Ethics and the IRB: The History of the Belmont Report

The Belmont Report, a founding IRB document, has a rich history of development.

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“Good judgment comes from experience and experience comes from poor judgment.”

- An Aphorism

The Institutional Review Board (IRB) is a system of checks and balances for research with human subjects. It was founded on three guiding principles from the Belmont Report: 1) respect for persons, 2) beneficence, and 3) justice. Although review boards are now a regular part of the modern research process, the Belmont Report—and the ethical oversight it created—was only developed in the last century.

Researchers have collected human subjects data in one form or another for centuries (e.g., public observations, medical experiments, etc.). Individuals have wrestled with the application of ethical decision making and its place in research, as well as daily conduct. Efforts leading to the formation of the IRB were in part catalyzed by highly publicized cases documenting researchers’ abuse of power.

One well known example dates back to 1945. During World War II, Nazi scientists committed egregious crimes against the Jews, including experiments that showed no regard for human rights or life. After the war ended, the scientists were convicted by trial in Nuremberg, Germany. The crimes discussed during the trials shocked the scientific community. These trials set the stage to produce the Nuremberg Code, which was one of the first modern documents addressing ethical research with human subjects.

The Nuremberg Code outlines ten points for conducting ethical research, including the requirement for voluntary consent, researcher qualifications, risks versus benefit, and participant’s right to terminate. The Nuremberg Code became the building block for a number of other important codes of research, including the Declaration of Helsinki (1964), which specifically addresses medical research.

The Nuremberg Code
  1. The voluntary consent of the human subject is absolutely essential.
    This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  8. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  9. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

A second contributing factor to the development of the Belmont Report was the Public Health Service’s (PHS) Tuskegee Study. In 1972, the Associated Press covered the Tuskegee Study, in which black men with syphilis consented to be “treated” by researchers in exchange for meals, medical exams, and burial insurance. However, the full extent of the study was not disclosed to participants: the researchers were actually examining the course of untreated syphilis in the body, and the participants were denied information and access to penicillin, a cure for syphilis. A class-action lawsuit was brought against the PHS to end the study. The study revealed a striking flaw in current human subjects' protection policies; they were not sufficient to protect their participants from harm. In response, President Nixon signed the National Research Act (1974) into law, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (also referred to simply as the National Commission). He charged the National Commission with establishing a code of research ethics to govern domestic research. The National Committee released The Belmont Report in 1979, which identifies basic ethical principles underlying biomedical and behavioral human subjects research.

Though the Belmont Report is the most widely cited article in the United States for the protection of human subjects research, it is important to remember the events that contributed to its origination. Even with the current wealth of research ethics literature available to modern researchers, unifying the protections of human subjects with research aims can still present a challenge. Review committees, such as the IRB, aim to support researchers in identifying possible harm that may come to participants and assessing the risks versus benefits of a study. The IRB promotes the ethical conduct of research and strives to foster cooperation and collaboration among institutions, investigators, and research staff.

References

— Kailee Kodama Muscente, Ed.M.

Published Monday, Aug 3, 2020

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