PROJECT SUMMARY: ETHICS AND REGULATORY KNOWLEDGE CORE The overarching goal of the Ethics and Regulatory Core (ERKC) Key Component Activity (KCA) of the Louisiana Clinical and Translational Science Center (LA CaTS) is to create a unified systematic approach to the conduct of clinical and translational research across Louisiana. We will build on the successful research infrastructure established during the 1st funding cycle and expand ERKC services to a wider variety of researchers in more sites. The ERKC KCA proposes to achieve the following goals: 1) Advance the facilitated review process among all LA CaTS institutions. As part of achieving this goal, the ERKC will take the next steps in improving the IRB process by integrating a procedure for early determination of whether a project is appropriate for facilitated or ceded review. 2) Implement a state-wide regulatory network to include institutions not part of LA CaTS. This initiative will support the expansion of facilitated review and will greatly enhance efforts across the state to support multi-institutional and multi-disciplinary projects designed to address health outcomes and disparities. 3) Further enhance the LA CaTS mission to facilitate initiation, conduct, and completion of trials by aligning the ERKC activities as part of a ?Translational Medicine? working group in close coordination with the Health Literacy Core, Community Engagement and Outreach Core, and Clinical Research Resources. Our specific Aims are designed to improve the regulatory process and address early on the ethical issues research projects face before being implemented in the community. Aim 1. To integrate facilitated review models or full reliance review models into the initial protocol design and review process by working in close collaboration and consultation with 1) investigators and research staff and 2) the regulatory review committees (IRB or IACUC) at each LA CaTS institution. Aim 2. To incorporate ethics and regulatory resources into 1) training and professional development of investigators at all LA CaTS institutions and 2) community advisory boards, which will act as the research subject advocacy resource. Aim 3. To promote the ethical design of clinical trials through interdisciplinary analysis with biostatistics and biomedical informatics. Particular attention will be given to the creation of consent procedures and participant protection for biorepository and large data sets. We will accomplish these aims by: 1) expanding training to include responsible conduct of research and research participant advocacy 2) guiding investigators in developing trusting relationships with safety-net patients and providers to improve participation in clinical trials and biorepositories; 3) aligning our activities with the other LA CATS KCAs to provide more comprehensive and coordinated investigators training with a goal of streamlining the regulatory process and 4) guiding collaboration with LA CaTS bioinformatics experts and other KCAs to develop transparent and appropriate informed consent documents on genomics and bio banking, a new initiative for LA CaTS.
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