information for reviewers

GENERAL INSTRUCTIONS  I  RESEARCH & TRAINING GRANTS  I  PROGRAM PROJECT GRANTS  I  CLINICAL INVESTIGATION GRANTS I CONFIDENTIALITY & CONFLICTS OF INTEREST POLICIES

Review of Program Project Grants

Purpose
The purpose of the JDRF Program Projects grant is to provide a mechanism to stimulate new collaborations between clinical and basic scientists and/or between scientists from diverse backgrounds as a means to conceive and develop new approaches to persistent obstacles to progress along the various paths to a cure for type 1 diabetes and its complications.

JDRF Program Projects must have a central theme highly relevant to the priority areas of research for JDRF. A Program Project proposal should clearly demonstrate, by the nature of the collaborations, resource sharing, institutional recognition or other factors, that its value is significantly greater than the sum of its parts. Program Projects should have a set of clearly defined goals and well articulated milestones that can be met within a three-year period. In most instances, JDRF expects its Program Projects will focus on basic or pre-clinical research that seeks to impact the treatment or prevention of type 1 diabetes and its complications. However, clinical studies meeting the other criteria for program projects will be considered.

General Instruction and Context for Review
The JDRF Program Project grant review process is unique. As an organization founded by the parents of children with type 1 diabetes, our Program Project review process includes and indeed emphasizes full participation by lay reviewers. Further, the context for our research funding decision-making is very personal, and our intent is clear - we wish to fund those program projects that will potentially have the greatest impact on accelerating progress along the path from discovery to cure. In some cases, where the fundamental science is poorly understood or long standing beliefs are coming under question, this may require funding basic work that is very speculative or high risk or unconventional. In other cases, where the science is more mature, this may require funding the direct testing of a clinically plausible intervention, or a technology driven descriptive study for therapeutic targets and candidates. Essentially, what we want to do most is do what is necessary to make a real difference - perhaps the critical difference - re: delivering a cure to our loved-ones.

As background for conducting their reviews we ask that reviewers first try to put themselves in the frame of mind of a parent who has just been told that their child has Type 1 diabetes, and then to use their scientific expertise and awareness of the relevant fields to answer the question: "what would I do, today, or want to see done to ensure that we have the best chance of finding a cure, as soon as possible?"

At the minimum each proposed project should ask a specific and substantive question of high relevance to achieving the JDRF mission of finding a cure for Type 1 diabetes and its complications, and should discuss how positive or negative results would lead to a specific potential new therapeutic or relevant experimental approach.

Program Project proposals are triaged via a "Letter of Intent" (LOI) process. All Program Project Applications distributed for formal review have been recommended for consideration by the JDRF Research Executive Committee based on their screening of the related LOI.

Reviewers are responsible for familiarizing themselves with the research goals and priorities of JDRF, writing formal critiques of the Program Project proposals assigned to them, and participating in the peer review discussion at the Program Project review. The applicant receives a summary of the review group discussion and recommendations (written by the JDRF Research Staff) and the de-identified written critiques from the primary, secondary, and reader reviewers.

Application Requirements
Each Program Project application should contain a well-developed overview and description of individual projects. The overview should include a clear declaration of the scientific purpose of the program and its connection to solving a specific problem related to finding a cure for Type 1 diabetes and its complications. Proponents should detail their overall goals as well as identify specific scientific milestones, which they believe represent fair means for evaluation of their progress. Similarly, goals and milestones should be identified for each individual project and core. A statement of the relationship of the projects to each other and their relationship to the overall project as well as a description of the cores (shared facilities used by most of the investigators in the program project), and a composite budget for the entire project should also be included. Each individual project proposal should articulate a clear research purpose and end points, a detailed research plan and budget request, biographical sketches, and information about other funding support for the applicants. Each core should include a description of its purpose and the anticipated utilization, detailed budget requests, biographical sketches, as well as other pertinent information.

Scientific Review
A Program Project application should be assessed in the context of its responsiveness to JDRF research priorities and its potential to accelerate progress toward the development of specific clinical interventions to benefit people with Type 1 diabetes and its complications. It should be structured as a well integrated, collaborative program and reviewers should emphasize evaluating the team's potential to address issues which could not readily be approached were the components to be funded separately. Each individual project should be evaluated for its standalone scientific merit as well as its potential contribution to the whole program. Generally, the final overall score should not be simply an average of the individual project and core scores, but rather reflect the tangible and intangible aspects of the Program Project proposal that make it more (or less) than the sum of its parts. In limited instances it is possible that individual projects may not be approved as part of a successful program project application.

Lay Review
There will be Lay Review Committee (LRC) members present at the Program Project review meeting. Each of the lay reviewers will be assigned components of the application in a similar manner to the scientific review committee. In addition to having reviewed components prior to attending the meeting, Lay Reviewers will listen to the scientific deliberations and use the outcomes of peer review as the basis for their assessment of scientific merit which they must then -- for the purpose of funding decisions -- place in the context of JDRF goals, research priorities, and overall research portfolio. The LRC meeting will take place following the scientific review. All components will be examined closely and those deemed inconsistent with the mission of the JDRF will be removed from further consideration. Applications which are judged scientifically meritorious and potentially high impact and which further match JDRF goals, priorities and fit within our portfolio targets, are recommended to the JDRF International Board of Directors for final funding approval.

Details of Scientific Review
A) Review of Individual Projects
Reviewers are asked to: 1) assess each project on its own merits; and 2) assess each project as part of the overall project and whether it should be included in the program project. Reviewers will be provided with the full program project application to assist them in their evaluation. Each project will be rated from 1.0 to 5.0 in 0.1 increments as indicated below (scoring guide). Primary and secondary reviewers should comment on the "program project aspects" of the application - that is the relationship, contributions, and synergies of each individual research project and core to the overall theme of the program project application. Please provide a paragraph(s) evaluating the core(s) in your critique. 

B) Review of Cores
Core facilities: Each core must provide essential facilities or services for two or more individual research projects. Review criteria for scientific cores consist of the following:

* justification and usefulness of the core facilities to the various research projects;
* relationship of each core to the central focus of the overall program project;
* quality of relevant facilities or services provided by the core (including procedures, techniques and quality control) and criteria for prioritization and usage;
* qualifications, competence and commitment of the core leader and key personnel.

Core Budget Recommendations: Core support may be requested for normal operating expenses of shared facilities used by most of the investigators in the program project. Such expenses include salaries for technicians, equipment, materials and supplies, maintenance contracts, and extra travel funds required for members separated by a significant distance. In addition, requests may be made for the salaries of a limited number of research assistants and research trainees whose participation will enhance the productivity of the program project.

Review of OVERALL Program Project Aspects
The relationship and contributions of each individual research project and core to the overall theme of the program project application will be evaluated by the review of the "program project aspects" of the application. Two reviewers and a reader will be assigned to review these aspects of the application. These reviewers should also have been reviewers for the majority of the individual projects. If you are a reviewer for the program project aspects of an application, please write your review in the following format:

1) Summary: Provide a short summary of the program project proposal (names of the investigators, aim of the overall project, etc.).

2) Assessment: Assess the strengths and weaknesses of the proposed program project; the following questions are among those, which should be considered.

• Significance of the overall goals
• Scientific merit of the program project as a whole, as well as that of the individual research projects
• Synergy - Will there be a team of three or more investigators with various types of expertise undertaking collaborative multidisciplinary research? Will there be research components, each scientifically meritorious, which together form an integrated research program able to address issues which could not readily be approached were the components to be funded separately? Evaluate the cohesiveness of the program project and the coordination and interrelationships of individual projects and core(s) to the common theme. What are the relative priorities of the various projects is there a chronological relationship, and should they all be included in the program project?
• Investigators - Comment on the leadership and scientific ability of the Director of the program project: his or her ability to develop a program of integrated research projects with a well-defined central research focus; and his/her commitment and ability to devote adequate time and effort to the program. What is the role of each investigator as part of the program project: time commitment and who is going to do what? Will each investigator be able to devote adequate time and effort to the program?
• Relevance - How relevant is the research proposed to the goals of the JDRF, i.e., to target research at finding a cure for Type 1 diabetes and its complications?
• Organization and Communication - Will the organizational aspects of the program project structure allow the proposed research to occur? Assess the plans for meetings, other interactions, and exchange of data, material and techniques. Comment on the geographical distribution of the program project members.
• Training - Will the research setting permit research training?
• Institutional and other sources of support - What is the institutional commitment to the program project and the impact of the program project on the institutions involved in terms of research priorities of the institution, financial support, time protection, and laboratory space and equipment? Are there any other sources of financial support for the request, which could include: cost-sharing arrangements with the sponsoring institution(s), industry, or other agencies; estimates of institutional expenditures involved in upgrading or constructing laboratory facilities; estimates of indirect institutional support such as provision of services and computing resources; user fees.
• Evaluation - Are the specific aims of the program project related to the accomplishment of clearly defined tasks in a specified timeframe? Is adequate information provided, including a timeline, to give JDRF a basis for evaluating the progress of the investigators toward achieving the overall goals?

Note: All reviewers of PPGs should provide written critiques (via the proposalCentral web site) prior to the review.