Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey Workshop Summary (2014) / Chapter Skim
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4 Framing the Discussion
4 Framing the Discussion
Pages 17-24
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From page 17... ...
In the session, chaired by Ellen Clayton, Vanderbilt University, two recent ethical frameworks that address the issue of return of results were also considered. THE EVOLUTION OF GENOMIC TECHNOLOGY AND CLINICAL UTILITY Gail Jarvik talked about the current state of genetic technology and clinical utility.
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In addition, there are genome regions that are of high homology to another region, and one does not know if the variant being observed is in the gene of concern or in another part of the genome that looks similar. She cited the pharmacogenetic gene CYP2D6 as a good example; although the desire to know people's sequences for CYP2D6 is strong, the information cannot be determined using current technology because there is a highly homologous region.
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. 7 The Clinical Sequencing Exploratory Program, initiated by NHGRI in 2010, is intended to support the development of methods needed to integrate sequencing into the clinic, and also the ethical, legal, and psychosocial research required to responsibly apply personal genomic sequence data to medical care.
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This work is moving toward agreement that researchers should offer information on actionable variants discovered, whether purposively or incidentally, in the course of their analyses. If a research finding is pathogenic and actionable, Jarvik said in closing her presentation, it should be returned.8 ETHICAL FRAMEWORKS The workshop delved further into the return-of-results discussion with Benjamin Berkman referencing the active debate in the bioethics literature about whether there is an obligation for researchers to return incidental findings.
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The therapeutic misconception may present an ethical problem in clinical research insofar as the failure to distinguish the aims of research participation from those of receiving ordinary treatment may seriously undermine the informed consent of research subjects.
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The notion that research participants are equivalent to patients, and that the two groups should be treated similarly, also received low support, which tends to weaken the ACMG recommendation in the research realm. As the study showed, IRB members understand that research subjects are different than clinical subjects, and feel that something developed in the clinical context is not necessarily appropriate in the research context.
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Another is to actively not look, in other words, filter results in a way that will not produce results that one does not want to have to respond to. In a sense, the participant commented, NHANES has been taking the latter approach by not accepting protocols that would produce results that would potentially provide an obligation to disclose results.
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