29
May2014

by Meryn Robinson, education and membership services intern

Since its founding in 1974, PRIM&R’s highest priority has been to provide those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with the education, practical tools, and cutting-edge strategies needed for their work protecting subjects. As we celebrate our 40th anniversary, we are reflecting upon four decades of connecting and protecting, and recounting some of the events that have shaped the field’s rich history in our 40 Years of Research Ethics series.

In 1951, Albert M. Kligman, MD, PhD was asked by prison officials to examine the 1,200 inmates at Holmesburg Prison in Philadelphia, due to the prevalence of athlete’s foot in the population.  Dr. Kligman, a dermatologist from the University of Pennsylvania, was known for his research interest in ringworm, a biological relative of the athlete’s foot fungus. Later, Dr. Kligman would describe his reaction, “All I saw before me were acres of skin. It was like a farmer seeing a fertile field for the first time.”

Dr. Kligman’s visit marked the beginning of 23 years of unethical, non-therapeutic human subject research at Holmesburg. Deodorants, shampoos, detergents, and foot powders, as well as more hazardous materials such as dioxin, radioactive isotopes, and mind-altering drugs, were among the products tested on the inmates under the direction of Dr. Kligman. Although the inmates received small payments for their participation, they received very little information about the tests—and the possible harm—to which they were being subjected.  The experience left many with debilitating long-term health conditions. 

Twenty years after they began, author Allen M. Hornblum discovered the abuses when teaching an adult literacy program at the prison. His book, Acres of Skin: Human Experiments at Holmesburg Prison, documented the injustices he observed, and gave voice to the affected prisoners. Though published 20 years after federal regulations were established limiting experimentation on incarcerated subjects, the book contributed to the ongoing discussion of the ethical issues inherent in conducting research with prisoners. 

Inmates, while an appealing population to study because of their accessibility and controlled living environment, deserve additional protections under many ethical guidelines and regulatory statutes.  Their ability to give fully voluntary consent is impeded, some believe, by their limited autonomy and the potential for coercion and undue inducement.  In 1978, following recommendations from The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 45 CFR 46 subpart C was passed codifying additional protections for prisoners used in biomedical and behavioral research in the United States. 

Research conducted in prisons today must fall under one of four categories defined in 45 CFR 46.306(a)(2), and IRB review of such protocols must include the participation of a prisoner or prisoner representative.  However, while research with prisoners necessitates and requires additional protections, in recent years there has been a push to ensure that past injustices do not prevent potentially beneficial research. 

Cynthia A. Gómez, PhD, founding director of Health Equity Institute at San Francisco State University, and Julia Gorey, JD, a public health analyst in the Division of Policy and Assurances at the Office for Human Research Protections, explored the requirements for conducting research with vulnerable populations, including prisoners, as well as mechanisms for ensuring that it is effective, equitable, and ethical in a webinar hosted by PRIM&R, titled Research Involving “Edge” Populations: Ethical and Regulatory Considerations.  

PRIM&R members can read the webinar overview, view the webinar, or read the handout. PRIM&R members can also access examples of related tools submitted by their peers in PRIM&R’s Knowledge Center:

Share your organization’s best practices on this topic or another by contacting Avery Avrakotos, education and policy manager, by email or by phone (617.423.4112, ext. 130).

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