The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and 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. (shrink)

Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...) what consent process is needed to address them. (shrink)

Recently, several researchers and philosophers argued that clinical research trials are not therapy. Their position is based on foundational research ethics documents, such as the Belmont Report, on conceptual analysis, and on the general way clinical trials are conducted. After examining and rejecting these arguments, we claim that good research is consistent with good therapy; that often trials are good therapy; and that a blanket attack on clinical trials as non-therapeutic creates a research misconception. This misconception is potentially harmful because (...) it could weaken trial recruitment, could adversely affect funding for trials, and could overturn needed moral safeguards on therapeutic trials. Our more careful and accurate analysis of the nature of clinical trials can avoid such problems. (shrink)