Human Research Protection Program: Policy

Provision of Sufficient IRBs

Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School

Adoption Date:  December 8, 2005

Purpose:  This document describes how the UW-Madison assures that it has a sufficient number of Institutional Review Boards (IRBs) to review research protocols in a thorough and timely manner.

Policy

I.      UW-Madison has made a commitment, under its Federalwide Assurance (FWA)  to ensure that each Institutional Review Board (IRB) designated under the FWA has meeting space and sufficient staff to support the IRB’s review and recordkeeping duties.

II.     UW-Madison has established four IRBs that are responsible for reviewing research protocols and a Human Research Protection Program Advisory Committee. 

The four IRBs include the Health Sciences IRB and the Health Sciences Minimal Risk IRB, both of which are located in the School of Medicine and review health sciences protocols, the Social and Behavioral Sciences IRB, which is located in the College of Letters and Sciences and reviews all social and behavioral science research, and the Education Research IRB, which is located in the School of Education and reviews all education research protocols.

The HRPP Advisory Committee is responsible for oversight of the UW-Madison’s HRPP, including the UW-Madison IRBs. The Advisory Committee advises the UW-Madison Institutional Official and IRBs on issues relating to human research protection, including the suspension of research privileges and reporting to federal authorities of noncompliance, unanticipated problems and suspension and termination of research. It approves all HRPP policies and communicates those policies to the UW-Madison community. It oversees campus-wide communications and training regarding human research protections. It also hears investigator appeals from decisions of the UW-Madison IRBs on issues of noncompliance, unanticipated problems and suspensions and terminations of research and reviews matters referred to it by the IRBs.

III.    The UW-Madison Institutional Official (IO), in concert with the Associate Deans for Research for the relevant schools/colleges, is charged with assessing the appropriateness of the number of IRBs and the level of IRB staffing and making additions to UW-Madison’s research review program as needed based on measures of the timeliness of review and staff workload.

Procedure

I.      The appropriateness of the number of IRBs and the level of IRB staffing are assessed at the time IRB offices submit their annual IRB reports and when special needs are identified.

II.     Periodically, a comparison of IRB workload, including numbers and types of protocols, with other similar institutions will be made to assess the appropriateness of the number of IRBs and the level of IRB staffing.

III.    The IO, in concert with the Associate Deans for Research for the relevant schools/colleges, will review the workload of each IRB using the annual report, reports of special needs, the comparison with peer institutions, and other information obtained from school/college officials, IRB chairs and staff. 

IV.   In response to the needs assessment, the IO, in concert with the relevant college/school, may create a new IRB, adjust the configuration and composition of existing IRBs, adjust IRB staffing and/or assign or reassign protocols according to category.