Leadership Operations Center
The IDCRC institutions are leaders of influential infectious diseases, immunology and clinical research programs focused on vaccines and STIs at eight top academic institutions and affiliates across the country. The programs, faculty and collaborators at these institutions have exceptional NIH/NIAID network and international connectivity, a history of performing outstanding ID clinical research and the experience and capability of rapidly responding to ID threats.
Key Activities
Research Priorities and Research Agenda
The LOC works closely with NIAID to ensure the research agenda is consistent with NIAID’s infectious diseases research priorities. NIAID members serve on the Scientific & Operations Governance Committee (SOGC) and Expert Working Groups (EWGs) to facilitate engagement. The LOC oversees the EWGs in prioritization and implementation of the NIAID current research priorities and in developing the capacity to respond rapidly to emerging threats.
The LOC research plan, designed for flexibility, adaptability, efficiency and for rapid infusion of new concepts in infectious diseases clinical research, includes innovative elements that enhance sensitivity and the integration of new information to advance scientific knowledge and clinical practice. Through new approaches to connectivity (public-private partnerships), the utilization of novel concepts in clinical trials design and methodologies, incorporation of sensitive and specific laboratory assays, new instrumentation and novel interventions (e.g. cutaneous vaccine “patch,” vaginal ring or gel delivery, new drugs or biologics), the Innovations Committee, identifies and evaluates approaches that shift infectious diseases clinical research paradigms.
Mentoring
The LOC through the Mentoring and Career Development Committee identifies robust clinical research experiences, programs and training opportunities for junior investigators. This takes the form of mentoring committees, career development through T, K, or other grants, small clinical research projects, classroom training in clinical research and statistical analysis, participation in IDCRC committees, participation as junior investigators on studies and trials, and exposure to other aspects of clinical research. The IDCRC develops a program to support effort of young investigators in the IDCRC. Training opportunities
Monitoring and Evaluation
The LOC through the Performance Evaluation Committee, develops and incorporates policies, methods and approaches for monitoring implementation of clinical research conducted by the VTEUs and evaluates the operational performance of the overall IDCRC and each IDCRC.
Through the Quality Assurance and Ethics Committee, the LOC develops strategies for assuring Quality Management and ensures that the risk assessment and mitigation strategies are an integral part of all research activities within the IDCRC. These strategies complement quality management systems and processes established by NIAID. A key component of this function is ethical conduct of research and performance standards of leaders, investigators, clinical coordinators, laboratory and other staff. The Laboratory Sciences Committee specifically oversees integration and quality of laboratory approaches.
Collaborative Responsibilities
The LOC collaborates with other NIH-supported clinical networks, and other Federal and private sector clinical research programs and clinical networks. The IDCRC represents a national leadership network with leading infectious diseases research programs in the East, South, Midwest, Southwest, and West; has multiple links to other NIH/NIAID-supported clinical networks, healthcare networks, other Federal and private sector clinical research programs, Bio, international sites in Africa, Southeast Asia, and Australia, and other global programs in infectious diseases research. These collaborations and interactions of the LOC, facilitated by the Collaborations and Publications Committee, are essential to disseminate the results of the IDCRC and for the development and implementation of a comprehensive research agenda that utilizes the strengths, experience and expertise of the collaborating organizations of the IDCRC and NIAID.