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50. Ethical Foundation: The Belmont Report

All University and affiliate personnel involved in the conduct and oversight of human subjects research must abide by the fundamental principles set forth in the Belmont Report.

The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the ethical foundation for the federal regulations for the protection of human research subjects. The Report is summarized below.

Respect for Persons

  • Individuals should be treated as autonomous agents whose opinions and choices are valued.
  • Individuals with diminished autonomy (e.g. minors, prisoners, persons who are mentally disabled) are entitled to additional protections.

This principle embodies the concept of informed consent whereby individuals (by themselves or under the auspices of a legally authorized representative)

  • enter into a research study voluntarily,
  • have sufficient information to make an informed decision about their participation, and
  • are free from coercion or undue influence from the researchers or others who may profit from the individuals' participation.

Beneficence

Human subjects research must be designed and implemented to

  • minimize harms to participants and
  • maximize possible benefits whether for subjects or for science or society.

This principle requires that research be justified on the basis of a favorable risk/benefit assessment.
Such assessments

  • consider the probability and magnitude of psychological, physical, legal, social, and economic harms;
  • consider risks and benefits of alternatives to the research;
  • weigh the reasonableness of seeking certain benefits despite the risks involved; and
  • determine when potential benefits may not sufficiently justify risks to subjects.

Justice

In human subjects research, justice relates to

  • "fairness in distribution" and
  • "what is deserved?"

This principle requires that those who bear the burdens of research (i.e., those who are exposed to the discomforts, inconveniences, and risks) should receive the benefits in equal measure to the burdens.

Determinations about justice require close scrutiny of subject selection and enrollment processes.

  • Sample populations should be selected for reasons related to the problem being studied.
  • Particular classes (e.g., welfare patients, racial and ethnic minorities, or persons confined to institutions) are not targeted because of ease of access or manipulability, or for the convenience of the investigators.
  • Publically funded research that leads to the development of therapeutic devices and procedures should
    • neither provide advantages to the more affluent in attaining these benefits
    • nor unduly involve persons from groups least likely to benefit from the developments.

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