Definition of “Minimal Risk”

Federal Regulations, 45 CFR 46, §46.102 (i), use the following to define a research protocol as “minimal risk”:

“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.”

According to the regulations, non-exempt human subject research protocols that present no more than minimal risk to the research participants may be reviewed by the IRB with Expedited review procedures. Exempt or Expedited review processing at JCU can take up to three weeks from the time an application is submitted.

Any research that presents more than minimal risk to the participants will most likely be reviewed by the fully convened IRB. At John Carroll University, full board reviews usually require 4-6 weeks, and even longer if significant revisions are necessary. Researchers who plan greater than minimal risk research should plan accordingly for a possibly lengthy review period.

If you have any questions about IRB review categories or processes, please contact the IRB Administrator, in AD140, x1527.

Office of Sponsored Programs

Definition of “Minimal Risk”

“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.”