Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants' Genomic Results

Abstract

Objectives: Genomic information will increasingly be used to aid in the prevention, diagnosis, and treatment of disease. Several national initiatives are paving the way for this new reality, while also promoting new models of participant-engaged research. We compare the opinions of research participants in a cancer registry, human genetic researchers, and institutional review board (IRB) professionals about the return of individual-level genetic results (ROR).

Methods: Online surveys were administered to participants in a cancer registry (n = 450) and overlapping questions were compared to our previous online national surveys of human genetic researchers (n = 351) and IRB professionals (n = 208).

Results: The majority of respondents agreed that researchers have an obligation to return individual results when they would affect a participant's health. While 77% of registry participants favored ROR if the researcher feels the participant might be interested in the results, only 30% of the IRB professionals and 25% of the genetic researchers agreed with this statement.

Conclusions: Significant differences emerged between the stakeholder groups in several ROR scenarios. Policies that are acceptable to participants, researchers and IRBs, and that ensure human subject protections and facilitate research are needed.

Keywords: Cancer; Genomics; Precision medicine; Research participant perspective; Return of results.

Fig. 1.

Comparison of agreement with 3 possible scenarios: genetic researcher (ASHG), Institutional Review Board member (PRIM&R), and research participant (PIP) groups. Scenario 1: researchers have an ethical obligation to return individual research results when the results would affect a participant’s health or health care. Scenario 2: researchers have an ethical obligation to return individual research results when a participant asks for them. Scenario 3: researchers have an ethical obligation to return individual research results when the researcher feels that the participant might be interested in knowing about them.