Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...) if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

In this article, we provide an ethical analysis of the first porcine cardiac xenotransplant, performed in Maryland, USA in early 2022. David Bennett was offered the experimental procedure after he was deemed ineligible for human heart transplantation and mechanical circulatory support, based on a history of non-compliance. It was reported that Mr Bennett’s previous instances of non-compliance were for medically non-life-threatening conditions years earlier, where the risks of non-compliance were not as high. We argue that, in Mr Bennett’s case, a (...) history of non-compliance in a different context, should not necessarily rule him ineligible for a potentially life-saving treatment now. Furthermore, using previous non-compliance to exclude individuals from donor organs may have the unintended effect of placing the burden of testing xenotransplantation on those who are already disadvantaged. We then argue that it is not enough to rely on patient consent to ethically justify xenotransplantation research. Taking a broad ethical perspective is crucial when mapping a clinical pathway for xenotransplantation. (shrink)

Understanding why individuals opt out of living donation is crucial to enhancing protections for all living donors and to identify modifiable barriers to donation. We developed an ethical approach to conducting research on individuals who opted out of living kidney donation and applied it in a small-scale qualitative study at one US transplant centre. The seven study participants had varied reasons for opting out, the most prominent of which was concern about the financial burden from lost wages during the postoperative (...) period. Several reported feeling alone during their decision-making process. Although no participants used an alibi, a centre-provided statement of non-eligibility to donate, all believed that centres should offer alibis to help preserve donor autonomy. Given the complexity of participants' decisions and the emotions they experienced before and after deciding not to donate, we suggest approaches for independent living donor advocates to support this population. This study demonstrates that research on individuals who opt out of donation is feasible and yields valuable insight into methods to improve the evaluation experience for potential living donors. (shrink)