The American Journal of Bioethics has published a special issue on ethics of research in usual care settings. These publications were supported by a bioethics supplement awarded to the NIH Collaboratory’s Regulatory/Ethics Core by the NIH Office of the Director. The issue includes an introduction from Jeremy Sugarman, MD, MPH, MA, along with 5 additional articles:
- Ethics of research in usual care settings: data on point (Sugarman 2016) introduces the special five-article supplement, stating that the “growing empirical ethics literature regarding research in usual care settings provides data to inform conceptual and policy debates regarding this research and suggests areas that require further study.”
- Patients’ views concerning research on medical practices: implications for consent (Weinfurt et al. 2015) describes the results of focus group sessions that elicited a range of patients’ views and opinions about different types of research on usual medical practices. The authors state that “our data suggest that effective policy and guidance will involve balancing different patients’ interests and potentially different sets of interests for different types of research studies on usual medical practices.”
- Alternative consent models for comparative effectiveness studies: Views of patients from two institutions (Kass et al. 2016) describes engagement sessions conducted with patients to gather input on consent practices for comparative effectiveness research. “Our findings suggest there may be much more flexibility in patients’ minds about how the values of being informed and being given a choice can be operationalized in CER than we are seeing on the policy front,” note the authors.
- Patient and physician views about protocolized dialysis treatment in randomized trials and clinical care (Kraybill et al. 2015) describes interviews with patients and physicians who were given two hypothetical scenarios for a pragmatic clinical trial design.
- The patient’s perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure (Kaplan et al. 2016) describes development and testing of a survey to assess patient preferences for and understanding of consent in quality assessment activities. The authors state, “as efforts to improve care and accelerate the implementation of effective interventions continue to challenge the understanding and practical boundaries of informed consent, in addition to ethical analysis, more careful studies of understanding patients’ and other stakeholders’ perspectives on these boundaries are needed in order to develop appropriate policies.”
- Adrift in the gray zone: IRB perspectives on research in the learning health system (Soo Jin-Lee et al. 2016) describes discussions with IRB members to understand their experiences and perspectives on ethical oversight of research on medical practices.