Regulatory Knowledge Support

The overall goal of RKS is to support high quality, reproducible research across the spectrum of clinical and translational sciences by identifying efficient and cost effective ways in which to promote adherence to regulatory requirements and overall responsible conduct of research. Previously, the RKS focused on: a) identifying common concerns related to the oversight of translational research, including institutional review processes perceived by investigators as "burdensome" and/or "redundant"; and b) defining and pilot testing new workflows, standard metrics and opportunities for inter-institutional collaboration.

While these efforts have promoted vital discourse between major local research entities in Cleveland, additional steps must be taken to translate these process improvement theories and pilot work flows into actionable items capable of supporting research network expansion, thus increasing the amount of "bench-to-bedside" and "bedside to community" research. The RKS has outlined three aims that will help synthesize its own unified efforts with those individually taken by CTSC partners to form a more centralized process improvement plan.

Aim 1: Harmonize cross institutional policies and infrastructure to improve the quality of human subject protections and promote a clear culture of responsibility among CTSC investigators. The CTSA, national level and locally has made significant strides in identifying and addressing inefficiencies in the federally mandated research review process. However, continued focus on national level integration of these streamlined regulatory processes is essential as new technologies and therapies are developed and require rigorous scientific testing. This is consistent with the recent call to action promulgated by the IOM and NCATS and the now finalized HHS Federal Notice of Proposed Rule Making (NPRM) (i.e., revisions to the Federal Human Subject Protection Regulations promulgated by the Office of Human Research Protections). RKS focuses on innovations in the area of participant protections to promote regulatory competency. The RKS strives to: a) improve the consent process; and b) promote responsible access to clinical trials data and biospecimens to support transparency of results and secondary use in a regulatory compliant manner.

Aim 2: Streamline regulatory review process to promote research collaboration, which will facilitate translation of scientific ideas to clinical practice. There is a focus on integration of the best research management practices into the clinical trial process to facilitate efficient regulatory compliance. Centralization of research administration services encourages Phase I investigator initiated clinical trials as well broader community based health outcomes research. Collaboration with informatics and BERD promotes site networking to support multi-center evidence based outcomes research more efficiently. This increases subject pools and decreases time to study implementation, thereby ensuring rapid dissemination of results to the community.

The RKS supports Collaborative Engagement with external partners encouraging shared regulatory process and data/information platforms supporting clinical trial regulatory activities. Three of four CTSC institutions are partners in the National Smart IRB model, allowing for single-IRB review of multi-center clinical trials. Additionally, the RKS is participating as 1 of 11 CTSA sites identified to pilot test a unified "Scientific Review Committee" framework, designed to streamline scientific review processes, confirm scientific validity and feasibility of proposed clinical research trial in a meaningful way so as to have impact, or in some cases reduce, time required to complete IRB review. Both initiatives support changes in HHS regulation requiring research review centralization for multicenter clinical trials.

Aim 3: Provide innovative educational opportunities in Regulatory Sciences to complement and extend existing CTSC Regulatory offerings to all members of the translational workforce. Education and training for the CTSC research community supports a collaborative environment between researchers and regulatory staff, finding more ways in which to work together to promote responsible conduct of research. Many efforts such as IRB "office hours," in which IRB staff meet with research staff prior to IRB submission to review new protocols prior to submission, and mandated research staff regulatory training, in which research staff are trained by institutional research compliance monitoring staff to develop a partnership to support clinical trial conduct, are resulting in quicker study completion times (through improved IRB review times and better compliance monitoring outcomes).

The RKS is providing more comprehensive and innovative offerings to train the next generation of research professionals. The RKS will review course offerings, determine market feasibility and develop both a Certificate program and a Master's Degree in Regulatory Science geared towards investigators and/or members of their research staff. This detailed education and training will directly complement BERD Translational Workforce Development by training research professionals to conduct research according to local, state, and federal requirements. The RKS facilitates information sharing such as on-line, interactive courses expanding the reach to meet the research community needs and increase retention of highly trained research professionals via on-line investigator resources such as "FAQs" and community blog/information pages covering human subjects research and regulatory compliance.


Core Resource Leadership

  • Philip Cola, PhD, Director
  • Carey Gorden, Co-Director
  • Carolyn Apperson, MStat, Co-Director

Regulatory Knowledge

Smart IRB (Reliant IRB Review) Support

FDA Guidance