Institutional Review Board (IRB)
The Institutional Review Board (IRB) has been established to assure the protection of human subjects involved in the conduct of biomedical, clinical, and behavioral research. The IRB is designated to review and monitor research involving human subjects. The IRB is a committee, composed of members from a variety of scientific disciplines as well as community members. The purpose of the IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. All human research projects must be reviewed and approved by the IRB prior to initiation and then conducted in full compliance with the IRB guidelines. IRB approval of research is required for research involving human subjects conducted by anyone on the premises of the Institution and to research conducted elsewhere by faculty, students, staff, or other representatives of the Institution in connection with their Institutional responsibilities.
Office for the Protection of Human Subjects (OPHS)
The Office for the Protection of Human Subjects (OPHS) is the administrative office for the Institutional Review Board (IRB) and provides support for the IRB committee functions and duties. OPHS staff also assists investigators and their research team in complying with federal, state, and University policies regarding human participant research. OPHS conducts audits on behalf of the IRB to ensure compliance. OPHS is under the jurisdiction of the Office for the Vice President of Research and Health Affairs.
OPHS services provided to the investigators
- Consultation with investigators on designing ethically sound human subject research protocols and preparing the documents for IRB review.
- Pre-review of IRB documents prior to submission.
- Education and training on applicable regulations and laws, CDU IRB policies and procedures.
- Determine whether the study requires IRB review.
- Pre-review of Human Subjects Protection section in grants