Session C: Pragmatic clinical trials (PCT)– challenges and innovations in getting informed consent

Gregory E. Simon, M.D., M.P.H.
Kaiser Permanente Washington Health Research Institute
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Ryan Ferguson, Sc.D., M.P.H.
Director, Cooperative Studies Program Coordinating Center, U.S. Department of Veterans Affairs
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Sarah Leatherman, Ph.D., M.A.
Associate Center Director, VA Cooperative Studies Program Point of Care Program, U.S. Department of Veterans Affairs
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The high cost of traditional explanatory clinical trials, a growing appetite for pragmatic comparative effectiveness data, and the emergence of a conceptual ‘rapid learning healthcare system’ (RLHS) collectively account for an increasing interest in embedding research activities into the clinical care ecosystem. The goal of the VA Point of Care (POC) Program is to deliver state of the art treatments to patients, while simultaneously enrolling them as participants in experimental comparative effectiveness research that aims to redefine that care. By institutionalizing a process of statistically sound and efficient learning, and by integrating that learning with automatic implementation of best practices, participating VA health care systems will accelerate improvements in effective veteran care. Progress in this area requires rethinking all aspects of clinical research, from design—identification of subjects, delivery of interventions, and ascertainment of outcome—to ethical and operational issues of consent and randomization in the clinical care ecosystem. One of the most difficult and complex issues to rethink (and then to operationalize) is that of informed consent. Many models exist for incorporating learning within the clinical care ecosystem, but few models present a ‘one size fits all’ consent solution. In this presentation, Drs. Ferguson and Leatherman will formally present the VA’s POC Program: the models selected to inform participants, challenges and barriers experienced, and lessons learned from implementing pragmatic studies into clinical care.

George Annas, M.P.H., J.D.
Distinguished Professor of Health Law, Ethics & Human Rights, Health Law, Policy & Management, Boston University
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Informed consent can be described as a protective cloak, without which patients and research subjects can rightfully feel “naked and afraid.” Pragmatic trials seductively promise new knowledge about the safety and efficacy of clinical practice, yet they gaslight institutional review boards (IRBs) into thinking that trials are so important and low-risk that informed consent should be streamlined, if not waived altogether, for them. How seriously informed consent—including the right to withdraw at any time—and clinical judgment are taken in pragmatic clinical trial settings are critical issues.

In this presentation, Professor Annas argues that we should not modify either IRB review or informed consent rules for pragmatic trials, based on a few core arguments:

• Informed consent is a legal requirement to protect autonomy and dignity. It is mandated by court opinions, statutes, and regulations. IRBs should have a strong presumption against waiving the informed consent requirement. Nonetheless, methods of documenting consent should be the subject of continued exploration, including limiting the size of consent forms to one page, and supplementing forms with audio or video recordings of informed consent discussions.
• The public reasonably takes the Hippocratic injunction to “do no harm” seriously and values the advice of physicians based on their clinical judgments, evidence-based or not. Replacing the medical judgment of one’s physician with a coin flip should only be done with informed consent. (“Standard of Care” is a legal term used in medical malpractice cases, has created confusion in pragmatic trials, and has no useful role in describing risks.)