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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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9 Summary of Presentations and Discussion
Pages 59-68

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From page 59...
... GENETICS AND THE NHANES MISSION Most participants agreed that the National Health and Nutrition Examination Survey (NHANES) has great potential to help medical science, and the question is whether or not NHANES should become a 21st-century public health and medicine research study.
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From page 60...
... Jennifer Madans stated it would be helpful for NHANES to have people who are interested in gene-environment relationships look at what is currently in the survey in terms of environmental information and the sample size, and try to simulate the array of useful information that could be derived. Many workshop participants expressed their opinions that the gene-environment data are a potentially unique source of research information.
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From page 61...
... Not only are there consents saying that results will not be returned, she continued, but also some if not most of the genetic data are from non-CLIA (Clinical Laboratory Improvement Amendments) samples run in non-CLIA labs using non-CLIA procedures, and none has a high enough expected validity to compel return.
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From page 62...
... In her opinion, this is a "nonstarter" in view of the fact that NHANES already touts the return of nongenetic results as a benefit of participation. She commented that some of the questions that this workshop has agonized about have been asked and answered already in the design of the study, and that it makes sense to contextualize the genomics issue in light of NHANES policies regarding nongenetic data.
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From page 63...
... She said that some changes can be made at an executive board level, some changes require consultation with other advisory boards, perhaps including community advisory boards, and other changes are at a significant enough level that each individual must be asked what they would like to do going forward, as some at the workshop proposed with the re-contact/re-consent approach to the retrospective data collection. A proactive opting into a return-of-results model is a straightforward way of reengaging participants, Edwards observed.
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From page 64...
... SHOULD POPULATION-BASED BIOBANK RESEARCH LIVE BY DIFFERENT RULES? Several workshop presenters discussed whether NHANES is going to produce data that will generate findings, and whether the science will
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From page 65...
... Burke noted that there seems to be strong support within the field for the notion that secondary uses of biobank specimens may generate less concern, obligation, sense of duty, or even ability to return results, which is a very important distinction. But, as Jarvik argued, highly actionable genetics findings should be returned in keeping with the fact that other highly actionable medical findings are returned to human subjects.
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From page 66...
... A "Returning Results Board," a third party, could be extremely useful, suggested Edwards. She pointed out that an analogy that occurs in clinical settings is end-of-life decision making, where one has a living will or an advance directive and has tried to think through every worstcase scenario but may end up in a different ambiguous scenario that the written wishes did not anticipate.
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From page 67...
... Burke said in her view, feedback at the workshop from most participants suggested that it would be ethically acceptable to generate genomic data, even genomic data that met some criteria of reportability, and not report back for samples that were collected under a consent that said no return of results. One could also consider a re-consent process to return, Burke suggested.
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From page 68...
... further reduces the probability that this would ever be an issue. Weir agreed, adding that the consent used was state of the art then and is still state of the art in much of the rest of the research community, even if standards are evolving.
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  • environmental information
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  • regarding nongenetic


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