West Virginia Clinical & Translational Science Institute (WVCTSI) - Ethics, Regulatory Knowledge & Support

The long-term objectives for the WVCTSI is to establish a competitive CTSA infrastructure and expand the Institute's capacity to conduct clinical and translational research in order to achieve the ultimate goal of eliminating health and healthcare disparities amongst West Virginians/Appalachians. The Ethics, Regulatory Knowledge, and Support program will coordinate components of the individual regulatory programs, integrate training and education, establish or enhance contract and technology transfer guidelines, and develop an overarching program in research ethics and the responsible conduct of research (RCR). This will ensure regulatory compliance and facilitate the conduct of clinical and translational research for all institutions across the state of WV, and with our IDeA partner, the University of Kentucky in the region.

The overall goal of the Ethics, Regulatory Knowledge, and Support program is to develop effective coordination measures that ultimately are directed at enhancing the conduct of research and ensuring the respect for participant autonomy and wellbeing. We have established an Ethics, Regulatory Knowledge and Support program to strengthen the formal training and individualized consultation on human subjects research and the responsible conduct of research for clinical researchers, health professionals and research participants in all WVCTSI partner institutions. We also plan to utilize a Regulatory Working Group composed of representative and knowledgeable members of the three WVCTSI partner institutions to streamline and harmonize regulatory and integrity services and technology development and contracting policies and procedures related to the clinical and translational science research in West Virginia. Finally, we wish to develop an independent WVCTSI Research Participant Advocacy Program designed to provide objective advocacy resources for the lay community to include past, present and future patients and subjects.