Dr. Cristina Aguayo-Mazzucato in her lab
Cristina Aguayo-Mazzucato, MD, PhD Joslin Diabetes Center Recipient of a 2018 P&F award to support her research.

Supporting New Research

The Joslin Diabetes Center Diabetes Research Center (DRC) offers Pilot and Feasibility (P&F) Grants in research areas directly related to diabetes - including types 1 and 2 diabetes and their complications - from basic, translational or clinical perspectives. Two P&F grants are offered for up to $50,000 per year, for a duration of two years.

The Joslin Diabetes Center DRC P&F Grant Program has been highly successful for more than 30 years. Projects funded in past years have covered a wide range of topics in the fields of type 1 and type 2 diabetes and their complications, including the control of insulin gene expression, mechanisms of insulin action and resistance, stem cell biology, beta cell apoptosis and potential regeneration, mechanisms of leptin action and resistance and autoantigen therapy of type 1 diabetes. The approaches have also been very diverse, covering wide varieties of biochemical, molecular biologic, genetic, immunological and clinical strategies. This breadth of topics and efforts also reflects the diverse interests of Joslin's diabetes research program as a whole.
 

Recruiting talented new investigators and embracing promising new experimental strategies or methods is critical to advancing the science of diabetes. Therefore, this program has traditionally provided support to three types of researchers:

  • New investigators in the diabetes field who have not previously received substantial NIH funding (“New investigators” are defined as having an academic appointment associated with independent space and an independent project. This does not include fellows.)
  • Experienced investigators in the diabetes field who wish to strike out in a novel direction
  • Investigators from other fields embarking on a diabetes-related project for the first time

To accomplish this we hold a yearly competitive application process. Several months before the submission deadline we announce the upcoming P&F grant opportunity as broadly as possible to eligible departments and institutions. Each year we award two new grants of $50,000 per year, and for two years duration, to researchers based either at Joslin Diabetes Center or at neighboring institutions within Harvard Medical School and affiliated hospitals and centers. Special efforts are made to foster interactions between Joslin Diabetes Research Center (DRC) investigators and the external P&F Study Program awardees. Applicants are asked to submit a description (abstract) of the proposed project using the designated website. Applications that are eligible are invited to submit a full proposal. Full proposals are judged by internal and external reviewers chosen on the basis of expertise. We utilize a nationwide network of experts in the various fields related to diabetes to identify appropriate reviewers. 

Proposals receiving the highest scores are recommended for funding to begin April 1 of the submission year. Anonymous reviews are provided to the applicants. We try to integrate P&F grant recipients, within Joslin and from other institutions, by encouraging use of the DRC cores and facilities. This includes facilitating access to Joslin DRC cores, an invitation to give a seminar at the Joslin, and invitations to Joslin retreats and other enrichment activities. Please visit the Enrichment Core portion of this website.

We encourage the submission of translational research projects, in particular new collaborative projects between a Principal Investigator (PI) who is a basic scientist and a PI who is a clinician or clinical scientist. These projects must focus on patients or patient samples. At least one of the two collaborating PIs must be from Joslin. If you are applying for this paired Basic/Clinical award, please specify this within the "Letter of Intent." Please click here for an NIH definition of "translational research"

 

Important Information Regarding Submissions

How do I apply?
Potential candidates should register, using their email address, on the Joslin Pilot and Feasibility Grant Program Registration site, and then follow subsequent instructions to submit a required "Letter of Intent" (LOI) and biosketch. Recieved LOIs will be reviewed for eligibility and priority, and the successful candidates will be invited to electronically submit a five-page Research Plan proposal following an abbreviated version of a standard NIH application.

   Deadlines:

  • Letter of Intent: 5 p.m., Monday, December 2, 2019
  • Full Application (by invitation only): 5 p.m., Monday, February 10, 2020

Decision announcements will be made in late March, 2020 with the funding cycle to begin on or about April, 1, 2020 lasting one year. A second year of funding is contingent upon positive review of the P&F year one progress report.


What forms are required for submission?
Candidates determined eligible will be invited to submit proposals using the PHS 398 instructions and PHS 398 forms

A major purpose of the P&F program is to prepare new faculty for the successful submission of competitive NIH grants, hence the requirement for using the NIH format and NIH forms. We also use data collected on the forms for renewal of the DRC parent grant. We ask that you use the current, non-fellowship NIH biosketch format.  


What is the format for the scientific portion of the P&F?
As noted above a major purpose of the P&F program is to help prepare new faculty for successfully submitting competitive grants to the NIH. We therefore require submissions to be in the NIH format, but the Research Plan is limited to five pages.

The five-page Research Plan should include:

  • Specific Aims
  • Significance
  • Innovation
  • Approach, as outlined by the NIH for R01 submissions

Given the reduced length of the P&F, modify section lengths accordingly but include all sections following NIH guidelines. The rest of the items in the Table of Contents (i.e. 5-15) should be included if they fall within your proposal (i.e. if your project involves animal research, include item 10; if you have a SUB, include item 13). However, only the Specific Aims, Significance, Innovation and Approach sections of the proposal are required to be within the five-page limit.


Are there any specific requirements given the new NIH guidelines regarding clinical trials?
Yes. P&F projects that will support clinical trials of more than minimal risk to a participant must receive prior, written approval from NIH. You must document whether your application will support such a clinical trial at the time you apply. Should your application be selected for funding, we will request additional information to be provided to NIH officials. Please see these guidelines regarding Human Subjects Research Proposals


Why is an EIN required on the application?
The EIN is a required field in the PHS 398 forms. We also need this information for awardees from sites other than Joslin Diabetes Center.


Are IRB/IACUC approvals required when applying?
In many cases applicants will already have relevant institutional IRB or IACUC approvals, and studies can begin immediately upon initiation of the award. While IRB/IACUC approvals are not required at the time of application, if an award is made neither experiments nor spending can begin until all institutional approvals are in place.
 

What budget is required?
P&F funding is limited to $50,000/year in direct costs. Submission of a detailed budget and justification helps the reviewers and oversight committee appropriately evaluate the proposal. P&F awards do not cover indirect costs.
 

How much money is available for each Pilot and Feasibility grant?
Pilot and Feasibility awards are for up to $50,000 per year for a maximum of two years. Awards are made annually, with the second year of funding contingent upon adequate progress in Year 1 and the absence of new overlapping funding, as documented in a required Progress Report to be submitted during the 4th quarter of the first year of funding. These awards are for direct costs only. As with any grant, if you wish to receive a second year of funding, you must submit a two-year budget request.


How many Pilot and Feasibility grants will be funded?
The total number of Pilot and Feasibility grants awarded during any individual cycle is determined by (1) the availability of Pilot and Feasibility (P$F) Program funds and (2) the quality of the applications received. In general, the Joslin Diabetes Center DRC aims to fund two new Pilot and Feasibility projects each year and two renewals of the previously awarded P&Fs.


What happens once I apply?
All applications will be reviewed by two to three (or more) reviewers. Decisions will be based on reviewer scores as well as applicability to the DRC mission. Final decisions will be made by an oversight committee and notification letters will follow.


What is the timeline?
The application process is a two-step procedure:

  • The interested candidate should submit an electronic “Letter of Intent” (LOI) and NIH biosketch by 5 p.m. on Monday, December 2, 2019 
  • Received LOIs will be reviewed for eligibility and priority, and successful candidates will be invited to electronically submit a five-page Research Plan proposal, following an abbreviated version of a standard NIH application, due by 5 p.m. on Monday, February 10, 2020.

These applications will be reviewed and the awarded P&Fs will be eligible for funding to start on or about April 1, 2020.

At the end of the year, each investigator will be asked to demonstrate progress on their project in order to justify a second year of support, and a final report is required at the end of the funding period.


What if my proposal involves human subjects?
If your proposal involves human subjects, please review the Human Subjects Project Proposal Resources Document

 

What is the "2020 Special Program Opportunity?"

The purpose of the NIDDK’s Division of Diabetes, Endocrinology and Metabolic Diseases (DDEMD) Administrative Supplement Program for its Diabetes Research Centers program is to enable opportunities for licensed and board-eligible MDs to conduct patient-oriented research within the Division’s mission. The program will provide supplementary funds to the Centers’ Pilot and Feasibility (P&F) Programs to co-support clinical research opportunities for exceptional emerging physician-scientists (hereafter, “candidates”) holding the MD (or equivalent) or MD/PhD, and who are early in their clinical research careers and show great promise to develop into future independent researchers. Please see more information in the FAQs Regarding the Special Program Opportunity for 2020 below.

 

What is the Program?
Administrative Supplements for NIDDK Diabetes Research Centers to Enable Clinical Pilot & Feasibility Studies in Diabetes, Endocrinology and Metabolic Diseases for Emerging Physician Scientists

The purpose of the NIDDK’s Division of Diabetes, Endocrinology and Metabolic Diseases (DDEMD) Administrative Supplement Program for its Diabetes Research Centers program is to enable opportunities for licensed and board-eligible MDs to conduct patient-oriented research within the Division’s mission. The program will provide supplementary funds to the Centers’ Pilot and Feasibility (P&F) Programs to co-support clinical research opportunities for exceptional emerging physician-scientists (hereafter, “candidates”) holding the MD (or equivalent) or MD/PhD, and who are early in their clinical research careers and show great promise to develop into future independent researchers.

The supplement is intended to allow candidates to expand their clinical research experience and productivity to help them successfully compete for independent research funding in the next stage of their research careers as physician-scientists. The supplement cannot be used to replace Center P&F funding of the candidate’s project but to augment the level of funding to allow human subjects research activities that might have been too expensive under the Center’s standard funding policies.

Administrative supplements must support work within the scope of a currently funded (or approved for funding) patient-oriented clinical research P&F project (see definition below).

Successful supplement applications will demonstrate:

  • How the proposed P&F project will advance the candidate’s independent research career consistent with his/her career stage and goals
  • The candidate’s qualifications and potential to succeed as a physician-scientist to conduct independent research within DDEMD’s mission


Who is Eligible to Apply?
A PI/PD, or Multi-PIs, of an active NIDDK Diabetes Research Center P30 award with a project period end date in June 2022 or later. Centers must have an identified candidate who is eligible and meets the criteria described below at the time of application. Only one supplement application will be accepted from each Diabetes Research Center.


Eligible Candidates
Each candidate must (1) hold an MD (or equivalent) or an MD/PhD degree; and (2) be licensed and board-eligible or board-certified in the US. US Citizenship or permanent residency is not required but candidates must have legal verification that allows them to work in the United States; (3) have no more than 4 years of postdoctoral research experience at the time of supplement application; (4) have no current or prior independent career development support from either a federal or non-federal agency; (5) have never been a PD/PI of a substantial NIH independent research award (R01, R21, etc., or equivalent); and (6) be starting a new P&F award no later than September 2020, or currently be the recipient of a DDEMD-funded Center P&F award for which the clinical research project has not been on-going for more than 3 months.


Eligible P&F Projects
The P&F project must have undergone the Center P&F Program review process, and already be approved for funding by the Center. For P&F projects that already received their first year of Center P&F funding, the clinical study itself may not be on-going for more than 3 months at the time of submitting an application to NIDDK. P&F projects in their second year of funding are not currently eligible for this pilot program. The P&F project must be a patient-oriented research project defined as: research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which the candidate directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients. For this opportunity, patient- oriented research is research where it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects’ research are not included in this definition.

In addition, the P&F research project must fall within the primary research mission of DDEMD

  • Diabetes: diabetes and other metabolic disorders, including inborn errors of metabolism and rare genetic metabolic diseases such as lipodystrophy and maturity onset diabetes of the young (MODY); non-pulmonary aspects of cystic fibrosis pathogenesis and pathophysiology; metabolic or endocrine complications related to HIV or anti-retroviral therapy; complications of diabetes that affect multiple organ systems, or the specific complication of diabetic foot ulcers, peripheral sensory neuropathy, and neurovascular or neurocognitive complications of diabetes.
  • Endocrinology: development, metabolism of the endocrine system including pathophysiology of endocrine disorders involving thyroid and parathyroid; neuroendocrinology of energy balance, including neural pathways and peptides that regulate feeding behavior, satiety and energy expenditure;
  • Metabolism: mechanisms regulating metabolism, metabolic dysfunction and tissue crosstalk in specific peripheral tissues such as adipose, bone, muscle, or liver; effects of the intrauterine environment on metabolic responses in offspring.

Topics outside of the areas noted above that are within the mission of other NIH ICs, or other scientific Divisions of NIDDK will not be considered responsive to this initiative. For example, nonresponsive research topics include diabetic cardiovascular disease (NHLBI); diabetic retinopathy and non-autoimmune ophthalmopathy (NEI); diabetic nephropathy and uropathy, or studies of the renin-angiotensin system (supported by NIDDK's Kidney, Urologic and Hematologic Diseases Division); diabetic gastroparesis, Nonalcoholic Fatty Liver Disease, or complications of obesity (supported by NIDDK's Digestive Diseases and Nutrition Division).

In addition, studies focusing on the primary prevention or treatment of gestational diabetes, or the immediate pregnancy outcomes of women with diabetes are in NICHD mission areas. Reproductive endocrinology is also not within the mission of NIDDK and studies on this topic will not be supported under this announcement.


How would I apply for this supplemental funding?
Additional information will be provided to those candidates whose LOI indicates that they (and their proposed project) would be eligible for the supplemental funding from NIH. If eventually selected by Joslin as an awardee, such a project can be nominated by Joslin for the supplemental funding.

Apply now for the Pilot and Feasibility Grants.
All applicants are required to log in and submit proposals. For further questions about the Joslin DRC P+F Grant Program and the application process, please email PandF [at] joslin.harvard.edu.