Key Dates

Related Announcements

NOT-HL-24-020 - Notice of Early Expiration and Reissuance of NOT-HL-22-039

PA-20-272- Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

RFA-HL-24-004 - Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (R25 Clinical Trial Not Allowed)

RFA-HL-24-003 - Programs for Inclusion and Diversity Among Individuals Engaged in Health-Related Research (PRIDE) Coordination Core (U24 Clinical Trial Not Allowed)

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

Purpose

This Notice invites applications for administrative supplements to existing PRIDE Summer Institute (SI) programs to support program mentees in carrying out Small Research Projects (SRPs). Briefly, mentees in an active cohort will be eligible to be supported by their host PRIDE SI to conduct SRPs during or immediately following their first SI. These pilot studies are intended to be conducted over 9-12 months in the interim between the first and second SIs with guidance from SI and institutional mentors. Updates on projects are expected to be provided at the mid-year SI meetings, the consortium-wide PRIDE Annual Meetings, and/or during the mentee's second SI.

Background

The NIH recognizes a unique and compelling need to promote diversity in the NIH­-funded biomedical, behavioral, clinical, and social sciences workforce. The National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases, and sleep disorders and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups, improve the quality of the educational and training environment, balance and broaden the perspective in setting research priorities, improve the ability to recruit subjects from underrepresented groups into clinical research protocols, and improve the Nation's capacity to address and eliminate health disparities.

The overarching goal of the Programs for Inclusion and Diversity among Individuals Engaged in Health-Related Research (PRIDE) program is to increase research independence among biomedical research scientists, including individuals from underrepresented groups (e.g., see NOT-OD-20-031), focused on heart, lung, blood, and sleep (HLBS) conditions. The program will be comprised of Summer Institutes (SIs) led by faculty mentors supported by RFA-HL-24-004, a Coordinating Core supported by RFA-HL-24-003, and the NHLBI Program Office. Each SI focuses on an area of science relevant to the NHLBI mission, and will conduct a 2-year mentoring program for 4 sequential cohorts of 6 to 12 mentee-scholars. The SIs work together with the Coordinating Core (CC) to establish mentor(s)-scholar teams which are matched based on common research interests. Mentors are recruited from the mentee-scholars' institutions, the SI’s sponsoring institution, and nationally, to complement the needed expertise for the mentees’ career goals. Mentees are selected via an application process managed by both the CC and the SI programs. Eligible candidates must have a doctoral degree, a faculty position upon matriculation, an early career status or new career focus, and protected time assured by their department chair or dean to participate in the program and conduct mentored research. In 2019, the PRIDE program added support for Small Research Projects (SRP) which enabled funding for pilot studies led by mentees participating in the summer institutes, intended to provide preliminary data to bolster a future grant application.

Research Objectives

Proposed studies must focus on an NHLBI mission interest area or cross-cutting methodological area in an NHLBI area of scientific focus. As administrative supplements, the work proposed needs to be within the scope of the research or training that is already supported. Funds will be provided to perform additional research within the scope of the parent grant (i.e., aligned with the scientific focus of the R25 program) to help foster the research career development of the PRIDE mentee. Types of mentee research studies that can be supported by the SRP funds are limited to:

a) ancillary studies to an NIH-funded and registered clinical trial (no independent, NIH-defined clinical trial can be supported); and

b) independent, non-clinical trial research studies. These non-clinical trial research studies do not have to be attached to an NIH-funded study and can be qualitative/formative studies such as focus groups, interviews, surveys, observational study designs, etc., or basic science studies not involving humans.

Applicants will need to provide documentation of regulatory approvals/compliance as applicable to the proposed studies (e.g., Institutional Animal Care and Use Committee approval , institutional review board approval).

Eligibility

Only currently awarded PRIDE Summer Institute programs (R25) are eligible for this program. Mentees supported by the SI's SRP supplement must have an active appointment to the PRIDE program and have completed only the first summer institute at the time of application for the administrative supplement. Upon award of the SRP, mentees are expected to conduct their research during the interim between the first and second summer institute. Pending the timing of the SRP supplement award, it may be necessary for mentees to continue their research several months after the completion of the second summer institute (even if their formal appointment to the R25 has been terminated) in order to complete their award term.

Evaluation

The PRIDE Coordination Center will be expected to include the impact of SRPs as a part of the overall PRIDE program evaluation.

Before submitting an application, applicants are strongly encouraged to consult with the Program Official for the parent grant or the contact listed below to confirm eligibility and to obtain technical assistance.

Application and Submission Information

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

• PA-20-272 - 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-20-272 must be followed, with the following additions:

• Application Due Date(s) – Applications for a new supplement may be submitted immediately following the cohort's participation in their first Summer Institute (SI1) between August 1 and November 1. Administrative review will begin after October 1.
• For funding consideration, applicants must include “NOT-HL-22-039” (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.
• Applications nonresponsive to terms of this NOSI will not be considered.
• Applicants may submit one administrative supplement request per mentee cohort (i.e., one supplement request per performance period following the first Summer Institute). Mentees who have completed their second summer institute may not be supported on the supplement application without prior approval by NHLBI program staff.
• Budget: Each SI site may request up to $113,636 in direct costs plus 8% Facilities and Administrative costs per cohort. NHLBI may enhance support for SRPs if additional resources become available.
  • Applicants must have sufficient time remaining to complete the proposed studies within the current approved project period of the parent award.
  • Duration of support may be a minimum of 6 months and a maximum of 12 months for each mentee.
  • A detailed budget justification must be provided individually for each mentee that will be supported with supplement funds.
• Research Plan Form: When preparing the administrative supplement request, applicants must follow the appropriate page limits for the activity code of parent award, in this instance, the R25. The Research Education Program Plan (uploaded via the Research Strategy on PHS 398 Research Plan form) should include:
  • A summary of the funded R25 award and a description of how the proposed project of each mentee fits within the SI’s focus area;
  • For each mentee include:
    • description of the planned studies;
    • a mentoring plan to facilitate the research and career development of the mentee;
    • how the proposed study will prepare the applicant to be competitive for NIH grant funding as an independent biomedical scientist; including milestones and a timeline for submitting an NIH grant application or equivalent within two years of completing the PRIDE program.
• Senior/Key Person Profile (Expanded) form: List the PD(s)/PI(s) as the first person and include a biographical sketch. List the PRIDE mentee(s) to be supported as subsequent person(s).
  • Include a biosketch for each mentee, any mentors, and any senior or key persons directly involved in activities related to the supplement. Biosketches of mentors and other senior and key persons should provide evidence of past mentoring experience.
  • The personal statement of the mentee's biographical sketch should address the mentee’s motivation to enter and/or remain in biomedical research in HLBS conditions; their research objectives and career goals; evidence of scientific achievement or interest; and any source(s) of current funding.
• R&R Other Project Information form, in the "Other Attachments" field:
  • Mentee Eligibility Statement(s): For each mentee, attach a signed statement from an institutional official establishing the eligibility of the mentee for support under this program. The statement must include clearly presented information on citizenship status of the candidate, affirm mentee has an active appointment to the parent award at the time of application (i.e., mentee is a member of the cohort completing their first Summer Institute), and a description of how the specific mentee would further the goals of this funding opportunity, consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). The strength of this statement will be considered by the NIH administrative review committee along with all other material provided.
  • PRIDE Coordination Center Concurrence: A signed statement from the PRIDE Coordination Center PD(s)/PI(s) affirming their review of the application and concurrence for submission. This letter may include a brief summary of the PRIDE Coordination Center's assessment of the application for alignment with program goals, and, for each supported mentee, confirm mentee's eligibility for the SRP, appropriateness and feasibility of study aims and timeline, and appropriateness of mentoring plan.
  • Home Institution Approval: For each mentee, especially under circumstances where the mentee(s) and/or mentor(s) would be at a site other than the grantee institution, an appropriately signed letter(s) from the institution(s) where the research is to be conducted must also be submitted. It should re-affirm the protected research time and available resources (e.g., personnel, office/laboratory space, core facilities, etc.) provided to the mentee upon matriculation into the PRIDE program and affirm adequate protected research time (a minimum of 10% effort) and resources that will be available for the research to be supported by the supplement. The request must be signed by the mentee, the mentee's Dean or Division/Department Chair, and the appropriate institutional business official of the home institution and/or subrecipient organization.
  • Regulatory approvals: If applicable to the supplement activities, attach PDF documentation indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution and/or applicable performance site. Name the documents “[Mentee Name] IACUC Documentation.pdf” and/or “[Mentee name] IRB Documentation.pdf” Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.
• Applicants are strongly encouraged to notify the program official of the parent award that a request has been submitted in response to this NOSI in order to facilitate efficient processing of the request.

The progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested.

NHLBI must be informed no later than 30 days of award termination. If the supplement has been in effect at least six months, a Final Progress Report must also be submitted.

Application Review Information

Administrative supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

In coordination with the PRIDE CC, the NHLBI Program Staff will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used to evaluate supplement applications:

• The plan and timeline for the proposed research and career development experiences in the supplemental request and their relationship to the parent grant.
• Proposed work is within NHLBI scientific areas and within scope of the parent award.
• The qualifications of the mentee(s) including career goals, prior research training, research potential, and any relevant experience.
• Evidence that the proposed experience will expand and foster the research capabilities, knowledge, and/or skills of the mentee(s).
• Strength of the commitment of the PI(s)/PD(s) commitment to their mentees' scientific and professional development and career progress within the biomedical research enterprise; adequacy of mentoring and scientific oversight of proposed studies.
• Appropriateness of the milestones and timeline for submitting an NIH grant application or equivalent within two years of completing the program.

Funding for supplement applications is not guaranteed. As with all supplement requests, a financial review to determine the need for additional funds will take place by the Office of Grants Management before a final funding decision is made.

Inquiries

Please direct all inquiries to:

Nicole Redmond, MD, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0379
Email: [email protected]