"Single gene mutations will be much more predictive, but the probability of finding known mutations will be relatively low [Janssens and van Duijn, 2010]. Nevertheless, if researchers would truly believe that eventually (also on the long term) no information relevant for health would accrue from the research one could seriously wonder why they expose participants to the risks of participation or use public resources for it [Manolio, 2006]. The blurring between research and clinical care, by the way, does not necessarily have to be negative if appropriately recognized and may increasingly occur in the context of biobanks and WGS, where cutting edge science and clinical care are intertwined. "
[Show abstract][Hide abstract] ABSTRACT: This article discusses whether and when researchers have a moral obligation to feedback individual genetic research results. This unsettled debate has rapidly gained in urgency in view of the emergence of biobanks and the advances in next-generation sequencing technology, which has the potential to generate unequalled amounts of genetic data. This implies that the generation of many known and unknown genetic variants in individual participants of genetics/genomics research as intentionally or collaterally obtained byproducts is unavoidable. As we conclude that valid reasons exist to adopt a duty to return genetic research results, a qualified disclosure policy is proposed. This policy contains a standard default package, possibly supplemented with (one or more of) three additional packages. Whereas the default package, containing life-saving information of immediate clinical utility, should be offered routinely and mandatory to all research participants, offering (one of) the three additional packages is context-specific. Such a qualified disclosure policy in our opinion best balances the potential benefits of disclosure with the potential risks for research participants and the harms of unduly hindering biomedical research. We appeal to the genetics community to make a joint effort to further refine the packages and set thresholds for result selection.
Human Mutation 08/2011; 32(8):861-7. DOI:10.1002/humu.21518 · 5.14 Impact Factor
"When designing studies and implementing informed consent processes, investigators and their research teams should be aware of the controversy surrounding access to research results. Not providing such results has been the norm in genetic research (Manolio, 2006), and researchers may not realize the range of opinions and understandings held by prospective participants. the Informed Consent Task Force of the Consent and Community Consultation Workgroup for the Electronic Medical Records and Genomics (eMERGE) Network. "
[Show abstract][Hide abstract] ABSTRACT: DISCLOSURE OF INDIVIDUAL RESEARCH results to research participants has been the subject of professional guidelines as well as scholarly commentary, yet controversy remains. To gather data on participant perspectives, we interviewed 40 individuals from the Durham, North Carolina area about a biorepository consent form and conducted an in-depth analysis of responses to a series of questions concerning access to research results. Cross-cutting themes emerged about (1) the nature of research; (2) the nature of research results; (3) expectations concerning access to research results; and (4) practical issues in providing access to research results. Our findings highlight the importance for sound policy development of soliciting stakeholder input, and exploring the complexities behind their evaluations.
Journal of Empirical Research on Human Research Ethics 09/2009; 4(3):99-111. DOI:10.1525/jer.2009.4.3.99 · 1.25 Impact Factor
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