NHLBI Research Supplement Application Guidelines

The National Heart, Lung, and Blood Institute (NHLBI) participates in the NIH Research Supplements to Promote Diversity in Health-Related Research (Admin Supp – Clinical Trial Not Allowed) (PA-21-071). This document has been prepared to assist Principal Investigators, Project Leaders of Program Project grants, and Contractors with active NHLBI grants and contracts, and their prospective candidates with the preparation of research supplement applications. This document constitutes what the NHLBI will accept for consideration within the scope of the NIH Funding Opportunity Announcement (FOA). This program is designed to attract and encourage individuals who are underrepresented in the biomedical, behavioral, biometric, clinical, social sciences, and nursing research, by providing a continuum of research opportunities, from as early as high school student to faculty levels. The overall goal is to increase diversity in the research workforce by providing training opportunities to individuals whose basic or clinical research interests and skills are grounded in the advanced methods and experimental approaches needed to solve research problems. These guidelines should also be used for applications by Established Investigators who are or become disabled during the life time of their award and for Re-Entry and Re-integration (NOT-OD-21-134) applicants.

The research emphasis in the NHLBI program is on cardiovascular, pulmonary, and blood diseases; transfusion medicine; sleep disorders; and all other mission areas supported by the NHLBI.

The NHLBI encourages diversity on all research training support mechanisms. Before submitting a supplement application, individuals and their mentors should explore other training and career development programs which may provide research training opportunities (e.g., F30, F31, F32, K01, K08, K23, K99/R00, T32, and T35). Candidates should include plans to apply for individual fellowships, career development awards, or research grants for faculty candidates.

The list of eligible grant and contract mechanisms is provided in SECTION 4.2.

As with all supplement requests, a financial review to determine the need for additional funds will be performed by the NHLBI Office of Grants Management before a final funding decision is made. Therefore, the application should state the current unobligated balance for the parent grant at the time of application submission. All applicants must include a statement addressing the bona fide need for additional funds and why the use of current grant funds cannot be utilized for this supplement.

1.1. Diversity

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-20-031).

Every facet of the United States scientific research enterprise — from basic laboratory research to clinical and translational research to policy formation –requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, particularly those from underrepresented groups, who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

1. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).
2. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.
3. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:
   1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
   2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
   3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
   4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
   5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
   6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
   7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

4. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/ ).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.

Note: This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

1.2. Established Investigators Who Are or Become Disabled

Established investigators (PDs/PIs) on an NHLBI research grant, program project grant, center grant, cooperative agreement or contract who are or become disabled during the current project period and costs are not covered by disability insurance provided by employer, State or Federal Government may request funds for reasonable accommodations to permit completion of the currently funded research project. Any currently funded PD(s)/PIs of an NHLBI research project grant, program project grant, cooperative agreement or contract may request support for special equipment, an assistant, or other modifications to facilitate reasonable accommodation to a disabling injury or illness that has occurred during the current project period. Refer to Section 6.8.

1.3. Re-Entry, Re-integration and Re-training

The goal of this program is to provide support for a mentored research training experience for individuals with high potential to re-enter or re-integrate or re-train in an active research career, after an interruption for family responsibilities or other qualifying circumstances. This program encourages administrative supplement applications to existing NIH research grants to support full or part-time mentored research experiences by these individuals. The supplement grants are intended to provide these scientists an opportunity to update or extend their research skills and knowledge and prepare them to re-establish or revitalize their careers in basic biomedical, behavioral, clinical, translational or social science research. Refer to Section 6.9.

2.1. SUBMISSION

NHLBI Diversity Supplement and Re-Entry Supplement applications must be submitted using the following methods for each specific type of award:

• Grants and Cooperative Agreements through eRA Commons. Please refer to PA-21-071, Section IV. Application and Submission Information
• Contracts may be submitted by email as a PDF.

Prepare supplement applications according to instructions in Section 7. APPLICATION PROCEDURES.

All requests for a supplemental diversity award must include the following items:

• Name of Candidate congruent with eRA Commons profile information (NOTE: Please ensure that the candidate being proposed for the diversity supplement has a profile in the eRA Commons)
• Proposed diversity supplement research aims separate from the activities of the parent award
• Proposed budget and budget narrative

NOTE: Only one candidate may be included for each administrative supplement request, though more than one request may be submitted for different candidates. Each applicant for a diversity research supplement will follow the SF 424 instructions for supplement submission.

2.1.1. ERA COMMONS SUBMISSIONS

For grant and cooperative agreement supplement submissions, please refer to: PA-21-071 Section IV. Application and Submission Information.

Effective January 25, 2018, all grant applications for diversity supplements must be submitted electronically.

For eRA Commons, login to the eRA commons, identify the parent award, and prepare an administrative supplement request.

Include the candidate’s eRA Commons Username and attach the Research Experience Plan (in the SF424 Research Plan Form), Candidate Biosketch (in the Senior/Key Personnel Form, also called the Applicant Biosketch), and the Candidate Eligibility Statement (in Other Project Information/Appendix, also called the Applicant Eligibility Statement) in the fields provided. Although only one candidate may be supported on each request, grantees may submit more than one request on separate applications for the same parent grant.

2.1.2. Email Submissions – CONTRACT SUPPLEMENTS

PDF files of the application elements from the PHS 398 application package are available from the NIH Grants forms page. All elements of the application, including elements not available for download from the PHS 398 application package, namely, transcripts, letters of recommendation, etc., should be clearly scanned as PDF files and included in the application as a single PDF file sent by the Authorized Organization Representative (AOR). The subject line of the email must contain the phrase, ‘NHLBI DIVERSITY SUPPLEMENT APPLICATION’ and include PD/PI NAME and CONTRACT NUMBER, or ‘NHLBI RE-ENTRY SUPPLEMENT APPLICATION’ and include PD/PI NAME and CONTRACT NUMBER.

Submit Contract Application to:

• Office of Acquisitions: Elizabeth Bulger and Linda Smith

• Copy: Chair NHLBI Diversity Programs Working Group Desirée Salazar

• Copy: Division Representative (See Section 3) for your application

• Copy: Division Project Officer for the contract

2.2. RECEIPT DATES

An application for a new supplement may be submitted at any time. All applications should arrive at least three months before the requested start date to allow time for review. Applications seeking awards before the end of a fiscal year (September 30) must be received no later than May 31. Applications that arrive after this date will be considered for the next fiscal year’s funding.

For postdoctoral and investigator level supplements - Principal Investigators are strongly encouraged to synchronize the start date for the supplement award and the budget start date for the parent grant. The NHLBI may synchronize the requested start date if it is within three months of the budget start date of the parent grant to eliminate more than one award being made in a single fiscal year. Synchronization does not apply to contracts.

2.2.1. APPLICATION RECEIPT AND AWARD START SCHEDULE

For clarification of the provisions of the NHLBI Supplements Program, Program Directors/Principal Investigators planning to apply are encouraged to consult the appropriate Division Representative named below, the Program Official/Project Officer responsible for the parent grant/contract, or the Chair, NHLBI Diversity Programs Working Group.

4.1. Eligible Program Director(s)/Principal Investigator(s)

Program Director(s)/Principal Investigator(s) must hold an active NHLBI research grant, cooperative agreement, program project grant, or contract.

For supplements to parent grants that include multiple PD(s)/PI (s), the supplement should be requested by the contact PD/PI and submitted by the awardee institution of the parent grant. However, the mentor of the trainee may be any or all of the PD(s)/PI(s) on the award. Visit the Multiple Program Director(s)/Principal Investigator(s) policy and guidance for more information.

NOTE: Do not use this administrative supplement application to add, delete, or change the PD(s)/PI(s) listed on the parent award as per the NIH GPS please follow the prior approval requirements.

In addition, subproject PD(s)/PI(s) on multi component research grants (e.g. P01) must request supplements to their project through the overall PD/PI of the grant.

Established Investigators Who Are or Become Disabled: Established investigators (PDs/PIs) on an NHLBI research project grant, program project grant, cooperative agreement, who are or become disabled during the current project period may request funds for reasonable accommodations to permit completion of the currently funded research project. Any currently funded PD(s)/PI(s) on an NIH research project grant, program project grant, or center grant may request support for special equipment, an assistant, or other modifications to facilitate reasonable accommodation to a disabling injury or illness that has occurred during the current project period.

4.2. Eligible Grants or Contracts

NHLBI supported grant mechanisms listed in current PA announcement in addition to NHLBI supported research contracts (both within domestic institutions only) are eligible for Diversity Supplements - with the following exceptions:

R00 phase of the K99/R00, R03, R15, R21, and R61 Phase I & II - May support candidates at all career stages except for faculty level candidates.

R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II &

R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II &

U43/U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase I, Phase II

The NHLBI Diversity Supplement guidelines do not apply to the NHLBI SBIR/STTR Diversity Supplement program Refer to PA-24-255

R35: For transition of existing supplements and for new supplement submissions for support through the R35 Program, please see V. Award Administration Information, Question 11 within the R35 Program FAQs.

P20, P30, and P60 award mechanisms - only if they contain research components.

SC1, SC2, SC3 - Support of Continuous Research Excellence award mechanisms - are only to support postdoctoral researchers and faculty.

4.3. Candidates

4.3.1. ELIGIBLE CANDIDATES

Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-20-031). The strength of an institution's description and justification for the appointment of an identified candidate will be evaluated along with all other aspects of the proposed experience. Please refer to the review criteria in PA-21-071 Section V. Application Review Information.

The candidate may be affiliated with either the applicant institution or another academic institution.

Candidates may have had support on a National Research Service Award (NRSA) grant (T32 or F30, F31, or F32). Because this program is not intended to provide an alternative or additional means of supporting individuals who receive support from PHS funding mechanisms, individuals who are supported by an institutional Kirschstein-NRSA may not be transferred to supplemental support prior to the completion of their appointed period of training. A candidate's current NRSA training grant support cannot be terminated early to place the candidate on a research supplement. Please see Section 5.1. for the number of supplements candidates may have during their career. A scholar who has been appointed to an Institutional Career Development Award (K12, KL2) remains eligible for the diversity supplement program.

4.3.2. Ineligible Candidates

For diversity research supplements, an individual who has received previous funding from NIH as an independent PD/PI on a research grant (e.g., R01, R21), as the project leader on a component of a program project or center grant (e.g., P01, P50), or as PD/PI on an individual research career development award (e.g., K01, K02, K07, K08, and K23) is not eligible.

The supplement awardee can accept non-overlapping Federal or non-Federal support (e.g., an American Heart Association fellowship) while receiving support from a supplement, depending on the level of commitment (percent effort) to the various sources of support. It is the responsibility of the Recipient Organization to inform the NHLBI of any changes in non-supplement support to the candidate during the course of the supplement. Individuals may not be transferred to a supplement to increase the availability of funds to the parent grant or contract for other uses. Individuals may be supported by the parent grant for short periods, at the recipient’s risk, pending Institute/Center decision on the supplement application. (See “Pre-Award (Pre-Agreement) Costs” in the Section 2.5 of the NIH Grants Policy Statement for further information).

4.3.3. CITIZENSHIP REQUIREMENTS

Supplement awards are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of Permanent Resident Card, Form I-551) or some other legal evidence of admission for permanent residence at the time of application.

5.1. Number of Supplements Candidates May Have During Their Career

A candidate may be consecutively supported by, a high school (HSS), an undergraduate (URS), a post-baccalaureate (PBS), a graduate (GRS), a post-master's degree (PMS), a postdoctoral (PDS), and an investigator (IRS) supplement during his/her career advancement. Candidates may receive support from only one supplement program at a time as supplement awards may not overlap each other. These awards may be from different awarding components of the NIH.

NHLBI will award another supplement at the same level to the same individual to allow the maximum of up to 4 years of support to complete her/his research experience. Please contact the Program Administrator/Project Officer of the parent grant/contract or the NHLBI Division Representative in Section 3 - for the Supplements Program for more information.

5.2. Number of Supplements to a Grant, Subproject, or Contract

A parent grant or contract may support more than one individual on a supplement with the exception of Re-Entry and Re-integration candidates (see Section 6.9.), however, each request must be strongly justified and include assurances that each candidate will receive appropriate mentoring. Investigators are encouraged to recruit more than one high school or undergraduate student for support on a parent award to stimulate peer engagement and mentoring. Appointment of more than one individual to a single grant or contract above the high school or undergraduate level depends on the nature of the parent grant/contract, the circumstances of the request, and the program balance. Candidates may receive support from only one supplement program at a time, but may be supported by more than one supplement during the development of their careers. (Section 5.1.) Supplement awards are not transferable to another individual or transportable to another institution, grant, or contract.

A separate application must be submitted for each candidate provided adequate mentorship is assured.

5.3. Length of Supplement Award

The length of an award varies based on supplement level but may not exceed the current project period of the parent grant. NHLBI support for PBS and PMS level supplements may not exceed 2 years. Refer to the individual supplement levels in Section 6. for complete information.

Applications for supplements to grants or contracts with less than one year of research support remaining will only be considered for high school, undergraduate, and medical or other health professional students research support for a summer experience or during the academic school year.

PD(s)/PI(s) can support supplements through the duration of an active parent grant. This does NOT include time remaining for “no-cost” extensions or anticipated renewals. New supplement awards cannot be requested for grants in a no-cost extension status but supplement extensions can be requested while the parent grant is on a no-cost extension. See Section 10.

6.1. Overview

In addition to eligibility provisions discussed in section 4 there are special considerations associated with different career levels. The tables below describe special requirements for High School Students (HSS); Undergraduate Students (URS); Post-Baccalaureate (PBS) and Post-Master's (PMS) Degree Holders; Graduate (Predoctoral/Health Professional) Students (GRS); Postdoctoral Researchers (PDS); Investigators Developing Independent Research Careers/Investigator Research Supplement (IRS); Established Investigators who Are or Become Disabled; and Re-Entry or Re-integration Candidates (GRS/PDS/IRS).

Candidates. These programs are designed to attract individuals from underrepresented groups into research careers and are not intended to provide an alternative or additional means of supporting individuals who already receive support from an NIH research grant, an NIH National Research Service Award (NRSA), or any other DHHS funding mechanism. Individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses. Individuals who are supported by an Institutional NRSA (T32) may not be transferred to supplemental support prior to the completion of their appointed period of training. This program may not be used to provide technical support to NIH-supported investigators.

Supplement awards are not transferable to another individual or transportable to another institution, grant, or contract.

Research Plan. The research plan should be appropriate to the academic level of the candidate and discussed in sufficient detail to clarify the goals, milestones, and objectives of the work proposed. Refer to specific levels in the tables below. No aim deleted during the initial peer review may be proposed as the basis for any research supplement. The proposed research experience must be an integral part of the approved, ongoing research of the parent grant, and it must have the potential to contribute significantly to the research career development of the candidate. Applications for supplements must include a plan for the candidate to interact with other individuals on the parent grant, to contribute intellectually to the research, and to enhance her/his research skills and knowledge regarding the selected area of biomedical, behavioral, biometric, clinical, nursing, or social sciences. It must also provide evidence of a focus on the enhancement of the research capability of the supplement candidate and that the research experience is intended to provide opportunities for development as a productive researcher. In addition, it must demonstrate that the PD(s)/PI(s) is/are willing to provide appropriate mentorship, in accordance with the NIH criteria listed for Individual Development Plans.

NOTE: Research proposed for a supplement to a grant or contract that is determined by the NHLBI as being outside the scope will not be approved - See Section 7.1.4.

Budget. PDs/PIs can apply for support through the duration of an active parent grant. This does NOT include time remaining for “no-cost” extensions or anticipated renewals. New supplement awards cannot be requested for grants in a no-cost extension status. However, “cost” extensions of previously awarded supplements may be requested while the parent grant is on a “no-cost” extension - See Section 10. Requests for indirect costs (F&A) must be at the same rate in effect for the parent grant.

Reasonable Accommodations. As part of these awards, funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with her/his role on the project. The accommodations requested under this program must be DIRECTLY related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable, allowable and allocable and in relationship to the direct costs of the parent grant and the nature of the supplement award. Awardee’s are to follow their established written policies and procedures for reasonable accommodation to ensure consistent treatment of cost. See Section 7.1.10.5.

6.2. High School Student Supplement (HSS)

6.3. Undergraduate Research Supplement: (URS)

6.4. Post Baccalaureate (PBS) and Post Master's (PMS) Degree Holders

6.5. Graduate and Health Professional Students: (GRS)

6.6. Postdoctoral Supplement/Individuals in Postdoctoral Training: PDS

6.7. Investigators Developing Independent Research Careers/Investigator Research Supplement (IRS) - Long-Term Investigator Supplement

6.8. Supplements for Established Investigators Who Are or Become Disabled - PA-20-071

6.9. Research Supplements to Promote Re-Entry, Re-integration into, and Re-training in Health-Related Research Careers (Admin Supp - Clinical Trial Not Allowed) - NOT-OD-23-170

The instructions below apply to all grants or contracts requesting Diversity Supplements, Established Investigators Who Are or Become Disabled Supplements, and Re-Entry or Re-integration Supplements. Applications must be submitted via the parent grant or contract, thus subproject leaders/consortium PIs will submit their application through the PD/PI and the Authorized Organization Representative (AOR) listed on the parent grant. See Section 2.1. Prior to submission, Principal Investigators are strongly encouraged to contact the appropriate NHLBI Division Representative for the grant/contract (Section 3.). Although only one candidate may be supported under each request, grantees may submit more than one request on separate applications for the same parent award within the limits in Section 5.2.

7.1 Prepared by the program director/principal investigator

7.1.1. – ALL CONTRACT SUPPLEMENT EMAIL SUBMISSIONS REQUIRE:

• A new contract application face page from the PHS 398 for the supplement with the PD(s)/PI(s) contract information;
• The “Proposed Period of Support” dates to reflect the Supplement start and end dates (not the parent contract dates);
• The period of support cannot extend beyond the end date of the parent contract. Do not include periods for anticipated competing renewals or “no-cost” extensions of the parent contract.
• Please note that supplements that support a student’s pursuit of a degree will terminate at the time the degree is awarded;
• While “no-cost extensions” may occur throughout the life of a contract, new supplement applications will not be accepted during these periods.

7.1.2. CANDIDATE/APPLICANT ELIGIBILITY STATEMENT – INCLUDED AS PART OF “OTHER PROJECT INFORMATION” (SECTION 7.1.10.) 

• Parent Grant/Contract number and title;
• Type of supplement (Diversity, Investigator Who Is or Becomes Disabled, or Re-Entry/Re-Integration/Re-Training);
• Level of supplement requested (e.g., High School, Undergraduate, etc.);
• Statement verifying candidate’s U.S. citizenship or Permanent Resident status;
• Describe the basis for eligibility of the candidate (see Section 4.3. - Eligible Candidates);
• Describe how this particular appointment will help meet the NIH’s compelling interest in fostering diversity. See Section 1.1;
• Include a statement addressing the legitimate need for supplement funds and why awarded funds from the parent grant cannot be used to support this candidate. All supplement requests will have a financial review to determine the bona fide need for additional funds before a funding decision is made. The current unobligated balance for the parent grant should be provided;
• Statement that the Candidate has never received the type of PHS support prohibited by the Supplements Program (See Section 4.3.2. - Ineligible Candidates);
• Current email addresses for: Principal Investigator/Contractor, Authorized Organization Representative (AOR), Candidate, and Mentor if different from PI;
• Must be signed by the Program Director/Principal Investigator, and AOR on Institutional letterhead;
• Post-baccalaureate and Post-master's supplement must address the reason for the minimum 1 year research hiatus and provide a statement of the candidate’s intention to attend graduate/medical school;

7.1.3. SENIOR/KEY PERSONNEL & BIOGRAPHICAL SKETCH

List the PI/PD as the first person (regardless of their role on the supplement activities). List Candidate (who is being added through this supplement, or for whom additional funds are being requested through this supplement) as the Second Person - Enter 'Candidate' as Project Role. List any other Senior/Key Personnel (with a role on the supplement) i.e., Primary Mentor if not the PI/PD.

Biographical Sketch: Include a biosketch for all individuals listed on the Senior/Key Personnel profile, including the PD/PI, supplement candidate, and any other individuals directly involved in activities related to the supplement, including mentors, technicians, etc. Biosketches of mentors and other senior and key persons should provide evidence of past mentoring and training experience. Mentors should describe commitment to promoting inclusive and supportive scientific environments.

Co-PI Biosketches are not necessary. Include PMCID numbers for publications. See the NIH Public Access Policy for details.

If the institution would like to request support for multiple individuals, it must submit a separate application for each.

7.1.4. RESEARCH PLAN/RESEARCH EXPERIENCE PLAN/RESEARCH STRATEGY 

A brief summary of the parent grant, P01 subproject, or contract (typically the abstract or a summary paragraph). Contractors may choose to use the "Summary of Objectives", which is obtainable from the NHLBI Project Officer;

• Scope of the research planned for the Candidate - description of the Candidate’s research consistent with the supplement level;
• Must address how the supplement's research is related to the parent grant or contract's goals or how it is a logical extension of that research, depending on the level of the supplement;
• Describe how the proposed research experience will be an integral part of the approved, ongoing research of the parent grant;

While many Supplement levels require that the research be “a logical extension” of the parent grant, supplements must support work within the scope of the original project. Include a brief statement of assurance that the research delineated in the supplement is not an expansion (change in scope) requiring peer review (see the NIH Grants Policy Statement).

• Include a statement that the research proposed was not deleted by the Initial Review Group.

7.1.5. RESEARCH ENVIRONMENT/PROJECT PERFORMANCE SITE 

Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations;

Briefly describe and provide assurance that the Candidate can conduct her/his research in a well-equipped research environment with adequate space.

7.1.6. SUPPLEMENT BUDGET AND JUSTIFICATION 

Please provide the following information:

• Direct costs requested are only for the Candidate. The Budget Justification section should provide details about the costs requested for each budget item;
• For a grant supplement: the initial budget period ends on the parent grant's budget end date;
• For a contract supplement: the initial budget period requested is for one year;
  Refer to Section 7.1.7. for Funding Restrictions;
• The initial budget period, if less than 12 months, is prorated for all categories except travel;
• Indirect Costs (F&A): The F&A rate applied for the supplement is at the current rate for the Awardee institution. Please include a copy of the current F&A rate agreement with the application;
• Specify candidate's effort (Calendar/Person months) for each budget period;
• "Salary and fringe benefits" are in accord with the institution's salary compensation structure, but not to exceed the NHLBI’s salary cap or policy detailed for each academic level in Section 6. Details should be described in the Budget Justification section of the Budget Form;
• "Consortium/Contractual" category should be justified;
• Equipment is not an allowable cost except on Investigator-level supplements. Laptops or personal computers are not an allowable cost. "Equipment" category for the investigator supplement (IRS) is applicable only if very well justified;

Budget forms must contain the following:

Senior/Key Personnel information: PD/PI, primary mentor, and diversity candidate (name, role, person-months effort requested, base salary, requested salary, fringe benefits, and total funds requested for candidate only).

Other Personnel: Costs for Other Personnel should not be requested with the exception of supplements requiring reasonable accommodations or Supplements for Established Investigators Who Are or Become Disabled.

Equipment: In general, equipment may not be purchased as a part of this supplement except for IRS and For Established Investigators who Are or Become Disabled. Laptops or personal computers are also not allowable. See Sections 6.7. & 6.8.

Additional Funds: Additional funds may be requested for supplies, domestic travel, and publication costs relevant to the proposed research. See Section 6.

7.1.7. FUNDING RESTRICTIONS

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. (see also Section VI. Award Administration Information in PA-21-071 and NOT-OD-21-134).

An award does not preclude the institution's use of funds from other sources to supplement the award.

In most cases, during the first budget period, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds.

7.1.8. MENTORING PLAN

Provide a detailed mentoring plan for the Candidate that describes the approaches to be used such as frequency of one-on-one and group meeting; oral scientific presentations; instruction on how to critically evaluate the literature and experimental design; training in scientific writing (e.g., grant proposal preparation, manuscripts, and abstracts); designing experiments, etc.

Plans to enhance the candidate’s research capabilities should include:

• Specific skills to be acquired during the supplement experience;
• Milestones that will be reached during the supplement experience (e.g., acquisition of preliminary data, new research skills, presentation of research findings at local/national meetings, and publications);
• Opportunities to interact with research team;
• Opportunities to develop independence and to acquire presentation and publication skills;
• The mentoring plan must include guidance in the ethical conduct of research (including training in animal and human subjects' protection, if applicable). See Section 7.1.10.1.;
• A plan to attend and participate in poster sessions or oral presentations in at least one scientific meeting during each year of the award (particularly for the higher level supplements such as the PDS and IRS). (How opportunities will be provided for the Candidate to participate in writing and publishing scientific papers);
• It may be appropriate to include an experienced co-mentor in the development plan;
• Describe any planned outside laboratory experiences or collaborations for the Candidate;
• The role of other investigators who will contribute to the research mentoring should be described in the application. Their biosketches need not be included with the application. However, biosketches of the mentor and co-mentors must be included;
• How this experience will help the candidate move toward achieving her/his stated career goals;
• GRS, PDS and IRS candidates must provide, after developing in conjunction with the mentor, a projected time line delineating specific research milestones and other activities that will be undertaken in an attempt to secure independent research funding (i.e., anticipated publications, grantsmanship workshops, timeframe for grant submissions and type of independent research support the candidate seeks).

7.1.9. HISTORY OF MENTORING

The PD/PI/Primary Mentor should provide evidence of mentoring experience and success. Please provide a list containing: (1) Current Trainees, (2) Past Trainees (≤ 10 years), and (3) any current and past awarded Diversity/Re-entry research supplement awardee(s). For each of the individuals listed, please provide their current positions.

For the PD(s)/PI(s) with current and past Diversity/Re-entry research supplement awardee(s), please also provide:

• Supplement level;
• Start and end date of the award;
• Describe the outcome of the previous supplement(s) including the current status of the candidate(s) (i.e., title of current position and name of institution);
• Describe the outcomes of the prior development/mentorship plan;
• Describe any unexpected positive or negative occurrences that affected specific aspects of the development/mentorship plan or success of the candidate(s);
• Describe how these prior experiences influenced the development/mentorship plan proposed for the current candidate(s).

7.1.10. OTHER PROJECT INFORMATION/APPENDIX:

This section must include the items listed below and the Candidate/Applicant Eligibility Statement from Section 7.1.2.

7.1.10.1. Required Education in the Protection of Human Research Participants

For all NHLBI supplement awards involved in human subject research, candidates are considered “key personnel” and are required to submit documentation that they have received this education. NIH Human Subject Research information.

7.1.10.2. Candidate's Pending, Current, and Prior PHS or Non-PHS Support (“Other Support”) 

A Supplement awardee may participate in a federal or non-federal grant/contract other than the parent grant/contract as a non-key investigator, during support on the supplement award, providing the supplement percent effort requirement is met. Approval of the NHLBI Program Official/Project or Contract Officer is required to ensure that this activity will not interfere with the research training proposed in the supplement application and the required percent effort for the specific supplement level.

• List all pending, current, or previous PHS research grant/contract support with grant/contract numbers, start and end dates and associated percent effort devoted to each activity;
• List all pending, current, or previous non-PHS grant or contract support (e.g., from the Howard Hughes Institute, the American Heart Association, etc.) with start and end dates and associated percent effort devoted to each activity;
• Include information on current support from all other sources - private and public - jobs, university positions, etc;
• Provide assurance that these commitments will not interfere with the research proposed in the supplement application.

7.1.10.3. IACUC/IRB Documentation (Animal or Human Use Description and Documentation) - Number of pages as necessary

A detailed description of the involvement of human subjects and animals must be included in accordance with the instructions provided in the standard grant application, SF 424 for grants and PHS 398 for contracts.

Using the same animals or human subjects: If animal or human research is approved in the parent award, research proposed for the supplement will normally use the same animals or human subjects as is in the parent grant. Thus, if the supplement will use the same animal or human research protocols that were approved for the parent award by the Institutional committees--no new approval document is necessary. It may be necessary to modify the IRB or IACUC approval to add the Candidate as a participating investigator; check with your organization.

Using additional animals or human subjects: A new Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approval document from the appropriate institutional committee is required. The additional animals must be of the same species, and humans will generally possess the same gender, age, and reproductive status characteristics as those being studied in the parent award. In some cases, the Principal Investigator must also submit a new approval document from the IRB/IACUC as part of the supplement application or later under “Just-in-Time" procedures with a detailed description of the proposed changes.

Changing the animal or human model, from those approved in the parent grant, P01 subproject, or contract may constitute program expansion (or change of scope) and is not permitted for a supplement.

Inclusion of Women, Minorities, and Children in Research: If research involving human subjects is proposed, the supplement application must adequately address the NIH policies.

Biohazard: NIH Staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

7.1.10.4. Home Institution Approval/Approval to Conduct Research Away from Grantee Institution 

Under unusual circumstances where the candidate and mentor (usually the PD/PI of the parent grant) would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the Principal Investigator, the diversity candidate, and the appropriate authorized organization representative.

7.1.10.5. Reasonable Accommodations 

If the request is for a supplement based on disability, the institution should indicate what, if any, reasonable accommodations the institution has supported or plans to provide along with a full description of how any additional support for accommodation might be used. The relationship of the proposed accommodation to the proposed project must be described – See Section 6.1.

7.2.1. BIOGRAPHICAL SKETCH OF THE CANDIDATE - ADDITIONS TO SENIOR/KEY PERSONNEL FORM 

For eRA submissions: Candidates for diversity supplement support must have a profile in the eRA Commons, and the candidate’s Commons Username should be entered on the Senior/Key Personnel form. Submit the biographical sketch below as a single attachment under “Applicant Biosketch”.

A biographical sketch should follow the format available on the Biosketch Form or for contracts for email submissions. Include PMCID numbers on each publication as applicable. See NIH Public Access Policy for details.

Provide the following details:

• Degree(s), majors/area of concentration, "month" and "year"(s) awarded/expected, awarding institution(s);
• Name of home institution;
• Evidence of scientific interest, research experience, and accomplishments;
• List honors, awards, publications, and presentations, if applicable. Include PMCID numbers for each publication. See NIH Public Access Policy for details.

7.2.2. ADDITIONAL ITEMS

The items below must be included as part of “Other Project Information” (Section 7.1.10.) for the supplement application to be complete.

7.2.2.1. Candidate's Statement: Career Goals

Provide a signed statement with the following applicable details depending on supplement level:

• A one- to two-page statement prepared and signed by the Candidate outlining their career goals and how the supplement award will assist in achieving them;
• PBS/PMS should address the reason for the one- two year research hiatus and provide any steps taken to gain admittance into a graduate/medical school;
• Where relevant, the Candidate's work/experience/personal background may be included;
• For postdoctoral (PDS) supplements, career goals should be focused and specific; Individuals with more than 2 years postdoctoral research experience must justify the need for the additional training requested;
• For investigator (IRS) supplements, career goals should be focused and specific, the IRS candidate should specifically address how the supplement award will assist in achieving both short-term and long-term (securing independent research support) career goals;
• The Candidate’s Statement must include a telephone number and email address for the Candidate.

7.2.2.2. Certification that the Candidate Has Time to Conduct Research 

Only for high school or undergraduate students who wish to do their research during the academic year at another institution - Provide a letter from an appropriate official at the student's institution certifying that the student's participation at the stated level of effort is approved and will not interfere with the student's academic performance (not required for high school and undergraduate students participating in a summer-only research experience).

7.2.2.3. Letters of Acceptance/Documentation of Further Education Intention 

If the Candidate is a recently graduated high school, undergraduate, or graduate student (Master's level) and is seeking the next level of supplement (i.e., the summer before entering undergraduate/graduate school), a letter of acceptance from the admitting academic institution must be included with the supplement application.

If a post-baccalaureate or post-master's supplement candidate wishes to extend their research experience for a second year, evidence must be provided to show that the candidate is actively pursuing entry into a graduate or a health professional school. In addition, research progress and research proposed with additional aims for the additional year must be well documented. The request for funding must be submitted 3 months before the current supplement ends.

7.2.2.4. Education Achievement/References/Letters of Support

If relevant, confirmation that all requirements for graduation/degree have been completed at the time of application must be provided by the Institution.

High school, undergraduate, post-baccalaureate, post-master's, medical student or graduate student applications are to include either a scanned copy of their most recent transcript or provide a list of coursework and grades in their biosketch.

Reference letters are not required.

8.1. Review Process

Supplement applications will undergo an administrative evaluation by NHLBI staff, but not a full peer review. Applications will be evaluated using the criteria in Section V Application Review Information of the Program Announcement. Decisions will be based on the nature of the parent grant, circumstances of the request, the program balance and budgetary constraints. The Chair of the Diversity Program Working Group emails the PI, the candidate, and the AOR informing them of the outcome of the review. Depending on the status of the supplement application, the NHLBI Division-specific Representatives may contact the PI and Candidate. No announcement or commitments should be made before you receive an official Notice of Grant Award from the NHLBI. The supplement award decision cannot be appealed.

8.1.1. REVIEW CONSIDERATIONS FOR PRIORITIZING DIVERSITY SUPPLEMENT APPLICATIONS

• The qualifications of the candidate including career goals, prior research training, research potential, and any relevant experience;
• Evidence of educational achievement and interest in science, if the candidate is a student;
• The strength of the description of how this particular appointment would further the goals of this funding opportunity, consistent with the Notice of NIH's Interest in Diversity (NOT-OD-20-031);
• The plan and timeline for the proposed research and career development experiences in the supplemental request and their relationship to the parent grant;
• Evidence that the proposed experience will expand and foster the research capabilities, knowledge, and/or skills of the candidate.
• Evidence that the activities of the candidate will be an integral part of the project.
• Evidence of adequate mentoring experience and success.
• Evidence that the candidate will receive high quality research career mentoring.
• In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

8.1.2. REVIEW CONSIDERATIONS FOR PRIORITIZING RE-ENTRY/RE-INTEGRATION SUPPLEMENT APPLICATIONS

• The qualifications of the re-entry/re-integration candidate, including career goals, prior research training, research potential, relevant research experience prior to the onset of hiatus, and length of career hiatus.
• The plan for the proposed mentored research experience and its relationship to the parent grant.
• Evidence from the PD(s)/PI(s) that the experience will enhance the candidate’s research potential, knowledge, and/or skills
• Evidence from the PD(s)/PI(s) that the activities of the re-entry/re-integration candidate will foster the candidate’s independent research career trajectory. Evidence of effort by the re-entry candidate to initiate the re-entry process, such as attending scientific meetings, or keeping current with journals.
• Evidence that proposed research will achieve the stated objectives of the re-entry/re-integration supplement.
• Quality and appropriateness of the mentoring and career development plans, including the consistency of the proposed plan with the candidate's prior research experience and current and future research career goals.
• Strength of the mentor’s commitment to the applicant's continued research career development and independence.
• Strength of Institutional commitment to immediately address unlawful harassment and fully support and protect the candidate’s pursuit of continued research training in a safe and supportive environment

8.2. Supplement Funding Policy

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.

9.1. Supplement Progress Reports (Annual and Final)

9.1.1. ANNUAL PROGRESS REPORT

Grants: Every year, a noncompeting continuation application (Type 5), containing a satisfactory progress report, is required before funding is awarded for the next year of support. As part of this process and included in the Type 5 application, the Principal Investigator report must provide a progress report for the diversity supplement awardee. This supplement progress report should consist of two parts, one prepared by the Principal Investigator, the other by the candidate.

Contracts: Every year on or just before the anniversary date of the supplement award, a supplement progress report must be provided, as described for grants.

Components of Annual Progress Report

PD/PI:

• Dates for the period of support covered in the progress report (usually a year);
• A summary of major research objectives/experiences achieved in the current supplement award period.

Candidate:

• A summary of the research experience during the current supplement award period from their perspective;
• Details of any new techniques learned;
• A summary of participation at national and local meetings, workshops, poster sessions, and oral presentations;
• List any publications (as author or as part of the research team). Include PMCID if applicable. Discuss any literature research;
• HSS, URS, and GRS should provide evidence (statement from the PI) that the Candidate is maintaining good academic standing;
• Update on status of attempts to secure independent research support, particularly at the higher levels (GRS, PDS and IRS).

9.1.2. FINAL PROGRESS REPORTS

Within four months of the end of the supplement, the final supplement progress report must be submitted with the Final Research Performance Progress Report (RPPR). This is critical to the continuing success of the program as a whole at the NIH.

Components of Final Progress Report

PD/PI:

• Dates for the entire period of support provided for the supplement;
• A summary of major research objectives/experiences achieved during the supplement;
• Any comments or suggestions about the strengths or shortcomings of the supplement program.

Candidate:

• A summary of the entire supplement research experience from the candidate’s perspective;
• Details of any new techniques learned;
• A summary of participation at national and local meetings, workshops, poster sessions, and oral presentations. List any publications experience (as author or as part of the research team);
• The impact the supplement program has had on future career plans, indicate all research support being sought or already obtained; professional appointments and honors, brief description of any new research responsibility the individual will assume;
• A future forwarding address and email contact;
• Any comments or suggestions about the strengths or shortcomings of the supplement program;
• Post-baccalaureate (PBS) or post-master's (PMS) candidate - must provide documentation on the outcome of the graduate/health professions school admission process on letterhead from the organization to which the candidate submitted an application;
• When the supplement ends, Program Directors/Principal Investigators are encouraged to maintain contact with the supplement awardees, particularly students and post-doctoral individuals, to encourage their continued involvement in biomedical research and promote their research careers.

9.2. Early Termination of Supplement Award

NHLBI must be informed no later than 30 days of award termination. The AOR must submit a letter by email, copying the Candidate indicating the reason for the termination, effective date of termination, the dollar amount being relinquished for current and future years, and follow-up contact information for the candidate. If the supplement has been in effect at least six months, a Final Progress Report must also be submitted. Submit the letter and the Final Progress Report to the NHLBI contacts listed in Section 3.

Requests for extensions should follow the submission procedures (See Section 10.1.1.) and must be submitted at least three months before the requested start date. To avoid gaps in support, extensions must begin immediately following the end date of the initial supplement award.

10.1. Cost Extension for Varying Periods for Supplements supported by grants

For students who have not yet completed their research experience, funds for continuation of support must be requested as a cost extension research supplement to ensure continued tracking of the individual supported. The request for continued support should NOT be included in the competing renewal, but instead, should be prepared as a Supplement Extension. Funds for continued support for a postdoctoral fellow or an investigator must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Postdoctoral fellows and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support.

NHLBI support for individual students by the supplement mechanism will be limited to four years at each Supplement level with the exception of PMS and PBS – Section 6.4. Additional time may be considered, particularly for students and investigators who have disabilities, but must be well justified.

An extension with additional funds for a limited period of time may be requested only under extenuating circumstances, provided that adequate time remains on the parent grant and the maximum time permitted for an NHLBI supplement is not exceeded. An application for a “cost” extension is permissible when the parent grant is on a “no-cost” extension. Cost extensions will not be made for less than three months. Support for cost extensions is not guaranteed. Applications must arrive at least three months before the requested start date, to allow adequate time for review and notification of the outcome.

10.1.1. COST EXTENSION APPLICATION PROCEDURES

Resubmit a new electronic supplement request for grant submissions. See Section 2.1. SUBMISSION

The cost extension application must include the following:

• Updated Research Experience Plan/Research Plan with a summary of the Candidate's research progress and a brief description of the research that will be conducted during the extension, with assurance that the research to be conducted during the extension is a part of the research proposed in the original supplement application. No new aims may be proposed (an exception, however, would be if the supplement is awarded until the end date of the parent grant, and the parent grant is renewed, the cost extension might extend with new aims related to the parent grant up to the maximum time permitted for the supplement);
• Updated Senior/Key Personnel information – with an updated biographical sketch for the Candidate which includes a list of publications resulting directly from the supplement award, including manuscripts submitted or accepted for publication. Include the PMCID, if applicable;
• A detailed budget with All other submissions submit new budget details along with justification in appropriate fields;

Other Project Information:

• A letter from the Program Director/Principal Investigator, countersigned by the institution’s Authorized Organization Representative and the Candidate, stating that the request represents an extension, justifying the extension and its critical importance in the Candidate's career;
• HSS, URS, and GRS should provide evidence (updated transcript and statement from the PI) that the Candidate is maintaining good academic standing. If a post-baccalaureate or post-master's supplement candidate who initially applied for one year wishes to extend their research experience for a second year, evidence must be provided to show that the candidate is actively pursuing entry into a graduate or a health professions school. In addition, research progress and research proposed with additional aims for the additional year must be well documented in the Research Experience Plan/Research Plan Section;
• Updated Mentoring Plan: The steps taken and timeline for career advancement, such as other grants awarded, pending awards, and their status and/or outcomes. If the initial supplement plan included any coursework, provide an update on the status of each course, especially those pertaining to Protection of Human Subjects.

Please send an email to the Chair of the NHLBI Diversity Programs Working Group, Division Representative, and Office of Grants Management contact to confirm submission of your cost extension application.

10.2. No-Cost Extension

No-cost extensions will be allowed on supplements to grants.

Provided adequate time remains on the parent grant, a no-cost extension may be requested via email from the institution’s AOR. This letter is sent to OGM; with copies to the NHLBI Division Representative, See Section 3. The extension will not be given beyond the end date of the parent grant. Effective FY 2011, supplements to contracts may not be extended through a “no-cost extension".