Every study submitted to Schulman will be evaluated to determine if it qualifies for Minimal Risk Review, including studies that are not submitted using Schulman’s Minimal Risk submission forms. There is no need to request Minimal Risk Review.
Minimal risk means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Phase I, II, and III studies generally do not qualify for Minimal Risk Review.
The submitting party may opt out of a Minimal Risk Review if a full Board review is preferred. In order to opt out, indicate this selection on the Multisite Study Submission Form or Single Site Study Submission Form.
To learn more about Schulman’s Minimal Risk Review services, please contact Business Development or call 513.761.4100.