Parents Students Faculty & Staff Alumni Give Visit Apply

IRB Resources

The Belmont Report and the Federal Regulations are the two most important federal documents that Institutional Review Boards must follow.

In 1974, the United States Government passed the National Research Act, which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This led to the development of the Institutional Review Board (IRB) system and codification of rules regarding structure, function, informed consent, risk-to-benefit ratios, and documentation. Ethicists and scholars on the commission reviewed historical ethical codes like the Declaration of Helsinki as well as cases of abuse like the Tuskegee Syphilis Study. The commission’s report, named after the conference center where they met, came to be known as "The Belmont Report."

The Belmont Report

The Belmont Report outlines three basic ethical principles that underlie U.S. regulations:

  • Respect for Persons: Protects individual autonomy and requires treating people with dignity. It provides the foundation for obtaining informed consent from research participants.
  • Beneficence: Requires maximizing potential benefits for the research while minimizing possible risks and harms to subjects.
  • Justice: Ensures fair, reasonable, and non-exploitative distribution of the burdens and benefits of research.

Federal Regulations

Federal regulations for the protection of human participants in research have been adopted by multiple federal agencies and are known as the "Common Rule." The Belmont Report forms the philosophical foundation for these regulations. The Department of Health and Human Services (DHHS) regulations are codified at 45 CFR 46.

Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides leadership in protecting the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP achieves this by providing guidance, developing educational resources, maintaining regulatory oversight, and offering counsel on ethical and regulatory issues in biomedical and social-behavioral research.

NIH / Human Subjects Training

Applications submitted for approval to the Andrews University IRB require certificates of completion for training in the protection of human subjects. Principal investigators and co-investigators must complete training through Andrews University Training & Education or the Protecting Human Research Participants (PHRP) site. For applications submitted by student researchers, a completion certificate for the faculty research advisor must also be included.

Formation en éthique de la recherche (FER)

Course on research ethics in French: International Development Program cohort students who are native French speakers may take their training via the Canadian Tutorial:

Le didacticiel EPTC 2: Formation en éthique de la recherche (FER)

Supplementary Resources