Human Research Protection Program: Policy

Adequate Resources for Human Research Protection Program

 

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

Adoption Date:  December 8, 2005

 

Purpose:  This document describes how UW-Madison assures that its Human Research Protection Program has adequate resources for conducting the activities under its jurisdiction.

Policy

I.      The UW–Madison’s Research Policy Office (RPO) provides the central mechanism for coordinating the campus Human Research Protections Program (HRPP). The RPO works with the IRB Offices to assure that research involving human participants conducted at the UW-Madison complies with applicable ethical principles, local, state and federal laws, federal guidance, international codes of conduct, and University policies and procedures. The RPO coordinates compliance reviews and audits, coordinates education programming on human subject research, and communicates pertinent and timely information about human subjects research to members of the research community as well as the University in general. The RPO provides staff support for the Human Research Protection Program Advisory Committee and the IRB WebKit information management system.

II.     UW-Madison HRPP includes four Institutional Review Boards (IRBs) that review research protocols and the HRPP Advisory Committee.  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.    UW-Madison’s Institutional Official (IO) is responsible for assuring adequate resources for UW-Madison’s HRPP.

Procedure

I.      On an annual basis or when special needs are identified, UW-Madison’s IO, in conjunction with the RPO, assesses the adequacy of resources for UW-Madison’s HRPP.

II.     In conducting the assessment, the IO will review the HRPP budget, existing programs and strategic plans, IRB offices’ annual reports, reports of special needs, and other information obtained from HRPP and other University personnel. 

III.    In response to the resource assessment, the IO may adjust HRPP funding or staff.