Offering Individual Genetic Research Results: Context Matters

摘要

The disclosure of individual genetic research results to participants continues to be the subject of vigorous debate, centered primarily on the nature of the results: What are the criteria for the kinds of information that should, could, or should not be offered? There are widely diverging views about how to define these categories, as reasonable people can disagree about the value of various kinds of information. Data concerning participant preferences regarding receipt of results are important, but not determinative of researchers’ fundamental obligations.We suggest that research context is a vital consideration that has not been sufficiently incorporated into the discussion. We adapt an ancillary care framework to explore what different contexts might call for with regard to offering individual genetic research results. Our analysis suggests that, beyond exceptionally rare circumstances that give rise to a duty to rescue, a “one size fits all” threshold cannot be developed for decisions about return of individual results. Instead, researchers and IRBs must consider the scope of entrustment involved in the research, the intensity and duration of interactions with participants, and the vulnerability and dependence of the study population. The strength of this approach is that research context is foreseeable at the time a study is designed. Assessments of the nature and value of the information may still be required to decide whether to offer a particular result, but perhaps will be facilitated by a more grounded understanding of researchers’ obligations in different contexts.