| Human Subjects
Research Compliance Program
This program was established in 1998 as a result of a collaborative
effort between the Office of the Vice President for Research (OVPR)
and the Academic Health Center (AHC) at the University of Minnesota.
Compliance reviews are performed on any research under the purview
of the University Of Minnesota's Institutional Review Board (IRB),
which include:
- The University of Minnesota
- University of Minnesota Medical Center, Fairview
- Fairview-affiliated hospitals and clinics
- Gillette Children's Hospital
The purpose of the Human Subjects Research
Compliance Program is to provide internal oversight on compliance
issues relating to the performance of human research trials. The
emphasis of the program will be:
- To ensure the rights and well-being of research subjects and
the quality and integrity of the research
- To identify educational and research support needs through the
review of current clinical studies
- To ensure compliance with federal, state, local and institutional
regulations and guidelines
Register Studies
with the Office of Regulatory Affairs
Studies involving human embryos or
embryonic stem cell lines ineligible for federal or state funding
must be registered with the Office of Regulatory Affairs (ORA) in
the Office of the Vice President for Research and will be subject
to oversight by ORA.
ORA will register the
project at its start and issue a registration number before you
can initiate the research and will also deactivate the project at
its end. ORA will review the project records when the project
becomes active or inactive and will provide oversight of all regulatory
aspects of the project.
According to the Registration
policy, Academic/Administrative
Policy 2.1.11 and Academic/Adminstrative
Policy 2.1.12, the Human Subjects Research Compliance Program
is responsible for verifying that:
- The research study uses only private funding
- The study has University of Minnesota IRB approval
- The PI and other staff have the appropriate training offered
by SPA regarding conducting research with Human Embryos
Please contact one of
the Human Subjects Research Compliance
Officers to register your study. |
