After World War II, the Nuremberg Military Tribunal revealed atrocities committed in the name of science by Nazi physicians and scientists. The Nuremberg Code, the first internationally accepted codification of the ethics involved in human experimentation, was one result. The code accepted as its first principle "the voluntary consent of the human subject is absolutely essential."

In the late 1940's and 1950's researchers acting under the auspices of the U.S. Department of Energy administered radioactive substances to human subjects, apparently without their knowledge or consent. In some cases these subjects were particularly vulnerable persons, including terminally ill cancer patients and mentally retarded children.

In 1964, the World Medical Association issued the first version of the Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. This document affirmed the principles of informed consent, minimization of risk, consideration of the risk/benefit ratio for any protocol, and freedom from coercion to participate.

Into the early 1970's U.S. researchers, in a project now known as the "Tuskegee Experiment" studied the effects of untreated syphilis infections in African-American men. This was a longitudinal study which spanned 40 years, during which the subjects were not informed of the nature of their infection, nor were they ever offered appropriate treatment with penicillin when it became available.

The history of modern biomedical science is marked by an ongoing tension between the necessity to respect individual rights and the need to employ human subjects for some types of medically valuable research. As the sequence of events outlined above illustrates, even when the principles underlying protection of human subjects are generally recognized and accepted, some researchers have been found to violate those principles. For this reason, the federal government developed guidelines in the form of legislation which applies to all institutions which receive federal research funds.

The principles underlying this legislation are contained in The Belmont Report, issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The ongoing implementation of this legislation is carried out by a system of Institutional Review Boards which must approve every use of human subjects at institutions receiving federal research funds.

The Belmont Report found three quintessential requirements for the ethical conduct of human subjects research:

1. Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. This principle leads directly to the requirement for informed consent. For consent to be informed, it must meet the standards of information, comprehension, and voluntariness. Subjects must be given sufficient information on which to base their decisions, including information about the research procedures, purposes, risks and anticipated benefits, alternative procedures, and a statement offering the subject the opportunity to ask questions and to withdraw from the research at any time.

The information must be comprehensible, written in a format matched to the individual's capacity to understand it. Most importantly, this means that medical jargon cannot be substituted for lay language, that probing to see if the subject has understood the information may be necessary, and that even persons of limited capacity be helped to understand their participation at the appropriate level.

Voluntariness means that subjects must be well aware that they may refuse to participate, or may cease to participate at their discretion at any time, without penalty or threat of penalty. Conditions of consent must be free from coercion or undue influence.

2. Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. This implies that the investigators must conscientiously undertake a risk/benefit assessment of the protocol. From the viewpoint of the participant, all risks -- physical, psychological, social or other -- must be kept to the minimum possible. The risks that do exist must be balanced by clear benefits to the individual subject and/or to the general social good. Subjects must be thoroughly and completely informed of the risks entailed.

The beneficence principle also implies that the protocol will be based on scientifically sound reasoning. Neither risk nor inconvenience to subjects can be justified if the activity will not clearly advance the state of scientific knowledge.

3. Justice requires that the benefits and burdens of research be distributed fairly. Selection of research subjects must be the result of fair procedures and result in fair selection outcomes. The "justness" of subject selection relates not only to the subject as an individual but also to the subject as a member of social, racial, sexual or ethnic groups. Researchers may not base selections on individual or social favor or disdain. Subjects may not be selected simply because they are readily available in settings where research is conducted or because they are easy to manipulate as a result of their illness or socioeconomic condition.

Social justice in research also implies an order of preference in the selection of classes of subjects -- adults are preferred over children, for instance -- and some classes of potential subjects, such as the institutionalized mentally infirm or prisoners, may be involved as subjects only under certain restrictive conditions.

The Institutional Review Boards (IRB's) for Cook County Bureau of Health Services entities are called Scientific Committees. Scientific Committees are maintained at Cook County Hospital, Oak Forest Hospital and Provident Hospital. For more information on each of these IRB's, see the Bureau Guidebook for Grants and Research and Bureau Scientific Committees.

See Also:
Office for Protection from Research Risks (OPRR)
The Belmont Report
Federal Regulations for Protecting Human Subjects (45 CFR Part 46)
Human Subjects: Summary of Basic Protections
Informed Consent: Key Points