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.
Is an activity Research involving Human Subjects?
- Refer to the Office of Human Research Protections (OHRP)'s Chart 1 to help determine whether an activity may require IRB review.
- Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. If the project involves some characteristics of a research project, submission to the IRB for review is expected. To address the issue of documentation, the IRBs have developed decision tools (HS IRBs Tool and ED/SBS IRB Tool) that can provide self-certification that the project does not require IRB review and oversight. See the HS IRBs QI/Program Evaluation Self-Certification Tool or the ED/SBS IRB Guidance: Research vs. Quality Improvement/Program Evaluation for more information.
- The Engagement in Human Participants Research at UW-Madison policy defines when UW-Madison employees or agents engage in human participants research as well as certain activities that do not meet the definition of human participants research but nonetheless require UW–Madison IRB oversight.
Below are policies and guidance detailing responsibilities of investigators engaged in human subjects research.
Investigator Responsibilities for Exempt Research
Investigator Responsibilities When UW-Madison Cedes IRB Review
Investigator Responsibilities When UW-Madison Serves as the Reviewing IRB
Collaborating Investigator Responsibilities
Data Storage & Retention
Policy on Data Stewardship, Access, and Retention
The University of Wisconsin–Madison is committed to protecting the rights and welfare of individuals participating as subjects in its research. The campus has three Institutional Review Boards (IRBs):
The Health Sciences IRB: Reviews research protocols involving medical interventions or procedures where medical expertise is required for evaluation.
The Minimal Risk IRB: Reviews research protocols that present minimal risk to subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting.
The Education and Social Behavioral Science IRB: Reviews and approves human participants research occurring within the social and behavioral sciences, and non-medical health research, including social and behavioral science, genetic research, and non-medical prison research.
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 that provide administrative support and oversight of human participants research on campus: Health Sciences Research; Educational & Social Behavioral Research & the Office of Research Compliance.
Office of Research Compliance
The Office of Research Compliance (ORC) within the Office of the Vice Chancellor for Research & Graduate Education oversees a range of HRPP administrative and compliance activities including post-approval monitoring, ClinicalTrials.gov registration and reporting, AAHRPP accreditation activities, and quality assurance oversight. The ORC supports key advisory committees to the IO including the Cross Campus HRPP Committee and the Quality and Compliance Oversight and Advisory Committee (QCOAC). Working groups to support the HRPP advisory committees and HRPP program include the Quality and Compliance Operations Committee (QCOC), the HRPP Policy Revision working group, the HRPP Education working group, the ClinicalTrials.gov committee, and the PAM working group.
Health Sciences Research
Health Sciences Research is a component of the HRPP and includes the Health Sciences and Minimal Risk IRBs, which review and approve human participants research occurring within the health sciences (e.g. clinical trials, medical intervention research, review requiring medical expertise) and works with campus stakeholders to develop training and educational materials for researchers on topics relating to Health Sciences/Minimal Risk research. A Health Sciences Research Advisory Committee advises the IO on policies related to health sciences human subjects research. There are several working groups to support the Health Sciences Research Advisory Committee including a policy committee, FDA and VA policy committee.
Education & Social Behavioral Research
Education and Social Behavioral Research IRB is the component of the HRPP that reviews and approves 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.