November 10, 2022
Charles (Charlie) Raymond McCarthy, Ph.D., past Director of the predecessor office to the Office for Human Research Protections (OHRP), passed away on October 14, 2022, in Richmond, Virginia. He was 96 years old.
Charles McCarthy received his doctoral degree in philosophy and political science from the University of Toronto, and taught for a number of years at Catholic University and George Washington University. He also went through Catholic Paulist seminary, served as a priest for 15 years, and eventually left the priesthood in 1971 over the issue of contraception.
Dr. McCarthy began his federal service in 1972, the same year that the Office for Protection from Research Risks (OPRR, the predecessor of OHRP) was created from what had been the Institutional Relations Branch of the Division of Research Grants in the National Institutes of Health (NIH). OPRR’s mandate was to encourage compliance with the NIH policy for the protection of human subjects, which was articulated in what was then called “the Yellow Book.” Dr. McCarthy’s first position was in NIH’s Division of Legislative Analysis, where he served as a liaison between the NIH and the U.S. Congress with respect to Congressional legislation that might impact the NIH. Following the public revelation of the research study originally called “Untreated Syphilis in the Male Negro” (now referred to as the “US Public Health Service’s Syphilis Study at Tuskegee”) in Macon County, Alabama, Senator Edward Kennedy held a series of hearings about human experimentation and related issues, and numerous bills were introduced with the intent of strengthening the system to protect the rights and welfare of human research subjects. This led to the passage of the National Research Act in 1974.
Dr. McCarthy was right in the middle of the events. He was a member of the three-person committee that drafted the first version of the protection of human subjects regulations of the Department of Health, Education, and Welfare (HEW), codified in 1974. He also drafted language that was included in the National Research Act of 1974, which charged the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify the ethical principles underlying research with human subjects; the Commission’s response to that charge, the Belmont Report, is the leading reference in research ethics in the United States, and provides the ethical foundation for the federal regulations for the protection of human subjects in research.
In 1978 McCarthy became the Director of OPRR. At the same time he was appointed Staff Director of the Ethics Advisory Board of HEW, which continued until 1979, and which produced a number of documents on ethical issues including a report on research involving human in vitro fertilization and embryo transfer. As the Director of OPRR, over the next five years, he oversaw a series of revisions of the regulations in Subpart A, the basic policy for the protection of human subjects in research, and additional subparts for specific subject populations, namely, pregnant women, fetuses and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D.) Subsequently, Dr. McCarthy was appointed by the Office of Science and Technology Policy to chair the Interagency Human Subjects Coordination Committee responsible for leading the effort to adopt a revised version of Subpart A; on June 19, 1991, 15 federal departments and agencies adopted what came to be known as “The Common Rule.”
As the Director of OPRR, Dr. McCarthy oversaw both the regulations for the protection of human subjects in research and the regulations for the care and research use of laboratory animals. As the Director of an office with scarce resources, his approach to enforcement was largely collegial and diplomatic. As he put it in testimony to the National Bioethics Advisory Commission in 2001, “Education and persuasion were then [before the 1974 regulations] and remain today the most effective tools of policy implementation.”
Dr. McCarthy was a creative agent in the federal bureaucracy. When the regulations for the protection of human subjects in research were first introduced, they were met with skepticism by some of the scientists at NIH; ethicists, they thought, were always silent while research studies were under way, and then would second guess those studies after their completion, arguing that the subjects’ rights had been violated. To address this attitude, with the help of Leroy Walters and others, McCarthy initiated and ran a series of seminars at NIH, in which a scientist would give a presentation about a current topic in scientific research, and an ethicist would comment on the ethical aspects of the research. The seminars altered the culture at NIH: two people showed up for the first seminar meeting, but at the last meeting several years later there were 485.
Dr. McCarthy was also a creative office manager. For example, to short-circuit the standard human resource acquisition process during a hiring freeze, Dr. McCarthy would go to other NIH offices and offer to relieve the office manager of their most troublesome employee. This meant that OPRR included some rather independent-minded staff members.
Dr. McCarthy retired from federal service in 1992. For five years after that he was a senior research fellow at the Kennedy Institute of Ethics at Georgetown University, working with the likes of Leroy Walters and Thomas Beauchamp. In 2000 he was hired by Virginia Commonwealth University (VCU) to overhaul the human subjects protection program there, which had been faulted for noncompliance by his own former office. He continued to provide technical assistance to VCU until the end of his professional career. He served on the board of Public Responsibility in Medicine and Research (PRIM&R) from 1993 until 2011, and was a frequent speaker at its annual meetings.
For additional information about Charles McCarthy, and to view interviews with him, you can go to the OHRP website at https://www.hhs.gov/ohrp/education-and-outreach/luminaries-lecture-series/belmont-report-25th-anniversary-interview-cmccarthy/index.html, or go to the People and Perspectives page of the PRIM&R website at https://primr.org/resources/people-and-perspectives#:~:text=People%20%26%20Perspectives%20is%20an%20online,of%20advancing%20ethical%20research%20today.