What Is an Institutional Review Board?
An Institutional Review Board is a committee mandated by the National Research Act to be established within each university or other institution that conducts biomedical or behavioral research involving human participants and that receives federal funding for research involving human participants.
IRBs were established as an outcome of legislation passed in 1974 as a result of unethical treatment of human subjects. Before this, other committees existed as a requirement of the United States Public Health Services policy established in 1965.
IRBs are currently regulated by the Office of Human Research Compliance, a part of U.S. Department of Health and Human Service and the U.S. Food and Drug Administration.
Institutions not in compliance with regulations pertaining to the protection of human subjects participating in research may lose federal funding.
The Fundamental Responsibility of the IRB
- is to assure that all ethical issues have been fully addressed in the protection of human subjects who volunteer to participate in research studies.
The Institutional Research Boards (IRB) for UMKC is responsible for protecting the rights and welfare of human research subjects recruited to participate in research conducted under the auspices of UMKC, the Truman Medical Center, St Luke’s Hospital, and Children’s Mercy Hospital.
To fulfill the responsibility of being an advocate for the research subject, the IRB reviews all protocols for research using human subjects, guided by three overriding principles:
- inform subjects about the nature of the study and to ensure that their participation is voluntary
- ensure that the benefits of the research outweigh the risks
- ensure the risks and benefits of research are evenly distributed among the possible subject populations
Do I need to submit to the IRB?
Guidance document on what is considered Human Subjects Research and what level of review may be required.
A non-exempt research project must undergo review by the IRB if it qualifies as “research," and involves “human subjects." "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
- You must apply for a determination of research involving human subjects. Your activity may also be determined to not be human subjects research (based upon the above definitions).
- You must apply for exemption (eProtocol link). Your research may be exempt from IRB review if it falls under one of the categories identified in 45 CFR 46.101 (b).
- You must apply for expedited review or full board review (eProtocol link). Your research may qualify for expedited IRB review if it falls under one of the expedited review categories.
- Requesting to Rely on IRB Review from Children's Mercy, St. Lukes, KCUMB or KUMC. For agreements with any other institution complete the Institutional Authorization Agreement (IAA).
If you are unsure if your research project meets the definition of research involving human subjects, requires a full board review of research, or qualifies for exemption or expedited review, please consult the advising faculty member overseeing the research or contact the administrative office of the IRB.
Tips for Getting Through the Human Subjects Research Review Process
The University of Missouri – Kansas City (UMKC) Adult Health Sciences and Social Sciences Institutional Review Boards, FWA #00005427, are organized and operate in compliance with all U.S. regulatory requirements related to the protection of human research participants. Specifically, the UMKC IRBs comply with 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 45 CFR 164.508‐514.
In addition, the UMKC IRBs operate in compliance with portions of the Health Insurance of Portability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164 as appropriate as well as with the Guidelines of the International Conference on Harmonization (ICH) to the extent required by the FDA.
If you have any questions and/or concerns, please contact the UMKC IRB Office at 816-235-5927 or via e-mail at: email@example.com.