Administrative (Exempt) 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 required in all research activities.
Administrative review requires 5 - 10 business days for IRB review. The IRB highly recommends the application be submitted at least 1 month before the proposed start date of the study.
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 7 to 10 business days for IRB review. The IRB highly recommends the application be submitted at least 1 month before the proposed start date of the study
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 Regulations.
Full Board review requires 10 - 15 business days for IRB review. The IRB highly recommends the application be submitted at least one 1 1/2 months before the proposed start date of the study.
Faculty, students, staff, and other campus employees that engage in human subjects research without CSUSB IRB approval or an exempt determination can result in disciplinary action and a investigation under CSUSB's University Policy on Misconduct in Research and Authorship. Engaging in human subjects research without prior IRB approval or exempt determination is non-compliance with the protection of human subjects in research. Incidents of non-compliance are reported to the Office of Human Research Protections (OHRP) under the U.S. Department of Health and Human Services (DHHS) which may warrant further investigation by the federal agency.
Reportable incidents under the OHRP regulations include:
1. Any unanticipated problems involving risks to subjects or others:
2. Any serious or continuing non-compliance with OHRP policy or the requirements or determinations of the IRB; and
3. Any suspension or termination of IRB approval.