Human Research Protection Program: Policy

Institutional Official in Charge of HRPP

 

Adopted By: Chancellor, UW-Madison

Adoption Date: December 8, 2005

Purpose:  This document describes the authority and responsibility of the UW-Madison official in charge of the Human Research Protection Program.

Policy

I.      UW-Madison delegates responsibility for the UW-Madison’s Human Research Protection Program (HRPP) to an institutional official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program.

II.     The Associate Dean for Research Policy of the Graduate School is the Institutional Official for the protection of human research subjects at UW-Madison.  In this federally-mandated role, the Institutional Official assumes operational authority for UW-Madison’s HRPP and is directly responsible for assuring that the program is functional, adequately staffed and funded, and respected in the research community.

Procedure

I.      Appointment of Institutional Official.

A.  The Institutional Official (IO) for the HRPP is appointed by the Vice Chancellor for Research/Dean of the UW-Madison Graduate School, to whom the UW-Madison Chancellor has delegated the responsibility for oversight of the research review process. 

II.     Authority and Responsibility of Institutional Official.

A.    The IO is responsible for assuring that UW-Madison IRBs comply with all applicable ethical principals, federal and state laws and institutional policies and procedures for the protection of human research participants, setting the "tone" for an institutional culture of respect for human research participants, and ensuring effective institution-wide communication and guidance on human research.

B.    The IO assures that the IRBs function independently and free from coercion and undue influence and that the IRBs have access to: (1) independent legal counsel and (2) more senior UW-Madison officials when an IRB deems such access to be warranted.

C.    In addition, the IO is responsible for ensuring that UW-Madison officials are aware of the activities of the IRBs. 

D.    The IO is also the resident expert on federal and institutional regulations involving the use of human research subjects, acting as a consultant in service to the UW-Madison research community when needed.

E.    The IO also serves as the Chair of the HRPP Advisory Committee, which 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.

F.    The IO approves IRB authorization agreements and Independent Investigator Agreements for cooperative research activities involving human subjects.

G.    The IO has the authority to suspend an investigator’s privileges to conduct human subjects research in cases of noncompliance.

H.    The IO has the sole authority to report to federal authorities’ determinations by an IRB of noncompliance, unanticipated problems and suspensions and termination of research.

I.      The IO conducts an annual evaluation of the resource needs of the HRPP.