In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals are epistemologically (...) and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks (...) of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent. (shrink)

In biomedical research lack of trust is seen as a great threat that can severely jeopardise the whole biomedical research enterprise. Practices, such as informed consent, and also the administrative and regulatory oversight of research in the form of research ethics committees and Institutional Review Boards, are established to ensure the protection of future research subjects and, at the same time, restore public trust in biomedical research. Empirical research also testifies to the role of trust as one of the decisive (...) factors in research participation and lack of trust as a barrier for consenting to research. However, what is often missing is a clear definition of trust. This paper seeks to address this gap. It starts with a conceptual analysis of the term trust. It compares trust with two other related terms, those of reliance and trustworthiness, and offers a defence of Baier’s attribute of ‘good will’ a basic characteristic of trust. It, then, proceeds to consider trust in the context of biomedical research by examining two questions: First, is trust necessary in biomedical research?; and second, do increases in regulatory oversight of biomedical research also increase trust in the field? This paper argues that regulatory oversight is important for increasing reliance in biomedical research, but it does not improve trust, which remains important for biomedical research. It finishes by pointing at professional integrity as a way of promoting trust and trustworthiness in this field. (shrink)

This essay responds to an article, ‘Variation in university research ethics review’, published in this issue. It argues that the authors of that paper do not fully distinguish the usual function of university research ethics committees from that of a gatekeeper. The latter term more accurately describes the task they happen to have asked them to fulfil in the course of conducting some empirical research. Whilst they are not alone in making it, the result of this conflation is that the (...) reflections they offer are misguided. In this short comment I briefly discuss the distinction between a REC and a gatekeeper, and indicate how it impacts on the proposals sketched by Vadeboncoeur et al. (shrink)