Informed Consent for Comparative Effectiveness Research Should Include Risks of Standard Care

Abstract

Recent research controversies and debate have called into question whether existing ethical norms and regulatory structures adequately address the challenges of comparative effectiveness research (CER). CER studies generally make head-to-head comparisons of commonly accepted medical treatments to compare outcomes between patient-subjects. Much of the debate about CER has been over consent—the kind of disclosures necessary for the consent of research subjects to be considered properly informed, but even whether obtaining consent is or should be required. But this debate is also part of a larger conversation about whether certain traditional precepts of research ethics remain valid. This article explains that comparative effectiveness research (CER) must continue to be regulated as research, rather than treated as clinical care, and that informed consent for randomized CER must include risks of standard care. Uncertainty about which standard treatment is “better” does not mean a study is minimal risk and does not obviate the need for informed consent. Using the controversial SUPPORT Study, which altered the breathing therapies of premature infants, the article explains how and why disclosures of risks of standard care in CER are legally and ethically required.