Expedited and Full Board ICF/Protocol Reviews
To qualify for an expedited review, research must fall into a federally-defined expedited category (45 CFR 46.110). These categories involve collection of samples and data in a manner that involves no more than minimal risk (45 CFR 46.405) to subjects and is not anonymous.
Expedited review allows the IRB chairperson, or another experienced IRB reviewer designated by the chairperson, to evaluate and approve these types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a reviewer cannot approve the research under expedited review, the study is referred to the full board for review.
A full board review is necessary for any proposed human subject research that does not fall into either the exempt or expedited review categories. This research is deemed greater than minimal risk.
Necessary documents for expedited and full board reviews include:
- CVs and licenses for all relevant staff including the PI
- Study protocol (signed by the PI) and ICF
- Recruitment materials
- Investigator Submission Form
- Investigator Agreement to Terms
- Sponsor Submission Form
- Sponsor Agreement to Terms
Please contact Pearl IRB (email@example.com) to begin the review process.