Impact of Cognitive Load on Family Decision Makers' Recall and Understanding of Donation Requests for the Genotype-Tissue Expression (GTEx) Project.

Genomic research projects that collect tissues from deceased organ and tissue donors must obtain the authorization of family decision makers under difficult circumstances that may affect the authorization process. Using a quasi-experimental design, the Ethical, Legal, and Social Issues (ELSI) substudy of the Genotype-Tissue Expression (GTEx) project compared the recall and understanding of the donation authorization process of two groups: family members who had authorized donation of tissues to the GTEx project (the comparison group) and family members who had authorized organ and tissue donations in years previous, who subsequently participated in two different mock-authorization processes that mimicked the GTEx authorization process (the intervention groups). Participants in the comparison and intervention groups were matched on key demographic characteristics. We found that participants in the intervention groups who experienced a mock-authorization process demonstrated better recall of the tissue donation request than members of the comparison group. Our data indicate that the stress associated with the loss of a loved one limited the ability of family members to recall details about the GTEx project. However, we found a similar lack of knowledge in both the comparison and the intervention group participants, suggesting lack of knowledge may be due to the complexity and unfamiliarity of the information presented to them during the authorization process. We discuss these findings in the context of everyday clinical decision making in cognitively challenging conditions.

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.