Regulatory Knowledge Support

The Regulatory Knowledge Support (RKS) Core is central to all aspects of research administration, RCR training and education, bioethics, program evaluation, pilot awards, community-based research (including practice based research networks) and bioinformatics support and is very active in the overall mission and vision of the CTSC. The main goal of the RKS Core is to build integrity into clinical and translational research programs, promote responsible conduct, and help investigators meet their regulatory responsibilities by establishing a CTSC program in which ethical values serve as the driver of regulatory knowledge and support.

The RKS Core continues to review and improve internal processes to decrease real and perceived regulatory burdens for investigators. For example, a significant process improvement made is the creation of the Facilitated IRB HUB. Prior to this initiative, investigators at each of the separate legal entities were required to submit common research protocols to each site's IRB for review and approval. Now, there is a process to allow studies approved by one institution to receive facilitated review via a newly created central electronic "HUB" accessible to all participating institutions. This process relies on executed Inter-Institutional Agreements (IIAs) between separate institutions that share investigators and protocols. It allows investigators to make a single IRB submission for multiple reviews within the Cleveland CTSC.

For more details, click here for an overview and click here for step by step instructions.


Core Resource Leadership

  • Philip Cola, Director
  • Dan Beyer, Co-Director
  • Kathy Lawry, Co-Director

Regulatory Knowledge Specialists