Testimony of Harold E. Varmus, M.D., Director, National Institutes of Health Before the Subcommittee on Human Resources and Intergovernmental Relations Committee on Government Reform and Oversight, United States House of Representatives

Mr. Chairman and Members of the Subcommittee:

I am Harold Varmus, Director of the National Institutes of Health. I am pleased to
appear before the Subcommittee to describe our system of protection of human research subjects,
a responsibility of enormous weight and critical importance. While the collection of scientific
data to expand our knowledge of human ills is the ultimate aim of medical research, of equal
importance is the protection of the individuals who assist us through their participation in
research studies. Without these individuals, it would have been impossible for us to have made
such remarkable progress in the development of effective treatment and prevention strategies for
a host of human diseases and conditions.
History of Human Subjects Protection
May 30 marks the 23nd anniversary of the formal promulgation of the Department of
Health and Human Services' (DHHS) regulations for Protection of Human Subjects in research
(Title 45 Code of Federal Regulations Part 46). This rigorous system of protections, designed to
preclude the very problems we will discuss today, is guided by a set of principles--respect for
persons, beneficence, and justice--which are the three quintessential requirements for the ethical
conduct of research involving human subjects. It is based on a succession of judgments made by
a variety of individuals in the context of DHHS regulations. Scientists, ethicists, lawyers,
advocacy group members, and, most importantly, private citizens look at research protocols and
weigh risks and potential benefits.
Let me take a moment to give you some background on the development of human
subject protections. Our modemrn-day system began with the Nuremberg Code, which was
developed for the Nuremberg Military Tribunal to provide standards by which to judge the
human experimentation conducted by the Nazis. Many of the Code's principles regarding the
ethical conduct of research involving human subjects still are followed today. It was followed in
1964 by the World Medical Association's Declaration of Helsinki: Recommendations Guiding
Medical Doctors in Biomedical Research Involving Human Subjects; and in 1966, NIH issued
"Policies for the Protection of Human Subjects." which established the institutional review board
(IRB) as one mechanism through which human subjects would be protected.
As I have mentioned. it was in May 1974 that the DHHS regulations were issued,
elevating to regulatory status NIH's "Policies." Then in July 1974, the National Research Act
was enacted. which established the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research. The activities of the National Commission, which was
active from 1974 to 1978, culminated in the development of the Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research. The Report set
forth the three basic ethical principles underlying the acceptable conduct of research involving
human subjects. mentioned above, which continue to guide us today. Over the years, the DHHS
regulations have been revised six times, adding additional protections for vulnerable populations.