How will the NIH ensure that data obtained from the NIH GWAS data repository are used in a manner consistent with the informed consent provided by research participants?
Through the Controlled Access process for providing data access to secondary users, mechanisms are in place to minimize the likelihood of usage of GWAS data in ways that are inconsistent with the original informed consent. For instance, the NIH expects that an IRB or Privacy Board will have reviewed all proposed submissions of data to the NIH GWAS data repository and determined that the submission and subsequent sharing for research purposes are consistent with the informed consent of the study participants from whom the data were obtained. In addition, submitting institutions are expected to certify that the appropriate research uses of the data and the uses that are specifically excluded by the relevant informed consent documents are delineated. For example, the consent forms for some GWAS studies may have restrictions regarding the disease(s) to be studied. Information from the submitting institution about data use limitations will then be used by the NIH Data Access Committees to i
Related Questions
- How will the NIH ensure that data obtained from the NIH GWAS data repository are used in a manner consistent with the informed consent provided by research participants?
- Are the data included in the NIH GWAS data repository subject to the Freedom of Information Act (FOIA)?
- What is the IRBs role in submission of data to the NIH GWAS data repository?
