FULL COMMITTEE REVIEW
The following categories of research require full IRB review.
- Projects for which the level of risk is determined by the Human Subjects Committee to be greater than minimal. (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.)
- Projects which involve the intentional deception of subjects, such that misleading or untruthful information has been provided.
- Projects which involve sensitive or protected populations; e.g. minors, prisoners, fetuses, mentally retarded, mentally disabled, test subjects for new drugs or clinical devices, pregnant women, illegal behavior, or legally incompetent persons. Students or employees may be at risk when they are asked to participate in research by professors or supervisors.
Research that is judged to involve more than minimal risk, intentional deception, or the use of special populations as subjects, must receive this full committee review.
The full committee receives copies of your protocol in advance of their regular meeting. When they meet, they will discuss your protocol, decide if they feel it needs any revisions, additions, or clarifications, and will vote on whether it is approved or not approved, with or without the revisions. Investigators will be notified about the decision immediately after the meeting. It will not be at all unusual to have to make changes, particularly if an informed consent form is necessary. This is another reason to allow plenty of time for the review process to take place. Human subjects research is a complex and sensitive matter to conduct, and it is to the investigator’s benefit to get the perspective that the HSC can bring to his or her project.
