Routine Research Education and Regulatory Reviews (RRERR) are a type of human research regulatory compliance review known as “not for cause”.  RRERRs are a campus wide initiative. In general, the purposes of not-for-cause reviews are as follows:

 

1. Contribute to the dynamic research culture at the University of Michigan in a way that demonstrates continuing value for the safety, rights and welfare of study participants and feedback to the investigators and the organization regarding the current implementation of such protections.
   
   
2. Assist investigators and their staff in: a) identifying areas within their research that are or could become non-compliant with regulatory standards; b) understanding the principles of study participant protections, and c) methods to meet study participant protections best practices. This assistance will prevent situations that might place additional risks on study participants.
   
   
3. Identify standards of excellence and potential areas for improvement in order to enhance the quality of human subjects participant research protections at the University of Michigan.
   
   
4. Verify that human participant research is being conducted in a compliant fashion.

 

They differ markedly from “for cause “reviews in that “for cause reviews” are done when there are concerns or complaints about a specific study or a specific investigator.

 

Each year OHRCR will develop a Review Plan for the conduct of routine not-for-cause reviews. The reviews conducted as part of this routine review process are known as Routine Research Education and Regulatory Reviews (RRERR). The Review Plan will be approved by the Vice-President for Research or his designee. Since the number of IRB-approved studies at UM is consistently large, not all studies can be reviewed. Thus sampling of studies will be used by OHRCR.