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NIH Policy For Data Sharing: Genome Wide Association Studies (GWAS)

The NIH policy for data sharing of genome-wide association studies (GWAS) aims to maximize the public benefit from GWAS data. It requires investigators to share GWAS data through the NIH database of Genotypes and Phenotypes (dbGaP), after removing direct identifiers and obtaining Institutional Review Board approval. Researchers must submit a data sharing plan and sign a Data Use Certification to access dbGaP data. The policy balances effective data sharing with protecting research participants and their privacy. It provides oversight through Data Access Committees while allowing submitting investigators exclusive publication rights for 12 months after data submission.

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114 views21 pages

NIH Policy For Data Sharing: Genome Wide Association Studies (GWAS)

The NIH policy for data sharing of genome-wide association studies (GWAS) aims to maximize the public benefit from GWAS data. It requires investigators to share GWAS data through the NIH database of Genotypes and Phenotypes (dbGaP), after removing direct identifiers and obtaining Institutional Review Board approval. Researchers must submit a data sharing plan and sign a Data Use Certification to access dbGaP data. The policy balances effective data sharing with protecting research participants and their privacy. It provides oversight through Data Access Committees while allowing submitting investigators exclusive publication rights for 12 months after data submission.

Uploaded by

Harikrishna Reddy
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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NIH GWAS Data Sharing Policy 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
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NIH GWAS Data Sharing Policy 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 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

NIH Policy - GWAS


(http://grants.nih.gov/grants/guide/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
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NIH GWAS Data Sharing Policy Data Sharing Plans


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.
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NIH GWAS Data Sharing Policy Data Sharing Plans


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, Not sharing is an exception that or individuals will be considered on a case-bycase basis.
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NIH GWAS Data Sharing Policy Data Sharing Plans


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 unless stated otherwise in Announcement.


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NIH GWAS Data Sharing Policy Data Sharing Plans


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.

NIH GWAS Data Sharing Policy Annual Progress Reports


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.


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NIH GWAS Data Sharing Policy


Core Elements of the NIH GWAS Policy Data Management
Protection of research participants Data submission procedures Data access principles

Scientific Publication Intellectual Property

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NIH GWAS Data Sharing Policy

GWAS Data Management


NIH Staff POs/SROs/GMOs dbGaP Data Submission & Management Data Access Comm Data Distribution & Secondary Use

Data Flow

Data Collection

Research Participants

Submitting Investigators

GWAS data repository

Recipient Investigator
s

Informed consent

Institutional Certification

Identifying information removed, replaced with random unique code

Data Access Request for Coded data

Data Use Certification


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NIH GWAS Data Sharing Policy GWAS Data Management CONTINUED


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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NIH GWAS Data Sharing Policy


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
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NIH GWAS Data Sharing Policy Points to Consider for IRBs


http://grants.nih.gov/grants/gwas/gwas_ptc.pdf

Resource for IRBs and Privacy Boards Ethical issues Informed consent considerations, e.g.
Vulnerable populations Proxy consent

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NIH GWAS Data Sharing Policy dbGaP (http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap)


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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NIH GWAS Data Sharing Policy Access to GWAS Data


1. Log in (eRA or NIH) 2. Select dataset 3. Complete SF424 4. Institutional Signing Official

7. Retrieve dataset

6. Referral to NIH DAC

5. Submit to dbGaP
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NIH GWAS Data Sharing Policy Data Use Certification Agreements


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
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NIH GWAS Data Sharing Policy Scientific Publication


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
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NIH GWAS Data Sharing Policy Intellectual Property


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
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NIH GWAS Data Sharing Policy GWAS Oversight Structure


NIH Director
Advisory Committee to the Director

Senior Oversight Committee

Technical Standards Steering Committee

Participant Protection & Data Management Steering Committee


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NIH GWAS Data Sharing Policy 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
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