LeRoy Walters’ Tribute to Charles McCarthy

Charles McCarthy Award 2When Charles McCarthy left academia to join the National Institutes of Health in 1971, the U.S. federal government received a great gift. Here was a person with a Ph.D. in moral and political philosophy who would in the next 21 years have a profound impact on both the ethos and the research policies of NIH. That impact continues until the present moment.

Dr. McCarthy’s first assignment at NIH was to the Division of Legislative Analysis, which tracked congressional actions affecting NIH. Almost immediately, Dr. McCarthy assumed a second role, as executive secretary to the NIH Director’s Advisory Committee. In carrying out these two responsibilities, Dr. McCarthy quickly achieved a broad overview of NIH activities and of the complex interactions of NIH with the legislative branch.

By November 1972, Dr. McCarthy was already deeply – though anonymously – involved in discussions of research ethics. It was he who drafted an eloquent speech by NIH Director Dr. Robert Marston on the ethics of research involving human subjects. That speech, delivered at University of Virginia on November 10, 1972, was entitled “Medical Science, the Clinical Trial, and Society.” Tom Beauchamp and I were so impressed with Dr. Marston’s speech that we included it in the first edition of our anthology, Contemporary Issues in Bioethics, published in 1978.

Between 1971 and 1978, Dr. McCarthy was involved with research ethics in multiple ways. He tracked the 1973 Senate hearings on “Quality of Health Care – Human Experimentation.” He also served as the NIH liaison person to the newly-created National Commission for the Protection of Human Subjects. From 1976 to 1977, he participated in the HEW Secretary’s Task Force on the Compensation of Injured Research Subjects, which produced an excellent (but neglected) three-volume report in January 1977. In his spare time, Dr. McCarthy assisted the late NIH Director, Dr. Donald Fredrickson, in planning a February 1976 public consultation on proposed NIH Guidelines for Recombinant DNA Research.

Dr. McCarthy’s expertise and insight resulted in his appointment to two key positions during the remainder of his career in the federal government. In 1978, he was appointed as Staff Director to the newly-created DHEW Ethics Advisory Board. Two years later, he assumed a long-term role as Director of NIH’s Office for Protection from Research Risks, a post that he held from 1980 until 1992. During these leadership years, Dr. McCarthy was the principal guiding spirit in the evolution of federal policy for research with both human and animal subjects. I will only have time to mention one disappointment and two successes from those years.

During his time with the DHEW Ethics Advisory Board Dr. McCarthy and Ms. Barbara Mishkin coordinated a comprehensive study of research involving human in vitro fertilization and embryo transfer. The 100-page report of the Ethics Advisory Board, published in May 1979, was complemented by an 800+-page appendix. This report was in many ways a masterpiece. Both the scientific and ethical analyses it contained were comprehensive and up-to-date. This report predated the British Warnock Committee report on the same topic by five years. Unfortunately, both the Carter and Reagan administrations were too timid to confront the questions of clinical IVF and human embryo research, with deleterious effects until the present moment. Had these administrations had more courage, I am sure that more of us would know about and also admire the McCarthy-Mishkin-Gaither report on IVF research from 1979.

Dr. McCarthy’s patience, perseverance, and unmatched diplomatic skills led to two lasting achievements in the 1980s and early 1990s. The first achievement is one with which we are all familiar. It is the adoption of the federal Common Rule for human subjects research in 1991. How Dr. McCarthy succeeded in convincing 17 federal agencies to agree on a single policy I will never understand, but I will always admire his accomplishment.

The other achievement was often less visible and did not result in a Federal Register publication. Dr. McCarthy carefully nurtured a research oversight system in OPRR that was universally regarded as flexible and reasonable, but at the same time deeply committed to the welfare of human and animal research subjects. He did so while working within NIH, the primary funding agency for biomedical research in the United States. He did so with exemplary integrity – an integrity that sometimes required taking courageous stands against high officials at NIH.

When I think of Dr. McCarthy and his 21-year career in the federal government, the phrase that comes most immediately to my mind is “dedicated public servant.” We can only hope that there will be other men and women in this new time with its new challenges who will follow in his footsteps – and who will exhibit similar qualities of competence, perseverance, and integrity.

It is most appropriate that this organization today honors Dr. Charles R. McCarthy with its Lifetime Achievement Award.

LeRoy Walters, PhD
December 6, 2003