Changes in the NIH Management of Genomic Summary Results Access Policy

The NIH recently announced changes in the NIH Management of Genomic Summary Results Access Policy (available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html) , which will permit unrestricted download of genomic summary results data by third parties from the NIH Database of Genotypes and Phenotypes (“dbGaP”). Please note these changes apply to the sharing of summary results only and do not impact requirements for sharing of individual-level data.

For new NIH funded studies that will collect genomic data that is subject to the NIH Genomic Data Sharing Policies, all JHU Institutional Review Boards (“IRBs”) have developed new template language for informed consent documents to inform research participants about the further dissemination of genomic summary results data. Investigators should make certain that they are using the most current template language for new or on-going studies subject to the data-sharing requirements.

For studies that have already deposited data into dbGaP, the NIH has acknowledged that this change in policy may heighten the privacy risks to subjects for studies that are particularly sensitive; including studies involving populations from isolated geographic areas, populations with rare traits, or populations with stigmatizing traits. The NIH has given institutions until May 1, 2019, to designate, through the Institutional Certification process under dbGaP, whether any studies previously submitted will be designated as “sensitive” by the institution and which therefore should be maintained as controlled access only. Johns Hopkins University IRBs have convened a small group of internal experts to develop a consistent rubric to review already deposited studies and will be communicating with impacted investigators directly about any further action required. Investigators who have been contacted by their program officers, or who have questions about an existing study, may contact the relevant IRB office with questions about their particular study.