February 2005

The University of Arizona Human Subjects Protection Program (HSPP) has developed a draft of policies and procedures. These documents are currently under review by a sub-committee comprised of members from the three IRBs (Behavioral Science Committee, Biomedical Committee and Continuing Review Committee). Once this sub-committee has completed its review and has determined that the HSPP policies meet federal regulations and institutional requirements, they will be signed off by the Vice President for Research, Graduate Studies and Economic Development. Written procedures are required by federal regulation. This requirement is listed in the federal regulations 45 CFR 46.103(b)(4) and (b)(5) and is among the requirements for a federal assurance (see July 2004 issue of the Program in Research Integrity Education newsletter for information regarding assurances). The Office for Human Research Protections (OHRP) lists the lack of such documents as a deficiency (Common Findings No. 64, updated 7/10/02 ) . OHRP strongly recommends that institutions develop and distribute detailed information to investigators that includes the following: IRB roles and responsibilities; Requirements and procedures for initial and continuing IRB review and approval of research; Rationale and procedures for proposing that the research may meet the criteria for expedited review; Requirements and procedures for verifying that research is exempt from IRB review; Responsibilities of investigators during the review during the review and conduct of research; Requirements and procedures for notifying the IRB of unanticipated problems or events involving risks to the subjects or others as well as any other expected or unexpected adverse events; Explanation of the distinction between FDA requirements for emergency use of test articles versus HHS regulation; Examples and user-friendly forms for providing information to the IRB; Copies of the institution’s Federal-Wide Assurance, HHS regulations (45 CFR Part 46), and the Belmont Report. The Food and Drug Administration (FDA) regulations require written procedures when auditing a human subjects program. Recent FDA audit reports have sanctioned IRBs not only for failing to have written procedures but for failing to follow written procedures in accordance with 21 CRF 56.108.

Accreditation standards also require that an institution develop written policies and procedures for IRB functioning. According to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must follow written policies and procedures governing all research involving human subjects. The policies and procedures must also specify to whom they apply, and that they are to be reviewed periodically.

Producing, maintaining, and using written procedures for the IRB, its administrative staff and researchers are obligatory. Not having written policies and procedures is contrary to federal regulations and can result in sanctions against the institution.

*Walker, C. S. (2002). IRB Policies and Procedures. In R. J. Amdur and E. A. Bankert (Eds.), Institutional Review Board Management and Function (pp. 43-49). Sudbury, MA: Jones and Bartlett.