Bioethics of Quality Improvement and Comparative Effectivenss Research
This project will accomplish its work through ongoing, collaborative meetings of a core group of six experts in research ethics, clinical trials, comparative effectiveness, quality improvement, and/or public policy. Through sub-group and core group interactions, the development of rich case studies, and empirical data collection, this project will produce a conceptual analysis that considers a research-treatment interface rather than exclusively a separation, and will produce policy guidance and safeguards relevant to our evolving research agenda. The aims of this project include:
Aim 1: Produce a clear, conceptual analysis that defines and characterizes the constitutive elements of “research” and “treatment” through the development of rich case studies of specific examples of (a) clinical trials of unapproved drugs and devices (CTUn); (b) comparative effectiveness (CE) research; and (c) quality improvement (QI) research, against which the conceptual analysis can be tested and refined;
Aim 2: Examine the implications of this conceptual analysis for the moral and policy purposes to which the research-treatment distinction has been and continues to be put, with particular focus on rich case studies developed from CTUn, CE, and QI research;
Aim 3: Conduct empirical research with investigators who conduct CTUn, CE, and QI research to (a) list a range of designs and examples within their area and discuss how constitutive elements of research and treatment apply; and (b) later, with additional inclusion of federal officials, to elicit reactions to draft conceptual and moral analyses and policy recommendations for feasibility and applicability;
Aim 4: Based on our conceptual, moral, and empirical findings, develop policy guidance and safeguards for research participants in CTUn, CE, and QI research specific to investigators, to informed consent, and to research oversight.