Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The NIH Clinical Center’s Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. The manuscript describes areas of agreement as well as areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.
Whether researchers have an obligation to disclose secondary genetic research findings, and, if so, in what circumstances, remains a matter of heated debate. This paper suggests that much of this confusion is definitional or conceptual in nature. That is, there is significant variability in the way that threshold terms and concepts such as “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” and “actionability,” are used in the literature, which is impeding efforts to clarify the scope of an obligation to return findings. This paper analyzes the definitional muddle underlying the debate about returning genetic research findings, first, to explain the range of definitions being used in this debate. We go on to propose that, underlying all the seeming confusion and disagreement, three central and widely agreed upon concepts are at work in this debate — validity, value, and volition. Refocusing attention on these core concepts, and their appropriate conceptualizations, can produce a more productive debate regarding the return of genetic research findings.
While the development of next-generation sequencing technology has had a paradigm-changing impact on biomedical research, there is likely to be a gap between discovery of therapeutic benefits in research and actual adoption of the new technology into clinical practice. This gap can create pressure on the research enterprise to provide individualized care more typical of the clinic setting because it is uniquely accessible in research. This blurring of the line between research and clinical care is understandable, and perhaps even inevitable. But even if the gap is only transitory, such a blurring can have lasting implications, both by expanding obligations imposed on researchers, but also by challenging long-held ethical views. We explore this idea, focusing on how the dissolving distinction between research and clinical care has influenced the vigorous debate around how researchers should manage genetic findings (sometimes separated into primary and incidental or secondary findings) resulting from research.
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