Federally Funded Clinical Research
The National Institutes of Health (NIH) is the nation’s medical research agency and the largest source of funding for medical research in the world. NIH is made up of 27 Institutes and Centers, each with a specific research agenda, focusing on particular diseases or body. NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting scientific research, and is responsive to Congressional legislation that adjusts to changing research needs.
NIH has a $29.15 billion budget for FY 2013. More than 80% of the NIH’s funding is awarded through almost 50,000 competitive grants to more than 300,000 research personnel at more than 2,500 universities and research institutions.
Obtaining NIH Funding
Obtaining NIH funding for your research idea requires a well-organized and structured approach that is effectively tied in to the grant application and award cycle. An overview of the steps required for an application to proceed from application planning and submission through award and close out is provided by the Office of Extramural Research: http://grants.nih.gov/grants/grants_process.htm. Obtaining funding for clinical trials is much more involved than seeking an individual grant for non-clinical research. There is increased complexity at each step of the grants process, from clinical trial concept generation to protocol development, protocol review and approval, to implementation of protocol and subsequent trial conduct. There are additional regulatory requirements that must be met with regards to human subjects protection and clinical trial conduct. There usually are additional levels of review convened by the individual NIH Institute and/or specific research program, in addition to the NIH Peer Review. A successful application for a clinical trial grant often requires collaborative and dedicated efforts from a multi-disciplinary team, including seasoned investigators with clinical trial research experience and institutional support for the principal investigator.
Definition
Clinical research receiving federal funding is defined as research involving human subjects in:
- Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:
- mechanisms of human disease
- therapeutic interventions
- clinical trials
- development of new technologies
- Epidemiological and behavioral studies.
- Outcomes research and health services research.
CLINICAL TRIAL CONSULTATIVE SERVICES
- Application
- NIH Guide for Grants and Contracts: Funding Opportunity Announcement (FOA), Program Announcement (PA), Request for Application (RFA)
- Application package
- Review
- Peer Review
- IRB Review
- Data and Safety Monitoring Board Review
- Clinical Trial Development
- Protocol development
- Data and Safety Monitoring Plan development
- Clinical Trial Implementation
- Manual of Procedures development
- Site Monitoring
- Study Monitoring
- Safety Monitoring
- Regulatory
- Compliance with OHRP regulations
- Compliance with FDA regulations
- Compliance with NIH Policies & Requirements
- Training
- By application and review process
- By study phase: study launch, ongoing study conduct
- Regulatory components: human subjects protections, FDA regulations
- Safety component: data standards, data capture, safety reports & assessments, expedited reporting requirements
- Audience: Investigators, clinical site personnel, regulatory & QA/QC personnel
- Curriculum: modular, interactive, beginner & advanced levels, refresher boosters
- Customization: e.g. for specific study protocol, or generalized for clinical research professionals