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Why do we have research review?

Research Ethics and the Belmont Report

The conversation about ethics in research began after the Holocaust. Nazi medical experiments led to the development of the Nuremberg Code, which established the basic principles governing the ethical conduct of research with human subjects.

The atrocious human rights violations observed during the Nazi medical experiments, and the Tuskegee syphilis experiment in the United States, led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in July of 1974. This commission produced the Belmont Report, published in 1978. They set out three basic ethical principles underlying acceptable conduct of research with human subjects. These are the principles that the Marlboro College IRB follows.

  • Respect for persons 
  • Beneficence
  • Justice

Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection for those persons with diminished autonomy. It is from this principle that we emphasize the need for informed consent and voluntary participation in research.

[url=https://nook.marlboro.edu/public/academics/irb/informed_concent]Informed consent[/url] contains three elements: information, comprehension, and voluntariness. Participants must be given sufficient information to determine whether or not they want to participate (including the research procedures, their purposes, risks, anticipated benefits, alternative procedures where therapy is involved, and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research). Subjects must also be able to comprehend the information that is given to them. The information must be adapted to the subject's ability to understand it.

The conditions under which an agreement to participate is made must be free from coercion and undue influence. IRBs should be especially sensitive to these factors when vulnerable subjects are involved.

Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. It is from this principle that we emphasize the need for risk/benefit assessments.

Five basic principles apply when making a risk/benefit assessment: a) “brutal or inhumane treatment of subjects is never morally justified;” b) risks should be minimized, including the avoidance of using human subjects if at all possible; c) IRBs must be scrupulous in insisting upon sufficient justification for research involving ‘significant risk of serious impairment” (e.g. direct benefit to the subject or ‘manifest voluntariness of the participation’); d) the appropriateness of involving vulnerable populations must be demonstrated; and e) the proposed informed consent process must thoroughly and completely disclose relevant risks and benefits.

Justice requires that the benefits and burdens of research be distributed fairly. It is from this principle that we emphasize the fair selection of research participants. The “justness” of subject selection relates both to the subject as an individual and to the subject as a member of a social, racial, sexual, or ethnic group.

With respect to their status as individuals, subjects should not be selected either because they are favored by the researcher or because they are held in disdain (e.g., involving "undesirable" persons in risky research).

Furthermore, subjects should not be selected simply because they are readily available in settings where research is conducted, or because they are "easy to manipulate as a result of their illness or socioeconomic condition." Care should be taken to avoid overburdening institutionalized persons who "are already burdened in many ways by their infirmities and environments.” (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

For more background on these principles and their applications, please see the Department of Health and Human Services page on Institutional Review Boards.