February 2019 Cancer Epidemiology Matters E-News
Cancer Epidemiology Matters E-News
The NIH Genomic Data Sharing (GDS) Policy and Informed Consent
NIH’s Genomic Data Sharing (GDS) Policy includes specific guidance for informed consent [PDF] regarding the use of biospecimens and data for genomic research. For instance, participants should be informed that their data may be used in future research and that the data will be shared broadly. This guidance about elements of consent only applies to research or clinical specimens collected or cell lines created after the implementation date of the GDS Policy, January 25, 2015. Individual-level data may be shared through a controlled-access process or openly, depending on the provisions in the informed consent. NIH recently issued updated guidance that allows for open sharing of summary genomic results through NIH-designated data repositories (e.g., dbGaP).
For projects that fall under the GDS policy, institutions must affirm that participants provided appropriate consent; this is documented in an Institutional Certification from the primary institution. Additional information about Institutional Certification and official forms are available on the NIH website.
Some projects that don’t generate genomic data are also expected to share data broadly; any project sharing data through an NIH-designated data repository will need to affirm that participants provided appropriate consent for sharing their data broadly.