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Monitoring the Consent Process
This policy describes the authority of the UW-Madison Human Research Protection Program (HRPP) to observe the informed consent process for human research studies to monitor compliance with relevant federal, state and institutional requirements.
- The UW-Madison HRPP may observe the consent process to assure that research teams satisfy all federal, state and institutional requirements for obtaining informed consent from participants in human participants research.
- UW-Madison IRBs may require consent monitoring and designate a monitor for the informed consent process as part of their role in protecting the rights and welfare of research participants.
- The factors that the IRB may consider in making the determination to require consent monitoring include, but are not limited to: vulnerabilities of prospective participants, type of consent process, complexity of the research, presence of study team conflicts of interest, prior complaints about the consent process, and concerns raised about study team performance, such as prior findings of noncompliance related to the consent process.
- The UW HRPP includes several components in addition to the IRB that may observe or monitor the consent process conducted by research teams that fall under UW purview as part of their oversight and quality assurance activities, such as the Office of Research Compliance, the UW Cancer Center Research Compliance Office, and the Institute for Clinical & Translational Research auditing and monitoring programs.
- If the UW cedes IRB oversight of a human participants research study to another institution or entity, the reviewing IRB also may require consent monitoring and designate a monitor for the informed consent process. In addition, the institution providing IRB oversight may observe the consent process as part of its auditing and monitoring program.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised By: Cross Campus Human Research Protection Program (HRPP) Advisory Committee
Revised: March 26, 2015
Revised: November 7, 2019
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