Aaron Eli Segal

In recent years, some have argued that supported decision-making can be ethically superior to surrogate decision-making with respect to decisions involving adults with cognitive and intellectual impairments or disabilities. In this paper, we argue that supported decision-making could also be ethically superior to surrogate decision-making in the context of clinical research that involves greater than minimal net risks. In current practice, adults who lack decisional capacity are often excluded from research that involves greater than minimal net risks (call this the minimal risk requirement). While this approach is intended to protect them, it can be ethically problematic, in part because excluding adults who cannot consent blocks scientifically valuable research that needs to enroll them and undermines the generalizability of the research that excludes them. With this concern in mind, we argue that supported decision-making can provide an ethical means to enroll adults who cannot independently consent in greater than minimal net risk research. Supported decision-making thus offers a valuable modification to the surrogate enrollment requirement, and provides good reason to reject the minimal risk requirement as well.

We advocate for a change in the way individuals with cognitive impairment are enrolled in minimal risk clinical research. We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participants retain some interest in decision-making as well as the ability to express a decision. In these cases, we argue that the common practice whereby researchers either obtain consent from the individual or consent from a surrogate and assent from the individual, is ethically unnecessary. Instead, a process of facilitated decision-making based on SDM (supported decision-making) should be employed. Although it is possible that this process of facilitation will enable some individuals to make a capacitated choice who would not otherwise have done so, this should not be a requirement of getting to choose. In those cases where a would-be participant, despite support, fails to make a capacitated choice, the individual should still have the final say about participation. In this respect, our proposal deviates from standard practice. However, we argue that our proposal offers participants as much ethical protection as the more common procedures involving surrogates.

Background: In current practice, individuals rarely share in the profits of research using their biospecimens. Many commentators defend this practice on the grounds that the contributions donors make are not important enough to merit a share of profits. Others argue that if researchers and sponsors profit, donors should too. Despite the importance of this debate, there are no data on the public’s views. Subjects and Methods: On-line survey of US adults selected to approximate the 2020 US census on age, gender, race, ethnicity, and geographic region. Respondents were asked whether biospecimen donors should share in the profits or receive payments across six scenarios, differing on whether the research yields a profit and which other parties share in the profits. Results: 77.2% of respondents indicated that donors should share in the profits when researchers profit and 78.9% when sponsors profit. Support for profit sharing was strong across all groups assessed, although respondents aged 65 and older were less likely to think donors should share in the profits. Conclusions: A significant majority of a sample of the US public thinks individuals who donate their biospecimens should share in the profits of research that uses their samples. These findings offer compelling reason to reconsider current practice of not sharing profits with biospecimen donors.

Many philosophers hold that we never owe others gratitude in return for their treating us in ways that we are owed. Instead, we owe others gratitude only for treating us in ways that go above and beyond the demands of morality. In this paper, I argue that this view is mistaken: we sometimes owe others gratitude for treating us in ways that we are owed. In particular, I argue that some moral duties require us to act in ways that express good will to one another, and when we act in accordance with these duties, we trigger duties of gratitude on the part of others.

Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted.