Regulatory Knowledge and Support
The overall vision of the Meharry Translational Research Center (MeTRC) Regulatory Support Core is to provide regulatory knowledge and support through a process of standardization and consistent implementation of advances in information technology /services to all investigators and clinical research personnel. Our mission is to reduce their administrative burden and improve participant safety and regulatory compliance in an effort to foster translational research and expedite the speed with which findings are translated to patient care. This vision involves improved quality.
As a result, documents will be submitted to the Institutional Review Board (IRB) and other administrative offices in a higher quality form resulting in fewer steps/delays in approval and less frustration from investigators. Streamlined communications, standardized processes, forms, templates and staff with knowledge of regulatory and reporting requirements will result in improved efficiency and satisfaction.
The Specific Aims of the Regulatory Core are:
- Guided by data-driven needs assessments, the Vanderbilt Institute for Clinical and Translational Research (VICTR) will provide a "One-Stop Shopping Environment" in support of the research community by adding in an expanded menu of services. This includes:
- Improve regulatory compliance and protection of human subjects by expanding Individualized
Measured Performance and Collaborative
Training Techniques (IMPACTT);
- Help researchers navigate the process by creating a central point of access to research resources;
- Design and coordinate efforts to provide access to educational tools, resources and sessions designed for investigators and research personnel;
- Improve communication and identification of regulatory, compliance or process issues.
- Improve regulatory compliance and protection of human subjects by expanding Individualized Measured Performance and Collaborative
2. Support new investigators by creating an Investigator Advocacy Program to provide a specialized set of research services consultants assisting with some or all components of the regulatory administrative efforts and serve as a liaison in interactions with IRB and other regulatory bodies of internal administrative offices. Investigators and clinical study personnel represented by the Investigator Advocate (IA) will bear less of the burden of administrative regulatory requirements thereby allowing investigators and research personnel to focus on participant interactions, safety and most importantly, their scientific interests.
3. Ensure research subject safety and knowledge, as well as research integrity and quality by expanding the Research Subject Advocacy (RSA) Program to help ensure human subject protection.
4. Support "big science" by implementing our Professional Management Program, staffed with personnel trained to move teams toward a common vision on complex, multi-disciplinary projects.
Supported by the National Institute On Minority Health And Health Disparities of the National Institutes of Health under Award Number U54 MD0007593.