Why is there a need for IRBs?

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.

OHRP provides instructions for institutions as to how to register their institutional review boards (IRB) and obtain Federalwide Assurances (FWA). An institution must have an FWA in order to receive HHS support for research involving human participants. Through the assurance of compliance, an institution commits to HHS that it will comply with the requirements set forth in the regulations for the protection of human participants at 45 CFR part 46. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.

How do IRBs protect human participants?

The current U.S. system of protection for human research participants is heavily influenced by the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human participants (see link above for details on respect for persons, beneficence and justice).

In 1981, with this report as foundational background, HHS and FDA revised and made as compatible as possible - under their respective statutory authorities - their existing human subjects regulations. With leadership from HHS, the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies (recently updated in 2018).

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The revised Common Rule is effective July 19, 2018.

What groups of human participants have extra protections?

According to HHS, the following groups are considered vulnerable populations, which require greater protections than non-vulnerable populations:

  1. Pregnant women
  2. Human Fetuses and Neonates
  3. Children (i.e. Persons under age 18)
  4. Prisoners
  5. Persons diagnosed with HIV/AIDS

Who is allowed to serve as a member of an IRB?

The requirements for IRB membership are addressed in the HHS regulations at 45 CFR 46.107 [Note: 45 CFR 46.304 requires a specialized IRB composition when research involving prisoners is being reviewed, including the presence of a prisoner representative].

An IRB must:

  1. Have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
  2. Make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
  3. Include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
  4. Include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution; and
  5. Not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.