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  7. Centers for Diabetes Translation Research (P30 Clinical Trial Optional) FOA: RFA-DK-20-002 Frequently Asked Questions

Centers for Diabetes Translation Research (P30 Clinical Trial Optional) FOA: RFA-DK-20-002 Frequently Asked Questions

What is the purpose of the CDTR (P30) Program?

The purpose of this Centers program is to accelerate innovation of the spectrum of T2-T4 diabetes translational research (i.e., bedside to clinical practice and community settings, dissemination and implementation) to maximize positive impacts of research on population health through activities and core services that offer specialized expertise, tools, education, and support. For this renewal, an emphasis is placed on novel methods and research to address health equity and reduce diabetes-related health disparities as these are high priority areas for NIDDK. Additionally, novel research cores designed to improve other aspects of person-centered, community, and population health are also encouraged with a rationale for how such strategies may be adapted to meaningfully inform disparity-reduction approaches.

For the purposes of this FOA, T2 - T4 translational research is defined as research focused on translating interventions and approaches that have demonstrated efficacy into real-world healthcare settings, communities, and diverse populations with an emphasis on reach, sustainability, and potential for widespread implementation. This spectrum of research is distinct from T1 translational research (bench to bedside) which is not allowed for this FOA. Refer to the RFA for details and contact the program officer with questions about allowable T2-T4 translational research topics.

What NIH award mechanism is used for this Centers Program?

The CDTR program currently uses the “Center Core Grants (P30)” mechanism that supports shared resources and facilities for use by multiple investigators to enhance multidisciplinary approaches and collaborative research efforts focused on a common research problem or goal. The core grant is utilized by independently funded research projects. It is not intended for gap or bridge funding support for PIs/Co-Is and should be used by a broad membership base (versus the PI and Core Directors only).

How long has the CDTR program been in existence?

The NIDDK funded CDTR program was launched in 2010, RFA-DK-10-009. It has been renewed twice with RFA-DK-15-003 and the current RFA-DK-20-002. The RFA is an open competition whereby eligible renewal and new applications are allowed. For more information about the current program, visit the national CDTR website: https://www.diabetes-translation.org/.

General Eligibility

Can applicant organizations submit more than one application?

Yes. However, any application submitted by the same institution must be scientifically distinct and provide compellingly strong justification for why the investigators are not collaborating on one application to fully maximize intellectual and institutional resources and avoid potential redundancy. The CDTR program has limited funds and achieving portfolio balance will be considered in funding decisions that, in addition to a meritorious review outcome, will include objectives of obtaining as much national reach and breadth of relevant scientific topics as possible.

Can a renewal application propose a new PI who was not a PI/MPI on a previously funded CDTR grant?

Yes, institutions may propose a new eligible PI or MPI on renewal applications.

Can institutions propose a multiple PI structure from different institutions? For example, can University A and University B submit an application with PIs from each?

Yes, but only one of the PIs/institutions can serve as the contact PI. All requirements for a multiple PI application must be addressed. The Notice of Award will be issued to the institution of the contact PI.

Can a consortium member/sub-contract recipient partner institution on a previously funded CDTR grant propose a renewal application as the PI/MPI if the previously funded CDTR grantee institution is not included as a partner? For example, University A was funded in the last cycle under RFA-DK-15-003 with partners at University B and others. Can University B submit a ‘renewal’ application without University A listed as a PI/MPI?

No. Only the currently funded primary recipient awardee may submit a renewal application. However, a renewal application may propose to include a new consortium member institution(s). A renewal application may also propose a new multi-PI structure.

The consortium member institution may submit an application, but it must be submitted as a new application. The applicants may not include an Introduction but may discuss their role/experience as part of the previous CDTR in their Research Plan.

What is the required research base for this CDTR competition?

Per the FOA, a CDTR must be an identifiable unit within a single institution such as a university medical center or a consortium of cooperating institutions. CDTR applications must demonstrate an existing strong base of successful external research funding (NIH or non-NIH) that is related to T2-T4 translational research in diabetes and addressing health equity or disparities. Program excellence includes a consistent and outstanding record of publications and peer-reviewed research funding in related areas.

Conducting research on the social determinants of health (SDoH) is expected to require strong academic capacity involving traditional partnerships (academic, healthcare systems, etc.) and novel partnerships relevant to upstream conditions affecting the onset and progression of diabetes. The CDTRs are expected to leverage relevant skills and collaborations with other institutions, agencies, and sectors (e.g., different academic departments, health departments, healthcare systems, human service organizations, community-based organizations) to demonstrate a diverse scientific base that includes well-established and funded academic diabetes translation researchers and multidisciplinary and cross-sector expertise, where appropriate, for addressing the core service themes proposed.

How much funded research is required for the research base?

The research base for the CDTR, including any affiliated hospitals and proposed partners, must consist of at least $3,000,000 in direct costs per year of peer-reviewed research projects. All active grants (including those in a no-cost extension (NCE) may be included in Table A.1. Table A.1 may only include those grant mechanisms listed in the instructions.

For Table A.1 (research base), co-investigators may be listed, but their names should be included in parentheses in column 1. The direct and total costs should be those listed in the Notice of Award and not prorated based on an investigator’s role or share of an award.

May foreign institutions or non-domestic components apply?

No. Refer to RFA-DK-20-002 - Part 2, Section III Eligibility Information.

Is eligibility limited by the amount of current carryover on a renewal grant?

Eligibility is not limited by the amount of carryover funds on the renewal award.

Application Withdrawals

Applicants should review the RFA-DK-20-002 and application resources very carefully prior to submission. Missing or unallowable components may result in the application being administratively withdrawn.

https://www.niddk.nih.gov/research-funding/process/apply/funding-mechanisms/p30/centers-diabetes-translation-research-application-resources

CDTR Membership

Can CDTRs share members from different funded CDTR programs?

Other Centers

If there are other related NIDDK-funded centers or related centers funded by other entities at your institution, you should clearly articulate in the grant application what new areas your CDTR will address, i.e., avoid duplication, promote collaborations, and maximize institutional resources.

Requirments for Cores and Programs

How many research resource cores are required by this RFA? How many are optional?

Required translational research cores: The CDTR must address a minimum of two translational core services. It is strongly encouraged that applicants focus on interrelated clinical research or interventional activities that address health equity (e.g., health equity or health disparity reduction approaches) in addition to novel methods/measurement activities as these are high priority areas for NIDDK. Applicants may also propose additional core services to support novel prevention and intervention diabetes research that raise the health potential of all Americans, particularly those that may be adapted to reduce disparities; and for renewal applications, to ensure continuation and momentum and progress gained in relevant or complimentary research areas that may inform health disparities research.

As shown in the table below, a minimum of 2 translational cores are required and a maximum of 5 translational cores may be proposed.

Optional Resource Cores and Programs include

  • Optional National/Regional Resource Core: A CDTR may serve a wider scientific community on a geographic or national level through the establishment of national or regional resource core. This core can be located at the applicant institution or an affiliated institution, but any funds requested above the cap must be used to support national /regional activities outside the applicant institution(s) and its affiliated hospitals. Support for the expansion of outreach for the Center's Pilot and Feasibility (P and F) program to investigators at the institution where the National/Regional Resource Core is located may also be requested but is not sufficient to be considered a National/Regional program for the purposes of expanding the allowable requested funds. See Section IV (Application and Submission Information) for more details.
  • National Enrichment Program (to manage a national research symposium): The applicant may request support for a National Enrichment Program to attract graduate students and early stage career investigators to improve their understanding of cutting-edge scientific topics and pursuit of careers in diabetes translation research. Senior level researchers transitioning to the field may also be engaged. The primary goal of this national enrichment program is to manage a scientific symposium on an innovative diabetes translation research topic and seminal works to accomplish the following objectives (a) assess the state of the science of a novel topic/theme, (b) identify research gaps and needs CDTRs may be well suited to address through research resources, and (c) promote career development. The symposium will be held for a minimum of three years of the funding period. To further enhance activities in a coordinated fashion across all the NIDDK CDTRs, the national enrichment program should address or be complementary to health equity research topics. See Section IV (Application and Submission Information) for more details. Important note: The optional National Enrichment Program is distinct from the required Enrichment Program that must be included in each CDTR application.

What is the minimum number of translational research cores and programs my application should contain?

The FOA provides strict guidance on the maximum and minimum number of research cores and programs allowed as shown below.

  • Overall: 1 Required (Minimum: 1; Maximum: 1)
  • Administrative Core: 1 Required (Minimum: 1; Maximum: 1)
  • Translational Research Core: 2 Required (Minimum 2, Maximum 5)
  • Optional National/Regional Resource Core: None required (0 Minimum, 2 Maximum)
  • Pilot and Feasibility Program: 1 Required (Minimum: 1; Maximum: 1)
  • Enrichment Program: 1 Required (Minimum: 1, Maximum: 1)
  • Optional National Enrichment Program: None Required (0 Minimum, 1 Maximum)

If an optional National Enrichment Program is awarded, how many times will the research symposium meet and are all CDTR Directors and/or Co-Directors and Core Directors required to attend?

Frequency of the National Enrichment Program: If awarded, this program must organize and manage a national research symposium for a minimum of 3 years starting in grant year 2 of the award (i.e., a maximum of 3 symposia over the course of 3 years). Each symposium is expected to consist of 2-days using a format that integrates scientific sessions with nationally recognized speakers and investigators (including CDTR directors and affiliated investigators), poster presentations by early stage investigators, and time to interact with attending faculty and each other. A single CDTR award will be funded to operate this program in collaboration with an executive steering committee with representation from each funded CDTR.

Required attendance: CDTR PD(s)/PI(s) must participate in annual meetings of the Center Directors and, if funded, the National Enrichment Program’s symposium activity (again, if one is awarded). Thus, each CDTR must include travel costs for the CDTR Director and others as appropriate (i.e., co-Director, core Directors) to attend an annual grantee-related meeting each year in Bethesda Maryland area or at a location to be determined to attend the National Enrichment Program meeting.

What is the locus of review?

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by NIDDK in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

     

  • Will receive a written critique (summary statement).

How are reviewers instructed to review the different components of the application?

Reviewers are instructed to use only the review criteria set forth in the RFA. https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-20-002.html#_Section_V._Application

Reviewers give scores for individual components, and then an overall score for the entire Center application. The overall score is not an average of the scores of the individual components, as reviewers are encouraged to weight the criteria for the overall application as they deem best.

Are appeals allowed?

Appeals of initial peer review will not be accepted for applications submitted in response to this RFA.

How many optional cores or programs will be funded?

  • Optional National/Regional Cores: The number of awards will vary based on the number of meritorious cores received and available funds.
  • National Enrichment Program: It is anticipated that only a single CDTR award will include a National Enrichment Program that will be managed in collaboration with an executive steering committee with representation from all funded CDTRs.

Will applications be reviewed by NIDDK’s National Advisory Council?

Yes.

When will funding decisions be announced?

The awards will be announced by July 2021 which is the earliest possible start date for the grantees.

What are key dates for the CDTR RFA?

Opportunity Release Date Letter of Intent Due Date (optional) Application Due Date Scientific Merit Review Approx. Award Date
https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-20-002.html May 22, 2020 September 20, 2020 October 20, 2020 Feb/March 2021 July 2021

How do I apply to the RFA?

In order to submit an application to the CDTR RFA, Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Pay careful attention to all application instructions in the RFA; noncompliant applications may be administratively withdrawn and not reviewed.

If I submit my application early, will it increase my chances of being funded?

No. All applications will be reviewed by a single peer-review panel organized by the NIDDK Scientific Review Office. Additionally, the funded grants will have the same start dates. As with any submission to the NIH, applicants are highly encouraged to submit early to allow time to correct any potential submission errors. Please allow plenty of time for preparation and submission of your application, and check with your institution’s grants office for their required timelines.

Will the RFA be renewed?

The CDTR program will be reviewed for potential renewal in approximately 4-5 years. If approved for renewal, a new RFA will be issued around that timeframe.

If my application is rejected, can I resubmit?

This RFA has a single submission date. Resubmissions are not allowable.

What are the budget limitations for applications to the CDTR RFA?

Application budgets are limited to $400,000 per year for directs costs, which includes: Administrative and Translational Cores, Enrichment and Pilot and Feasibility Program funds.

Additional funds will be provided for awarded optional National/Regional Resource Core(s) (up to $100,000 per year in direct costs beyond the $400,000 per year cap) or an optional National Enrichment Program (up to $100,000 per year for a maximum of 3 years in direct costs beyond the $400,000 per year cap). Refer to RFA-DK-20-002 - Part 2, Section II Award Information.

Prior Approval of Pilot Projects

Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIDDK prior to initiation.

In accordance with NIH policy https://grants.nih.gov/grants/policy/hs/index.htm and the NIH Guide

Announcement NOT-OD-15-129, the awardee institution is responsible for ensuring that any awarded P&F projects follow all relevant regulations and policies for Human Subjects Research. The following elements or procedures must be included in the awardee institution’s P&F program oversight plan, as appropriate for all HS research inclusive of both clinical studies and clinical trials:

  • Development and implementation of appropriate data and safety monitoring plans
  • Documentation of IRB approval
  • Registration of all clinical trials in clinicaltrials.gov
  • Development and monitoring of appropriate milestones
  • Oversight of participant recruitment and retention
  • Results reporting in clincaltrials.gov, as appropriate
  • Planning for dissemination of research results

Will applicants be required to attend a grantee meeting or other meetings?

As noted above, CDTR PD(s)/PI(s) must participate in annual meetings of the Center Directors and, if funded, the National Enrichment Program’s symposium activity (again, if one is awarded). Thus, each CDTR must include travel costs for the CDTR Director and others as appropriate (i.e., co-Director, core Directors) to attend an annual grantee-related meeting each year in the Bethesda Maryland area or at a location to be determined to attend the National Enrichment Program meeting.

The NIDDK has facilitated a monthly CDTR teleconference to promote scientific exchanges, collaborations, and to feature early works of P and F awardees. This opportunity may be available in the next funding renewal period. If so, grantees will have the option to participate and plan meeting agendas with topics of interest. Additionally, the CDTR grantees may opt to form Special Interest Groups to feature and promote cutting edge scientific research, and discuss research gaps and opportunities the CDTR program may be well-suited to address. These opportunities would be optional.

On 8/24/2020, a Notice was published to clarify the reporting requirements for P and F outcomes (renewal applications only). Renewal applications should report outcomes for the past 5 years or 10 years, if applicable. https://grants.nih.gov/grants/guide/notice-files/NOT-DK-20-044.html.

How can I get more information about these opportunities?

Websites:

Please visit the CDTR Application Resource page here for information about application tips and suggested tables.

Please visit the national CDTR Program website here for information about the currently funded Centers.

What additional resources or references are available online?

Clinical and Translational Science Award (CTSA) program (https://ncats.nih.gov/ctsa, https://clic-ctsa.org/)

NIH Common Fund activities (https://commonfund.nih.gov/)

NIDDK-funded Center programs such as the Diabetes Research Centers (https://diabetescenters.org/)

Nutritional Obesity Research Centers (https://norccentral.org/)

Digestive Diseases Research Centers (http://www.digestivediseasescenters.org/)