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About :: IRB: a brief history

IRB: A Brief History

The concept of an Institutional Review Board developed in reaction to researcher abuse of study participants in the twentieth century. Nazis doctors conducted egregious studies on their coerced participants and the doctors were later tried for their experiments. The Nuremburg Code was developed during these trials as an ethical standard by which to judge the doctors and it became a founding document for any ethical human subjects study. One of its core principals is the concept of “participant consent” as an essential element for conducting ethical research of human subjects. The Code details the necessary elements for consent such as determining the participant’s capacity to consent, freedom from coercion, and the comprehension of the risks and benefits involved. Other provisions require the minimization of risk and harm, a favorable risk/benefit ratio, qualified investigators using appropriate research designs, and freedom for the subject to withdraw at any time. The Declaration of Helsinki, adopted by 18th World Medical Assembly in Helsinki, Finland, in 1964, reiterates the concepts established in the Nuremburg Code as well as distinguishes therapeutic from nontherapeutic research.

The need for a review system in the United States wasn’t recognized for several more years after the Nuremburg trials, but studies such as the Tuskegee Trials illuminated the need for more proactive review in the U.S.  Regulations protecting human subjects first became effective on May 30, 1974 set forth by the U.S. Department of Health, Education, and Welfare (DHEW, which was renamed the Department of Health and Human Services or DHHS) and these regulations established the Institutional Review Board as the body in charge of reviewing human subjects research. In addition, the Belmont Report was created by the former DHEW in 1979. The Belmont Report explains that the three fundamental ethical principles for using any human subjects for research are:

  1. Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;
  2. Beneficence: The philosophy of "Do no harm" while maximizing benefits for the research project and minimizing risks to the research subjects; and
  3. Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of costs and benefits to potential research participants — and equally.

The DHHS regulations are codified in Title 45 Part 46 of the Code of Federal Regulations. These "basic" regulations became final on January 16, 1981 and they constitute the formal rulebook by which the IRB is run.

The documents as described above create the foundation for the IRB-SBS’s ethical review as well as their standard operating procedures. One challenge often present in IRB review is the discord between biomedical and social/behavioral research as the two have significantly different methodologies and risks, but they are governed by the same code of conduct. For this reason, the University of Virginia has separate IRB’s; the IRB-HSR’s mandate is to have a board comprised of biomedical researchers who review biomedical research, while the IRB-SBS has a board comprised of social and behavioral scientists who review social and behavioral science research, with the intent that each will be able to provide more accurate and appropriate reviews.

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