Types of IRB Review
Depending on the level of risk of the research protocol and the participant population, IRBs may conduct either full board review or expedited review.
For certain kinds of research involving no more than minimal risk, and for minor changes in approved research, the IRB Chair or a designated voting member or group of voting members review the proposed research rather than the entire IRB. It cannot be assumed that research poses minimal risk because it involves only interview or survey data collection. Sensitive questions may lead to distress that exposes participants to greater than minimal risk. Loss of confidentiality can cause harm to participants, their relatives, and others.
Full Board Review
When full board review is necessary, the research proposal is presented and discussed at a meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those voting members present. (Note that, in effect, an abstention counts as a negative vote.)
Research Exemptions from IRB Review
Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared exempt from review by the IRB. *This determination must be made by the IRB prior to the research being conducted.
The following are the six exempt categories as listed in 45 CFR 46.101(b):
These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or newborns. Further, the exemption in item 2 above does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed. Interviews, surveys, and interactive observations are not exempt, while educational tests and noninteractive observations are.
Note that when research is conducted in countries outside the United States by foreign Principal Investigators, the rules for IRB review and exemption may differ if the bases for the institutional assurances are founded upon documents other than the Belmont Report and the Common Rule. Note that research conducted in countries outside the United States by U.S.-based Principal Investigators is not affected by this potential modification. Researchers should review the section covering international research for further information and always consult with their institution’s IRB.