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.
Organizational Structure of UW–Madison's HRPP
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 (HS) Research; Educational & Social Behavioral Research & the Office of Research Policy.
Health sciences (HS) 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:
- 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 HS/MR research.
- The HS IRBs Policy Committee: Develops, approves, and maintains Health Sciences IRBs specific policies
- The HS HRPP Steering Committee: Advises Deputy Institutional Official for Health Sciences Research.
The Office of Research Policy 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.
- 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
- 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.
- 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.
- 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
Education and Social Behavioral (ED/SBS) research is a component of the HRPP overseen by the Deputy Institutional Official for Educational & Social Behavioral Research. The ED/SBS research component consists primarily of the efforts of the ED/SBS IRB.
- The ED/SBS 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 ED/SBS research.