Human research protection is a collaborative effort involving multiple groups at UW-Madison working closely together to ensure the ethical, safe, and legal conduct of the research enterprise. Through outreach, education, careful reviews of research applications and protocols, and post-approval monitoring, the HRPP’s goal is ensuring that
- All key personnel engaged in human research have sufficient training in their ethical and regulatory responsibilities,
- No research activities begin until all required approvals are in place, and
- Researchers do not implement changes in a human research study without first obtaining approval for the amendments from the IRB.
As one component of the HRPP, the Quality & Compliance team within the Office of Research Compliance 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 Quality & Compliance team also supports key advisory committees to the Institutional Official, as well as several working groups that support the HRPP. Below is more information about some of the activities overseen by the Quality& Compliance team and HRPP.
Post-Approval Monitoring
Post-Approval Monitoring Program
Developing an Internal Quality Assurance Program
Investigating Noncompliance & Implementing Corrective and Preventive Action Plans
Guidance for the Research Community
Clinicaltrials.gov Registration and Reporting
Certificate of Confidentiality Application Help
Guidance on External Sharing of Human Subjects Research Data
Guidance on Receiving Human Subjects Research Data from an External Entity
Information for Research Participants
Information for Research Participants