RESEARCH TIPS

This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

This Month’s Subject—Expedited IRB Review: OHRP guidelines 45 CFR 46.111

Did you know?

The IRB performs expedited reviews on some or all of the research appearing on the list of categories of research eligible for expedited review and found by the reviewer to involve no more than minimal risk or where minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Research subject to CFR 21 Part 312 (IND), or CFR 21 Part 812 (IDE) regulations is not eligible for expedited review.

Minimal risk is defined as 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 examinations or tests.

Minor change is defined as:

• The level of risks to subjects

• The research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)

• The number of subjects enrolled in the research (no greater that 10% of the total requested)

• The qualifications of the research team

• The facilities available to support safe conduct of the research

• Any other factor which would warrant review of the proposed changes by the convened IRB

The review is completed by an IRB Chairperson, or designated experienced IRB Reviewer.

Additional Resources

Categories subject to expedited review are available at

BMC SOP 3.5.1 Categories of Research Eligible for Expedited Review and on the OHRP website.