When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection - respect for persons, beneficence, and justice.
Respect for persons: Addresses the personal dignity and autonomy of individuals, and the importance of proper informed consent for individuals participating in research.
Beneficence: Addresses the obligation to protect human subjects from harm by assessing the risks and benefits of the research and assuring that the anticipated benefits are greater than the anticipated risks.
Justice: Requires that research subjects are fairly selected with regard to the purpose and expected outcome of the research, including consideration of the subject as an individual and as a member of society. The population of research subjects should be similar to those who may benefit from the outcome of the research.
These ethical principles, are discussed in the Belmont Report, and form the basis for the regulatory standards for human subject protection in the United States. The U.S. federal regulations are found in 45 CFR 46 Protection of Human Subjects. In addition, these principles are also incorporated in international guidance for ethical and scientific quality standards, Guideline for Good Clinical Practice.
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