HRPP Innovation & Demonstration Initiative
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Background
In 2007, the University of Michigan Office of the Vice President for Research (OVPR) began the HRPP Policy Innovation and Demonstration Initiative (Michigan Initiative). The intent was to identify and improve Human Research Protection Program (HRPP) policies and procedures to minimize administrative burden for investigators and the institution without compromising the protection of the human participants. The initiative focuses on utilizing the flexibility allowed by federal regulations and identifying new process standards in areas where these regulations do not apply. Ethical, rather than process standards form the basis for developing equivalent protections for human subjects in order to reduce regulatory excess.
The Michigan Initiative includes two types of process improvements:
- Innovations - Institutional policies, processes or procedures that are changed outright.
- Demonstrations - Temporary changes to policies, processes or procedures that are piloted to ensure that the change reduces administrative burden without increasing risk or adversely impacting subjects' rights or welfare.
Progress reports on the Michigan Initiative are periodically submitted to the U-M IRB Council, Research Associate Deans, and the Senate Assembly Research Policy Committee. The Office of Human Research Compliance Review (OHRCR) provides monitoring support to the project.
The HRPP encourages members of the research community to suggest new innovations and demonstrations. Contact hrppumich@umich.edu with your ideas.