IRB Review Categories

Administrative Review: OHRP federal regulation section 46.101 provides that certain kinds of research (e.g., some surveys, field interviews, observations, and evaluations of standard educational practices or tests) involving no more than minimal risk to subjects can be exempt from full IRB review and record keeping. Final determination of administrative review status is the responsibility of the IRB Chair. Please note that Informed Consent is always required in all research activities except where the participants cannot be located or contacted. No other entity, faculty member, committee or highest level of campus administrator(s) may approve your research under any of the IRB review categories below..

(Administrative review requires 5 - 8 business days for IRB review)

Expedited Review: Federal regulations also provide that certain kinds of research may receive expedited review. Section 46.110 of the OHRP regulations lists the categories of research appropriate for expedited review. In such cases, the Chair and one other member of the IRB need evaluate the proposal which includes the IRB Coodinator.

(Expedited review requires 5 - 8 business days for IRB review)

Full Board Review: For those projects that do not fit into the above two categories, a full board review by the IRB is required. This normally involves research within any of the protection participant (human subject) populations. These include fetuses, pregnant women, children, and prisoners. This also applies in some cases to severely vulnerable populations such as the mentally impaired or the elderly. See OHRP Federal Fegulations.

(Full Board review requires 7 - 15 business days for IRB review)

 

Faculty, staff, or students that take it upon themselves to engage in human subjects research without IRB determination and approval on the above noted review categories may be brought up under the CSUSB faculty and student misconduct policy. Should this be a continuing problem of non-compliance on part of any faculty, staff, or student, it will result in report filing to the Federal Office of Human Research Protections (OHRP) which may warrant an investigation by that federal agency.