January 2006

Policies and procedures explain why and how certain matters are handled. The policies are the general statements and principles, and the procedures are the specific, step-by-step directions. The policies provide overall guidance, but the procedures are what are followed on a day-to-day basis.

Written procedures are required by federal regulations and the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Food and Drug Administration (FDA) audit letters sanctioning Institutional Review Boards (IRB), almost always include one with a finding of "failure to have and follow written procedures for IRB functions and operations in accordance with 21 CFR 56.108 and 812.66". AAHRPP's standard 1.7 requires written procedures governing all research involving human subjects.

The University of Arizona Human Subjects Protection Program (HSPP) has newly developed policies and procedures. They can be found on the HSPP website at www.arizona.edu. The following sections provide the title and general description for existing HSPP policies and procedures:

Section I: Authority And Institutional Commitment

Institutional authority under which the IRB is established and empowered, cooperative agreements, and research conducted with the Southern Arizona VA Healthcare System

Section II: IRB Compliance Activities

Investigating, managing, and reporting issues related to non-compliance.

Section III: IRB Review Procedures

Committee responsibilities, determinations, and motions, IRB composition, and materials to be reviewed by the IRB.

Section IV: IRB Informed Consent Process

obtaining legally effective and prospective informed consent.

Section V: Records, Documentation, And Fees

Documentation of minutes, processing applications, and organization of the research file.

Section VI: Investigator Responsibilities

General responsibilities, conflict of interest, certificates of confidentiality, and data and safety monitoring plans.

Section VII: IRB Membership

Member conflict of interest, compensation, and relationships to other University of Arizona committees.

Section VIII: HSPP Education And Training

Training requirements for HSPP administrative staff, IRB members, and the research community.

Section IX: Vulnerable Populations

Research with special categories of individuals (i.e., children, prisoners, pregnant women, and those individuals with cognitive impairment).

Section X: Conduct of Research

HIPAA, compensation for injury, payment, recruitment/advertising, and student/employee participation in research.

Section XI: Investigational Drugs, Biologics, And Devices

Storage, handling, dispensing, and disposal of investigational drugs, devices and biologics.

Written procedures are the references used by HSPP administrative staff, IRB members, and the institution's research community. It is required that institutions have written procedures for regulatory and accreditation purposes. This requirement provides consistency, reduction in errors, training for the research community and equitable treatment of complaints and grievances.

*Walker, C. S. & Barnard, D. (2005). Documentation, Policies, and Procedures. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 33-39). Sudbury, MA: Jones and Bartlett.