Obtaining Informed Consent for Future Reuse of Patient Data

Obtaining Informed Consent for Future Reuse of Patient Data
Kelly FitzGerald
Applied Clinical Trials, 8 June 2023; 32(6)
Excerpt
…One of the first national policies regarding this was the National Institutes of Health (NIH) Genomic Data Sharing Policy enacted in 2014, which established the expectation of broad and responsible sharing of genomic research data. During the public comment period and subsequent publication of the final policy, the issue of adequate informed consent for this kind of far-reaching research was raised. This resulted in NIH recommending that investigators seek the broadest consent possible when first obtaining consent from participants. However, NIH recognized that in some cases, limits will still be required, and it allows for use of controlled access databases as a way to mitigate concerns.

The policy requires that participants provide consent for sharing their data, even after it is de-identified, in order for the data to be deposited in an accessible database. The policy also requires that institutions, usually by way of their institutional review boards (IRBs), confirm the data sharing is consistent with the informed consent of study participants, and that consideration was given to the risks to individual participants and their families as well as groups or populations associated with the data…