Ethics of research in usual care settings: Data on point

Conducting research in usual care settings—which includes pragmatic clinical trials, comparative effectiveness research, and analyses of clinical databases—is associated with an array of questions about the appropriate mechanisms to protect the rights, interests, and welfare of research participants. Not only is there a lack of agreement about many of the conceptual issues at hand, but there have also been debates and controversy around particular cases. Although some of the unsettled issues reflect basic moral disagreements, others might be resolved with empirical data. The recent empirical ethics scholarly literature related to the ethics of research in usual care settings provides some preliminary data regarding the perceptions, views, and opinions of stakeholders regarding some of the categorical distinctions that have been employed in the conceptual literature and in policy debates (e.g., medical treatment vs. research, quality improvement vs. research), matters relevant to whether explicit informed consent should be required for this research, and proposals for ethics and regulatory oversight. This special supplement of AJOB Empirical Bioethics includes five papers that add to our current empirical understanding of the ethics of research in usual care settings: (1) “Patients' Views Concerning Research on Medical Practices: Implications for Consent”; (2) “Alternative Consent Models for Comparative Effectiveness Studies: Views of Patients From Two Institutions”; (3) “Patient and Physician Views of Protocolized Dialysis Treatment in Randomized Trials and Clinical Care”; (4) “The Patient's Perspective on the Need for Informed Consent for Minimal Risk Studies: Development of a Survey-Based Measure”; and (5) “Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.” This 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. In particular, across the reports published to date, there seems to be a consistent finding that at least a substantial minority of patients wants to be engaged in making decisions about participating in research in usual care settings. However, it is important to recognize that this research has relied in large part on hypothetical examples and choices, which necessarily limits validity. Accordingly, future empirical work should endeavor to be prospectively nested in actual research in usual case settings.