Institutional review board (IRB)

An institutional review board (IRB) is a committee that oversees scientific experiments involving human subjects. The IRB monitors the research to ensure that the subjects are treated ethically. Subjects have a right to respect and information, the highest possible level of safety, and just treatment and compensation. IRBs may exist in many levels of governments or institutions, in widely varying sizes and types. However, all IRBs must follow guidelines and uphold the basic ideals of ethical human experimentation. IRBs were created after outrage over unethical human experimentation brought a wave of reform in the United States starting in the 1970s.

Background

Throughout the early centuries of scientific and medical development, experimenters faced relatively few official restrictions or regulations. Some subjected animals and even humans to experiments that led to serious pain, psychological trauma, and even physical damage or death. Legal protections for experiment subjects were slow to arrive and did not start making a serious impact until the twentieth century.

The call for human research subject protection came from a growing awareness of the potential damages caused by scientific experimentation as well as an increasing respect for human rights. A few scandals and shocking cases of unethical abuses in the name of science also helped to spread this idea. One of the most infamous of these scandals in the United States surrounded the Tuskegee syphilis study.

In 1932, the Public Health Service made an arrangement with the Tuskegee Institute to study syphilis, at the time a widespread disease. Researchers gathered 600 Black men, 399 of whom had the disease and 201 who did not. They were all told they had blood-borne illnesses and that they would be receiving free medical treatment for six months. In the course of the experiment, which in reality extended for 40 years, the men received no actual treatment. Moreover, even when new treatments for syphilis became available, researchers did not allow the subjects to take them. The researchers did not allow men to leave the study, and monitored many until their deaths.

Only in the late 1960s did some people begin to publicly question the ethics of this research. The Tuskegee subjects had been deceived into not receiving treatment for a life-threatening disease in the name of science. A major outcry in the early 1970s ended the study and began exposing the shocking lack of ethics involved. Soon afterward, courts ruled in favor of the research subjects, and a worldwide call for new ethical protections arose. These protections would include new regulating bodies and institutional review boards (IRBs).

Overview

In the 1970s, the United States began devising protections for human experimentation subjects. In 1974, the National Research Act was passed, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR). This breakthrough would ultimately bring about the creation of IRBs.

The NCPHSBBR's work revolutionized thought on scientific experiments involving humans. It also set the groundwork for the establishment of many new overseeing organizations. Chief among these in the US was the Office for Human Research Protections (OHRP), a branch of the US Department of Health and Human Services (HHS). These new offices helped to define, design, organize, and regulate IRBs across the country.

IRBs are overseeing and administrative bodies that monitor experimentation with the goal of protecting the rights and safety of any humans involved as research subjects. The IRB must initially study a proposed research project and determine whether it upholds proper ethical codes. If approved, the project may continue, but the IRB must monitor the ongoing work to ensure that it adheres to its approved plan.

All IRB-approved experiments must uphold the ideals of the NCPHSBBR that were summarized in a 1979 document known as the Belmont Report. This report established three ethical guidelines for all acceptable human experiments. The first is that subjects be treated with respect and that their informed consent be gained without any deception. The second is to do no unnecessary harm to subjects by finding ways to minimize risk while maximizing results. The third is to justly and equally administer the procedures of the experiment and any rewards or benefits due to the subjects.

IRBs exist on many levels, ranging from large bodies created by federal departments down to small teams overseeing experiments at colleges, universities, and private research institutions. In the US, however, all of these IRBs must follow the same general guidelines and uphold the ethical ideals set forth by the NCPHSBBR. Otherwise, they risk losing their legal sanctioning and may face penalties, cancellation of their work, or even criminal charges.

According the NCPHSBBR and OHRP, although IRBs may vary greatly, they must include at least five members. These members should come from diverse backgrounds to best represent a range of personal and cultural belief systems. There should also be one non-scientist member, and another member who is not part of the institution. This planned diversity is meant to gather the broadest perspectives on the ethical, legal, social, and scientific implications of the experiment, and its likely effects on its subjects.

IRBs approach different experiments in different ways. Some experiments are judged exempt from IRB review. These experiments may pose little or no risk to humans, such as surveys, research on existing public data, or taste tests of regular foods. Experiments posing a slight risk to humans may get expedited treatment from IRBs, meaning the IRB reviews the work quickly. These tests may include observation of informed and consenting people in situations not likely to cause harm, or the collection of physical data by weighing or measuring people.

Full IRB reviews are usually reserved only for research that poses a likely risk to subjects, such as potentially stressful or traumatic tests, or research that requires intentional deception of subjects. Full reviews are also generally applied to research that involves minors, disabled individuals, or other sensitive or protected subject groups. These full reviews may take more time and involve more reviews and documentation to gain approval.

Bibliography

Amdur, Robert, and Elizabeth A. Bankert. Institutional Review Board Member Handbook, Jones and Bartlett Publishers, 2011.

"Institutional Review Board (IRB)." American Public University System, www.apus.edu/academic-community/research/institutional-review-board/. Accessed 1 Aug. 2024.

"IRB Registration." US Department of Health & Human Services, 14 Dec. 2021, www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/index.html. Accessed 1 Aug. 2024.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. "The Belmont Report." US Department of Health & Human Services, www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Accessed 1 Aug. 2024.

"Office for Human Research Protections." US Department of Health & Human Services, www.hhs.gov/ohrp/. Accessed 1 Aug. 2024.

"The Untreated Syphilis Study at Tuskegee Timeline." Centers for Disease Control and Prevention, 5 Dec. 2022, www.cdc.gov/tuskegee/timeline.htm. Accessed 1 Aug. 2024.

"What Is the Institutional Review Board (IRB)?" Oregon State University, research.oregonstate.edu/irb/frequently-asked-questions/what-institutional-review-board-irb. Accessed 1 Aug. 2024.