When reviewing research, the IRB is guided by three ethical principles that are fundamental to human subject protection, respect for persons, beneficence, and justice, which are laid out in the Belmont Report. (See part B of the report for more detail.)
- 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.
The following links provide the federal regulations that govern research that involves human participants and documentation regarding the ethical foundation for the treatment of human subjects in research. (This list is not exhaustive.)
Federal Regulations for the Protection of Human Subjects
The U.S. Department of Health & Human Services (HHS) regulations for the Protection of Human Subjects in research is found in the Code of Federal Regulations, Title 45, Part 46 (45CFR46).
The Belmont Report, identifies three basic ethical principles that should underlie research involving human participants: respect for persons, beneficence, justice. (See part B of the report for details.) This report also establishes guidelines that address ethical issues arising from the conduct of research with human subjects and is used as a foundation for the federal regulations for the Protection of Human Subjects in research 45CFR46.
The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
American Psychological Association, Ethical Principle of Psychologists and Code of Conduct
The APA Ethical Principles and Code of Conduct provides both aspirational goals to guide psychologists toward the highest ideals or ethical courses of action as well as a set of enforceable “Ethical Standards” (rules) for conduct as psychologists. While the Ethical Standards are not exhaustive, they do provide guidelines for developing best practices within psychological work,and other disciplines may find these guidelines to be helpful. (For example, Section 8 discusses research and publication, including informed consent, the use of deception in research, etc.)
World Medical Association, Ethical Principles for Medical Research
The World Medical Association (WMA)’s Declaration of Helsinki provides ethical principles for medical research involving human subjects.