This administrative supplement is designed to increase the diversity of the clinical research workforce with a specific focus on positions of research coordinators. The supplement will provide funds to hire, train and support a clinical trial research coordinator position for individuals underrepresented in the US Clinical research enterprise for currently funded NIDDK clinical trials for up to two years.

Background

Clinical studies and clinical trials are essential to finding appropriate strategies for the management of diseases. Full representation of the United States population in clinical trials/studies is critical to ensure the quality of medical care and biomedical research. Unfortunately, the participation rates of racial and ethnic minority groups and women in clinical studies/trials have not been sufficient in addressing the full spectrum of diseases in the country. Recognizing this need, the NIH has focused efforts and attention to the inclusion of women and minorities in clinical researchas 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 underrepresented communities, more work is still needed to move recruitment numbers closer to population metrics. Clinical research coordinators are central to the success of recruitment and retention of patients in clinical trials. It has been shown that patients participating in clinical trials are more comfortable and more compliant with study protocols when approached and managed by study coordinators who are culturally competent and from their corresponding communities.

Despite the importance of the clinical research coordinators, only a small percentage come from communities that participate in clinical studies and clinical trials supported by NIDDK. Therefore, this supplement is intended to provide support for currently funded NIDDK clinical trials to hire and train a clinical trial coordinator to increase the outreach and work of the already funded clinical trial.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date(s) July 1, 2020, July 1, 2021, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-DK-20-021” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for up to two years of support.
• The Research Strategy section of the application is limited to 6 pages.

• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-F-ADMINSUPP”. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

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 trial. The administrative supplement budget is limited to 2 years. The application budget cannot exceed a maximum direct cost of $100,000, applicable F & A (indirect) cost can also be requested.

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 $750,000 in FY 2020 to fund approximately 6 awards.

Administrative Review Process

NIDDK will conduct administrative reviews of applications submitted to the IC. NIDDK will support the most meritorious applications submitted for consideration, pending availability of funds.

Review Criteria:

• Will the administrative supplement increase recruitment and or maintain retention of diverse participants of the clinical trial?
• Has the progress of the project prior to the supplement been adequate?
• Will the administrative supplement provide a clear training and experience base for the candidate to pursue further employment as a clinical trial research coordinator?
• Does the administrative supplement provide a training description for the candidate and mentoring experience for the PI or key personnel that will train the candidate?
• Are the overall strategy, methodology, and analyses proposed in the supplement application well-reasoned and appropriate to accomplish the proposed training in the proposed time period?
• Will the administrative supplement increase or preserve the likelihood for the project to succeed, and assist the candidate to complete their research project and submit a timely renewal or new research project grant application?
• Is there strong institutional commitment (e.g., protected time, policies, programs, and other strategies) to ensure future career and clinical trial opportunities for the trainee?