Broadening research consent in the era of genome-informed medicine

Kronenthal, Courtney J.; Delaney, Susan; Christman, Michael F.

doi:10.1038/gim.2011.76

Cited by 16 publications

(14 citation statements)

References 18 publications

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“…One example of this latter variation of the model is the “informed cohort” approach proposed by Isaac Kohane and colleagues, which has been adopted by the Coriell Personalized Medicine Collaborative . Although not focused specifically on incidental findings, the project makes sequencing findings about potentially actionable conditions available to research participants.…”

Section: Models Of Informed Consentmentioning

confidence: 99%

Models of Consent to Return of Incidental Findings in Genomic Research

Appelbaum¹,

Parens²,

Waldman³

et al. 2014

Hastings Center Report

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Genomic research has the capacity to generate a wide array of findings that go beyond the goals of the study—usually referred to as “incidental findings.” The evolving consensus of researchers, participants, and expert panels is that at least some incidental results should be made available to participants. However, there are a number of challenges to discussing these issues with participants and ascertaining their preferences, including the complexity and magnitude of the relevant information. Believing that usual models of informed consent are not likely to be effective in this context, we identify four approaches that investigators and IRBs might consider: traditional consent, staged consent, mandatory return, and outsourcing. Each has advantages and disadvantages compared with the other options, and which one is selected for a given project will depend on a mix of practical and normative considerations that are described in this paper.

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Section: Models Of Informed Consentmentioning

confidence: 99%

Models of Consent to Return of Incidental Findings in Genomic Research

Appelbaum¹,

Parens²,

Waldman³

et al. 2014

Hastings Center Report

View full text Add to dashboard Cite

show abstract

“…(33–36) Such an approach would lift much of the burden from the researcher obtaining consent, allowing in-person interactions to focus on reiterating key points and responding to questions. 2) Staged consent would replace current practices.…”

Section: Discussionmentioning

confidence: 99%

“…(37) In an interactive version of the staged consent model, a web-based portal, with links to extensive information about the options, would allow participants to select those results they desire to receive, and to return at any time to update preferences, receive additional information, and provide follow-up data. (35,36,38,39) 3) Consent to return of specific categories of IFs would be obtained as a condition of enrollment in the study (e.g., as with the ACMG recommendations for clinical sequencing)(40). Although this would not obviate the need for disclosure of information related to IFs, participants would not need to make choices about types of data to be returned.…”

Section: Discussionmentioning

confidence: 99%

Informed consent for return of incidental findings in genomic research

Appelbaum

Waldman

Fyer

et al. 2014

Genetics in Medicine

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Purpose Researchers face the dilemma of how to obtain consent for return of incidental findings (IFs) from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. Methods We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database and abstracts from the 2011 American Society of Human Genetics meeting; and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants. Results Most researchers and participants endorsed disclosure of a wide range of information about return of IFs, including: risks, benefits, impact on family members, data security, and procedures for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 minutes or less to this process, and expressed concerns that disclosed information would overwhelm participants, a concern shared by many participants themselves. Conclusion There is a disjunction between the views of investigators and participants about the amount of information that should be disclosed and the practical realities of the research setting, including time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process.

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“…Researchers point to the fact that the concept of "informed consent is not entirely attuned to the era of whole-genome sequencing" [1] and some write that a rethinking of the concept is demanded [2]. In this article, we present a philosophical analysis of dealing with informed consent in WGS in biobank research.…”

Section: Introductionmentioning

confidence: 99%