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University of Wisconsin–Madison

Human Research Protection Program

Human Research Protection Program

The Human Research Protection Program (HRPP) provides oversight for all research activities involving human participants at the University of Wisconsin–Madison. The HRPP is not an office, but rather a collective effort of all who participate in the conduct, review, approval and facilitation of human participants research at UW–Madison.

The Office of the Vice Chancellor for Research and Graduate Education conducted an online survey from August 29 through September 25, 2016 to obtain feedback from UW–Madison faculty about their experiences with human subjects regulatory mechanisms. The survey included users of the Education and Social/Behavioral Science (ED/SBS) IRB and the Health Sciences (HS) IRBs, and the data in the report that followed reflects the perceptions and experiences of UW-Madison human subjects researchers who completed the survey. A Human Subjects IRB Working Group has been formed to follow through on survey report recommendations.

As a result of the survey findings, the OVCRGE sought consultation from university governance groups and the campus leadership in determining the most appropriate administrative home for the ED/SBS IRB. In summer 2017, the Education and Social Behavioral Sciences (ED/SBS) Institutional Review Board (IRB) moved administratively to the OVCRGE.

ORGANIZATIONAL STRUCTURE OF UW–MADISON’S HRPP

INSTITUTIONAL OFFICIAL

The Institutional Official (IO) is ultimately responsible for ensuring the protection of human participants at UW–Madison, and maintaining oversight of the entire UW–Madison HRPP. There are three main components of the HRPP which the IO oversees and that provide administrative support and oversight of human participants research on campus: Health Sciences Research; Educational & Social Behavioral Research & the Office of Research Compliance.

HEALTH SCIENCES RESEARCH

Health Sciences Research is a component of the HRPP overseen by the Deputy Institutional Official for Health Sciences Research. The health sciences component is encompassed by three main committees:

  1. The Health Sciences and the Minimal Risk IRBs: Review and approve human participants research occurring within the health sciences (e.g. clinical trials, medical intervention research, review requiring medical expertise) and works to develop training and educational materials for researchers on topics relating to Health Sciences/Minimal Risk research.
  2. The Health Sciences IRBs Policy Committee: Develops, approves, and maintains Health Sciences IRBs specific policies
  3. The Health Sciences HRPP Steering Committee: Advises Deputy Institutional Official for Health Sciences Research.

OFFICE OF RESEARCH COMPLIANCE

The Office of Research Compliance within the Office of the Vice Chancellor for Research & Graduate Education oversees a range of HRPP administrative and compliance activities. There are four main committees which provide oversight and administration of human participants research occurring across campus.

  1. The ClinicalTrials.gov Committee: Ensures compliance with the FDA and ICMJE’s registration requirements for studies on ClinicalTrials.gov, and works to develop training and educational materials for researchers
  2. The Quality and Compliance Operations Committee (QCOC): Inventories and assesses campus-wise human participants compliance monitoring and quality, efficiency and effectiveness activities. The QCOC informs the QCOAC of any identified gaps or opportunities for improvement within the campus HRPP.
  3. The Quality and Compliance Oversight Advisory Committee (QCOAC): Acts as a steering committee for the QCOC to help prioritize institutional efforts to improve HRPP quality, effectiveness, efficiency, and outreach.
  4. The Cross Campus HRPP Committee (CCHRPPC): Advises the Institutional Official on human participant issues and approves campus wide policy for the UW–Madison HRPP. The CCHRPPAC also works with the QCOC to address operational issues that affect policy

EDUCATIONAL & SOCIAL BEHAVIORAL RESEARCH

Education and Social Behavioral Research is a component of the HRPP overseen by the IO. The Education and Social Behavioral Research Research component consists primarily of the efforts of the Education and Social Behavioral Sciences IRB.

The Education and Social Behavioral Science  IRB: Reviews and approve human participants research occurring within the social and behavioral sciences (e.g. most research in K-12 schools, and reviews not requiring medical expertise) and works to develop training and educational materials for researchers. on topics relating to Education and Social Behavioral Research Research.