: Policy does not apply to: –Book chapters, editorials, reviews, conference proceedings

17. Final Policy At the time of submission, author specifies the timing of the posting for public accessibility. At the time of submission, author specifies the timing of the posting for public accessibility. NIH strongly encourages authors to post for public accessibility as soon as possible (and within twelve months of the publisher’s official date of final publication). NIH expects that only in limited cases will authors deem it necessary to select the longest delay period. NIH strongly encourages authors to post for public accessibility as soon as possible (and within twelve months of the publisher’s official date of final publication). NIH expects that only in limited cases will authors deem it necessary to select the longest delay period.

18. Policy Supports All Publishing Models NIH supports the current publishing process by providing direct costs to its funded investigators for publication costs. NIH supports the current publishing process by providing direct costs to its funded investigators for publication costs. The Policy creates a stable archive of peer- reviewed, research publications financed with NIH funds. The Policy creates a stable archive of peer- reviewed, research publications financed with NIH funds. The Policy is compatible with any publishing model that authors and journals choose to employ. The Policy is compatible with any publishing model that authors and journals choose to employ.

19. Copyright Issues The NIH policy explicitly recognizes and upholds the principles of copyright. The NIH policy explicitly recognizes and upholds the principles of copyright. Authors/journals can continue to assert copyright in NIH-funded scientific publications, in accordance with current practice. Authors/journals can continue to assert copyright in NIH-funded scientific publications, in accordance with current practice. NIH encourages authors and institutions to sign agreements that specifically allow the manuscripts to be deposited with NIH for public posting on PMC as soon as possible after journal publication. NIH encourages authors and institutions to sign agreements that specifically allow the manuscripts to be deposited with NIH for public posting on PMC as soon as possible after journal publication.

20. NIH Public Access Implementation Public Access Advisory Working Group of NLM Board of Regents Public Access Advisory Working Group of NLM Board of Regents –To advise NIH and NLM on implementation and evaluation of policy –Participants include  Publishers / Editors  Public Interest / Patient Advocacy  Libraries / Universities  Scientists

21. NIH Public Access Implementation Information and training session provided to NIH program staff and funded researchers Information and training session provided to NIH program staff and funded researchers Development of the NIH Manuscript Submission System Development of the NIH Manuscript Submission System –Voluntary submissions by NIH funded authors –Deposits would involve:  Electronic version of author’s final manuscript  Include al modifications from peer review  Submission system will be password protected

22. NIH Manuscript Submission System Accepts most word processing formats or PDF Accepts most word processing formats or PDF System generates email confirming submission System generates email confirming submission Author specifies public accessibility as well as approval of materials submitted and presented online Author specifies public accessibility as well as approval of materials submitted and presented online Publisher’s final version may also be submitted Publisher’s final version may also be submitted

23. NIH Manuscript Submission System Sending electronic copies is voluntary and is not a factor in the review of scientific progress or in the review of new grant requests. Sending electronic copies is voluntary and is not a factor in the review of scientific progress or in the review of new grant requests.

24. NIH Manuscript Submission System Author deposits began May 2, 2005 Author deposits began May 2, 2005 Third party deposits began in July 2005 Third party deposits began in July 2005 Bulk submissions of articles from a journal on behalf of its authors began September 2005 Bulk submissions of articles from a journal on behalf of its authors began September 2005 Wellcome Trust grant conditions require author submission, October 1, 2005 Wellcome Trust grant conditions require author submission, October 1, 2005

25. FY 2006 House Appropriations Language “The committee is pleased that NIH is moving forward to implement its public access policy and is hopeful that the policy will be a 1 st step toward providing free and timely public access to the published results of all NIH-funded biomedical research. The Committee endorses NIH’s expressed goals for the policy… concerned, however, that the final policy may not achieve these goals.” (June 24, 2005)

26. FY 2006 House Appropriations Language “The Committee directs the Office of the Director to submit…by March 1, 2006 a comprehensive report on the progress achieved during the 1 st eight months… –Total # of applicable peer-reviewed articles deposited in PubMed Central –Embargo period requested by the author for each deposited work –NIH’s best estimate of the total # of applicable …articles available for deposit” (June 24, 2005)

27. Status Nov. 15, 2005, Public Access Working Group recommended that the request for public access be upgraded to a requirement and that the permissible delay be shortened from 12 months to 6 months. Nov. 15, 2005, Public Access Working Group recommended that the request for public access be upgraded to a requirement and that the permissible delay be shortened from 12 months to 6 months. Status Report submitted to Congress in February 2006 Status Report submitted to Congress in February 2006 Voluntary submission resulted in ~4% submission of what is estimated should have been submitted. Voluntary submission resulted in ~4% submission of what is estimated should have been submitted. Additional legislation has been proposed Additional legislation has been proposed

28. CURES Act of 2005 Bill by Senator Lieberman, December 14, 2005 Bill by Senator Lieberman, December 14, 2005 Creates the America Center for Cures, primary goal to translate research into therapies Creates the America Center for Cures, primary goal to translate research into therapies Mandates OA for DHHS funded research Mandates OA for DHHS funded research Requires free online access, deposit upon acceptance, and accessible 6 months after acceptance. Requires free online access, deposit upon acceptance, and accessible 6 months after acceptance. Explicitly says that non-compliance may be a ground for the funding agency to refuse future funding Explicitly says that non-compliance may be a ground for the funding agency to refuse future funding

29. Federal Research Public Access Act of 2006 (FRPAA) Bill introduced May 2, Senators Cornyn and Lieberman Bill introduced May 2, Senators Cornyn and Lieberman Mandate OA for all federal funding agencies spending > $100 million/year Mandate OA for all federal funding agencies spending > $100 million/year Involves 11 agencies currently: EPA, NASA, NSF, Agriculture, Commerce, Defense, Energy, Education, HHS, Homeland Security, Transportation Involves 11 agencies currently: EPA, NASA, NSF, Agriculture, Commerce, Defense, Energy, Education, HHS, Homeland Security, Transportation

30. Federal Research Public Access Act of 2006 (FRPAA) Agencies will have 1 year from adoption of bill to develop their OA policies Agencies will have 1 year from adoption of bill to develop their OA policies Agencies may host own repositories or use alternative that meets agency’s conditions for OA, operability and preservation Agencies may host own repositories or use alternative that meets agency’s conditions for OA, operability and preservation Applies to author’s final peer-reviewed manuscript, no later than 6 months after publication Applies to author’s final peer-reviewed manuscript, no later than 6 months after publication

31. Federal Research Public Access Act of 2006 (FRPAA) Requires each researcher to submit a copy of final manuscript accepted for publication in a peer-reviewed journal Requires each researcher to submit a copy of final manuscript accepted for publication in a peer-reviewed journal Requires manuscripts be preserved in a stable digital repository that permits free public access, interoperability, and long- term preservation Requires manuscripts be preserved in a stable digital repository that permits free public access, interoperability, and long- term preservation Agencies may host own repositories or use alternative Agencies may host own repositories or use alternative

32. Federal Research Public Access Act of 2006 (FRPAA) Applies to agency employees as well as grantees Applies to agency employees as well as grantees Applies to author’s final peer-reviewed manuscript accepted for publication in a peer-reviewed journal, and must be freely accessible no later than 6 months after publication Applies to author’s final peer-reviewed manuscript accepted for publication in a peer-reviewed journal, and must be freely accessible no later than 6 months after publication

33. Federal Research Public Access Act of 2006 (FRPAA) Does not apply to laboratory notes, preliminary data analyses, author notes, phone logs, or other information used to produce the fine manuscript Does not apply to laboratory notes, preliminary data analyses, author notes, phone logs, or other information used to produce the fine manuscript Does not apply to classified research, research that results in works that generate revenue or royalties for the author (such as books), or patentable discoveries to the extent necessary to protect copyright or a patent Does not apply to classified research, research that results in works that generate revenue or royalties for the author (such as books), or patentable discoveries to the extent necessary to protect copyright or a patent

34. American Innovation and Competitiveness Act of 2006 Proposed by Senator McCain, May 2006 Proposed by Senator McCain, May 2006 Requires the development of a set of principles for communication of scientific information; develop policies and procedures regarding public release of scientific information Requires the development of a set of principles for communication of scientific information; develop policies and procedures regarding public release of scientific information Encourages open exchange Encourages open exchange

35. Orphan Works Act of 2006 Bill by Rep. Lamar Smith Bill by Rep. Lamar Smith Limits liability of those who use copyrighted works after an unsuccessful but "reasonably diligent" search for an owner Limits liability of those who use copyrighted works after an unsuccessful but "reasonably diligent" search for an owner

36. NIH Manuscript Submission www.nihms.nih.gov

37. NIH Public Access publicaccess.nih.gov

38. Thank you. David Gillikin gillikd@mail.nih.gov Head, MEDLARS Management Section National Library of Medicine National Library of Medicine National Institutes of Health/DHHS