Much new global genetic research employs whole genome sequencing, which provides researchers with large amounts of data. The quantity of data has led to the generation and discovery of more incidental or secondary findings and to vigorous theoretical discussions about the ethical obligations that follow from these incidental findings. After a decade of debate in the genetic research community, there is a growing consensus that researchers should, at the very least, offer to return incidental findings that provide high‐impact, medically relevant (...) information, when it is not unduly burdensome to the research enterprise to do so. Much as genetic research has been limited to U.S. and European settings, the incidental findings debate has primarily focused on research conducted in high‐income countries. In a 2015 paper, Alberto Ortiz‐Osorno, Linda Ehler, and Judith Brooks note salient differences between the circumstances of research participants in low‐ and high‐resource settings that alter the analysis of when and why incidental findings should be offered to research participants. In this article, we expand on their analysis and present a framework for thinking about how investigators’ obligations to return genomic data might change in low‐resource settings, particularly in settings where participants do not have access to the medical care needed to treat, assess, or monitor incidental findings that are actionable in settings with plentiful resources. (shrink)

Shavelson et al. (2023) identify an important problem in their Target article: a significant number of terminally ill patients with impaired motor function are wrongfully excluded from receiving ai...

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...) the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)

The authors of the Target article, Shen and colleagues (2024) argue that there is a need for an ethical framework to help analyze when it is appropriate to return individualized research results (I...

The risk and crisis communication process in public health emergencies (PHERCC, public health emergency risk and crisis communication) matrix, as proposed by Spitale, Germani, and Biller-Andorno (2...

The authors of the target article discuss the expansion of the scope of noninvasive prenatal testing (NIPT) that is likely to occur in the near future, including its possible extension to “non-medi...

We would like to thank the authors of the excellent Open Peer Commentaries on our target article, “Implementing Expanded Prenatal Genetic Testing: Should Parents Have Access to Any and All Fetal Ge...