Required when research involves a submission of genomic data to the NIH database of Genotypes and Phenotypes (dbGaP).
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS).
The WVU IRB must determine that all of the following requirements are met:
- The submission of data to the NIH GWAS data repository and subsequent sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained
- The IRB has considered the risks to individuals, their families, and groups or populations associated with data submitted to the NIH GWAS data repository
- The genotype and phenotype data to be submitted were collected in a manner consistent with 45 CFR §46
- The identities of data subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data
- The 18 identifiers enumerated at section 45 CFR §164.514(b)(2) (the HIPAA Privacy Rule) are removed
- The submitting institution has no actual knowledge that the remaining information could be used alone or in combination with other information to identify subjects.