You are here
ORCR is committed to assisting U-M investigators in their understanding and application of human subjects protections.
Please see our Policies and Procedures page for standard operating procedures pertaining to compliance reviews.
The Office of Research Compliance Review (ORCR) provides objective analysis and evaluation of non-financial research activity compliance for investigator-led research studies, with emphasis on human subjects studies, units of U-M's Human Research Protections Program (HRPP) and of the HRPP as a whole.
ORCR's mission is to facilitate safe, ethical, efficient, and high quality 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 Research Ethics and Compliance programs, including the HRPP
- Education of individuals and groups engaged in the research enterprise
- Outreach to the university research community
- Innovation and leadership
The majority of ORCR’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 research activities, prevent noncompliance, and assist investigators in correcting any noncompliance. The majority of routine reviews are for individual human subjects studies.
- For-cause review - a directed review when allegations of research noncompliance are received by UMOR. The allegations may arise from the Institutional Review Boards (IRBs) or other U-M compliance oversight committees, the research administration, research subjects, faculty, research support staff, funding or regulatory agencies, or ORCR staff. In these cases, UMOR refers the review activity to ORCR. 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 ORCR routine and for-cause reviews. Overall, ORCR 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). ORCR’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, ORCR 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.
ORCR 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.
ORCR 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 ORCR educational activities as part of a scheduled visit or in an ad hoc fashion. If you would like to schedule an ORCR outreach visit, please contact email@example.com.
ORCR has and will continue to engage in innovation and leadership activities to improve the U-M Human Research 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 ORCR faculty and staff.
By expanding its innovation and leadership role to objectively analyze other U-M Research Ethics and Compliance programs, ORCR demonstrates a commitement to the continuous improvement of research compliance at U-M.