A full description of the types of reviews, proposal requirements and definitions may be found under IRB Information on this website.
A full review by the IRB will be conducted for research that involves greater than minimal risk. A full review must be conducted at a meeting of the IRB. In order to approve research under a full review the IRB will consider the following: 1) risks are reasonable in relation to expected benefits ad minimized by the use of the safest procedures consistent with standard research practices; 2) selection of subjects is equitable, taking into account the purposes of the research; 3) privacy of the subjects ad confidentiality of data are protected; and 4) informed consent is obtained and documented.
An expedited review by the IRB will be conducted for research that involves no more than minimal risk or to review minor changes in previously approved research. The IRB expedited reviewer will make one of five recommendations: 1) proposal qualifies for exempt status, 2) proposal is approved as submitted, 3) proposal is approved with required revisions, 4) proposal should be revised and resubmitted, and 5) proposal should receive full review.
Exemptions from IRB Review pertain to research where the subjects are at no more than minimal risk the subjects' confidentiality is maintained, and the research meets at least one of the six criteria for exemption. Although a research project may meet the criteria for exempt status, it does not mean the study is exempt from meeting federal regulations regarding informed consent and storage of confidential materials. In the case of minors, only research conducted in established or commonly accepted educational settings may be considered for exempt status. In this situation, the research must be conducted in the minor's classroom or school by his/her teacher, instructor, or therapist. This does not apply to student teachers in locations outside of the MSUM campus.