Strategic Research Agreements
Summary
Description
Designed to provide research funding for investigators to address critical gaps and challenges and make breakthroughs in type 1 diabetes research
Institutional Eligibility
Domestic & foreign non-profit organizations; public & private universities, colleges, hospitals, laboratories; units of state & local governments; eligible agencies of the federal government
Applicant Eligibility
Required: MD, DMD, DVM, PhD, or equivalent and faculty position or equivalent
Human Subjects Research
For a project proposing human subject research, please review the Human Subject Research Guidelines
Description
JDRF’s Strategic Research Agreements provide research funding for investigators to address critical gaps and challenges and make breakthroughs in type 1 diabetes research. The Strategic Research Agreement is a partnership between Investigator(s) and JDRF scientists to accelerate JDRF’s mission through support of cutting-edge scientific investigation. Further, this mechanism embodies cooperative development of a research plan, interim quarterly reporting on milestones and interaction with JDRF scientists prior to and during the award period. The budget and duration of funding are variable and continued funding is based on satisfactory effort and quarterly progress on milestones. Submission of an application requires permission from JDRF and is initiated with an LOI submitted to Project Concept Call in RMS360, an open JDRF Funding Opportunity, or by direct invitation from JDRF Staff.
Eligibility
Applicants must hold an MD, DMD, DVM, PhD, or equivalent and have a faculty position or equivalent at a college, university, medical school, company, or other research facility. Applications may be submitted by domestic and foreign non-profit organizations, public and private, such as colleges, universities, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Ordinarily, for-profit organizations will not be considered, except under special circumstances. See the Industry Discovery & Development Partnerships section for a description of special programs for for-profit entities. There are no citizenship requirements for this program. To assure continued excellence and diversity among applicants and awardees, JDRF welcomes applications from all qualified individuals and encourages applications from persons with disabilities, women, and members of minority groups underrepresented in the sciences.
Submitting an Application
Step 1: Project Concept or Request for Application
An investigator interested in pursuing a research opportunity with JDRF must submit an LOI through the project concept call or other open opportunity in RMS360. Full proposals are invited based on programmatic fit and robustness of the concept. In addition, projects that hold a prospect for transformative breakthroughs that prevent, treat or cure Type 1 diabetes will be given top priority.
Applications are due at 5pm on the deadline date, unless otherwise noted.
To view upcoming deadlines, click here.
Step 2: Full Application
If the applicant’s LOI is approved by JDRF, the applicant will be invited to submit a full research application. The applicant will be authorized to access and electronically submit the completed application via RMS360.
- The JDRF scientific personnel works collaboratively with the investigator or investigator team to develop a full application in accordance with JDRF strategic objectives.
- All research applications are submitted and reviewed using RMS360.
- The complete and submitted application is reviewed by scientific experts and written critiques are received by the staff, generally in 4-8 weeks.
- The reviewers’ critiques will be shared with the applicant. JDRF Staff may request a rebuttal from the applicant to address concerns raised by the reviewers.
- The entire application and review materials are evaluated by JDRF staff, reviewers, and by the JDRF Research Committee.
Note: For a project proposing human subject research, please review the Human Subject Research Guidelines.
Terms of the Award
Available funding for the Strategic Research Agreement will be reviewed on a per-application basis. Projects will be milestone-driven, require teleconferences with JDRF scientific staff to discuss project progress and research findings on a semi-annual or quarterly basis. In addition to quarterly or interim reports, an annual progress report will be due 2 months prior to the anniversary date of the award, except in the final year, in which the progress report is due 75 days following the close of the award. Projects are generally no more than 3 years duration. Support beyond 3 years will be determined based on a detailed scientific review of the accomplishments and future plans of the Project. Decisions on continued funding are made by the Program Director in consultation with Senior Management based on progress on milestones. Indirect costs cannot exceed 10% of direct costs (direct costs do not include equipment costs, fee-for-services, consultants, or subcontract costs).
Clinical SRA Details
Description
JDRF Clinical SRAs are intended to support research programs that qualify under the JDRF clinical review process. This funding mechanism is intended to support clinical trials to test therapeutic approaches as well as non-interventional patient oriented studies that are intended to lead to the development of clinical interventions and monitoring tools (such as biomarkers) for diabetes and its complications. Applications for Strategic Research Agreement – Clinical must be goal oriented and closely focused on the JDRF mission.
Clinical Application Guidelines
All applications involving human subject research must include supplemental information to address subject safety, study design and investigational product information. More details can be found in the Human Subject Research Guidelines. All applications that receive a funding recommendation after scientific review will undergo clinical review where a subsequent review of the study protocol and supporting documents will be performed.
Outcomes Beyond A1C Resources
The Steering Committee of the T1D Outcomes Program has defined the following outcomes: hypoglycemia, hyperglycemia, time-in-range, and diabetic ketoacidosis (DKA). JDRF requires that all newly funded clinical studies incorporate the appropriate outcomes. Further, outcomes incorporated into a study should be consistent with the definitions from the publication, and we recommend their usage as endpoints in all T1D studies. Protocols that include measurement of these outcomes that are not defined per the publication must provide justification prior to grant approval. Please see relevant resources- fact sheet and video.
Evaluation
Clinical SRAs will be evaluated for scientific merit, clinical standards of care for the proposed patient population and adherence to Good Clinical Practice. The scientific review criteria include:
- Relevance to the objectives of JDRF
- Scientific, technical, or medical significance of the research proposal
- Innovative quality of the proposed study
- Soundness of the clinical study design
- Availability of sufficient pre-clinical data to justify the proposed clinical study
- Qualifications and research experience of the principal investigators and collaborators
- Consideration of the potential benefits and risks to patients who will be involved in the research, plans to limit risks, and other ethical considerations
- Availability of resources and facilities necessary for the study
- Appropriateness of the proposed budget in relation to the proposed research
Clinical Trial Management
The mission of this group at JDRF is to facilitate execution of high quality clinical trials. Please click the link for the current Human Subject Research Guidelines with a few additions as listed below.
- Pre-award: an application for funding can be submitted for bundled studies, pre-clinical and clinical piece, etc but if deemed appropriate by the CTM, the below funding structures may apply requesting updated split budgets for each phase as applicable. No new application required.
- multipart funding structure for clinical trial set up and execution phase, if applicable
- if bundled trials within a single proposal, multipart funding structure
- Post-award: assigned JDRF-CTM will provide active management of clinical trial grants via site calls to understand the study progress, as applicable.
- In some cases, it may be necessary for the CTM to perform a site visit either in advance of study initiation or during study conduct.
Please speak with your proposal/study assigned JDRF-CTM if you have any questions or need clarifications.