1. The goal of GWAS (Genome Wide Association Studies) is to discover genetic factors that contribute to the development, progression and treatment of disease.
a. True
b. False
2. Who is required to submit data to the GWAS repository?
a. All CGREAL-funded genetic researchers
b. Researchers with NIH-supported or conducted genome-wide association studies
c. All industry-sponsored genetic researchers
d. No one is required, GWAS depends on voluntary submissions
3. With regard to GWAS data, IRBs/institutions have a duty to minimize risks to participants by ensuring all but which of the following:
a. PHI as identified by HIPAA are removed
b. that the scientific data will be useful
c. that all data submitted is de-identified and coded
d. that the submitting institution has no actual knowledge that remaining information could be used to identify a subject (either alone or in combination with other information)
4. The GWAS data use monitoring policy requires researchers to submit quarterly data use reports.
a. True
b. False
5. For retrospective studies, to be included in GWAS, informed consent needed to do which of the following?
a. be specific enough to inform subject of the possibility of future genetic studies
b. describe what data would be shared
c. be broad enough to cover the possibility of a repository
d. all of the above
6. For prospective studies, to be included in GWAS, the informed consent process and document needs to be clear that participants’ DNA will undergo genome-wide analysis and that genotype and phenotype data will be shared for research purposes through the NIH GWAS data repository.
a. True
b. False
7. The following are all risks to participants of GWAS studies:
a. Risk of a breach of confidentiality/security breach
b. Risk of receiving a placebo
c. Risk to family members
d. only A and C above
8. If a research participant requests that their information be withdrawn from the repository, they need to have a clear understanding that any data already released from the NIH GWAS data repository to a researcher will not be withdrawn, but that no future release of information will occur.
