The IRB – A Necessary Evil?

Research is an integral part of daily life. Through research one is able to investigate, discover, analyze, and evaluate phenomenon and contribute to an existing databank of knowledge in various fields, as well as to scrutinize existing facts, laws, and theories for refinement and general edification. This process is expected to ultimately provide some benefit not only because it increases knowledge, but also because there is so much that can be done with this new information. Educational research involves the systematic investigation and evaluation of knowledge in the field of education, with the explicit goal to improve the effectiveness and efficiency of educational institutions. Educational research is often times conducted with remediation as its focus. However, a research may be conducted to either dispute a claim or simply add more information to an already established body of knowledge. When educational research involves the use of human subjects, care must be taken in conducting investigations. The Institutional Review Board (IRB) is the body that seeks to regulate how research involving human subjects is conducted. It aims to protect the rights of human subjects in behavioral science, social science, and medical research.

Prior to establishment of the IRB and the enactment of the National Research Act in 1974 research studies were conducted without a set of ethical principles that would ensure that the welfare of the research subject is not compromised. Consequently, from even years prior to the post-World War II trials of war criminals before the Nuremberg Military Tribunals there were wide scale reports of unthinkable atrocities performed against human beings in the name of research. On the international scale, the aforementioned research is probably the most infamous. However, other similarly unethical researches involving human subjects were conducted in Asia and other parts of the world. Probably the most notorious of them was carried out by a Japanese army physician called Ishii Shiro, Ishii was fascinated with biological or germ warfare and his experiments resulted in the death of over 9,000 unwilling Chinese subjects. The United States too, is guilty of conducting numerous unethical researches. One of the most horrific is the Tuskegee Syphilis Study 1932-1972. This study, conducted on approximately 600 Black males, was intended to provide information on the natural progression of syphilis, so that more effective treatment options could be developed. However, even after an effective treatment was developed for syphilis, the men in the study were denied treatment so that the full progression of the disease could be observed. Similar to the Tuskegee study, the Willowbrook School Study further victimized the vulnerable in the society. In the Willowbrook School Study, mentally handicapped students were willfully infected with the hepatitis virus so that an effective inoculating treatment could be developed. In Europe and the United States the thalidomide debacle caused devastations when tens of thousands of mothers gave birth to babies with serious abnormalities after taking the drug (in its experimental stage) to relieve morning sickness. The U.S. Army LSD studies is yet another of many secret human experiments conducted in the United States without the informed consent of the participants. Another well-known study was the U.S. Radiation Experiments which were conducted during the Cold War years. Laud Humphries, Tearoom Trade Study explored the motivation of men who engaged in casual sex in public washrooms. The data for this study was gathered by deceiving the involuntary subjects. The Jewish Chronic Disease Hospital study was carried out to ascertain the nature of human transplant rejection. In this study, subjects were injected with live cancer cells without their knowledge or consent. These and many more studies, as well as the famed studies of Zimbardo and Milgram demonstrated how easy it was for one to inadvertently or knowingly conduct an unethical research.

The Nuremberg Code’s establishment in 1945 was the first legal attempt to deal with ethical issues of modern research. Subsequently a more specific code of ethics was formulated in 1964 known as the Declaration of Helsinki. However, when the Tuskegee Syphilis Study became public knowledge, the national outcry served as the catalyst that brought about the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. According to information found in Fordham University’s Center for Ethics Education:

In the United States, by 1953 the National Institutes of Health required that all proposed clinical research projects at its center in Bethesda obtain approval from a protection of human subjects review panel. In 1966, the United States Public Health Service issued its first set of regulations extending this review requirement to all "extramural" research supported by the agency. These rules were further revised in 1971 and 1974 and led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research.

The IRB was therefore established to protect human subjects, and to protect researchers from themselves.

The IRB comprised of a team of at least five individual who meet periodically to review request to conduct research. It uses the Belmont Report (1979), the National Research Act, and the Declaration of Helsinki as a guide when making judgments on a proposed research project. The committee responsibility is to safeguard the welfare of human subjects and use the federal regulations (45 CFR 46) as a guide in determining whether or not a research proposal is approved. In arriving at a decision, the interest of science must never supersede the welfare of the study participants. The IRB has to ensure that it weighs the matter carefully. However, as with any procedure that calls for human judgment there is bound to be controversies. A study that might be deemed justifiable at one institution might be flatly rejected at another. While this might not be prejudicial it often time serves to frustrate the researcher. Another major source of frustration for primarily the neophyte researcher is the somewhat tedious bureaucratic process that one must go through in order to get a favorable response from the IRB. One must submit a protocol or IRB application whose format is stipulated by the local IRB. This protocol provides all pertinent details for the study, including the reason for the study and the population. The IRB has to authorize any modification made after this submission. Part of this difficulty with this process is that the IRB might not meet as often as one would like, and road to approval involves a mountain of paperwork. Many educational researchers are able to bypass this tedious process because their review might be either expedited or exempt. Seldom do education researches require full board review. Furthermore, most classroom projects are approved for a course and not for individual projects. For that reason, the lecturer of the course would seek approval on behalf of the course and the onus is on him to ensure that the study is conducted appropriately.

Undoubtedly the IRB has faced numerous criticisms. Many people question whether it is excessive control or necessary restraint. Especially in light of the growing evidence of conflict of interest involving large international drug testing companies like SFBC. Pharmaceutical companies are reportedly using for profit IRB to circumvent the laborious process of getting approval to test their products on human subjects. Bloomberg news covered extensively the abuse of the vulnerable poor in a number of clinical trials carried out by large pharmaceutical companies recently – a clear evidence that the ethical principles outlined in Belmont Report (1979) are being ignored by many. However, despite all these negatives, the presence of the IRB has drastically reduced the incidents of such abuses; and thus it becomes a necessary evil. Besides, the history of man has shown that we do have the propensity for evil. Thus, for the most part; the IRB will help to curtail such natural evil inclinations.