Institutional Review Board

Background

The Institutional Review Board (IRB) is a hospital committee formally required by government regulation. IRBs are most commonly employed for studies in the fields of health and the social sciences.  Such studies may include clinical trials of new drugs or devices; studies of personal or social behavior, opinions or attitudes; or studies of how health care is delivered and might be improved.

The purpose of an IRB is to protect the rights and welfare of human research subjects participating in the hospital's biomedical and behavioral research. The IRB reviews proposed studies to ensure that any potential risks to human subjects are minimized and that those risks are justified by the relative importance of the study and the knowledge it could produce. The IRB’s critical oversight functions are scientific, ethical, and regulatory.

The IRB at New York Hospital Queens reviews every research proposal submitted by a medical center investigator to determine whether it meets the appropriate criteria for human subject research. This body has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction, as specified by both federal regulations and local institutional policy.

IRBs were established under the National Research Act of 1974, in direct response to significant research abuses in the early 20th century. Most notably, these included the experiments of Nazi physicians during World War II (Nuremberg Code, http://ohsr.od.nih.gov/guidelines/nuremberg.html) and the Tuskegee Syphilis Study, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama (Belmont Report, http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

IRBs are currently regulated by the Department of Health and Human Services (HHS) Offices for Human Research Protections (OHRP), http://www.hhs.gov/ohrp, and  the U.S. Food and Drug Administration (FDA), http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials.

Membership 

The composition of the IRB is specified by both OHRP and FDA regulations:

1. Each IRB must have at least five members that include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also include at least one member who is not otherwise affiliated with New York Hospital Queens and who is not part of the immediate family of someone affiliated with the hospital. This member is commonly referred to as the community or lay member.
2. IRB members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place. The IRB may also invite individuals with competence in a specific area to assist in a review that requires expertise beyond that which is available among the IRB members. Invited individuals would not be voting members.
3. If an IRB regularly reviews research involving a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, the IRB must consider the inclusion of one or more individuals knowledgeable about and experienced in working with these subjects.
4. The IRB should include both men and women, as long as they aren’t chosen specifically for their gender.
5. IRB members may not vote on their own projects or any project in which they may have a vested interest. They may, however, provide information requested by the IRB.

In order to vote on a proposal, a quorum, or one more than half of the members of the board, must be present and must include one non-scientist. In order for the research to be approved, it must receive the approval of a majority of the members present. The exception to this is a research proposal that meets the requirements for an expedited or exempt review (see below).

Expedited or Exempt Review 

In addition to the reviews made at its regular meetings by the chairman or designee, the IRB provides a process for an expedited review. An expedited or exempt review can be done by the IRB chairperson or by other experienced members who have been designated by the chairperson. In conducting their evaluation, these reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research proposal.

The IRB may use the expedited review when some or all of the research is found to involve no more than minimal risk, or for minor changes in previously approved research. Examples include the prospective collection of biological specimens for research purposes by noninvasive means, collection of data through noninvasive procedures, and research on individual or group characteristics or behavior. Although an expedited review does not go before the convened committee, it is not a faster or less extensive process.

Some research that involves human subjects may be exempt from the regulations requiring IRB review. One example is educational testing and survey procedures in which no identifying information will be recorded that can link subjects to the data; in addition, disclosure of the data could not reasonably place the subjects at risk of civil or criminal liability or be damaging to the subjects' financial standing, employability or reputation. Another example is research involving the use of existing data, documents or specimens from which no identifying information will be recorded that can link subjects to the data.