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OHRCR is committed to assisting U-M investigators to know and to apply human subjects protections.
Please see the OHRCR Policies and Procedures page for standard operating procedures pertaining to compliance reviews.
The Office of Human Research Compliance Review (OHRCR), a component of the University's Human Research Protections Program (HRPP), provides objective analysis and evaluation of human subjects research compliance for investigator research studies, units of the HRPP and the HRPP as a whole.
OHRCR's mssion is to facilitate safe, ethical, efficient, and high quality human subjects research. We accomplish this mission through the following activities relevant to human research regulatory issues:
- Compliance reviews of research studies and components of the U-M HRPP
- Education of individuals and groups engaged in the research enterprise
- Outreach to the university research community
- Innovation and leadership
The majority of OHRCR’s work consists of compliance reviews. These reviews can be broadly divided into two categories:
- Routine review - a proactive not-for-cause review to identify risks of human subject research, prevent noncompliance, and assist investigators in correcting any noncompliance. The majority of routine reviews are for individual studies.
- For-cause review - a directed review when allegations of human subjects noncompliance are received by UMOR. The allegations may arise from the Institutioanl Review Boards (IRBs), ancillary committees, the research administration, research subjects, faculty, research support staff, funding or regulatory agencies, or OHRCR staff. In these cases, UMOR refers the review activity to OHRCR. A for-cause review can be at the investigator/study level, the system level, or both.
An example of a system level review would be a review of a U-M IRB or an ancillary committee, such as the Investigational Drug Service (IDS).
Education is a major part of both OHRCR routine and for-cause reviews. Overall, OHRCR values the preventative, stabilizing and progressive nature of education with researchers, students and staff as it occurs in the everyday research setting, in formal programs, and in alternate forms of delivery (e.g., online forums, classes and podcasts). OHRCR’s educational perspective and knowledge are unique to the background, education and experience of the office and of its staff. Education and mentorship are foundational for:
- Advancing research
- Providing integrity in research
- Assuring human study participants' rights, welfare and safety are protected
A major reason researchers have difficulty applying ethical principles in the discreet research activities is a lack of knowledge. Education alone does not prevent errors or inappropriate application of ethical principles in decision-making and research conduct, but it does set the stage for, and advance the university's position about appropriate and ethical research conduct. To assist researchers, OHRCR organizes and participates in education about:
- Ethical principles in research
- Research best practices or good clinical practices (GCP)
- Application of specific regulations, including guidance for various disciplines and research methods
- Ways to mitigate or correct research problems or errors.
OHRCR educational activities and programs are integrated with U-M HRPP educational activities, including those of the U-M IRBs, the Michigan Institute for Clinical and Health Research (MICHR), and schools and colleges (e.g., unit-based responsible conduct of research programs). See References & Resources below for related links.
OHRCR conducts outreach activities with individual investigators and high-level administrative committees (e.g., Research Associate Deans) to identify the regulatory compliance questions and concerns of the U-M human research community. These activities may overlap with OHRCR educational activities as part of a scheduled visit or in an ad hoc fashion. If you would like an OHRCR outreach visit, please contact OHRCR.
OHRCR engages in innovation and leadership to improve the U-M Human Ressearch Protection Program along with other HRRP components by:
- Identifying or developing more efficient methods and new concepts for human subject protection;
- Implementing those methods and concepts;
- Evaluating the impact and effectiveness of those methods and concepts; and
- Providing information regarding the practice of human subjects research compliance to the U-M and external research community.
See Resources & References below for publications by OHRCR faculty and staff.