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)
We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...) In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership. (shrink)
The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)
Healthcare delivery is an interpersonal endeavor. In every clinical interaction, providers have an ethical obligation to show respect to their patients, and ideally over time these interactions lea...
Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...
Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...
Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...
