Regulatory Knowledge Support
The Regulatory Knowledge and 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. As part of its role in the overall mission of the CTSC, the RKS focuses on:
- Examining real and perceived regulatory burdens for investigators and pursuing new ways to reduce this through investigator support services;
- Expanding the purview of successful regulatory and clinical innovations that result in simplified processes; and
- Facilitating the understanding of regulatory framework by promoting RCR and FDA regulatory science through innovative and improved educational programs.
Most recent accomplishments include:
- Development of a true "reliant" IRB review process used by local CTSC partners and recently expanded to regional CTSA constituents, whereby an institution relies solely on the regulatory review and oversight of a different partner entity for collaborative research;
- Creation of the IND/IDE Regulatory Support Core with an innovative approach to managing drug and device applications to the US Food and Drug Administration (FDA) and expanding these services to CTSC investigators;
- Promote RCR and regulatory science through the addition of CWRU core curriculum offering, "Regulatory Science FDA Workshop."
Additionally the RKS promotes forward momentum into the next generation of research administration with future innovations planned such as:
- Expansion of Reliant IRB review system to national partners, thereby trialing a linked "national" network of IRBs;
- Assess institutional frameworks surrounding biobanking as well as genetic research and discuss potential areas for harmonization; and
- Explore community involvement projects to engage partners to take a more active role in the regulatory management of research.
This core consists of the following research regulatory entities and committees across each participating CTSC institution: IRB Advisory Committee, Institutional Animal Care and Use Committee (IACUC), Clinical Research Team Training Taskforce (CRTTT), Case\UH Technology Venture Fund Committee, Clinical Trials Grants and Contracts Harmonization Committee, Human Tissue Procurement Committee, Conflicts of Interests (COI) Harmonization Committee and IND/IDE Regulatory Support Core. Members of the RKS core regulatory team also participate on additional external institutional collaborative committees including the Human Stem Cell Research Oversight Committee (HSCRO) and the Institutional Biosafety Committee (IBC).
Core Resource Leadership
- Philip Cola, PhD, Director
- TBN, Co-Director
- Kathy Lawry, Co-Director
Regulatory Knowledge Specialists