Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death.

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

The Dobbs decision will directly affect patients and reproductive rights; it will also impact patients indirectly in many ways, one of which will be changes in the physician workforce through its impact on graduate medical education. Current residency accreditation standards require training in all forms of contraception in addition to training in the provision of abortion. State bans on abortions may diminish access to training as approximately half of obstetrics and gynecology residency programs are in states with significant abortion restrictions. (...) The Dobbs decision creates numerous hurdles for trainees and their programs. Trainees in restrictive states will have to travel to learn in a different program in a protective state. As training opportunities diminish, potentially leading to a decline in clinical skills, knowledge, and experience in the provision of abortion, the rate of complications and maternal mortality are likely to rise. This will likely have a disproportionately negative effect on preexisting disparities in reproductive health fueled by a longstanding history of systemic racism and inequities. This work aims to both define the looming problem in abortion training created by Dobbs and propose solutions to ensure that an adequate workforce is available in the future to serve patient needs. (shrink)

Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other’s altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14 to 17 years of age and 91% of their parents were mothers, (...) a majority of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents’ statements of altruism more frequently than adolescents responded to parents’ statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation. (shrink)