Research on medical practices and the ethics of disclosure.

Abstract

In March 2013, the Office of Human Research Protection (OHRP) issued a finding against the University of Alabama and other institutions for failing to meet regulatory informed consent requirements, in particular regarding reasonably foreseeable risks during the conduct of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial.1 This study compared 2 different target oxygen saturation levels that were part of usual practice in extremely premature infants. As a result of public disagreement regarding whether the differences in outcomes should be considered a “research risk,” OHRP suspended the determination and held a public hearing in August 2013.2 On October 24, 2014, the OHRP released draft guidance, for public comment, on disclosing reasonably foreseeable risks in research evaluating “standards of care,” which on the surface, seems to be a reasonable approach.3 But a more careful analysis reveals a view that may hinder research without increasing protection of participants. The OHRP draft guidance mischaracterizes the purpose of research, which we agree should be disclosed to participants, as risks of research. The OHRP draft guidance misidentifies minimal-risk research as greater than minimal risk. This will result in requiring misleading information in the informed consent process by making research sound riskier than it really is. This will be particularly problematic for pediatric research, as parents and institutional review boards (IRBs) need sound advice to protect children from risky research and to encourage ethically acceptable research that is important to improve child health. We suggest a number of changes should be made before any guidance becomes finalized. First, OHRP should not use the terminology of “standard of care” research. “Standard of care” is a legal construct to define a floor of treatment below which claims of negligence are appropriate. To better capture the range of … Address correspondence to Benjamin S. Wilfond, MD, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Research Institute, 1900 9th Ave, Seattle, WA 98101. E-mail: benjamin.wilfond{at}seattlechildrens.org