NIH Data Sharing

Dr. Belinda Seto, Deputy DirectorNational Institute of Biomedical Imaging and

Biomedical Engineering

September, 2005

South Africa Workshop

“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

PHS Grants Policy StatementApril 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.”

• 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

• 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?

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

YES!

• In application—budget and budget justification

• Administrative supplements

Will NIH Provide Supportfor Data Sharing?

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

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

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

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

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.

Reasons for Sharing Data

Scope Potential Cost

Add Health: Sensitive Data Sharing Example

Challenges to Sharing Data Data sensitivity Need to protect

confidentiality Danger of deductive

disclosure

Add Health: Sensitive Data Sharing Example

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

Solution: a multi-tiered system Public use data Contractual data sets Cold room for on-site data

use

Add Health: Sensitive Data Sharing Example

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

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

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

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

Policy on Enhancing Public Access Policy on Enhancing Public Access to Archived Publications Resulting to Archived Publications Resulting

From NIH-Funded ResearchFrom NIH-Funded Research

NIH-supported research is essential to improving NIH-supported research is essential to improving human health and public access to publications human health and public access to publications resulting from this research is vital. resulting from this research is vital.

• Good for ScienceGood for Science• Good for NIHGood for NIH • Good for the PublicGood for the Public

NIH Must Lead the Way in Public AccessNIH Must Lead the Way in Public Access

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?Why Public Access?

NIH Public Access Policy NIH Public Access Policy Embraces Growing TrendEmbraces Growing Trend

NIH examined the access policies of NIH examined the access policies of the top 20 journals based on citation the top 20 journals based on citation impact for medicine and medical impact for medicine and medical research and of the top 50 journals research and of the top 50 journals published by members of FASEB.published by members of FASEB.

As of October 2004:As of October 2004:• 80% of the 20 high impact journals allow 80% of the 20 high impact journals allow

public access of some sort through public access of some sort through HighWire press within 12 months of HighWire press within 12 months of publication.publication.

• 78% of the 50 FASEB journals offer public 78% of the 50 FASEB journals offer public access within 12 months. access within 12 months.

The Public Access PolicyThe Public Access Policy

With input from stakeholders and the public, With input from stakeholders and the public, NIH’s NIH’s Policy on Enhancing Public Access to Archived Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research Publications Resulting From NIH-Funded Research has several key elements:has several key elements:• The Policy strongly encourages, but does not require, The Policy strongly encourages, but does not require,

all NIH-funded investigators to make the peer-all NIH-funded investigators to make the peer-reviewed, author’s final manuscript available to other reviewed, author’s final manuscript available to other researchers and the public at the NIH National Library researchers and the public at the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) of Medicine’s (NLM) PubMed Central (PMC) immediately after the final date of publication in a immediately after the final date of publication in a journal. journal.

• At the time of submission, the author will specify the At the time of submission, the author will specify the timing of the posting of his or her final manuscript for timing of the posting of his or her final manuscript for public accessibility as soon as possible and within public accessibility as soon as possible and within twelve months of the publisher’s official date of final twelve months of the publisher’s official date of final publication.publication.

Note: The author’s final manuscriptNote: The author’s final manuscript is the final version is the final version accepted for journal publication and includes all accepted for journal publication and includes all modifications from the publishing peer review process.modifications from the publishing peer review process.

What to Submit for the Public What to Submit for the Public Access PolicyAccess Policy

• The Policy applies to peer-reviewed, The Policy applies to peer-reviewed, original research publications that original research publications that have been supported in whole or in have been supported in whole or in part with direct costs from NIH. It part with direct costs from NIH. It does not apply to book chapters, does not apply to book chapters, editorials, reviews, or conference editorials, reviews, or conference proceedings.proceedings.

• The Policy applies to all research grant The Policy applies to all research grant and career development award and career development award mechanisms, cooperative agreements, mechanisms, cooperative agreements, contracts, Institutional and Individual contracts, Institutional and Individual Ruth L. Kirschstein National Research Ruth L. Kirschstein National Research Service Awards, as well as NIH Service Awards, as well as NIH intramural research studies. intramural research studies.

What to Submit for the Public What to Submit for the Public Access PolicyAccess Policy

• NIH is requesting that authors NIH is requesting that authors submit manuscripts resulting submit manuscripts resulting from: from: 1)1) currently funded NIH research currently funded NIH research

projects or projects or 2)2) previously-supported NIH research previously-supported NIH research

projects if they are accepted for projects if they are accepted for publication on or after May 2, 2005. publication on or after May 2, 2005.

• Publications resulting from non-Publications resulting from non-NIH-supported research projects NIH-supported research projects should should notnot be submitted. be submitted.

The Policy requests and strongly The Policy requests and strongly encourages that authors specify posting of encourages that authors specify posting of their final manuscripts for public their final manuscripts for public accessibility immediately after the final date accessibility immediately after the final date of journal publication. Authors are given of journal publication. Authors are given the option to release their manuscripts at a the option to release their manuscripts at a later time, up to 12 months after the official later time, up to 12 months after the official date of final publication.date of final publication.

NIH expects that only in limited cases will NIH expects that only in limited cases will authors deem it necessary to select the authors deem it necessary to select the longest delay period.longest delay period.

Timing of Public Accessibility: Timing of Public Accessibility: Immediately to Twelve MonthsImmediately to Twelve Months

NIH’s Public Access Policy NIH’s Public Access Policy Does Not Affect CopyrightDoes Not Affect Copyright

The NIH Policy explicitly recognizes The NIH Policy explicitly recognizes and upholds the principles of and upholds the principles of copyright.copyright.

Authors and journals can continue to Authors and journals can continue to assert copyright in scientific assert copyright in scientific publications resulting from NIH-publications resulting from NIH-funding, in accordance with current funding, in accordance with current practice.practice.

NIH’s Public Access Policy NIH’s Public Access Policy Does Not Affect CopyrightDoes Not Affect Copyright

While individual copyright arrangements can While individual copyright arrangements can take many forms, NIH encourages investigators take many forms, NIH encourages investigators to sign agreements that specifically allow the to sign agreements that specifically allow the manuscript to be deposited with NIH for public manuscript to be deposited with NIH for public posting on PubMed Central. An example of the posting on PubMed Central. An example of the kind of language that an author or institution kind of language that an author or institution might add to a copyright agreement includes the might add to a copyright agreement includes the following:following:

““Journal acknowledges that Author retains the Journal acknowledges that Author retains the right to provide a copy of the final manuscript to right to provide a copy of the final manuscript to NIH upon acceptance for Journal publication or NIH upon acceptance for Journal publication or thereafter, for public archiving in PubMed thereafter, for public archiving in PubMed Central as soon as possible after publication by Central as soon as possible after publication by Journal.”Journal.”

The NIH Public Access Policy The NIH Public Access Policy Does Not Alter the Quality of Peer Does Not Alter the Quality of Peer

ReviewReview NIH does not anticipate that its NIH does not anticipate that its

policy will harm or otherwise policy will harm or otherwise affect the peer review process for affect the peer review process for scientific papers. scientific papers.

Only peer-reviewed manuscripts Only peer-reviewed manuscripts accepted for publication will be accepted for publication will be posted in PubMed Central.posted in PubMed Central.

The NIH Public Access Policy The NIH Public Access Policy Does Not Alter the Quality of Peer Does Not Alter the Quality of Peer

ReviewReview NIH recognizes peer review is a NIH recognizes peer review is a

hallmark of quality for journals and is hallmark of quality for journals and is vital for validating the accuracy and vital for validating the accuracy and interpretation of research results. interpretation of research results.

NIH also recognizes that publication NIH also recognizes that publication in peer-reviewed journals is a major in peer-reviewed journals is a major factor in determining the professional factor in determining the professional standing of scientists.standing of scientists.

Will NIH’s Public Access Policy Will NIH’s Public Access Policy Impact Scientific Publishing?Impact Scientific Publishing?

NIH is not aware that there will be a NIH is not aware that there will be a substantial impact. For example, only substantial impact. For example, only a minor portion of articles published a minor portion of articles published in scientific journals result from in scientific journals result from research funded by the NIH. research funded by the NIH.

• NIH-funded research represents about NIH-funded research represents about 10% of the articles in the nearly 5,000 10% of the articles in the nearly 5,000 journals indexed by PubMed.journals indexed by PubMed.

• NIH-funded articles account for more NIH-funded articles account for more than half of the total published articles than half of the total published articles for only 1% of these journals.for only 1% of these journals.

Will NIH’s Public Access Policy Will NIH’s Public Access Policy Impact Scientific Publishing?Impact Scientific Publishing?

An increasing number of journals An increasing number of journals already provide access to the already provide access to the published article immediately or published article immediately or within one year of the publication. within one year of the publication.

In addition, the NIH Public Access In addition, the NIH Public Access Policy does not affect authors' Policy does not affect authors' freedom to choose the vehicle or freedom to choose the vehicle or venue for publishing their results. venue for publishing their results.

The Policy May Streamline The Policy May Streamline Procedures for Investigators and Procedures for Investigators and

InstitutionsInstitutions Effective August 1, 2005, submissions under Effective August 1, 2005, submissions under this Policy afford NIH-supported this Policy afford NIH-supported investigators an alternate means by which investigators an alternate means by which they can fulfill the existing requirement to they can fulfill the existing requirement to provide publications as part of progress provide publications as part of progress reports. reports.

It is anticipated that, in the future, It is anticipated that, in the future, investigators applying for new and investigators applying for new and competing renewal support from the NIH competing renewal support from the NIH will also utilize this resource by providing will also utilize this resource by providing links in their applications to their PubMed links in their applications to their PubMed Central-archived information. Central-archived information.

Benefits to Principal Benefits to Principal Investigators Investigators and Authorsand Authors

Submission heightens the visibility of the Submission heightens the visibility of the research and enhances the likelihood of research and enhances the likelihood of early and increased citation. early and increased citation.

Ensures that the manuscript is accessible Ensures that the manuscript is accessible through PMC, a comprehensive, through PMC, a comprehensive, integrated, biomedical information integrated, biomedical information technology system, so authors will benefit technology system, so authors will benefit from the tools already available in PMC from the tools already available in PMC (e.g., GenBank, Clinical Trials, etc.).(e.g., GenBank, Clinical Trials, etc.).

When provided by the publisher, PMC When provided by the publisher, PMC provides the journal’s published article, a provides the journal’s published article, a link to the journal article, and/or links to any link to the journal article, and/or links to any corrections associated with the article on the corrections associated with the article on the publisher’s site.publisher’s site.

Offers NIH staff, scientists, and the public Offers NIH staff, scientists, and the public the ability to search, view, print, or save the ability to search, view, print, or save (subject to applicable copyright law) Public (subject to applicable copyright law) Public Access Policy manuscript submissions, full Access Policy manuscript submissions, full text Journal articles for 178 journals*, as text Journal articles for 178 journals*, as well as citations and abstracts from over well as citations and abstracts from over 5,000 journals.5,000 journals.

Benefits for Archiving in Benefits for Archiving in PubMed CentralPubMed Central

* As of May, 2005

Provides integration with the NIH eRA Provides integration with the NIH eRA Commons.Commons.

Integrates manuscripts into the PMC Integrates manuscripts into the PMC system which includes various system which includes various resources and tools including: PubMed, resources and tools including: PubMed, GenBank, Genome Map Viewer, GenBank, Genome Map Viewer, Molecular Database, MedlinePlus, Molecular Database, MedlinePlus, Clinical Trials, Taxonomy, Small Clinical Trials, Taxonomy, Small Molecules (PubChem), and DNA, Molecules (PubChem), and DNA, Protein Sequences, and Protein Protein Sequences, and Protein Structures.Structures.

Benefits for Archiving in Benefits for Archiving in PubMed CentralPubMed Central

Public Access PolicyPublic Access PolicyResourcesResources

• Public Access Policy Website:Public Access Policy Website: http://www.nih.gov/about/publicaccess/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 Public Access Policy (NIH Guide for Grants and

Contracts):Contracts):http://grants.nih.gov/grants/guide/notice-files/NOT-http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.htmlOD-05-022.html

• Authors’ Manual:Authors’ Manual:http://www.nih.gov/about/publicaccess/http://www.nih.gov/about/publicaccess/publicaccess_Manual.pdfpublicaccess_Manual.pdf

• Manuscript submissions can be found on PubMed CentralManuscript submissions can be found on PubMed Centralhttp://www.pubmedcentral.govhttp://www.pubmedcentral.gov

• Questions and Answers:Questions and Answers: http://www.nih.gov/about/publicaccess/publicaccess_http://www.nih.gov/about/publicaccess/publicaccess_QandA.htmQandA.htm