The SRA Symposium - College of Medicine

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Human Subjects Research and Protections: A Brief History
Elsa G. Nadler, EdD, Department of Community Medicine,
West Virginia University School of Medicine
1 Medical Center Drive, PO Box 9190
Morgantown, WV 26506-9190
304.293.3546; enadler@hsc.wvu.edu
Author’s Note: The author thanks Alan M. Ducatman, Chair of the WVU Department of Community
Medicine, for his insightful comments and suggestions that greatly improved the original
version. This paper is essentially a review of print and electronic sources and does not represent
original research.
Abstract: The Nuremberg Code is nearly sixty years old. The National Research Act (Pub. L. 93-
348), which created the National Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research, is now thirty. Most of us take for granted the existence of Institutional
Review Boards, consent forms, and protocols without giving much consideration to the principles
underlying those requirements or the history behind them. This paper will explore the history of
research with human subjects in advancing medical and social knowledge and will examine the
development of laws and restrictions pertaining to that research. Many are familiar with the Hippocratic
Oath and the stricture that physicians should do no harm. However, many are not equally
familiar with the history of research on children, ancient Jewish and Islamic medical laws, and
Russian and German regulations both before and during World War II. The National Institutes
of Health requirement for human research ethics education and training is one attempt to make
researchers aware of potential problem areas. An understanding of how human subject issues have
changed over the centuries will enhance efforts to sensitize researchers to the specialized concerns
of research with humans now and into the future.
Introduction and Generalities
The Nuremberg Code has been called “perhaps the most influential document in bioethics” (Kious,
2001). But it is not the first document whose intent was to protect the safety and health of
humans used in medical experiments, nor is it the first document to express concern about ethical
aspects of research with human subjects. While much current research is conducted on attitudes
and practices in many non-medical fields (agriculture, public administration, education, history,
to name a few), the origins of human subjects research are to be found in medicine. Medicine is
the natural home of substantial human subject dilemmas and errors of clinical judgment. This
paper is not intended to offer solutions or provide prescriptions for the future of human subject research.
However, an understanding of the past contributes to understanding present practice and
can lead us into the future with greater appreciation of the origins and limitations of our attitudes
and actions. As Santayana said, “Those who do not know the past are doomed to repeat it.”
Disease and pain are universal human conditions. From the beginning of human existence, people
have tried to cure disease and alleviate pain. The archaeological record indicates clearly that early
peoples had a cornucopia of herbal remedies, often coupled with ritual, magic, religion and mysticism,
as well as primitive surgical techniques (von Engelhardt, 2004). Skulls in the archaeological
record from several cultures show evidence of early trepanation and long bones show evidence of
primitive surgical intervention following a break. The Code of Hammurabi (ca. 1700 B.C.E.) lists
surgical fees and penalties for a failed surgical procedure. Observant early Egyptians categorized
diseases according to parts of the body. Von Engelhardt notes that early Greek and Roman sources
stressed public health and health maintenance. Medical treatments were designed to heal injuries
and improve an individual’s health status. It is natural to ask how and when diagnostic processes
and medical treatments were developed. At what point did practicing physicians, who were the
194 2005 Symposium Proceedings Book