NIH RFI on Data Sharing for Genome-wide Association Studies

1. NIH RFI on Data Sharing for Genome-wide Association Studies

2. Summary: NIH RFI on Data Sharing http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-094.html • Data repository controlled by NCBI/NLM would contain de-identified genotype and phenotype data from ALL genome-wide association studies supported by NIH • Descriptive summary of all GWA Studies publicly available (required) • Data submitted as soon after QC as possible • Data and analyses available to any investigator after cursory application/ approval process • Submitting investigators would have exclusive publishing for the first 9 months after submission of data

3. NIH RFI on Data Sharing in GWAS http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-094.html • NIH is requesting comments on proposed policy for sharing data obtained in NIH-supported or conducted genome-wide association studies (GWAS) • GWAS defined as “any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits or presence or absence of a disease of condition” • Proposed policy addresses: • Data sharing procedures • Data access principles • Intellectual property • Protection of research participants • Comments are due Oct. 31.

4. NIH RFI on Data Sharing in GWAS • Requesting input on overall concept and specific questions: • Benefits and risks of sharing de-identified data • Additional protections to minimize risks to research participants beyond de-identification of data • Advantages and disadvantages of proposed • Centralized repository • Approach to data submission • Approach to scientific publication • Approach to intellectual property • Additional resources needed by investigators to meet the goals of the proposed policy

5. NIH RFI on Data Sharing in GWAS Concerns (1) • Does this apply prospectively or retroactively? • If retroactive, current MESA consent is not consistent with proposed policy

6. NIH RFI on Data Sharing in GWAS Concerns (2) • Extensive covariate data makes a subject potentially identifiable

7. NIH RFI on Data Sharing in GWAS Concerns (3) • “Forensic-equivalent” genome-wide data makes a subject and their relatives potentially identifiable

8. NIH RFI on Data Sharing in GWAS Concerns (4) • Consent to include genetic, phenotypic, and covariate data in a government controlled database might be challenging • Particularly in minority groups that have been previously abused by research

9. NIH RFI on Data Sharing in GWAS Concerns (5) • Monitoring of data security delegated to investigators and IRBs with no direct interest in study participants

10. NIH RFI on Data Sharing in GWAS Concerns (6) • It is likely that none of these cohort studies and/or their IRBs and/or their investigators and/or their subjects contemplated any type of “forensic-equivalent”, wide-ranging data sharing and the accompanying potential for loss of confidentiality

11. NIH RFI on Data Sharing in GWAS Summary of Concerns • Does this apply prospectively or retroactively? • If retroactive, current MESA consent is not consistent with proposed policy • Extensive covariate data makes a subject potentially identifiable • “Forensic-equivalent” genome-wide data makes a subject and their relatives potentially identifiable • Consent to include genetic, phenotypic, and covariate data in a government controlled database might be challenging • Particularly in minority groups that have been previously abused by research • Monitoring of data security delegated to investigators and IRBs with no direct interest in study participants • Question if local IRB’s of existing cohorts will approve