by Anita Pascoe, MS, CIP, Project Coordinator at Intermountain Healthcare
PRIM&R is pleased to share a post from Anita Pascoe, MS, CIP, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD.
On December 7, the last day of the conference, Susan E. Lederer, PhD, the Robert Turell Professor of the History of Medicine and Bioethics at the University of Wisconsin School of Medicine and Public Health, delivered an excellent keynote presentation titled “Beyond the Bombshell: The Legacy of Henry K. Beecher’s Call for Reform in Clinical Research Ethics.” Lederer put current human subjects research issues into historical perspective with stories about renowned physician and researcher Henry K. Beecher, a professor of anesthesiology who was involved with human subjects research at Massachusetts General Hospital in the 1960s. Beecher wrote a controversial 1966 article,‘‘Ethics and Clinical Research,’’ in which he issued a scathing critique of contemporary human subjects research practices. The article caused a significant stir in the scientific community at the time of its publication. The paper has since been recognized as one of the most influential papers related to human subjects research in the United States. Its publication also set the stage for the development of our current regulatory framework, which is to a large degree focused around the principle of informed consent.
Informed consent refers to process by which research participants are informed of, and given the opportunity to ask questions about, potential risks, harms, benefits, and burdens of a study, so as to enable them to make an informed decision about whether or not to participate. Interestingly, as Lederer mentioned, Beecher did not agree that informed consent, as it is currently conceptualized, should be the basis for human research protections. He questioned the feasibility of ever obtaining ‘‘consent in any fully informed sense.” Rather, he argued, that the best protection for research participants was gained through investigators’ careful attention to ethical principles during the design research and conduct of a study.
Beecher’s misgivings about the feasibility of obtaining fully informed consent are becoming particularly relevant in today’s rapidly changing society. As I mentioned in a previous post, the widespread use of mobile and digital technologies is changing our social environment. Data research is becoming more prevalent and current consent practices may no longer adequately protect consumers.
“Consider how ideas and thoughts change when you really take a look at what is going on,” commented Anthony S. Fauci, MD, during his keynote address on December 4. The issues Henry Beecher was wrestling with in the 1960s and the current research protections issues we are considering today might seem radically different on the surface, but the underlying ethical question is the same: should our goal be fully informed research participants, fully ethical researchers, or both?