Informed Consent and Standard of Care: What Must Be Disclosed

Abstract

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of "standard of care" in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of "standard of care" may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

Patients' views concerning research on medical practices: Implications for consent

“…Perhaps most strikingly are the vigorous debates about the SUPPORT study, a trial that examined higher and lower levels of oxygen saturation targets in the treatment of premature infants. The debates about the trial, including arguments about the level and disclosure of risk, as well as whether the interventions tested could be considered accepted medical practices, have included disputes in the academic literature (Buchanan 2013; Drazen, Solomon, and Greene 2013; Hudson, Guttmacher, and Collins 2013; Macklin and Shepherd 2013; Macklin et al 2013; Magnus and Caplan 2013; Wilfond 2013; Wilfond et al 2013), a public hearing (OHRP 2013), controversial proposed guidance for this type of research (OHRP 2014; IOM 2014), and attempted legal action (First Amended Complaint and Demand for Jury Trial, Looney v. Moore , No. 2:13-cv-00733-UNAS-KOB (N.D. Ala. filed May 20, 2013)).…”

“…While conceptual work on these topics has started to address some of these complex issues (Anderson, Califf, and Sugarman 2015; Faden, Beauchamp, and Kass 2014; Feudtner, Schreiner, and Lantos 2013; Macklin and Shepherd 2013; McKinney 2013; Wendler 2013; Wilfond 2013), there remains a dearth of empirical data to further inform and contextualize these discussions. Moreover, policies and practices designed to protect the rights, interests, and welfare of those who participate in all types of research should reflect careful consideration of multiple stakeholder perspectives, particularly those of prospective participants.…”

Are Researchers Fundamentally Untrustworthy in a Way That Physicians Are Not?

“…In their analysis of the informed consent documents in the SUPPORT study, Macklin and Shepherd (2013) identify retrospectively risks that should have been disclosed, suggesting that such disclosures would have accomplished more than just obviating the harm of the faulty consent itself. This mode of argument has a well-established place in bioethics, whose writers tend to regard every controversy as yet one more episode in a history of scandal.…”

The “Research Misconception” and the SUPPORT Trial: Toward Evidence-Based Consensus

“…One relates to the distinction between research and therapy. In their target article Macklin and Shepherd (2013) write:…”