Health Sciences IRB
There are four types of review that can be applied to new research study applications: Not Human Subjects Research, Exempt, Expedited and Full. It is important to understand that none of the types of review is superior or inferior to the other. The type of review is strictly dependent on the research study design and the nature of the research.
- Exempt Review
- Expedited & Full Committee Review
- Pre-Review from the Scientific Review Committee
- Not Human Subjects Research
- Case Reports
- Single-IRB Review of Multisite Research
- Emergency & Compassionate Use
- Common Questions
According to federal regulations, investigators are responsible for obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects [45 CFR 46.103(b)(4)]. Depending on the type of research and the scope of the modification, these may be reviewed by expedited review or by full IRB review.
According to federal regulations, an IRB must conduct continuing review of previously approved research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)]. Depending on the type of research, continuing review may be performed by expedited review or by full IRB review.
During the course of a research study, unanticipated problems involving risk to subjects or others, non-compliances, and other events may occur that need to be reported to the IRB in accordance with 45 CFR.46.103(b)(5) and 21 CFR 56.108(b).