1. NIH Data Sharing Dr. Belinda Seto, Deputy Director National Institute of Biomedical Imaging and Biomedical Engineering September, 2005 South Africa Workshop

2. “Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.” -- NIH Statement on Sharing Research Data February 26, 2003 NIH Viewpoint

3. PHS Grants Policy Statement April 1994 “Restricted availability of unique resources upon which further studies are dependent can impede the advancement of research and the delivery of medical care. Therefore, when these resources are developed with PHS funds and the associated research findings have been published or after they have been provided to the agencies under contract, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. This policy applies to grants, cooperative agreements, and contracts.”

4. NIH expects timely release and sharing of final research data for use by other researchers. NIH expects grant applicants to include a plan for data sharing or to state why data sharing is not possible, especially if $500K or more of direct cost is requested in any single year NIH expects contract offerors to address data sharing regardless of cost Effective with October 1, 2003 receipt date for NIH applications NIH Data Sharing Policy

5. In general, no later than the acceptance for publication of the main findings from the final dataset No timeline specified—will vary depending on nature of the data collected First and continuing use, but not prolonged exclusive use –Investigators who collected the data have a legitimate interest in benefiting from their investment of time and effort What Is Meant by Timely?

6. How to Share Data Provide in publications Share under the investigator’s own auspices Place datasets in public archives Place in restricted access data centers or data enclaves

7. YES! In application—budget and budget justification Administrative supplements Will NIH Provide Support for Data Sharing?

8. Caveats for Studies Including Human Research Participants Investigators need to carefully consider –Studies with very small samples –Studies collecting very sensitive data However, even these data can be shared if safeguards exist to ensure confidentiality and protect the identity of subjects

9. Challenges  Cultural Challenges –Obtaining data in a traditionally data sharing adverse environment –Overcoming the competitive and costly “silo” approach to biomedical research –Removing barriers to information flow across the complex, heterogeneous environment  Technical Challenges –Dealing with a lack of interoperable technologies, unifying architectures, standards, and terminologies –Implementing strategies to process and analyze terabytes of data efficiently –Maintaining systems in a biologically changing environment –Securing, protecting, and tracking patient data across disparate systems

10. Examples of Current NIH Data Sharing Activities National Human Genome Research Institute (NHGRI)  Release of genomic sequence data National Library of Medicine (NLM)  Genome sequence submission and distribution  Enhanced access to other research data/tools  Outreach to research community  Possible support for research and development related to data sharing

11. The National Longitudinal Study of Adolescent Health (Add Health): An Example of Sensitive Data and Multi-Tiered Access Examples of Current NIH Data Sharing Activities

12. The National Longitudinal Study of Adolescent Health (Add Health)  20,745 adolescents enrolled in grades 7-12, followed between 1994 and 2002.  Data from: –adolescents and parents; –90,118 students attending sample schools; –school administrators; – independent data on neighborhood/community  Data collected in three waves, 1994 - 2002.  Measures of: –health –health-related behaviors (e.g., sex, drugs) –determinants of health at the individual, family, school, peer group, and community level.

13. Reasons for Sharing Data  Scope  Potential  Cost Add Health: Sensitive Data Sharing Example

14. Challenges to Sharing Data  Data sensitivity  Need to protect confidentiality  Danger of deductive disclosure Add Health: Sensitive Data Sharing Example

15. A further challenge… The timely release of these public use samples is essential. Reviewers understand this to mean that investigators outside of the Carolina Population Center will have ready access to the data as soon as investigators inside the center have such access. Procedures for the guarantee of confidentiality … should apply to all users, both the general public and those at University of North Carolina. Add Health: Sensitive Data Sharing Example

16. Solution: a multi-tiered system  Public use data  Contractual data sets  Cold room for on-site data use Add Health: Sensitive Data Sharing Example

17. Public use data  Made available through Sociometrics, a small business data archive  Contains only a subset of cases (6,504)  Rare over-samples not included  Contains most data on included cases  Potentially identifying information redacted Add Health: Sensitive Data Sharing Example

18. Restricted-use contractual data  Full data set available only under contract  Available to researchers with: –IRB- and UNC-approved data security plan –Signed agreement to maintain confidentiality –Fee covering costs of providing data & user support; monitoring compliance  Requires annual progress report and renewal after 3 years Add Health: Sensitive Data Sharing Example

19. Cold room for on-site use  Initial plan required access to some data only on-site at UNC  Cold room constructed at UNC  Limited use to date Add Health: Sensitive Data Sharing Example

20. Data security caveats  Security requirements require periodic updating as technology advances  IRBs often lack understanding of security needs  Smaller institutions handicapped in creating secure environments for restricted data Add Health: Sensitive Data Sharing Example

21. Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research

22. NIH-supported research is essential to improving human health and public access to publications resulting from this research is vital. Good for Science Good for Science Good for NIH Good for NIH Good for the Public Good for the Public NIH Must Lead the Way in Public Access

23.  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. Create an information resource that will make it easier for scientists to mine medical research publications, and for NIH to manage better its entire research investment.  ACCESS. Provide electronic access to NIH-funded research publications for patients, families, health professionals, scientists, teachers, and students. Why Public Access?

24. NIH Public Access Policy Embraces Growing Trend NIH examined the access policies of the top 20 journals based on citation impact for medicine and medical research and of the top 50 journals published by members of FASEB. As of October 2004: 80% of the 20 high impact journals allow public access of some sort through HighWire press within 12 months of publication. 80% of the 20 high impact journals allow public access of some sort through HighWire press within 12 months of publication. 78% of the 50 FASEB journals offer public access within 12 months. 78% of the 50 FASEB journals offer public access within 12 months.

25. The Public Access Policy With input from stakeholders and the public, NIH’s Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research has several key elements: The Policy strongly encourages, but does not require, all NIH- funded investigators to make the peer-reviewed, author’s final manuscript available to other researchers and the public at the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) immediately after the final date of publication in a journal. The Policy strongly encourages, but does not require, all NIH- funded investigators to make the peer-reviewed, author’s final manuscript available to other researchers and the public at the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) immediately after the final date of publication in a journal. At the time of submission, the author will specify the timing of the posting of his or her final manuscript for public accessibility as soon as possible and within twelve months of the publisher’s official date of final publication. At the time of submission, the author will specify the timing of the posting of his or her final manuscript for public accessibility as soon as possible and within twelve months of the publisher’s official date of final publication. Note: The author’s final manuscript is the final version accepted for journal publication and includes all modifications from the publishing peer review process.

26. What to Submit for the Public Access Policy The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH. It does not apply to book chapters, editorials, reviews, or conference proceedings. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH. It does not apply to book chapters, editorials, reviews, or conference proceedings. The Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies.

27. What to Submit for the Public Access Policy NIH is requesting that authors submit manuscripts resulting from: NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects or 2) previously-supported NIH research projects if they are accepted for publication on or after May 2, 2005. Publications resulting from non-NIH- supported research projects should not be submitted. Publications resulting from non-NIH- supported research projects should not be submitted.

28.  The Policy requests and strongly encourages that authors specify posting of their final manuscripts for public accessibility immediately after the final date of journal publication. Authors are given the option to release their manuscripts at a later time, up to 12 months after the official date of final publication.  NIH expects that only in limited cases will authors deem it necessary to select the longest delay period. Timing of Public Accessibility: Immediately to Twelve Months

29. NIH’s Public Access Policy Does Not Affect Copyright  The NIH Policy explicitly recognizes and upholds the principles of copyright.  Authors and journals can continue to assert copyright in scientific publications resulting from NIH-funding, in accordance with current practice.

30. NIH’s Public Access Policy Does Not Affect Copyright  While individual copyright arrangements can take many forms, NIH encourages investigators to sign agreements that specifically allow the manuscript to be deposited with NIH for public posting on PubMed Central. An example of the kind of language that an author or institution might add to a copyright agreement includes the following: “Journal acknowledges that Author retains the right to provide a copy of the final manuscript to NIH upon acceptance for Journal publication or thereafter, for public archiving in PubMed Central as soon as possible after publication by Journal.”

31. The NIH Public Access Policy Does Not Alter the Quality of Peer Review  NIH does not anticipate that its policy will harm or otherwise affect the peer review process for scientific papers.  Only peer-reviewed manuscripts accepted for publication will be posted in PubMed Central.

32. The NIH Public Access Policy Does Not Alter the Quality of Peer Review  NIH recognizes peer review is a hallmark of quality for journals and is vital for validating the accuracy and interpretation of research results.  NIH also recognizes that publication in peer- reviewed journals is a major factor in determining the professional standing of scientists.

33. Will NIH’s Public Access Policy Impact Scientific Publishing?  NIH is not aware that there will be a substantial impact. For example, only a minor portion of articles published in scientific journals result from research funded by the NIH. NIH-funded research represents about 10% of the articles in the nearly 5,000 journals indexed by PubMed. NIH-funded research represents about 10% of the articles in the nearly 5,000 journals indexed by PubMed. NIH-funded articles account for more than half of the total published articles for only 1% of these journals. NIH-funded articles account for more than half of the total published articles for only 1% of these journals.

34. Will NIH’s Public Access Policy Impact Scientific Publishing?  An increasing number of journals already provide access to the published article immediately or within one year of the publication.  In addition, the NIH Public Access Policy does not affect authors' freedom to choose the vehicle or venue for publishing their results.

35. The Policy May Streamline Procedures for Investigators and Institutions  Effective August 1, 2005, submissions under this Policy afford NIH-supported investigators an alternate means by which they can fulfill the existing requirement to provide publications as part of progress reports.  It is anticipated that, in the future, investigators applying for new and competing renewal support from the NIH will also utilize this resource by providing links in their applications to their PubMed Central-archived information.

36. Benefits to Principal Investigators and Authors  Submission heightens the visibility of the research and enhances the likelihood of early and increased citation.  Ensures that the manuscript is accessible through PMC, a comprehensive, integrated, biomedical information technology system, so authors will benefit from the tools already available in PMC (e.g., GenBank, Clinical Trials, etc.).

37.  When provided by the publisher, PMC provides the journal’s published article, a link to the journal article, and/or links to any corrections associated with the article on the publisher’s site.  Offers NIH staff, scientists, and the public the ability to search, view, print, or save (subject to applicable copyright law) Public Access Policy manuscript submissions, full text Journal articles for 178 journals*, as well as citations and abstracts from over 5,000 journals. Benefits for Archiving in PubMed Central * As of May, 2005

38.  Provides integration with the NIH eRA Commons.  Integrates manuscripts into the PMC system which includes various resources and tools including: PubMed, GenBank, Genome Map Viewer, Molecular Database, MedlinePlus, Clinical Trials, Taxonomy, Small Molecules (PubChem), and DNA, Protein Sequences, and Protein Structures. Benefits for Archiving in PubMed Central

39. Public Access Policy Resources Public Access Policy Website: http://www.nih.gov/about/publicaccess/Public Access Policy Website: http://www.nih.gov/about/publicaccess/ NIH Manuscript Submission (NIHMS) System:NIH Manuscript Submission (NIHMS) System: http://www.nihms.nih.gov/ http://www.nihms.nih.gov/ Public Access Policy (NIH Guide for Grants and Contracts):Public Access Policy (NIH Guide for Grants and Contracts): http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 05-022.html Authors’ Manual:Authors’ Manual: http://www.nih.gov/about/publicaccess/publicaccess_Ma nual.pdf Manuscript submissions can be found on PubMed CentralManuscript submissions can be found on PubMed Centralhttp://www.pubmedcentral.gov Questions and Answers: http://www.nih.gov/about/publicaccess/publicaccess_Qa ndA.htmQuestions and Answers: http://www.nih.gov/about/publicaccess/publicaccess_Qa ndA.htm