Post on 03-Dec-2014
transcript
NIH GWAS Data Sharing Policy
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NIH Policy for Data Sharing: Genome Wide Association Studies
(GWAS)
2008 NIH Regional SeminarsSally A. Amero, Ph.D.
NIH Review Policy OfficerOffice of Extramural Research
POLICY OVERVIEW
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GWAS – Genome Wide Association Studies• Studies of genetic variation across the
(entire) human genome• Designed to identify associations
between genetic markers &observable traits, or the presence/absence of a disease or condition
• Often markers of modest effect
NIH GWAS Data Sharing Policy
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Guiding Principle
The greatest public benefit will be realized if data from GWAS are made available, under terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of investigators.
NIH GWAS Data Sharing Policy
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NIH GWAS Data Sharing Policy
• Current NIH GWAS data repository = dbGaP• NIH-wide (all ICs)• Effective for January 25, 2008 receipt dates
and thereafter
• No direct cost threshold• Expectation, not a requirement• May be required for some FOAs
NIH Policy - GWAS(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html)
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Data Sharing PlansExpected in …
• Research grant applications• Proposals for contracts
… that propose a GWAS component
NIH GWAS Data Sharing Policy
Does not apply to studies of:• Acquired variation
• Particular sets of genes• Genomes in other species
• Linkage or• Genotyping facility.
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Data Sharing PlansExpected in …
• Research grant applications• Proposals for contracts
… that propose a GWAS component
NIH GWAS Data Sharing Policy
Or applicant may justify why GWAS data cannot be shared
• Limitations in informed consent• Risks to specific populations, groups, communities,
or individuals Not sharing is an exception that will be considered on a case-by-case basis.
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Data Sharing PlansPeer reviewers
• Will consider appropriateness of data sharing plan
• Comments included in summary statement (as an Administrative Note)
• Will evaluate reasonableness of proposed budget
NIH GWAS Data Sharing Policy
Merit rating not affected unless stated otherwise in Announcement.
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Data Sharing Plans• If plan is adequate: Terms & conditions on GWAS data sharing will be included in the Notice of Award
NIH GWAS Data Sharing Policy
• If plan is inadequate: NIH Program Officer will work with applicant to negotiate a revised plan or Award may be restricted or not funded.
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Annual Progress ReportsGrantees describe:
• How data has been shared• Whether this approach is consistent with
their submitted and approved plan
NIH GWAS Data Sharing Policy
In early years of award, data may not be available for sharing.
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Core Elements of the NIH GWAS Policy
• Data Management– Protection of research participants– Data submission procedures– Data access principles
• Scientific Publication
• Intellectual Property
NIH GWAS Data Sharing Policy
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NIH GWAS Data Sharing Policy
Research
Participants
Informedconsent
Submitting
Investigators
GWAS data repository
Identifying
information removed,
replaced with
random
unique code
RecipientInvestigator
s
Data
Access Request
for Codeddata
GWAS Data Management Data Access CommdbGaPNIH Staff POs/SROs/GMOs
Data Flow
Institutional Certification Data Use Certification
Data Submission& Management
Data Distribution &Secondary Use
Data Collection
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GWAS Data Management CONTINUED
NIH GWAS Data Sharing Policy
• Institutional Certification required to submit data to repository
• Data Use Certification (DUC) required to request data from repository
• NIH Data Access Committees (DACs) – Evaluate requests for data and proposed uses– Issue Data Use Certifications– Monitor annual progress reports– Federal officials
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Institutional Certifications (submitting)
• Data provided in accord with all applicable laws & regulations
• An IRB or Privacy Board has reviewed the submission plans
• Data coded by submitting investigators (no HIPAA identifiers)
• Key codes will not be shared with NIH GWAS data repository
• Limitations on data use requested at time of submission
NIH GWAS Data Sharing Policy
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Points to Consider for IRBshttp://grants.nih.gov/grants/gwas/gwas_ptc.pdf
NIH GWAS Data Sharing Policy
• Resource for IRBs and Privacy Boards
• Ethical issues
• Informed consent considerations, e.g.– Vulnerable populations– Proxy consent
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dbGaP (http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap)
NIH GWAS Data Sharing Policy
• Public Access– Study protocols– Consent conditions, terms for data access– Summary phenotype and genotype data– Published genetic associations
• Controlled Access– Coded genotypes (codes reside with submitting
institution/investigator)– Phenotypes– Individual-level data
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Access to GWAS Data
NIH GWAS Data Sharing Policy
1. Log in (eRA or NIH)
2. Select dataset
3. Complete SF424
4. Institutional Signing Official
5. Submit to dbGaP
6. Referral to NIH DAC
7. Retrieve dataset
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Data Use Certification Agreements
NIH GWAS Data Sharing Policy
• Partial listing of requirements:Use data only for approved research Protect data confidentiality; not attempt to
identify individualsUse appropriate data security protections Follow all applicable laws, regulations, local
institutional policies & procedures for handling GWAS data
Agree to report violations of the GWAS policy to the appropriate DAC
Acknowledge the GWAS policy with regard to publication and intellectual property
Provide annual progress reports
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Scientific Publication
NIH GWAS Data Sharing Policy
Contributing investigators have exclusive right to submit publications for 12 months after their GWAS dataset is made available• Includes any form of public dissemination• Other uses of the data
allowable during this time- all investigators
• IC’s may impose shorter time
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Intellectual Property
NIH GWAS Data Sharing Policy
• NIH encourages broad use of GWAS data consistent with NIH’s Best Practices for Licensing with Genomic Inventions (http://www.ott.nih.gov/policy/lic_gen.html)
• NIH discourages premature claims
• Data submitters and users
must “acknowledge” this
position
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GWAS Oversight Structure
NIH GWAS Data Sharing Policy
Advisory Committee to the Director
NIH Director
Senior OversightCommittee
Technical StandardsSteering Committee
Participant Protection & Data Management Steering Committee
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Web resources• NIH GWAS page: http://grants.nih.gov/grants/gwas/
– Policy (Guide Notice and Federal Register)– Governance Structure– Frequently Asked Questions– Points to Consider for IRBs and Institutions– General Brochure– Data Sharing Plan– End to End Diagram– Archived Webcast of Town Hall Meeting
• dbGaP: http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap
NIH GWAS Data Sharing Policy