Determining Level of Review
How do I determine which level of review to request for my research proposal?
Determining the level of review for individual research project proposals is the responsibility of the investigator in consultation with their faculty advisor or department chair, as appropriate. The following information is helpful in making that determination. All investigators are strongly encouraged to take formal training pertaining to the protection of human subjects in research. This includes determination of research review classification. On-line training is available through the CITI Program.
Determining the Appropriate Review Level:
There are three levels of review, and each level poses different requirements for investigators and reviewers. The review level determination is made on a number of factors, but primarily focuses on the potential risk to research subjects. The three levels are Exempt, Expedited, and Full Board. Full Board categories include everything not previously included in the exempt or expedited categories, and most research involving federally protected vulnerable populations(children, prisoners, and pregnant women, neonates, and fetuses).
The Code of Federal Regulations provides guidance on the initial steps to make the proper determination (http://www.hhs.gov/ohrp/ *). The full set of regulations is approximately 17 printed pages, including three subparts of special protections for vulnerable populations (subpart B: pregnant women, neonates and fetuses; subpart C: prisoners; subpart D: minors (children)).
If the review level requested is in error, it will be adjusted accordingly. The review procedures for both expedited and full board level reviews are identical. The only difference is the number of reviewers involved: 2 for expedited review, and 11 for full board review.
See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html, section Regulations and Policy Guidance in right hand column.
EXEMPT Categories (6): Regulations; 46.101
EXPEDITED Categories (9): Expedited Review Categories
FULL BOARD Categories: All research NOT included in the 6 EXEMPT or 9 EXPEDITED review categories.
Page last modified July 22, 2011