Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes shou...

Hastings Center Report, Volume 52, Issue 3, Page 9-17, May–June 2022.

The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...) affect people's choices. Choice-affecting features of the decision environment that do not restrict the range of choices or significantly alter the incentives have come to be known as “nudges.” Although some have criticized conscious efforts to influence choice, we believe that clinical nudges may often be morally justified. The most straightforward justification for nudge interventions is that they help people bypass their cognitive limitations—for example, the tendency to choose the first option presented even when that option is not the best for them—thereby allowing people to make choices that best align with their rational preferences or deeply held values. However, we argue that this justification is problematic. We argue that, if physicians wish to use nudges to shape their patients’ choices, the justification for doing so must appeal to an ethical and professional standard, not to patients’ preferences. We demonstrate how a standard with which clinicians and bioethicists already are quite familiar—the best-interest standard—offers a robust justification for the use of nudges. (shrink)

In the article “Informed Consent: What Must be Disclosed and What Must be Understood?” Joseph Millum and Danielle Bromwich argue that informed consent requires satisfaction of certain disclosure an...

The demands of respect for persons when conducting clinical research are often reduced to respect for autonomy. In this paper, I re-examine the concept of respect for persons in light of important intuitions from our ordinary language usage of respect. I propose that there are many ways to respect persons as persons and that the core elements of respect for persons are: appreciating what is valuable or important about a person, recognizing the constraints or demands that such a valuation places (...) on one's own conduct, and acting in a way that expresses that recognition. On this account, in addition to autonomous agency, respect demands attention to important subjective experiences, persons' existence as part of communities, and considerations of comportment. This account has important implications for the conduct of clinical research with persons who are autonomous as well as with those who are not. Its implications, however, are different for these two populations, particularly with regard to concerns about well-being. (shrink)

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated shared decision-making.

Volume 19, Issue 5, May 2019, Page 20-22.

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Volume 19, Issue 10, October 2019, Page 105-107.

BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating (...) may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment. (shrink)

: Research in emergency settings (RES) has become a major public issue with urgent policy implications. Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. Unfortunately, the discussion of the PolyHeme trial in the popular and scholarly press leaves important questions unanswered. This paper articulates three important lessons from the PolyHeme trial that have significant policy implications. First, the RES regulations should be re-visited, particularly the (...) requirement that existing treatments be unproven or unsatisfactory in order for research to be acceptable without consent. Second, further conceptual and empirical scholarship is needed to accomplish the goal of effectively involving communities. Third, a more subtle analysis is needed regarding how to balance the needs of maintaining public trust and protecting confidential trade information in the context of RES. (shrink)

Volume 20, Issue 8, August 2020, Page W12-W13.

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis (...) but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study. (shrink)