Confidentiality in Biobanking Research: A Comparison of Donor and Nondonor Families' Understanding of Risks

Aims: Confidentiality of personal identifiers potentially linking the genetic results from biobanking participants back to the donor and donor relatives is a concern. The risks associated with a breach of confidentiality should be ascertained when biobanks collect samples requiring the consent of a family decision maker (FDM) from deceased organ and tissue donors. This article explores FDM knowledge and opinions regarding risks associated with participation in biobanking research in the context of the Genotype-Tissue Expression (GTEx) Project. Methods: Data collection included a survey completed by organ procurement organization requesters (n = 37) and semistructured telephone interviews with the FDMs (n = 85). Results: Donor families were more likely to know that there was a risk that a patient's identity could be revealed through a breach of confidentiality (p < 0.05). They also were more likely to understand that researchers using biobanked tissue would not have access to the patient's exact identity (p < 0.05). FDMs who refused donation were more concerned about risks than donors and reported lower levels of support for medical research in general. Finally, families were frequently interested in the return of results and willing to trade absolute confidentiality for participation. Conclusions: Clear discussion of the risk of breach of confidentiality is needed during the consent process. The risk and benefit equation could be equalized if studies such as GTEx offered genomic results to interested participants.