GIM: Informed consent for return of incidental findings in genomic research

By Nicholson Price

In the second installment of our new collaboration with Genetics in Medicine, we are highlighting an article released last week discussing informed consent for the return of incidental findings in genomic research.

As whole-genome and whole-exome sequencing become increasingly common in medical research, the potential grows for identifying genetic findings that are unrelated to the main focus of the study (often called “incidental findings,” or “IFs”).  There is substantial debate about the duties associated with incidental findings, including whether researchers should or must search for them under ethical or legal frameworks, and whether and how to return the results to research participants.  One understudied aspect of the issue, though, is how informed consent should be obtained for the return of such findings, and this paper begins the task of addressing that question.

The research team (disclosure: I’m a co-author) conducted a web-based survey of U.S.-based genetic researchers focusing on human disease gene identification, receiving responses from 254, and conducted semi-structured interviews of 28 researchers and 20 research participants.  Views were solicited on which benefits and risks should be disclosed.

The resulting findings highlight the practical problems with the informed consent process.  A majority of researchers and participants alike supported the disclosure of every listed potential risk or benefit of IFs in the informed consent process (a supermajority for most).  Majorities also favored discussing issues including implications for family members,  the return of data from impaired or deceased participants, data from later studies of biobanked samples or archived data, and data security procedures.  But researchers and participants alike expressed concern about the potentially overwhelming complexity of informed consent procedures – and 70% of researchers thought a reasonable amount of time for this aspect of informed content should not exceed 30 minutes.  Given the tremendous amount of data that all agree should ideally be disclosed, this tension is potentially quite problematic, and suggests the need for more creative and efficient methods of informing participants in the informed consent process.

There’s much more detail and discussion in the article itself, which once again is available here.