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NIH Policy for Data Sharing: Genome Wide Association Studies GWAS

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Title: NIH Policy for Data Sharing: Genome Wide Association Studies GWAS


1
NIH Policy for Data Sharing Genome Wide
Association Studies (GWAS)
POLICY OVERVIEW
2008 NIH Regional Seminars Sally A. Amero,
Ph.D. NIH Review Policy Officer Office of
Extramural Research
2
GWAS Genome Wide Association Studies
NIH GWAS Data Sharing Policy
  • 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

3
Guiding Principle
NIH GWAS Data Sharing Policy
  • 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.

4
NIH GWAS Data Sharing Policy
NIH Policy - GWAS (http//grants.nih.gov/grants/gu
ide/notice-files/NOT-OD-07-088.html)
  • 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

5
Data Sharing Plans
NIH GWAS Data Sharing Policy
Expected in Research grant applications
Proposals for contracts that propose a
GWAS component
Does not apply to studies of Acquired
variation Particular sets of genes
Genomes in other species Linkage or
Genotyping facility.
6
Data Sharing Plans
NIH GWAS Data Sharing Policy
Expected in Research grant applications
Proposals for contracts that propose a
GWAS component
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.
7
Data Sharing Plans
NIH GWAS Data Sharing Policy
Peer reviewers Will consider appropriateness
of data sharing plan Comments included in
summary statement (as an Administrative Note)
Will evaluate reasonableness of proposed
budget Merit rating not affected
8
Data Sharing Plans
NIH GWAS Data Sharing Policy
If plan is adequate Terms conditions on GWAS
data sharing will be included in the Notice of
Award
If plan is inadequate NIH Program Officer will
work with applicant to negotiate a revised
plan or Award may be restricted or not funded.
9
Annual Progress Reports
NIH GWAS Data Sharing Policy
Grantees describe How data has been shared
Whether this approach is consistent with their
submitted and approved plan
In early years of award, data may not be
available for sharing
10
Core Elements of the NIH GWAS Policy
NIH GWAS Data Sharing Policy
  • Data Management
  • Protection of research participants
  • Data submission procedures
  • Data access principles
  • Scientific Publication
  • Intellectual Property

11
NIH GWAS Data Sharing Policy
GWAS Data Management
Data Access Comm
dbGaP
NIH Staff
POs/SROs/GMOs
Data Submission
Data Distribution
Data Flow
Data Collection
Management
Secondary Use
Institutional Certification
Data Use Certification
12
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

13
Institutional Certifications (submitting)
NIH GWAS Data Sharing Policy
  • 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

14
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

15
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

16
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
17
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 individuals
  • Use 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

18
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
  • ICs may impose shorter time

19
Intellectual Property
NIH GWAS Data Sharing Policy
  • NIH encourages broad use of GWAS data consistent
    with NIHs 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

20
GWAS Oversight Structure
NIH GWAS Data Sharing Policy
Advisory Committee to the Director
NIH Director
Senior Oversight Committee
Participant Protection Data Management
Steering Committee
Technical Standards Steering Committee
21
Web resources
NIH GWAS Data Sharing Policy
  • 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
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