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In the United States, all academic institutions and other entities that receive federal government funding and that conduct research involving human subjects must maintain an institutional review board (also known as an internal review board, or IRB) to oversee the adherence to federal regulations that govern research using human subjects. These boards are committees of professional researchers and administrators who screen research proposals with the intent of enforcing the federal regulations covering research on human subjects. The primary intent of these regulations is to protect human subjects from potential physical or mental harm that may result from participating in a research project.
All research projects that employ human subjects, from medical drug trials to social behavior surveys, must be reviewed by the host institution’s IRB to ensure that federal regulations are met within the proposed research design. Before proceeding with a project, researchers must receive approval, or in some special cases an exemption, from their local IRB. All research projects involving human subjects or employing data collected from people are subject to federal regulations, regardless of the source of financial support for the project. Since institutions found violating human subject regulations may be forced to forfeit all federal funding, the IRB is a critical component of any research university’s governance structure.
The global movement to safeguard and protect human subjects can be traced back to the aftermath of World War II (1939–1945) and the war trials held in Nuremberg, Germany, when the world learned of the atrocious medical experiments conducted on prisoners interned in Nazi concentration camps. The Allies developed what came to be known as the Nuremberg Code to assist the military tribunal in judging the Nazis’ conduct. This code outlined the basic tenets that became the foundation of the ethics that govern research on human subjects. From the subjects’ perspective, these tenets include: (1) the ability to voluntarily participate or withdraw from participation; (2) the freedom from coercion to participate; and (3) the right to be informed of all potential risks and benefits of participation. Furthermore, the code’s provisions require that researchers be professionally qualified for the specific type of research in question, that they use appropriate research designs, and that they seek to minimize the risk of potential harm to human subjects.
Throughout the 1950s and 1960s, numerous medical associations and national governments around the world passed declarations and endorsements of professional codes of conduct based on the Nuremberg Code. In the United States, this occurred when the National Institutes of Health issued its Policies for the Protection of Human Subjects in 1966. In 1974 the Department of Health, Education, and Welfare raised these policies to regulatory status and introduced IRBs as a mechanism for institutions to ensure the protection of human subjects through regulatory compliance.
The American codification of rules designed to protect human subjects in the 1960s and 1970s was spurred on by two high-profile cases that employed procedures that many considered to be unethical. In 1963 Yale psychologist Stanley Milgram (1933–1984) published the results of a study on obedience to authority in which one human subject was asked to deliver electrical shocks of increasing voltage to another person who was secretly collaborating with the experimenter. Even though the shocks were fictitious, the screams and pleas of the collaborator led the subject to believe that they were real. Ironically, Milgram’s motivation for the study was the psychology behind the Nazi atrocities. In 1972 the press revealed that the U.S. Public Health Service was conducting a decadeslong clinical study of the effects of syphilis using a sample of several hundred, mostly poor, African Americans living near Tuskegee, Alabama. While some subjects were given proper treatment, others were not informed of their diagnosis and were prevented from receiving treatment from other health-care providers. The primary goal of the Tuskegee study was to determine how, over extended periods of time, syphilis affects the human body and eventually kills. Not only did many human subjects in this experiment die from nontreatment, but the disease was also spread to the spouses and children of the untreated participants. The Tuskegee researchers did not receive the informed consent of the subjects and did not disclose the risks of participation to them and their families. Once it became public, the study was terminated and the remaining subjects were given proper medical care. Eventually, in 1997, President Bill Clinton issued a formal apology on behalf of the U.S. government.
The passage of the National Research Act (1974) established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission’s 1979 report, commonly referred to as the Belmont Report (named after the Smithsonian Institution’s Belmont Conference Center, where the commission met) served as the basis for the subsequent revisions to the federal regulations, which eventually evolved into the current Federal Policy for the Protection of Human Subjects (Code of Federal
Regulations, Title 45, Part 46). As of 2005, sixteen federal departments and agencies that support or conduct human subjects research had adopted this policy, which is sometimes called the Common Rule.
Regulatory Principles and Practices
Three general ethical principles outlined in the Belmont Report serve as the basis for the rules outlined in the Common Rule: (1) respect—honor for the personal dignity, autonomy, and the right to privacy of individuals; (2) beneficence—the obligation to minimize the risks of potential harm to human subjects while seeking to maximize the benefits of research to humanity; and (3) justice—ensuring that the benefits and costs of research on human subjects are distributed equitably. These principles guide the regulatory rules overseen by IRBs in the daily practice of academic research. For example, the requirement to obtain informed consent is derived from the principle of respect; the requirement to explicitly weigh potential risks against potential benefits is derived from the principle of beneficence; and the requirement to recruit human subjects fairly is derived from the principle of justice.
For an experimental project involving human subjects to fall under the regulations of the Common Rule, it must be classified as research. Specifically, the Common Rule defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Projects that fail to meet this definition of research are exempt from the regulations. In some cases, local IRBs have exempted whole classes of academic exercises, most notably oral history projects, from their oversight. However, individual researchers are not at liberty to make an exemption determination on their own; only an IRB is allowed to review a proposed project and to determine if it meets the Common Rule’s definition of research.
The technological revolution of the late twentieth and early twenty-first centuries spawned a resurgence in advocacy for the protection of privacy and individual rights. This was a contributing factor to what some saw as a tightened enforcement of Common Rule regulations by local IRBs, which were also being forced to respond to several high-profile cases of careless procedures during medical drug trials. As a result, many social scientists and educators discovered that their institutions wanted to make a closer examination of their research practices and procedures. The additional scrutiny and accompanying paperwork resulted in public complaints about the regulatory burdens imposed by the IRB system.
Some social scientists claim that the human subjects regulations are overly burdensome and have a stifling effect on the research climate. They say this is particularly true for survey-based research projects where the potential for personal harm to human subjects is either negligible or nonexistent. To date there is little compelling empirical evidence that the IRB system has significantly reduced the level of research using human subjects. However, most social scientists will agree that the enforcement of Common Rule regulations by IRBs does protect human subjects from highly risky experimental research practices. Given this, it is likely that the IRB system will remain entrenched in the governance of American academic research institutions for the foreseeable future.
- Levine, Robert J. 1986. Ethics and Regulation of Clinical Research. 2nd ed. Baltimore, MD: Urban & Schwarzenberg.
- Sieber, Joan E. 1992. Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards. Newbury Park, CA: Sage.
- U.S. Department of Health and Human Services: Office for Human Research Protections. 2005. Code of Federal Regulations: Title 45, Public Welfare; Part 46, Protection of Human Subjects (Common Rule).
- U.S. Department of Health, Education, and Welfare: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
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