Institutional Review Boards

Institutional Review Boards ("IRBs") are governed by Title 42 USC §289 and are required for entities applying for grants, contracts, or cooperative agreements from the United States government ("Government") for any project or program which involves biomedical or behavioral research using human subjects. When an entity performing such research submits its application for a grant, contract, or cooperative agreement, it must include assurances satisfactory to the Government that it has established an IRB to review the proposed research in order to protect the rights of the human subjects.

Federal regulations have greatly expanded the obligation to form an IRB to include entities performing research that, while not supported by the Government, is subject to regulation by a federal department or agency (e.g. research involving drugs which is regulated by the Food and Drug Administration).

When establishing an IRB, following are some of the criteria that must be met. Each IRB must: (1) have at least five members with varying backgrounds to promote complete and adequate review of research activities, (2) have qualified and experienced members with diverse backgrounds including race, gender, cultural background, and sensitivity to such issues as community attitudes although no IRB may consist entirely of men, women, or members of one profession, (3) include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas, (4) include at least one member who is not otherwise affiliated with the entity forming the IRB and who is not a part of the immediate family of any person affiliated such entity, (5) ensure that no IRB member has a conflict of interest with the research undertaken.

Each IRB must follow written procedures and approve research projects at convened meetings unless such project is eligible for expedited review. The Department of Health and Human Services has published in the Federal Register a list of categories of research that may receive expedited reviewed by an IRB. A copy of the list is available by writing the Office of the Protection from Research Risks, National Institutes of Health, Health and Human Services, Maryland, 20892.

An IRB must obtain and document informed consent. Information provided to the potential subject shall be in language understandable to the subject and may not include any exculpatory language whereby the subject waives or appears to waive any of his/her legal rights or releases the research entity from liability for negligence.

Included in the informed consent must be a statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental. In addition, informed consent must include a description of any reasonably foreseeable risks or discomforts to the subject, a description of any benefits to the subject, disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject, a statement describing the extent to which the subject’s records will be kept confidential, whether the subject will receive compensation and, if so, how much, available medical treatments, how to obtain further information, identification of who to contact for answers to pertinent questions about the research or in the event of a research-related injury, a statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, a statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements of informed consent include anticipated circumstances under which the subject’s participation may be terminated by the research entity without regard to the subject’s consent, any additional costs to the subject that may arise from participation in the research, the consequences of a subject’s decision to withdraw from the research, procedures for orderly termination of participation, a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject, the approximate number of subjects involved in the study; and an additional statement if the particular treatment or procedure may involve risks to the subject or to the embryo or fetus if the subject is or may become pregnant which are currently unforeseeable.

An IRB must identify criteria to evaluate which research to approve. Required consideration include minimizing the risks to the subjects by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk and, whenever appropriate, using procedures already being performed on the subjects for diagnostic or treatment purposes. Additional criteria include ensuring that risks to subjects are reasonable in relation to anticipated benefits the subject may receive from the research (not from therapies the subject may receive even if not participating in the research). Selection of subjects must be equitable.

In summary, an IRB must be established if seeking a government grant or merely performing biomedical or behavioral research using human subjects. The IRB must obtain and document informed consent and must develop criteria to evaluate which research projects will be undertaken in light of the anticipated benefits.