Common clinical practices might lack a robust evidence base if there have not been empirical interventional research studies to compare an array of available routine or standard treatment options. Fordham University Center for Ethics Education Director Dr. Celia B. Fisher, an internationally renowned expert on empirical research on research ethics, recently traveled to Washington, D.C. to participate in an Institute of Medicine (IOM) workshop aimed to inform practice and policy of regulated research studies involving standard of care interventions.
Clinical trials that study these “standard of care” interventions examine and compare treatments that fall within the range of what is considered usual clinical practice. The goal is to gather evidence that can be used when selecting a particular intervention.
The Federal Policy for the Protection of Human Research Subjects, known as the “Common Rule,” governs the ethical oversight of human participation in research, including standards for informed consent and procedures for research ethics review bodies, i.e., Institutional Review Boards (IRBs). Under the Common Rule, IRBs are responsible for overseeing clinical trials to ensure that the safety, well-being and rights of trial participants are protected. In addition, the IRB also oversees the process of obtaining informed consent, so that participants understand the risks and possible benefits of the trial before deciding whether to enroll.
Recently, questions have arisen about the key aspects of standard of care trials, including how to define reasonably foreseeable risks, and how to include in the consent process enough information about the risks and benefits of being in a trial of standard interventions. The aim of the recent IOM workshop was to bring together key stakeholders — including Dr. Fisher — to examine the ethical issues surrounding study design and informed consent for regulated research studies involving standard of care interventions.
Dr. Fisher co-chaired Session III of the workshop entitled “Framing Risks of Standard of Care Interventions: What Should the Consent Form Say?”on December 3. As chair, she summarized the session on the risks and potential benefits of standard of care interventions differ depending on whether they are received in a purely therapeutic clinical context or in a research trial.
Dr. Fisher also moderated the combined panel discussion, which addressed topics such as the principles, standards, or guidelines governing disclosure of risks among standard of care interventions in the clinical practice and research setting, as well as relevant areas of guidance.