September 9, 2024
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This administrative supplement is designed to broaden the clinical research workforce with a specific focus on research coordinators. The supplement will provide funds to hire, train and support clinical research coordinators for up to two years to improve the outreach, recruitment, and community engagement of NIDDK clinical research studies, leading to more transformative research.
Background
Clinical studies and clinical trials are essential for finding appropriate strategies for the prevention and management of diseases across the entire U.S. population; therefore, full representation of the United States population in clinical research studies is critical to ensure optimal quality of medical care and biomedical research. Historically, clinical research study participants have not reflected the demographics of those who suffer from the diseases and conditions targeted by clinical research studies. Recognizing this need, the NIH has focused efforts and attention on the inclusion of women and minorities in clinical research as required by federal law (42 USC 289a-2) and NIH policy (NOT-OD-18-014 and NOT-OD-18-116). Although some progress has been made to reach and enroll individuals from underrepresented communities in clinical research, more work is still needed to meet the goal of enrolling research participants who are reflective of the U.S. population, particularly those with or at risk for diseases and conditions within NIDDKs mission. NIDDK supports these concerted efforts as outlined in Pathways to Health for All: Health Disparities and Health Equity Research Recommendations and Opportunities.
Clinical research coordinators are central to the success of recruitment and retention of individuals in clinical studies. Individuals considering participation in clinical studies are often more comfortable and able to adhere to study protocols when approached and managed by research study coordinators who are culturally competent, have cultural humility, and are reflective of their corresponding communities. However, only a small percentage of clinical research coordinators come from communities who are underrepresented in research and at risk for NIDDK diseases. Therefore, this Notice of Special Interest is intended to provide support for currently funded NIDDK clinical studies to hire and train a research study coordinator to increase outreach and successfully enroll individuals from underrepresented groups in order to meet the goals of the clinical study.
Research Objectives
Administrative Supplements will support one to two years of support for research coordinators in order to add to the breadth of perspectives and representation of the clinical research team. This additional coordinator effort should provide needed additional support for an identified research study coordinator to improve participant engagement, recruitment, and retention to support the success of the parent grant in enrolling and retaining research participants from populations and communities that experience health disparities. This opportunity is intended to provide initial support for an identified research study coordinator to gain the experience necessary to sustain a research career and should provide training and other activities necessary to achieve this goal. The supplemental funds cannot be used for PI effort or for current members of the research team. Additionally, the supplement objectives are to support the current scope of the parent grant and cannot be used to modify research aims or the research study population.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent. Applications that are not responsive to this NOSI will not be reviewed.
All instructions in the How to Apply - Application Guide and PA-20-272 must be followed, with the following additions:
Budget:
To be eligible, the parent award must be able to receive funds at the time of the award and have at least two years remaining on the clinical research study. The administrative supplement budget is limited to two years. The application budget cannot exceed a maximum direct cost of $100,000 per year, commensurate with training and appropriateness for geographic location. Applicable F & A (indirect) cost can also be requested.
Funds can be used to cover the salary, training, and other activities necessary for the research coordinator to sustain a research career. The research coordinator is required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months).
Scope of Support
The number of awards is contingent upon NIDDK appropriations and the submission of a sufficient number of meritorious applications.
NIDDK intends to commit at least $640,000 in FY 2025 for this funding opportunity.
The proposed project period must be contained within the awarded project period of the parent award.
Administrative Review Process
NIDDK will conduct administrative reviews of applications submitted. NIDDK will support the most meritorious applications submitted for consideration, pending availability of funds.
Please direct all inquiries to:
Katrina Serrano, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-7855
Email: katrina.serrano@nih.gov