The clinical research enterprise is changing in fundamental ways. The bright line that separates research and clinical care is beginning to fade, as both “research” and “nonresearch” converge into and are embodied by the concept of the learning health care system. Here, data about care and operations are translated into practice improvement. VA has been a leader in this area, and based on its use of electronic health records and other inputs, has formed large databases and a data‐driven health care (...) system. These changes raise questions about the traditional approach to “research subject” protection. (shrink)

Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...) to an intervention known to be inferior to standard treatment. Second, the claim that RCTs preserve the therapeutic obligation of physicians misrepresents the patient-centered orientation of medical care. Third, the appeal to clinical equipoise as a basic principle of risk-benefit assessment for RCTs is incoherent. Finally, the difficulties with clinical equipoise cannot be resolved by viewing it as a presumptive principle subject to exceptions. In the final sections of the article, we elaborate on the non-exploitation framework for the ethics clinical research and indicate issues that warrant further inquiry. (shrink)

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, (...) but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform. (shrink)