IRB Research Requiring Full Board Review
The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair 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 that involve the intentional deception of subjects, such that misleading or untruthful information has been provided.
- Projects that involve sensitive or protected populations; e.g., minors (except as allowed under expedited review), prisoners, fetuses, cognitively disabled, test subjects for new drugs or clinical devices, pregnant women, illegal behavior, legally incompetent persons.
Research that is judged to involve more than minimal risk, intentional deception, or a protected population must be presented to the entire review board for discussion and consideration of approval or non-approval. The board schedules monthly meetings as required to accommodate such requests as well as to conduct other business. Individuals intending to conduct research involving more than minimal risk with special populations such as children, prisoners or institutionalized patients, or planning to use procedures that are personally intrusive, stressful or potentially traumatic (physical, psychological or moral) should request full board review and plan appropriately to account for the IRB monthly meeting schedule.
