This document describes the authority and responsibility of the UW-Madison Institutional Official and Deputy Institutional Officials in charge of the Human Research Protection Program (HRPP).
The Associate Vice Chancellor for Research Policy and Compliance in the Office of the Vice Chancellor for Research and Graduate Education (VCRGE) is the Institutional Official (IO) for the protection of human research participants at UW-Madison.
The IO 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.
The IO for the HRPP is appointed by the Vice Chancellor for Research and Graduate Education, to whom the UW-Madison Chancellor has delegated the responsibility for research oversight.
The IO has the following authority and responsibilities.
The IO is responsible for assuring that UW-Madison IRBs comply with all applicable ethical principles, 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.
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.
The IO is kept informed of the activities of the IRBs through consultation with legal counsel to the HRPP and staff from the Office of Research Compliance who attend IRB meetings, and the IRB Directors.
When necessary and appropriate, the IO communicates pertinent information about IRB activities to other UW-Madison officials and to federal regulatory agencies.
The IO keeps up to date on federal, state and University requirements for the protection of human research participants, through consultation with legal counsel to the HRPP, staff from the ORC, and the IRB Directors, and acts as arbiter and spokesperson for human participants protection issues in service to the UW-Madison research community when needed.
The IO serves as a non-voting member Cross-Campus HRPP Advisory Committee, which is the policy making and advisory committee for the UW-Madison’s HRPP, including the UW-Madison IRBs.
The IO serves as the Chair of the Quality and Compliance Oversight and Advisory Committee (QCOAC), which is the committee tasked with ensuring the quality, efficiency, and effectiveness of the entire HRPP.
The IO approves IRB Authorization Agreements and Independent Investigator Agreements for collaborative research activities involving human participants.
The IO has the authority to suspend an investigator’s privileges to conduct human participants research in cases of noncompliance.
The IO reports to federal authorities determinations by an IRB of noncompliance, unanticipated problems and suspensions and termination of research.
At least annually, the IO evaluates the resource needs of the HRPP in conjunction with the QCOAC.
Institutional Official, Associate Vice Chancellor for Research Policy and Compliance
Post Approval Monitor -- Travis Doran, firstname.lastname@example.org, (608) 890-4399