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​​​​​​​​​​​​​​​​​​​​​About the Travel Policy Branch

​The Travel Policy Branch develops policy and instructions for use across NIH, administers oversight of policies and procedures, and provides travel processing advice. Responsibilities​ include maintenance of the NIH Travel Manual contained in Manual Chapter 1500 assuring consistency with the Federal Travel Regulations and the HHS Travel Manual, provide advice to NIH Leadership and the travel community, and maintenance of the Conference Tracking System for NIH attendance at non-NIH hosted conferences providing approval for travelers to register, and supports the reporting requirements of the Cures Act.​​ ​

Additionally, the Travel Policy Branch administers NIH’s Travel Card program including application for cards, monitoring accounts to avoid delinquencies and improper card usage. For quick Travel Card do's and don'ts, proper use of travel card, traveler agreements, and additional FAQs, visit the  HHS Travel Policy Website.

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Visiting Program Scientists

About nih visiting program.

The National Institutes of Health (NIH) Visiting Program provides opportunities for foreign scientists to train and conduct collaborative research at the NIH, the principal agency of the U.S. ​Government responsible for conducting and supporting biomedical research. Annually, more than 2,000 scientists from other nations conduct research in the basic and clinical science laboratories on the NIH campus in Bethesda, Maryland, and in several field units around the country.

The NIH is composed of 27 different  Institutes and Centers . Working within and through these organizations, scientists investigate many aspects of basic biomedical sciences as well as specific diseases. These range from heart disease, cancer, stroke, and diabetes to influenza, tooth decay, arthritis, AIDS and other disorders that affect millions of people.

The knowledge, experience, and facilities at the NIH make it a unique international resource in the effort to understand, prevent, and cure disease. The NIH has long considered close interaction with foreign scientists in the conduct of collaborative research to be an essential ingredient in achieving its objectives.

The Visiting Program is open to foreign national scientists, typically those at the early stages of their careers. Foreign national scientists are not U.S. citizens or U.S. permanent residents. They are invited to conduct research and/or training at NIH on a temporary basis. NIH Intramural Research Program (IRP) designations are divided into two categories: Full-Time Equivalent (FTE) and Non-FTE. Each participant works closely with a senior NIH investigator who serves as supervisor or sponsor during the period of award or appointment. The Visiting Program is limited to the NIH IRP. NIH extramural programs are not authorized to use IRP designations.   

Visiting Fellow            

The Visiting Fellow award provides foreign national scientists with opportunities for developmental training and practical research experience in a variety of disciplines related to biomedical research, medical library research and related fields. There are two types of Visiting Fellows:          

• Postdoctoral Visiting Fellows – Candidates must have a doctoral degree or equivalent in the biomedical sciences and five years or fewer of relevant postdoctoral research experience at the start of the fellowship period.
• Pre-doctoral Visiting Fellows – Candidates enrolled in a doctoral degree program for whom the research experience is undertaken as an integral part towards completion of degree requirements.

A full description of the Visiting Fellow program, including eligibility requirements, can be found at the NIH policy manual for the Intramural Visiting Fellow Program (VFP). Current Fellowship opportunities are available under the “How to Apply” tab.          

Visiting Fellows receive a monthly stipend during the award period to cover living expenses. The stipend level is determined by the number of years of relevant postdoctoral research experience. Visiting Fellows are not considered employees of the NIH. U.S. citizens are not eligible for the Visiting Fellow award.*          

Visiting Fellow awards generally are made for two years, although a minimum one-year award is an option. Fellowships are renewable in one or two-year increments up to five years. Renewals are based on merit and are subject to approval by the hosting Institute/Center. All renewals are contingent upon applicable U.S. immigration rules and regulations.​​       

* U.S. citizens and permanent residents (“green card” holders) should apply for an Intramural Research Training Award (IRTA) or, if with the National Cancer Institute (NCI), for a Cancer Research Training Award (CRTA).       

Visiting Scientist            

Visiting Scientists are foreign national scientists appointed to Full-Time Equivalent (FTE) positions to conduct biomedical research. They are considered NIH employees, receive a salary and, depending on the length of appointment, receive most of the benefits available to employees of the U.S. Government. They are appointed via a special hiring authority referred to as “Title 42.”          

Dependent upon the amount of relevant postdoctoral research experience, the NIH Institute/Center will appoint the foreign national scientist to a particular FTE designation such as:           

• Research Fellow (VP)
• Clinical Fellow (VP)
• Staff Scientist (VP)
• Staff Clinician (VP)
• Investigator (VP)
• Senior Investigator (VP)

Current FTE opportunities are available under the “How to Apply” tab. Visiting Scientist appointments generally are made for up to two years, but may be made for a shorter period. Renewals are based on merit and are subject to approval by the employing Institute/Center. All renewals are contingent upon applicable U.S. immigration rules and regulations.​  

Visas         

Visiting Program participants must possess a valid United States non-immigrant, work authorized immigration status that permits training or employment. Most foreign nationals in the Visiting Program are found under one of the following non-immigrant visa classifications:        

• J-1 Exchange Visitor (Research Scholar)
• F-1 (Student - for post-completion practical training after award of doctoral degree)
• H-1B (Temporary worker in a specialty occupation)
• O-1 (Extraordinary ability in the sciences)

Under the NIH's J-1 Exchange Visitor Program, any clinical responsibilities are limited to incidental patient contact, and credit for medical specialty board certification is not available. To have full patient contact and/or obtain board certification, foreign national physician-scientists at NIH must conduct their training under as a J-1 Alien Physician sponsored by the Educational Commission for Foreign Medical Graduates (ECFMG) in those programs at NIH that meet graduate medical education or training accreditation standards.       

English Proficiency         

All Visiting Program participants must be proficient in the use and understanding of spoken and written English. This is necessary for the participant to successfully carry out the proposed research program and engage in day-to-day activities in the United States. Additionally, all Visiting Program participants must comply with the NIH Office of Intramural Research (OIR)’s policy on the Use of English for Official Scientific Communication in NIH Laboratories and Branches.        

Certain immigration regulations specifically require that the participant must be evaluated for English ability by an objective measurement of English language proficiency. This must be done by the hosting NIH Institute/Center (IC) before the participant can be offered immigration sponsorship by the NIH. In addition, the hosting IC must retain documentation of the measurement of English language proficiency and provide it upon request to the Division of International Services (DIS), Office of Research Services.   

To document English proficiency, the IC must retain documentation of one of the following:   

• Results from a recognized English language test
• For example: The participant provides a copy of an intermediate test score from the  Test of English as a Foreign Language  (TOEFL) or the  International English Language Testing System  (IELTS).

OR​​   

• Signed documentation from an academic institution or English language school
• For example: The participant provides a copy of his/her diploma and/or a signed, dated academic transcript if she/he obtained a degree from an educational institution in the United States or where instruction is all in English.
• For example: The participant provides a signed letter from his/her school that s/he possess English proficiency to be successful during his/her stay in the United States

OR   

• A documented interview conducted via in-person, videoconferencing, or telephone (if videoconferencing is not available)
• For example: The IC follows the  “English Proficiency Assessment: Sample Questions and Rubric”  to document the English proficiency of the prospective Visiting Program participant during the interview.

Taxes         

All Visiting Program participants must pay U.S. income taxes, unless they are determined to be exempt under an income tax treaty between the United States and their country of tax residence. Although the tax assessment differs according to stipend/salary level (higher levels are taxed at higher rates), Visiting Program participants can expect to pay at least 20 percent of their stipend/salary in federal income tax. (Those determined exempt due to a tax treaty may have to pay taxes to their home country, depending on the country/treaty). Visiting Program participants, including many exempt from federal taxes, must pay state income taxes, depending on their state of residence. Additional taxes may apply for those receiving Visiting Scientists/Full-Time Equivalent appointments.        

Additional details concerning taxes and income tax treaties are available here.        

Before leaving the United States, all foreign nationals must fulfill their tax obligations. After returning to their home country, they must file a final U.S. tax return by April 15 of the year following the year they received a stipend/salary in the United States.       

Vacation & Sick Leave         

Visiting Fellows may be granted excused absence at the discretion of their sponsors.       

In addition to federal holidays, Visiting Scientists/Full-Time Equivalent (FTE) appointments may request annual (personal/vacation) leave or sick leave. Guidance on leave for FTE appointments can be found on the NIH Office of Human Resources (OHR) website.       

Health Insurance         

All Visiting Program participants must have health insurance for sickness and accidents. J-1 Exchange Visitors (and accompanying J-2 dependents) are required by immigration regulations to be covered by health insurance, including medical evacuation and repatriation of remains. These regulations can be found on the U.S. Department of State website.       

The NIH pays the basic premium for health insurance coverage for Visiting Fellows and dependents (spouse and/or unmarried children typically under age 21) with the Foundation for Advanced Education in the Sciences (FAES). Information about the FAES insurance is available here.        

Visiting Scientists/Full-Time Equivalent (FTE) appointments have the option to enroll in the Federal Employees Health Benefits (FEHB) program that can also cover dependents (spouse and/or unmarried children typically under age 21) if the initial appointment is greater than 12 months. Details about FEHB and other government benefits can be found on the NIH Office of Human Resources (OHR) website. Those on an initial appointment of 12 months or less are responsible for making their own health insurance arrangements and paying the full cost involved.       

Compensation for Injury         

Visiting Program participants may use the Occupational Medical Service (OMS), ORS, OD, for injuries sustained and emergency care on the training assignment. Workers’ compensation and benefits under the Federal Employees Compensation Act may be available in the event of a work-related injury.       

Outside Work         

Immigration rules and regulations generally do not permit outside work, employment or income. Visiting Program participants may only work at the NIH as approved under his/her immigration status. NIH-sponsorship typically requires participants to work full-time at NIH facilities.       

All foreign national scientists—including those not sponsored by the NIH—must also abide by all applicable rules and regulations concerning conduct at the NIH. Therefore, Visiting Program participants may not accept outside employment or any compensation that results in a conflict of interest or even the appearance of such a conflict. Additional information is available under the NIH Ethics Program . For Visiting Fellows and other trainees, review the guidelines on outside and NIH-related activities .       

Foreign national scientists (pre/post doc) who wish to participate in the NIH Visiting Program must first secure an invitation for an award or appointment from a senior NIH investigator at the NIH. The award or appointment is offered based on a candidate's qualifications and the research needs of the host laboratory.        

Individuals interested in a Visiting Program fellowship or appointment should write to a senior NIH investigator at NIH who works in the same research field, enclosing a resume and brief description of their particular research area and interests. The NIH senior investigator serves as the participant's supervisor or sponsor during the period of award or appointment.        

Information about the research opportunities at the NIH may be obtained through the following websites:         

• Office of Human Resources  - Positions and additional resources
• NIH Office of Intramural Training and Education  - Research and Training Opportunities at the NIH
• NIH Intramural Database (NIDB)   - A compilation of information on NIH intramural scientists and their research.

Prospective Visiting Program participants should review the NIH Visiting Program overview and Information for NIH Visiting Program Participants brochure to help make an informed decision before accepting an award or appointment.        

Once an award/appointment recipient has been invited to participate in research at NIH, the Division of International Services, Office of Research Services, will be informed by the hosting Institute or Center (IC) and we will begin to process the immigration documents required by the prospective participant to obtain the appropriate visa to enter the United States.        

We appreciate your interest and hope this information is useful to you. Good luck in your search for research opportunities at NIH.        

Please note that the NIH is an E-Verify employer.​

Successful candidates for the NIH Visiting Program will be notified of selection for a fellowship award or appointment and the date it begins in a letter from the Director of the Division of International Services, Office of Research Services, NIH, along with the appropriate immigration document (such as the Form DS-2019 for those offered sponsorship as J-1 Exchange Visitors). At that time, candidates should refer to the Visiting Scientists section of our website for more information on coming to NIH.          

Until this official notice is received, a candidate should make no plans to come to the NIH. Correspondence between an individual and a potential NIH sponsor does not constitute selection, a contract, or an official offer.

The payment of travel expenses to the NIH for Visiting Fellows and Visiting Scientists is at the discretion of the sponsoring Institute/Center (IC) and subject to the availability of funds. Payment of travel to scientific meetings or training is also at the discretion of the IC and subject to the availability of funds.         

Immigration guidance about international travel for those currently sponsored by the NIH is available from the DIS’s Scientist Travel Guidance webpages.

Revised 03/2021

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Grants Information for Non-U.S. Scientists and U.S. Scientists at Foreign Institutions

Individuals living and working outside of the United States, whether U.S. citizens or citizens of other nations, may be eligible for research and training funding from NINDS. Read on for information on NINDS grants and funding for non-U.S. scientists.

NINDS seeks applications from diverse investigators with broad experience and perspectives. Review funding opportunities available from the Office of Global Health and Health Disparities .

General Eligibility Guidelines

All applications to NIH must be submitted in response to Notices of Funding Opportunities (NOFOs) which describe an institute or center's intent to award grants and/or cooperative agreements in certain programmatic areas. All NIH NOFOs are published in the NIH Guide for Grants and Contracts and on Grants.gov .

Section III.1.A of each NOFO describes the type of institutions/organizations that are eligible to apply. Section III.1.B provides information on the type of individuals that are eligible to apply. In addition, the NIH Grants Policy Statement describes general eligibility requirements for foreign organizations.

Career Awards

Non-U.S. individuals are eligible for a number of career awards and fellowships. Your institution is responsible for ensuring that you have an appropriate visa. You will need U.S. affiliation or citizenship to be a trainee on a training grant or receive a career award or fellowship with a couple of exceptions: the Pathway to Independence Award (K99/R00) and the International Neuroscience Fellowship (F05). For most other career development and training awards, you must be a U.S. citizen, a noncitizen national, or a permanent resident with a valid Alien Registration Receipt Card (green card) at the time of award.

Learn more from the Office of Research Training and Career Development .

• U.S. citizens and permanent residents at U.S. institutions may apply for the following career development awards: K01, K02, K08, K22, K23, K24, K25. 
• Foreign nationals at U.S. institutions may apply for the following: NIH Pathway to Independence Award K99/R00 . (Note: Both K99 and R00 phases must be conducted at a U.S. institution.)

Fellowships

U.S. citizens and permanent residents at U.S. or foreign institutions may apply for:

• National Research Service Awards for Predoctoral, Postdoctoral, and Senior Fellows (F31, F32, F33)

U.S. institutions may apply for:

• Conference Grant and Cooperative Agreement Conference Grants (R13/U13)
• NIH National Research Service Award Institutional Research Training Grant (T32)

Application Review Criteria for Foreign Institutions

Applications from foreign institutions or international organizations will be evaluated and scored during the initial review process using the standard review criteria. In addition, the following will be assessed as part of the review process and award decision:

• Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources.
• Whether the proposed project has specific relevance to the mission and objectives of the NIH Institute or Center and has the potential for significantly advancing the health sciences in the United States.

Note: These criteria are not applied to applications from domestic institutions with foreign components. Research grant applications from foreign institutions must be discussed and recommended for funding by the National Advisory Neurological Disorders and Stroke Council (NANDS Council) and are ineligible for expedited review.

Learn more about NINDS funding mechanisms .  

Domestic Grants with a Foreign Component

Some NIH grant mechanisms (e.g., R01) may support projects awarded to a domestic institution with a foreign component. For purposes of this policy, a "foreign component" is defined as performance of any significant element or segment of the project outside the U.S. either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. Activities that would meet this definition include:

• The involvement of human subjects/or animals.
• Extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities.
• Any activity of the grantee that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.

Travel for consultation is not considered a "foreign component."

Examples of grant-related activities that may be considered a foreign component are:

• Collaborations with investigators at a foreign site anticipated to result in co-authorship
• Use of facilities or instrumentation at a foreign site, or
• Receipt of financial support or resources from a foreign entity

Change of Grantee Organization

Prior  NINDS  approval is required for the transfer of a grant-supported project or activity from one entity to another before the expiration of the approved project period. Please note that a change of grantee status that involves the transfer of a grant to or between foreign institutions or international organizations must be approved by the NINDS Advisory Council subject to the additional review criteria for foreign applicants (see above). Investigators considering a move to a foreign institution should consult with their Program Director early in this process because approval of transfers is not automatically given.

U.S. Affiliation or Citizenship for NINDS Funding Applicants and Grantees

You do not need U.S. affiliation or citizenship to become a NINDS grantee. If you are working at a U.S. institution that is receiving the award, you must remain there long enough to finish your project. If you do not have a permanent visa, state in your application that your visa will allow you to remain in the U.S. long enough for you to be engaged on the project.

For complete information on NIH awards to foreign institutions and grants involving foreign components, see the NIH Grants Policy Statement on Definition of Terms . For more complete information on  NIH  awards to foreign institutions and grants involving foreign components, see the  NIH Grants Policy Statement  and the  NIH’s Office of Extramural Research  website. Additional information on International NOFOs supported by  NINDS  can be found on the  Find Funding Opportunities  page.

Application and Award Information for International Institutions and Organizations

International institutions and organizations (including public or private non-profit or for-profit organizations) are eligible to receive most research project grants from  NINDS . They are not eligible for the following: Institutional National Research Service Awards, Career Development Awards, Program Project Grants, Center Grants, Resource Grants, and  SBIR / STTR  grants. In addition, all eligible international applications must meet the review criteria outlined below.

Expanded  Grants.gov  registration instructions for international organizations are available on the eSubmission website.

When applying from an international/foreign institution, both electronic and paper applications have a checkbox for foreign institutions and domestic institutions with a foreign component. In addition, there are special budget requirements for applications from foreign institutions. For more information visit the  NIH About Grants information page  for international applicants and grantees.  Foreign postdoctoral fellows may work on NIH-funded research grants, but they may not work on a National Research Service Award fellowship or training grant.

According to the  NIH  Grants Policy Statement, PIs and other personnel supported by NIH research grants are usually not required to be U.S. citizens, though some programs have citizenship requirements. Check the program announcement or request for applications to be sure. When applying electronically, foreign organizations must obtain a NATO Commercial and Government Entity code. NIH does not require international organizations to obtain an Employer Identification Number (EIN) for application submission. International organizations may use 44-4444444 for the Employer Identification field in the SF424 (R&R) Cover Component of the application package. For more information on registering, see the NIH About Grants  Organization Representative Registration  page.

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NIH Global Health Funding

In addition to Fogarty-supported programs and the collaborations Fogarty is involved in, many Institutes and Centers at NIH offer funding opportunities to support research on global health topics, or in areas relevant to global health.

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NIH Career Development Opportunities for Global Health Researchers

• NIH Visiting Fellows Postdoctoral training in the NIH Intramural Research Program for citizens of countries other than the U.S.
• National Institute on Drug Abuse (NIDA) International Fellowships
• National Cancer Institute (NCI)Center for Global Health Research and Training Programs

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Institutional Training Grants (T) Kiosk

To provide individual research training opportunities (including international) to trainees at the undergraduate, graduate, and postdoctoral levels.

International Research Training Grant

To support research training programs for U.S. and foreign professionals and students to strengthen global health research and international research collaboration.

International Research Training Planning Grant

To plan for the preparation of an application for a D43 international research training grant or for a U2R international research training cooperative agreement.

Continuing Education Training Grants

To assist professional schools to establish, expand, or improve programs of continuing professional education, or refresher education dealing with new developments in the science of technology of the profession.

Ruth L. Kirschstein Institutional National Research Service Award

To enable institutions to recruit individuals selected by the program leadership for predoctoral and/or postdoctoral research training in specified scientific areas.

Ruth L. Kirschstein Undergraduate NRSA Institutional Research Training Grants

To enhance the undergraduate research training of individuals from groups underrepresented in biomedical and behavioral sciences through Institutional NRSA training grants, in preparation for research doctorate degree programs.

Ruth L. Kirschstein NRSA Short-Term Institutional Research Training Grant

To provide individuals with research training during off-quarters or summer periods to encourage research careers and/or research in areas of national need.

Ruth L. Kirschstein Interdisciplinary Research Training Award (T90) and combined Research Education Grant (R90)

To support comprehensive interdisciplinary research training programs at the undergraduate, predoctoral and/or postdoctoral levels, by capitalizing on the infrastructure of existing multidisciplinary and interdisciplinary research programs.

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Policy Notices

• NOT-OD-24-129: Updates to NIH Institutional Training Grant Applications for Due Dates on or After January 25, 2025
• NOT-OD-24-116: Childcare Costs for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellows and Institutional Research Training Awards
• NOT-OD-24-107: Implementation of Revisions to the NIH and AHRQ Fellowship Application and Review Process
• NOT-OD-24-084: Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025
• NOT-OD-23-111: Reminder – NIH Policies for NRSA Stipends, Compensation and Other Income
• NOT-OD-23-076: Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2023

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National Institutes of Health ( NIH )

UE5 / T32 Phased Institutional NRSA Training Award

• April 4, 2024  - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
• July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice  NOT-OD-19-109 .

See Section III. 3. Additional Information on Eligibility.

The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations (collectively termed, eligible Tribal Entities) to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible Tribal Entities to develop (UE5) and implement (T32) effective training and mentoring activities for research-oriented individuals earning a doctoral degree in a biomedical research field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete Ph.D.s in a biomedical field, and to transition into careers in the biomedical research workforce.

Not Applicable

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

• An institutional system-to-system (S2S) solution
• Grants.gov Workspace

Part 2. Full Text of Announcement

Section i. funding opportunity description.

The American Indian/Alaska Native (AI/AN) populations have long experienced health disparities when compared with other Americans. Multiple factors have contributed to these health disparities, including limited access to health care, the distrust of health-related research due to trauma inflicted on the AI/AN communities by past unethical and inappropriate research practices, and limited opportunities for AI/AN Tribes to lead health research.

The  Native American Research Centers for Health (NARCH) program was launched in 2000 to help reduce the distrust of health research by the AI/AN communities, promote AI/AN health research prioritized and led by eligible AI/AN Tribal Entities, and ultimately improve AI/AN health. To enhance the program’s efficacy in meeting its goals, NIGMS completed a comprehensive  NARCH program evaluation culminating in a formal Tribal Consultation. With consideration to the evaluation recommendations and the Tribal Consultation, the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program was developed to address AI/AN health equity, in part, by contributing to the development of a workforce of individuals who will lead and conduct research focused on AI/AN health.

The TURTLE program will support the research training of undergraduates (T34) and predoctoral students (T32) at degree-granting institutions across the United States and Territories through training grants administered by eligible  Tribal Entities .

Eligible  Tribal Entities are not well represented in the funded  NIGMS Training, Workforce Development, and Diversity institutional training programs ( dashboard accessed February 2024), potentially because the funds required for the infrastructure and personnel to administer large-scale training awards have not been available. NIGMS recognizes the need for a phased award with a capacity building period preceding the training component.

This NOFO will support a phased award (UE5/T32) to fund: 

• A development phase to hire personnel and develop educational activities and training grant program and administrative infrastructure (UE5). 
• A National Research Service Award (NRSA) predoctoral research training program phase to support trainees interested in AI/AN health research (T32). 

A companion NOFO ( PAR-24-236 ) is available for a phased award for undergraduate research training (UE5/T34). NIGMS intends for the TURTLE program to provide sustained support of effective undergraduate (T34) and graduate (T32) research training programs. When nearing the end of the T32 phase of the award, NIGMS intends to provide the opportunity to eligible Tribal Entities to apply to a renewable TURTLE institutional training program to sustain the training of future scientists interested in AI/AN health research.

Program Considerations

The phased award described in this NOFO is intended to develop capacity at eligible Tribal Entities and provide funds for institutional NRSA training programs. As with all NRSA grants, the funding in the second (T32) phase will provide trainee stipends to defray living expenses, tuition remission, travel, as well as training-related expenses to support the program. Trainees are expected to be supported by the grant for 1-4 years of their doctoral training to receive the full benefits of the training program.

The eligible Tribal Entities administering the TURTLE programs will be responsible for identifying and appointing trainees. The TURTLE T32 program should recruit full-time Ph.D. students. Recruitment of potential trainees from a broad range of educational organizations across the United States and territories is encouraged and supported trainees do not all need to be at the same institution. The eligible Tribal Entities are not required to confer doctoral degrees but are expected to administer the trainee financial support, and provide oversight and additional research training activities, for example, mentoring and skills development for students earning doctoral degrees.

A primary goal of this program is the development of a pool of scientists who earn biomedical Ph.D. degrees and have the technical, operational, and professional skills to pursue careers in AI/AN health research. Examples include:

• Technical (appropriate methods, technologies, and quantitative/computational approaches).
• Operational (independent knowledge acquisition, rigorous experimental design, interpretation of data, and conducting research in the safest manner possible).
• Professional (management, leadership, communication, and teamwork).

Funds will be awarded for up to seven years to support the two phases:

• Two years of support for the development phase (UE5) to hire personnel and to develop program management and grants administration capacity for training grants, educational activities, as well as trainee and mentor recruitment strategies.
• Five years of support for the research training of predoctoral trainees (T32) to identify and appoint trainees to the grant; dispense stipends, tuition remission payments and training-related expenses; provide training, mentoring and networking activities; track trainee progress; and report outcomes.

The first phase (UE5) will be a cooperative agreement, where NIH staff work closely with the Tribal Entities to support the development phase (refer to Section VI for details). The conversion from the first phase (UE5) to the second phase (T32) will occur after an NIH administrative review of the progress achieved during the first phase and the entity's preparedness for the training grant phase (T32) of the award. 

Progress will be assessed based on: 

• Adequate program personnel with the appropriate expertise. This may require hiring or training of staff during the development phase.
• Ability to recruit a pool of potential trainees in alignment with the goals of the TURTLE program. For example, plans may include the establishment of any needed partnerships with Ph.D. granting organizations providing predoctoral research training to future researchers interested in careers in AI/AN health research.
• Plans for research training, career development, and networking activities as well as the personnel and technologies to deliver these activities.
• Mentor and role model recruitment, training, and monitoring procedures.
• The infrastructure to administer the grant and the trainee stipends, tuition remission and training-related expenses.
• The capacity to track and report on trainee progress and outcomes.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

The  OER Glossary  and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

The total award period will be up to seven years: a maximum of two years for the UE5 component and five years for the T32 component.

Other Award Budget Information

Individuals designing, directing, and implementing the TURTLE program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the organization's policy for similar positions and may not exceed the congressionally mandated cap. Personnel costs for the two phases are described below:

• Development phase (UE5) - two-year budget request. For this phase, the personnel costs are to support program and administrative staff to focus on the development of the educational content and the administrative systems for the training phase of the award. Typically, salary support for program staff should not exceed 1.5 full time equivalents depending on the size and scope of the program.
• Training phase (T32) - five-year budget estimate . For this phase, personnel costs are part of the “training related expenses” in the “Other Program-Related Expenses” section described below. 

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an research education program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the research education program is not intended as a substitute for an NRSA institutional training program (e.g.,T34), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

Initial competing application budget: Applicant requests should include the following:

• Development phase (UE5) - two-year budget request. For this phase, the “Other Program-Related Expenses” is expected to be primarily for travel, consultant costs, and administrative infrastructure development.
• Stipends, tuition/fees- Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience. NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the  NIH Guide for Grants and Contracts,  and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA)  webpage .
• Trainee travel - Travel for trainees to attend scientific meetings and workshops that the organization determines to be necessary for their research training experience is an allowable expense. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost. NIGMS will provide up to $1000 per trainee for travel. Plans for trainee travel should be well justified.
• Training Related Expenses (TRE) - NIH will provide funds to help defray other research training expenses, such as health and dental insurance for trainees, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. For this NOFO, training related expenses may be requested at a rate of $20,000 per trainee. 

Transition application budget: Recipients will submit an updated proposed training budget prior to the end of the UE5 phase as part of a transition application for consideration to receive the second phase (T32) of funding. 

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. eligible applicants eligible organizations the applicant organization must meet one of the following criteria: a federally recognized ai/an tribe, as defined under 25 u.s.c. 1603(14); or a tribal college or university, a tribal health program, or a tribal organization as defined under 25 u.s.c. 1603 (24), (25), and (26), respectively; or a consortium of two or more of these tribal entities. the sponsoring institution must assure support for the proposed program. appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. institutions with existing ruth l. kirschstein national research service award (nrsa) institutional training grants (e.g., t32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. in many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution. foreign institutions an application may include foreign components only if one or more ai/an tribes with ancestral catchment areas crossing the u. s. border will participate in the proposed program. non-domestic (non-u.s.) entities (foreign institutions) are not eligible to apply non-domestic (non-u.s.) components of u.s. organizations are not eligible to apply. foreign components, as defined in the nih grants policy statement , are not allowed.  required registrations applicant organizations applicant organizations must complete and maintain the following registrations as described in the sf 424 (r&r) application guide to be eligible to apply for or receive an award. all registrations must be completed prior to the application being submitted. registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. the nih grants policy statement section 2.3.9.2 electronically submitted applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. system for award management (sam) – applicants must complete and maintain an active registration, which requires renewal at least annually . the renewal process may require as much time as the initial registration. sam registration includes the assignment of a commercial and government entity (cage) code for domestic organizations which have not already been assigned a cage code. nato commercial and government entity (ncage) code – foreign organizations must obtain an ncage code (in lieu of a cage code) in order to register in sam. unique entity identifier (uei) – a uei is issued as part of the sam.gov registration process. the same uei must be used for all registrations, as well as on the grant application. era commons - once the unique organization identifier is established, organizations can register with era commons in tandem with completing their grants.gov registration; all registrations must be in place by time of submission. era commons requires organizations to identify at least one signing official (so) and at least one program director/principal investigator (pd/pi) account in order to submit an application. grants.gov – applicants must have an active sam registration in order to complete the grants.gov registration. program directors/principal investigators (pd(s)/pi(s)) all pd(s)/pi(s) must have an era commons account.  pd(s)/pi(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in era commons. if the pd/pi is also the organizational signing official, they must have two distinct era commons accounts, one for each role. obtaining an era commons account can take up to 2 weeks. eligible individuals (program director/principal investigator) any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the program director(s)/principal investigator(s) (pd(s)/pi(s)) is invited to work with their organization to develop an application for support. individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for nih support. see, reminder: notice of nih's encouragement of applications supporting individuals from underrepresented ethnic and racial groups as well as individuals with disabilities, not-od-22-019 .  for institutions/organizations proposing multiple pds/pis, visit the multiple program director/principal investigator policy and submission details in the senior/key person profile (expanded) component of the sf424 (r&r) application guide. the pd(s)/pi(s) do not need to hold a higher degree in the biomedical sciences; however, it is expected that the pd(s)/pi(s) will consult with individuals with biomedical research experience regarding effective practices for training future research scientists. pds/pis employed at eligible tribal entities through special employment arrangements, such as interorganizational personnel agreements among federally recognized ai/an tribes, are allowable. 2. cost sharing.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility

Number of applications.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications )
• Program Mentors

Program mentors, who often serve as role models, are an important component of the TURTLE program. Program mentors may be drawn from across the United States and territories. Mentors should have expertise and experience relevant to the proposed program and must be committed to continue their involvement throughout the award period. 

Participants (UE5) and Trainees (T32)

Participants:  The UE5 development phase may include graduate students (participants) to pilot the training, mentoring, and networking activities and to build a pool of potential trainees for the training phase (T32) of the award. Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

Trainees: For the T32 training phase, the applicant organization will select the trainees to be supported by the research training program. It is the responsibility of the applicant organization to establish the qualifications, consistent with applicable law, of the trainees before they are supported by the program. The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement .

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the recipient organization in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of NIGMS.

This research training program may not be used to support health-professional students who wish to interrupt their studies for a year or more to engage in research training that will not lead to a Ph.D. degree.

Predoctoral trainees funded through this program must be enrolled in a program leading to a Ph.D.

Section IV. Application and Submission Information

1. requesting an application package.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application, with the following modifications:

Facilities & Other Resources.  Describe the facilities and resources that will contribute to the probability of success of the proposed research training program. Examples may include offices, information technology, computer facilities, software, conference rooms, virtual or in-person classrooms, and other training spaces. Applications should not include any data or examples of data, hyperlinks, or any material not listed as allowable for this attachment in the SF424 (R&R) Application Guide.

  Other Attachments.  Advisory Committee (optional): Applicants are encouraged to provide a plan for the appointment of an Advisory Committee that will provide guidance on the administration of the proposed TURTLE program. Describe the intended composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information. Potential Advisory Committee members should not be identified or contacted prior to receiving an award. Please name the file “Advisory_Committee.pdf”.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

Development phase (UE5): Two-year budget request. For this phase, the personnel costs are to support program and administrative staff to focus on the development of the educational content, recruitment, training and oversight procedures, institutional relationships and administrative systems for the training phase of the award. Include all personnel other than the PD(s)/PI(s), including participants, clerical and administrative staff in the Other Personnel section. Typically, salary support for program staff should not exceed 1.5 full time equivalents depending on the size and scope of the program. Requested costs for travel, consultant costs, and administrative infrastructure development should be entered in Sections D. Travel and F. Other Direct Costs.

Training phase (T32): Five-year budget estimate . For this NOFO, all costs for the training phase budget estimate should be included in Section E. Participant/Trainee Support Costs; follow instructions in the SF 424(R&R) Application Guide for Section E with the following additional guidance: 

• Item 1. Tuition/Fees/Health Insurance: Grantees should request the maximum allowable tuition/fees for predoctoral trainees as an estimate. Actual tuition and fee rates will be provided in the transition application for funding of the T32 phase. For this NOFO, do not include trainee health insurance in Item 1.
• Item 2. Stipends: Stipend levels should be requested according to the published NRSA levels for predoctoral trainees at the time of application. 
• Item 3. Travel: Trainee travel funds may be requested up to $1000 per trainee. Do not include faculty/staff travel in Item 3.
• Salary support for the program staff (PD/PI or administrative personnel). Typically, salary support for program staff should not exceed 1.5 full time equivalents depending on the size and scope of the program.
• Skills development training activities.
• Seminar speakers, consultants, mentors, or trainers, who will serve as role models to the trainees.
• Training or mentoring interventions designed to increase persistence in research (for example, those designed to increase science identity, self-efficacy and a sense of belonging in the scientific community).
• Limited program evaluation costs.
• Other program-related expenses may be included within the budget for training-related expenses. 
• Number of Participants/Trainees: The expected number of supported trainees at the steady-state level for each TURTLE program is on average 10 per year. For example, if trainees are to be supported for 2 years each the program will appoint 5 new students each year. 

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: The Research Strategy section of the application should be used to upload the Proposed Program Plan containing the components described below: 

• Development Plan (UE5 Component)
• Research Training Plan ( T32 Component )
• Program Staff
• Program Participants and Trainees
• Organizational Environment and Commitment

For the Proposed Program Plan, do not follow the instructions in the SF424 (R&R) Application Guide, instead, use the following instructions. 

Proposed Program Plan: While the proposed program may complement ongoing research training and education occurring at the applicant organization, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When other federally-funded research training programs are ongoing, the applicant organization should clearly distinguish between the activities in the proposed program and the currently funded program(s).

Development Plan (UE5 Component) : Applicants should describe the development plan and are encouraged to use the headings below.

• Adequate program personnel with the appropriate expertise. Achieving this milestone may be demonstrated by hiring or training program personnel with the appropriate expertise.
• Plans to recruit a pool of research-oriented trainees in alignment with the goals of the TURTLE program. For example, plans may include the establishment of any needed partnerships with Ph.D.-granting organizations providing predoctoral research training to future  researchers who are interested in pursuing a career in AI/AN health research.
• Development of research training, career development, and networking activities and the personnel and technologies to deliver these activities.Recipient organizations are encouraged to pilot the activities during the development phase.
• Grants administration capacity, including management of consortium arrangements, trainee appointments and terminations, grant reporting and the administration of trainee stipends, tuition and training-related expenses.
• Development Plan and Timeline: Applications should describe the plan and timeline for  achieving the milestones within the 2-year funding period. Meeting the milestones will be an indication that the program is ready for the transition to the training phase (T32) of the award (see Section VI. Award Administration Information of this NOFO for information about the transition ) . 

Research Training Plan (T32 Component) : The application should describe the research training plan by addressing the following topics. Applicants are encouraged to use the headings below when describing each area.

• Training Objectives: Applications should describe the specific, measurable, and attainable training objectives for the Research Training Plan. Training objectives should align with the overarching objective of this NOFO of supporting the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in an ethically responsible, culturally appropriate and rigorous manner, to complete a Ph.D. in a biomedical field, and to transition into careers in the biomedical research workforce.
• Research Experiences:   Appointed trainees are expected to gain research skills through authentic research experiences while earning their doctoral degrees. Describe how the TURTLE program will support the research training activities of the trainees. Examples include, organizing research seminars, discussions of the scientific literature, and trainee data presentations.
• Activities for Skills Development and Promotion of Trainee Success: Trainees are expected to participate in activities that will build a broad range of technical, operational, and professional skills to enhance their science identity and self-efficacy and facilitate the successful progression into careers in the biomedical research workforce. Sites are encouraged to use the educational and training literature to inform training, mentoring, and professional development activities. Discuss the anticipated time the trainees are expected to participate in TURTLE activities given their other Ph.D. training responsibilities.
• Cohort Building: TURTLE programs are encouraged to develop and implement activities to periodically bring together supported trainees to build a sense of community and belonging.
• Career Advancement:  Describe how trainees in the program will be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce for which their training prepares them.
• Outreach Activities: TURTLE programs are encouraged to engage in outreach activities. Examples include, facilitating opportunities for the trainees to give back to their communities, providing information to the training community on culturally-aware practices for future scientists focused on AI/AN health, and facilitating family understanding and engagement for supported trainees as they complete their research training.
• How the program will provide supported trainees with additional mentors with expertise complementary to their Ph.D. advisors (for example, from different fields or communities) and networking opportunities to support the trainees' interests in AI/AN health research and promote their success in obtaining Ph.D.s and continuing in research careers.
• How the program confirms that participating organizations where the trainees are enrolled are promoting the development and retention of trainees for the duration of their graduate careers. To increase the likelihood of success in completing their Ph.D. degrees, TURTLE programs are encouraged to maintain contact with trainees beyond the time they are financially supported by the training program.
• Mechanisms for mentor training for the TURTLE program mentors and for monitoring mentoring success, including oversight of the effectiveness of the trainee/research mentor match.
• Conflict resolution practices to address potential conflicts that may impede trainee progress, for example, mentor-mentee, peer-peer, faculty-student, staff-trainee, or faculty-faculty conflicts.
• Candidate Review Process: Describe plans for a candidate review process that will allow a broad group of research-oriented trainees interested in AI/AN health research the ability to participate in the training program. The process should employ selection processes that are consistent with applicable law.
• Trainee Appointments and Financial Support: Applications should describe at what stage in the trainees' careers they will be supported on the training grant and the length of appointments. NIGMS typically supports trainees for 1-4 years during the early years of their graduate program. If trainees are enrolled at different organizations, applications should describe how management of trainee appointments and terminations and disbursement of training funds will be handled. 
• Evidence that trainees conducted rigorous research that advanced scientific knowledge and/or technologies, with increasing self-direction (for example, peer-reviewed publications in  Training Table 5A , or other measures of scientific accomplishment appropriate to the field).
• The rate of Ph.D. degree attainment for program appointees and time-to-degree for trainees (for example,  Training Table 8A ), including how many individuals obtained a Ph.D. degree, are still in training, left the program with a master's degree, or withdrew from the program with no degree.
• The success of recent program graduates transitioning into careers in the biomedical research workforce (for example,  Training Table 8A ).
• The plan for the TURTLE program evaluation to determine whether the training program is effective in meeting the research training mission and objectives.
• Methods to determine if the TURTLE training climate is perceived as inclusive, safe, and supportive of trainee development and retention. Include methods to obtain reliable and representative input from trainees and to safeguard anonymity to ensure candid feedback.
• Mechanisms to ensure the TURTLE program is responsive to outcomes analyses, program evaluations, and trainee feedback regarding the effectiveness of the TURTLE research training environment.
• Activities designed to share outcomes and effective practices of the program with the broader community, for example, presenting program data or materials to members of the research training community via web postings or presentations.
• Strategy to ensure the secure storage and preservation of program data and outcomes and how the data will be centralized, safeguarded, and retrievable during leadership and staff changes.

Note: Training Program Evaluation is not a form of human subjects research. Training grants prepare individuals for careers in the biomedical research workforce by developing and implementing evidence-informed educational practices including didactic, research, mentoring, and career development elements. While funded programs are expected to conduct ongoing program evaluations and assessments to monitor the effectiveness of the training and mentoring activities, training grant funds are not intended to support Human Subjects Research (check additional information on Human Subjects Research from  NIH  and  HHS ).

Program Staff: Briefly explain the leadership and administrative structure as well as the succession plan for critical positions.

• The administrative and training experience to provide strong leadership, direction, management, and administration of the proposed program. 
• A commitment to training future biomedical researchers, leading recruitment efforts to broaden participation, and fostering inclusive research environments.
• Received training on how to effectively mentor trainees from all backgrounds, including trainees from groups underrepresented in the biomedical sciences . 
• Additional Administrative Staff: In addition to having the appropriate infrastructure, effective administration of a training grant requires personnel with the organizational skills to recruit, appoint and track students, report outcomes, monitor the budget, and ensure stipends and tuition are provided in a timely manner. Describe the current or planned administrative staff required to develop, implement and run the TURTLE training program. 

Program Mentors: Describe the plans for building a team of TURTLE program mentors. Mentors, who often serve as role models, are an important component of the TURTLE program. Program mentors will provide additional guidance, encouragement and support for trainees that complements what they receive from their Ph.D. research advisors. They may be drawn from across the United States and territories. Program mentors from diverse backgrounds, such as individuals from underrepresented racial and ethnic groups, , persons with disabilities, and women are encouraged  to participate. Mentors should have expertise and experience relevant to the proposed program. When recruiting a team of mentors and role models to support the TURTLE trainees, it is expected that the following characteristics will be considered:

• Experience with teaching, mentoring, and sustaining the interest of students in biomedical fields. Programs are encouraged to recruit mentors with AI/AN health research experience.
• Awareness of the evidence base for effective student development in the biomedical research workforce.
• The ability to make strong connections with the students and understand the challenges they are experiencing.
• Understanding of and experience with appropriate cultural norms and expectations of AI/AIN health research.
• Sufficient knowledge of the biomedical research enterprise to give sound advice to students about how to effectively navigate the academic environment and career advancement options.
• Flexibility to adapt to the needs of each student.

Program Participants and Trainees:  

• The UE5 development phase may include graduate students as program participants to pilot the training, mentoring, and networking activities and to build a pool of potential trainees for the training phase of the award. Describe any plans to recruit program participants for the UE5 phase.
• For the T32 training phase, the recipient organization will select the trainees to be supported by the research training program. It is the responsibility of the organization to establish the qualifications, consistent with applicable law, of the trainees before they are supported by the program. The T32 phase of the TURTLE program is intended to support full-time students earning a Ph.D. degree in a field that is relevant to AI/AN health research. Trainees from multiple Ph.D.-granting institutions and scientific fields can be supported by a single TURTLE program. A Recruitment Plan to Enhance Diversity is required in the transition application discussed below.

Consistent with existing NIH practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a participant, trainee, mentor, or faculty candidate as an eligibility or selection criteria, and (2) NIH does not use the race, ethnicity, or sex of prospective participants, participants, trainees, mentors, or faculty in the application review process or funding decisions.   Applicants and award recipients are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation .

Organizational Environment and Commitment: Describe any additional aspects of the organizational environment and commitment not addressed under “Facilities & Other Resources”. Appropriate organizational commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This section should not duplicate information provided elsewhere.

Resource Sharing Plan Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• A Resource Sharing Plan is not required for this NOFO.

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

Not Applicable.

Delayed Onset Study

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I.  contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review .

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Note, however, that for the training phase (T32), pre-award costs are not allowable charges for stipends or tuition/fees on training grants because these costs may not be charged to the grant until a trainee has actually been appointed, and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on a training grant.

Carryover of unobligated funds from the development phase (UE5) to the research training phase (T32) will require prior NIH approval. 

For the training phase (T32), the National Research Service Award (NRSA) policies  apply. An N RSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

NIGMS does not permit automatic carryover of training grant (T32) funds from one budget period to the next.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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 .

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the National Institute of General Medical Sciences. Applications that are incomplete and/or non-compliant will not be reviewed. 

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) are not required to contact a Scientific/Research Contact before submitting the application. The Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide is not applicable for this notice of funding opportunity.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35 .

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Applicants are required to follow the instructions for post-submission materials, as described in  the policy .

Section V. Application Review Information

1. criteria.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Specific to this NOFO: NIGMS recognizes that effective, well-designed research training programs that promote broad participation in the biomedical research workforce can take place in a wide variety of organizational environments and with mentors who have varying levels of NIH research project grant support. Reviewers should evaluate the proposed TURTLE program considering the applicant organization's stated objectives, organizational context, available resources, and the capacity of those resources to meet the stated objectives. Reviewers should note that identification by the applicant of current shortcomings and challenges can be viewed as positive factors if accompanied by sound plans for how the applicant would use the TURTLE award to overcome or remediate these challenges.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research training by fulfilling the goals of the program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Evaluate whether the proposed program will develop a pool of scientists who earn biomedical Ph.D.s and have the technical, operational, and professional skills to pursue culturally appropriate AI/AN health-related research careers.
• Consider whether the application provides convincing evidence that the proposed program will significantly advance the stated goal of the TURTLE program.
• Evaluate whether the PD/PI or PD/PI team have the potential to provide both administrative and research training leadership to the development and implementation of the proposed program.
• If the project proposes a multi-PD/PI team, evaluate whether the team has complementary and integrated expertise. Consider whether the leadership approach, governance, and organizational structure are appropriate for the proposed program.
• Consider whether an appropriate level of effort will be devoted by the program staff and leadership to ensure the program's intended goal is accomplished.
• Discuss whether the approach to recruiting the Program Mentor team is likely to assemble a pool of individuals who will have the appropriate scientific background, mentor training and experience in mentoring trainees to promote the success of the TURTLE program. 
• Evaluate whether the objectives, plan, and timeline for the Development Plan are feasible and attainable.
• Consider whether the Development Plan will sufficiently develop or enhance the appropriate staff expertise, trainee recruitment procedures, grants administration capacity, career enhancement activities, information technology infrastructure, and trainee tracking resources to support a successful training phase.
• Evaluate whether the overall training plans and timelines are feasible, attainable and will align with the TURTLE program objectives.
• Discuss whether the overall training plan describes effective activities for support of the Ph.D. training experiences, and for skills development, cohort building, career advancement and outreach.
• Assess whether the planned strategy and administrative structure to oversee and monitor the program will ensure appropriate and timely trainee progress.
• Assess the suitability of the program mentor recruitment, training and monitoring plan, as well as any plans for engaging the Ph.D. thesis advisors.
• Evaluate whether the planned activities are likely to recruit a sufficient pool of individuals interested in earning a Ph.D. and conducting AI/AN health research.
• Assess whether the plans for tracking TURTLE trainees and for the program evaluation are sound and likely to provide useful information on the effectiveness of the program.
• Evaluate whether the environment of the applicant organization(s) will contribute to the intended goals of the proposed program.
• Assess whether the application provides tangible evidence of sufficient organizational commitment.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed program.

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 will receive a written critique.

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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions, consistent with applicable law:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Broad geographic distribution.
• Contributions to portfolio breadth as outlined in the NIGMS Strategic Plan.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the  eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. award notices.

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the  NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see  Award Process.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200 , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities .
• HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in  NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See  2 CFR Part 200.340 Termination and  NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support . 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will function as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility will remain with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Adhering to the overall objective of the TURTLE program.
• Developing capacity to administer a National Research Service Award (NRSA) Training grant.
• Developing programmatic activities.
• Contributing to the cooperative nature of the TURTLE program.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

During the UE5 phase, NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Project Coordinator . The Project Coordinator will not participate in the oversight of the NOFO, application review, or programmatic and budgetary stewardship of the award. The Project Coordinator will also not participate as an active researcher in the evaluation of the TURTLE program. NIH Project Coordinator(s) will:

• Guide the development of each TURTLE award and the TURTLE network by providing overall advice and coordination.
• Facilitate, not direct, activities.
• Ensure that the activities supported by the TURTLE awards are consistent with NIH missions and goals.
• Make recommendations regarding project direction to accomplish the goals of the TURTLE program.
• Promote communication between NIH and the grantee.
• Provide support to facilitate the timely progress toward agreed-upon programmatic goals, outcome measures, and milestones.
• Work closely and effectively with awardees to ensure standardized information and data needed to evaluate program effectiveness and preparedness for the transition to the training grant phase are submitted in a timely fashion.

Program Official . The NIH Program Official will be responsible for oversight of the NOFO and the normal programmatic stewardship of the award, including participating in funding recommendations, and will be named in the Notice of Award. The Program Official will not partake of the duties of the Project Coordinator.

Joint Responsibilities:

There are no joint responsibilities between the recipient and NIH staff.

Dispute Resolution:

During the awarded UE5 phase, disagreements between award recipients and the NIH that arise regarding matters related to the direction of the funded program may be brought to a Dispute Resolution Panel. The panel will be composed of three members: a designee of the recipient, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the  Research Performance Progress Report (RPPR)  annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting .

For the Development phase (UE5): 

• Recipients will be required to submit progress as instructed in the Education RPPRs section of RPPR Instruction Guide .
• A final RPPR and the expenditure data portion of the Federal Financial Report are required at the end of the UE5 award period.

For the Research Training phase (T32):

• Recipients will be required to submit progress as instructed in the Training RPPRs section of RPPR Instruction Guide .
• The recipient institution must submit a completed Statement of Appointment ( PHS Form 2271 ) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at  xTrain (eRA Commons) . An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment ( PHS Form 2271 ). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice ( PHS Form 416-7 ) via  xTrain  for each trainee appointed for eight weeks or more.
• A final RPPR and the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of a T32 award as described in the  NIH Grants Policy Statement .

NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

Instructions for the Transition from the UE5 to the T32 Component

Transition Application

The transition to the T32 phase of funding is not automatic and is contingent upon satisfactory progress towards achieving the UE5 milestones, administrative review, and the availability of funds. NIGMS will provide detailed instructions about transition applications to UE5 recipients approximately six months prior to the end of the UE5 award period. TURTLE UE5 recipients wishing to submit the T32 transition application should prepare the application using the  PHS 2590 forms . Follow the PHS 2590 instructions unless instructed otherwise below. 

 The T32 Transition Application must include the following components:

• Detailed budget and budget justification. Submit an updated proposed training budget using PHS 2590 budget forms for each of the five years of the T32 phase.
• Biographical sketches.   Include biosketches for the PD/PI team and Program Mentors using the  Non-Fellowship Biosketch format . The PD/PI team and Program Mentors’ personal statements should include a description of their mentoring and training philosophy, including commitment to inclusion in the research training environments.
• Other Support
• All Personnel Report
• Hiring or training program personnel with the appropriate expertise.
• Ability to recruit a pool of research-oriented trainees in alignment with the goals of the TURTLE program. For example, the establishment of any needed partnerships with Ph.D. granting organizations providing predoctoral research training to future researchers interested in pursuing a career in AI/AN health research.
• An effective, updated plan for research training, career development, and networking activities and the personnel and technologies to deliver these activities. Include any data from piloting training, career development, or networking pilots.
• Establishment of effective recruitment, training and monitoring practices for mentors associated with the program.
• Development of grants administration capacity, including management of consortium arrangements if applicable, trainee appointments and terminations, reporting and the administration of trainee stipends, tuition  and training-related expenses.
• The capacity to track and report on trainee progress and outcomes
• Recruitment Plan to Enhance Diversity (3 pages) : Applicants should describe a Recruitment Plan to Enhance Diversity. For purposes of this requirement, “recruitment” refers to outreach efforts intended to encourage individuals to apply for the program.  “Recruitment” does not mean the appointment or hiring of an individual into the program. Include outreach strategies and activities designed to recruit a sufficient pool of potential trainees whose career goals align with the purpose of the program. Applicants are encouraged to consider strategies on the NIGMS webpage . Activities may include forming partnerships with Ph.D. programs that enroll students interested in AI/AN health research, attending national meetings for research-oriented students, or hosting summer experiences to conduct AI/AN health research.
• Plan for Instruction in Methods for Enhancing Rigor and Reproducibility (3 pages) . Applicants should include a plan that will be implemented in the training phase of the award for the oversight of "Instruction in Methods for Enhancing Rigor and Reproducibility". The plan should describe how the program will reinforce the principles important for enhancing research rigor and reproducibility, for example, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, computational and quantitative approaches, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting. The plan should be appropriate and reasonable for the nature and duration of the proposed activities. Applicants are encouraged to consult the  NIGMS clearinghouse for training modules to enhance data reproducibility and other resources when developing the plans.
• Plan for Instruction in the Responsible Conduct of Research (3 pages): Applicants should include a plan that will be implemented in the training phase of the award for the oversight of “Instruction in the Responsible Conduct of Research (RCR)” for appointed trainees to ensure the appropriate content is being provided by the Ph.D. degree granting organization. Applicants are encouraged to review the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide for topics typically covered. Programs are encouraged to provide additional modules for the responsible conduct of AI/AN health research. 

Trainee Diversity Reports and the NIH Training Data Tables are not required for the transition application but will be required for subsequent progress reports and renewal applications.

Combine the required components into one compiled ( Merge PDFs: How to combine PDF files for free | Adobe Acrobat ), flattened  PDF ( Print to PDF (adobe.com) ) document.

The Authorized Organization Representative should submit the transition application PDF by email to the NIGMS Grants Management Specialist and Program Official.

UE5 recipients who are not approved to transition will receive written notification from NIGMS communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the transition application.

Although the financial plans of NIGMS provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the UE5 award phase

If transition from the UE5 phase to the T32 phase occurs at the originally scheduled end date of the UE5 award, then no specific steps to terminate the UE5 award are necessary. 

If the transition from the UE5 phase to the T32 phase occurs prior to the scheduled end date of the UE5 award phase, then a revised Notice of Award will be issued to terminate the UE5 phase award. Carryover of unspent funds from the UE5 phase into the T32 phase is permitted with prior approval from NIH.

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement Section 8.6 Closeout .

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help  (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues) Website to Email: http://sbir.gov/feedback?type=reg

Kalynda Gonzales Stokes, Ph.D. National Institutes of General Medical Sciences (NIGMS) Email: [email protected]

National Institute of General Medical Sciences (NIGMS) Email: [email protected]

Justin Rosenzweig National Institute of General Medical Sciences (NIGMS) Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A and 45 CFR Part 75 and 2 CFR Part 200.

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• U.S. Department of Health and Human Services
• National Institutes of Health

NCCIH Research Blog

Tips for writing grant applications.

September 5, 2024

Wendy J. Weber , N.D., Ph.D., M.P.H.

Branch Chief

Clinical Research in Complementary and Integrative Health Branch

National Center for Complementary and Integrative Health

View biographical sketch

During my time at the National Center for Complementary and Integrative Health (NCCIH), I have seen hundreds of grant applications and talked with many investigators about their research ideas. I am often asked what advice I have for developing an application. These are my top five recommendations:

• Identify your research question. You need a clear, testable hypothesis. Don’t try to do too much. Be realistic about the scope of the research you can do with the available time and funds. Your hypothesis will shape your research design. Pick a topic you are passionate about; if you get funded, you will spend many hours of your life conducting the research. 
• Develop a strong set of specific aims. Succinctly summarize your research idea, specific aims, and hypotheses in a single page. While only two to four reviewers will be assigned to read your entire application, nearly all the reviewers will read your specific aims. You should provide a clear idea of the research proposed. Be careful not to create confusion or leave out key elements of your research design. The aims set the stage for review; you want reviewers to be excited to read the rest of your application.
• Find the right Institute or Center and program official. Next, figure out which Institute or Center (IC) at the National Institutes of Health (NIH) is the best fit for your research. NIH has a great tool called Matchmaker that allows you to search the RePORTER database of all funded research. You can insert your specific aims or project summary, find similar projects, and see which ICs funded them, which study sections reviewed the applications, and who served as program official for each award. This post by NIH describes how to use the Matchmaker tool. 
• Share your specific aims with a program official to identify the best funding opportunity.  Once you have identified the best IC, review its website to identify the available notices of funding opportunity (NOFOs). For example, NCCIH has a page that lists all of our funding opportunities  and a specific page that lists our clinical trial funding opportunities . Your application must be submitted electronically via an open NOFO. Reach out to the program official with awards most closely aligned with your proposed research. Email your specific aims to the program official and ask 1) if your aims are a good fit with their IC’s priorities and the NOFO you’ve identified; 2) whether you can set up a call to discuss your aims and application; and 3) if they are not the best contact, to whom you should reach out to at their IC. 
• Prepare your full application and make sure it is complete and responsive. As you put all the pieces together, be sure you include everything the NOFO requires and don’t include anything that is not allowed. This video by Dr. Jessica McKlveen, director of NCCIH’s Office of Scientific Review, can help ensure your application is reviewed . 

Follow these steps and you are well on your way to putting together a strong application!

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Creatine Improves Total Sleep Duration Following Resistance Training Days versus Non-Resistance Training Days among Naturally Menstruating Females

Ariel j. aguiar bonfim cruz.

1 Department of Movement Sciences, College of Education, Health & Human Sciences, University of Idaho, Moscow, ID 83844, USA; ude.ohadiu@aleira (A.J.A.B.C.); [email protected] (S.J.B.); ude.ohadiu.sladnav@0814ielk (K.K.); ude.ohadiu@hsurbc (C.J.B.); ude.ohadiu@niwrig (G.L.I.)

Samantha J. Brooks

Katelyn kleinkopf, c. j. brush, gena l. irwin, malayna g. schwartz.

2 WWAMI Medical Education Program, University of Idaho, Moscow, ID 83844, USA; ude.wu@ylbmahm

Darren G. Candow

3 Aging Muscle & Bone Laboratory, Faculty of Kinesiology & Healthy Studies, University of Regina, Regina, SK S4S 0A2, Canada; [email protected]

Ann F. Brown

Associated data.

The data sets generated in the present study are available from the corresponding author upon reasonable request.

Females historically experience sleep disturbances and overall poor sleep compared to males. Creatine has been proposed to impact sleep; however, the effects are not well known. The purpose of this study was to examine the effects of creatine supplementation on sleep among naturally menstruating females. Twenty-one participants completed a double-blind, randomized controlled trial in which they consumed 5 g creatine + 5 g maltodextrin or placebo, 10 g maltodextrin, daily for 6 weeks. Participants completed resistance training 2x/week using the TONAL ® (Tonal Systems Inc., San Francisco, CA, USA) at-home gym. Pre- and post-testing assessed body composition, Pittsburgh Sleep Quality Index (PSQI), dietary intake, and muscular strength. Sleep was assessed nightly using an ŌURA ® (Oulu, Finland) ring. Compared to the placebo group, those consuming creatine experienced significant increases in total sleep on training days ( p = 0.013). No significant changes in chronic sleep and PSQI (pre–post) were observed. There was a significant increase in TONAL ® strength score over time ( p < 0.001), with no between-group differences. Participants reduced their total calorie (kcal) ( p = 0.039), protein (g/kg) ( p = 0.009), carbohydrate (g/kg) ( p = 0.023), and fat (g) ( p = 0.036) intake over time. Creatine supplementation increases sleep duration on resistance training days in naturally menstruating females.

1. Introduction

Creatine (α-methyl guandino-acetic acid; CR) is endogenously synthesized in the liver and brain from reactions involving the amino acids arginine, glycine, and methionine. Exogenously, CR can be consumed in the diet (primarily from red meat and seafood) or through commercially manufactured creatine products [ 1 ]. On average, ≤5% of total body creatine stores are located in the brain [ 2 ]. CR supplementation has the ability (albeit in limited capacity) to cross the blood–brain barrier and increase brain creatine levels [ 3 ]. Using magnetic resonance spectroscopy, there is accumulating research showing that CR supplementation has favorable effects on indices of brain health and function [ 3 , 4 , 5 , 6 ]. Specifically, CR supplementation may affect cognitive processes related to sleep deprivation, which could have important implications on sleep quality, continuity, and quantity [ 3 , 7 , 8 ].

Despite multiple physiological mechanisms to replenish CR stores, female storage is ~70–80% lower compared to males [ 9 ]. Further, females often consume less dietary CR compared to males, likely due to lower meat consumption [ 9 ]. Thus, CR supplementation may be particularly useful given lower endogenous stores and/or exogenous consumption of CR which may contribute to overall female health. Young adult females experience greater severity of sleep disturbances and overall worse sleep quality compared to their male counterparts [ 10 ]. These findings could be attributed to menstrual cycle hormone fluctuations’ impact on circadian rhythm [ 11 , 12 ]. Baker and Driver identified that sleep quality was impacted by different phases of the menstrual cycle, but not sleep continuity [ 13 ]. Further, disrupted sleep has been associated with altered menstrual cycle phases [ 14 ]. Yet, Alzueta et al. examined sleep throughout the menstrual cycle measured by the ŌURA ® ring and identified that sleep did not significantly vary by menstrual cycle phase [ 15 ]. Although sleep is likely altered throughout the menstrual cycle, it remains unclear if CR influences sleep quality or quantity in the female population.

The positive effects of resistance training on muscular strength and body composition (e.g., lean soft tissue (LST), fat mass (FM)) are well established [ 5 , 16 ]. These beneficial effects are further augmented with CR supplementation [ 17 , 18 ]. Resistance training also improves sleep quality and quantity [ 16 ]. Despite its widely accepted benefits, only 24.3% of females in 2018 met the resistance training recommendations outlined in the Physical Activity Guidelines for Americans, 2nd ed. 2018 [ 19 ]. Given the beneficial effects of resistance training and CR supplementation, research is warranted specifically among females due to menstrual-cycle-mediated changes in circadian rhythm. Therefore, the primary purpose of this study was to examine the effects of CR supplementation and resistance training on sleep among naturally menstruating pre-menopausal females. A secondary purpose was to examine the effects of CR supplementation on measures of body composition and muscle strength. It was hypothesized that CR supplementation and resistance training would improve sleep quality more than resistance training alone. Secondarily, it was hypothesized that CR supplementation would augment the gains in LST and strength and decrease FM more than those on placebo (PLA).

2. Materials and Methods

2.1. participants.

Twenty-seven naturally menstruating, non-resistance-trained (≤1 day/week) females (18–24 years of age) were enrolled in this study. An a priori power analysis (G*Power v. 3.1.9.7; [ 20 ]) indicated that 24 participants were required to reach a moderate effect size (Cohen’s d = 0.5), alpha level of 0.05, and power of 0.80 for repeated measures design with two groups. Participants were included if they were naturally menstruating or using a copper intrauterine device (IUD). Participants were excluded if they were not biologically female, using any type of hormonal birth control, amenorrheic, regularly participating in resistance training (>1 day/week), consuming CR supplementation, vegan or vegetarian, using medications that could affect muscle biology (i.e., corticosteroids), if they had any pre-existing liver or kidney abnormalities, or if the responded ‘yes’ to any questions on the Physical Activity Readiness Questionnaire for Everyone (PARQ+). Participants were instructed not to change their habitual diet or engage in planned resistance training outside of the intervention training program. This study was approved by the Institutional Review Board at the University of Idaho and registered as a clinical trial (NCT05745870).

2.2. Experimental Design

This study was a randomized, double-blind, placebo-controlled, 6-week intervention. To minimize differences between groups at baseline, participants were matched based on body weight (kg), current physical activity frequency (moderate and vigorous minutes/week) and habitual animal protein consumption (g). Participants were then randomized into either the CR group or PLA group. All participants were enrolled in the resistance training program to standardize exercise throughout the study. Once randomized, participants began supplementation and resistance training concurrently ( Figure 1 ). Menstrual cycle phase was noted at the beginning of the intervention.

Experimental Design & Methodology Schematic. PARQ+, Physical Activity Readiness Questionnaire for Everyone; PSQI, Pittsburgh Sleep Quality Index; DHQ III, Diet History Questionnaire III; BIA, bioelectrical impedance analysis; DXA, dual energy x-ray absorptiometry; CR, creatine; PLA, placebo.

The primary outcome variables measured daily included sleep quantity (ŌURA ® ring) and ovulation testing. The primary outcome variables measured pre- and post-intervention included a health history questionnaire, sleep quality (Pittsburg Sleep Quality Index, PSQI) dietary intake (Diet History Questionnaire III, DHQ III), body composition (dual energy X-ray absorptiometry, DXA; and bioelectrical impedance analysis, InBody S10), and muscular strength (TONAL ® ). Figure 1 shows the study experimental design and methodology.

2.3. Supplementation

CR (Creapure ® AlzChem, Trostberg, Germany; GRAS Notice No. GRN 931) and PLA (Globe ® Plus 10 DE Maltodextrin, Calgary, AB, Canada) were consumed Monday through Friday (1200–1400 h) in the Human Performance Laboratory at the University of Idaho for 6 consecutive weeks. At the Friday laboratory visit, participants were given two doses of their assigned supplement in a travel container to take home for consumption (1200 and 1400 h) on Saturday and Sunday and were instructed to return the container at the subsequent Monday laboratory visit. Photo and video evidence of supplement consumption was captured by participants and sent electronically to researchers for compliance assurance on weekend days. The CR powder (5 g·day) was mixed with an equal volume of maltodextrin (5 g corn-starch maltodextrin) and the PLA powder contained only maltodextrin (10 g corn-starch maltodextrin). Both products were similar in color (white), texture, and appearance. To optimize taste, participants were offered a choice of Crystal Light ® (Kraft Heinz, Mendota Heights, MN, USA) pink lemonade, raspberry lemonade, or fruit punch powder to add with 0.25 L of water for supplementation consumption. The purity of Creapure ® was established at >99.9% by independent laboratory testing (The Cary Company, Addison, IL, USA). Participant supplementation compliance of >80% was required for inclusion in data analyses (i.e., >34 out of 42 days).

2.4. Resistance Training Program

Participants completed a 6-week TONAL ® resistance training program (TONAL ® Corporation, San Francisco, CA, USA). TONAL ® is a commercial electromagnetic resistance wall-mounted device that all participants used 2x/week in the laboratory for their scheduled resistance training sessions. Training days were two non-consecutive days to allow for recovery. If participants missed a session, they had the opportunity to reschedule for a different time during the same week. Participants were required to maintain 80% adherence to continue participating in the study. Prescribed TONAL ® full body workouts ranged from 35–47 min where the first four sessions were ‘beginner’, and the remaining eight sessions were ‘intermediate’. All sessions were supervised by a trained researcher to ensure participant safety. TONAL ® technology increased or decreased load based on the parameters of the custom prescribed workout and participants received feedback on form during each movement.

2.5. Daily Testing

Throughout the 6-week intervention, daily sleep quantity and quality and ovulation testing were assessed. Additionally, daily testing included an adverse event ‘check-in’ to give participants the opportunity to report perceived issues related to the supplement and/or training. Participants visited the laboratory between 1200 and 1500 h to assess these measures, Monday through Friday, and measured the same outcomes at home between 1200 and 1500 h on Saturday and Sunday.

2.5.1. Daily Sleep Assessment

Participants were given an ŌURA ring (ŌURA Health Oy, Oulu, Finland) for the duration of the 6-week study. The ŌURA ring assesses total sleep quantity and sleep quality, differentiating sleep into four distinct stages, awake, light sleep, deep sleep, and rapid eye movement (REM) sleep. ŌURA has been shown to be a valid device and comparable to gold-standard polysomnography [ 21 ].

2.5.2. Ovulation Urine Testing

Participants were provided with a dixie cup and gloves to collect a urine sample. The urine sample was handed to a researcher who then dipped the ovulation test strip (Easy@Home Fertility, Premom, Burr Ridge, IL, USA) for 5–10 s until the dye moved up the stick. The stick was placed on a white, flat, non-absorbent surface for 5 min. The test results were recorded immediately after 5 min. A positive ovulation test was recorded if two lines were present. If a positive ovulation test occurred, the participant completed a bioelectrical impedance analysis (BIA; InBody S10, Gangam-gu, Seoul, Republic of Korea) to assess total body water (TBW; kg), intracellular water (ICW; kg), and extracellular water (ECW; kg) at the time of ovulation. Body composition methodology details are below in Section 2.6.3 .

2.6. Pre- and Post-Testing

Participants visited the laboratory for a series of pre- and post-testing before and after the 6-week intervention. Pre- and post-testing laboratory visits occurred between 1200 and 1500 h and included health questionnaires, dietary assessment, body composition measures, and muscular strength testing which are all described in detail below.

2.6.1. Health Questionnaires

Participants completed a health history questionnaire to assess general health history and menstrual cycle history. Questions included perceived experiences and symptoms before, during, and after menses. Then, participants completed the PSQI, which is a validated metric to assess self-reported sleep quality and fatigue. The PSQI asked participants to rate daily fatigue based on their perception of how it affected their day on a scale of 0–3 (0 = no problems with fatigue and 3 = extreme problem with fatigue).

2.6.2. Dietary Intake Assessment

Participants completed the DHQ III ( https://epi.grants.cancer.gov/dhq3/ ; URL accessed on 15 December 2022), pre- and post-intervention. DHQ III is an online food frequency questionnaire for adults of at least 19 years of age and is widely utilized by researchers to assess food and dietary supplement intake using 135 food and beverage line-items and 26 dietary supplement questions. Each line-item asked participants the frequency of food item intake and portion size in the previous 30 days. Total calories (kilocalories), carbohydrate (g and g/kg), fat (g), protein (g and g/kg), and estimated habitual CR (g) were used for analysis. To estimate CR content in foods, the following categories were used from DHQ III reports and were summed to calculate habitual CR intake [ 22 ]: meat (0.13 g/oz: beef, pork, veal, lamb, game), cured meat (0.06 g/oz: sausages and luncheon meat), organ meat (0.08 g/oz: liver and kidney), poultry (0.11 g/oz: chicken and turkey), and seafood (0.08–0.16 g/oz: salmon, herring, anchovies, trout, cod, tuna).

2.6.3. Body Composition

Participants performed BIA (InBody S10, Gangam-gu, Seoul, Republic of Korea) at pre-intervention, ovulation, and post-intervention and dual energy X-ray absorptiometry (DXA; Hologic DXA Scanner, Hologic Horizon TM ; Danbury, CT, USA) at pre- and post-intervention. Prior to BIA testing, participant hydration status was confirmed using a urine sample and refractometer (Atago 3749-E04, Tokyo, Japan). Participants were required to be euhydrated (1.002–1.025) to complete body composition testing. Participants first removed their socks and had their wrists and ankles wiped clean prior to electrode placement. The minimal detectable difference using InBody for TBW (kg) was 0.19 [ 23 ]. Total body water (TBW; kg), intracellular water (ICW; kg), and extracellular water (ECW; kg) were used for analysis. Next, one non-invasive anteroposterior view of the total body lying supine was performed using DXA. Testing was completed according to the manufacturer’s instructions and specifications. Results were analyzed with APEX software, version 4.5.2.1 (Hologic Inc., Marlborough, MA, USA). The quality analysis for the densitometer was conducted daily using a standard aluminum spine block (Hologic Phantom) provided by the manufacturer. Measurements of the phantom fell within the manufacturer’s precision standard with a coefficient of variation <0.5%. Test–retest interclass coefficient of variation (CV; %) using DXA for lean soft tissue (LST; kg) and fat mass (FM; kg) was 1.1% and 0.69%, respectively [ 23 ]. The minimum detectable differences using DXA for LST (kg) and FM (kg) were 0.27 and 0.21, respectively. LST (kg and %), FM (kg and %), visceral adipose tissue (VAT; cm 2 ), and appendicular lean soft tissue index (ALSTI; kg/m 2 ) were used for analysis. Body composition index (BCI) was calculated as follows: BCI = [(LSTpost − LSTpre) + (FMpre − FMpost)], where pre is pre-intervention and post is post-intervention, to evaluate overall body composition changes.

2.6.4. Muscular Strength

All participants were familiarized with the TONAL ® equipment and then completed the TONAL ® Strength Assessment per the manufacturer’s specifications to generate a pre-and post-intervention total body TONAL ® strength score. The pre-intervention TONAL ® Strength Assessment established initial weight/intensity for TONAL ® training sessions based on a 3-repetition maximum lift of four primary movements including bench press, neutral grip deadlift, seated lat pulldown, and seated shoulder press. Participants completed this assessment using prompts from the TONAL ® program and safety monitoring from a trained researcher.

2.7. Statistical Analyses

All statistical analyses were conducted using SPSS version 29 (IBM Corp., Armonk, NY, USA) and jamovi version 2.2.5 [ 24 ] with statistical significance set at 0.05. ANOVAs were conducted to ensure that no significant group (CR vs. PLA) differences in baseline measures were observed. Repeated-measures ANOVAs were used to examine whether there were group (CR vs. PLA) differences across time (pre, post). Any significant interactions were decomposed using Bonferroni-corrected post hoc tests.

Given that participants provided daily measures across a six-week intervention, a multilevel modeling (MLM) approach was used to assess changes in sleep duration (total sleep, deep sleep, REM sleep, light sleep) measured via the ŌURA ring. The MLM approach was used not only to account for the nested structure of the data (i.e., repeated measurements within subjects) but also because of its ability to include participants with missing data in the analyses [ 25 ]. Using the GAMLj module in jamovi, group (CR = 1; PLA = 0)*week (1, 2, 3, 4, 5, 6) MLMs were conducted to examine whether sleep duration changed across the six weeks by group status. A random effect of participant was included in these models, while week was only included as a fixed effect since the models failed to converge when including it as a random effect. To examine whether sleep duration changed by group status following a workout, additional group (CR = 1; PLA = 0) x workout (non-workout = 0; workout = 1) MLMs were conducted, including random effects of participant and workout. All MLMs used the restricted maximum likelihood estimation method, the Satterthwaite method to approximate degrees of freedom, and the Wald method to construct 95% CIs. Any significant main effects or interactions were decomposed by using Bonferroni-corrected post hoc tests.

3.1.1. Sleep Quality

There were no significant differences in the PSQI between groups or from pre- to post-intervention. Notably, the majority of CR and PLA groups had a Global PSQI score < 5, indicating poor sleep quality at both pre-testing (55%, 66%, respectively) and post-testing (55%, 75%, respectively).

3.1.2. Sleep Duration

There were no significant group differences in sleep duration (total sleep, deep sleep, REM sleep, light sleep) or changes by week across the intervention for deep and REM sleep duration. Across both groups, there were significant differences by week in total sleep (F(5,87.16) = 2.33, p = 0.049) and light sleep duration (F(5,88.19) = 2.38, p = 0.045); however, none of the post hoc tests was significant (total sleep duration: Week 1: 427.4 min, SE = 11.66; Week 2: 438.1 min, SE = 11.97; Week 3: 413.0 min, SE = 11.66; Week 4: 412.8 min, SE = 11.97; Week 5: 399.1 min, SE = 12.12; Week 6: 428.6 min, SE = 12.29; light sleep duration: Week 1: 235.1 min, SE = 11.11; Week 2: 248.4 min, SE = 11.31; Week 3: 229.0 min, SE = 11.11; Week 4: 221.6 min, SE = 11.31; Week 5: 222.5 min, SE = 11.40; Week 6: 240.6 min, SE = 11.50).

On workout and non-workout days (one participant’s data were excluded given that they only had less than 10% complete data; therefore, these analyses included data from the remaining 20 participants), there was a significant group x workout interaction for total sleep duration (F(1,85.80) = 4.15, p = 0.045). Post hoc tests (Bonferroni-corrected alpha = 0.05/2 = 0.025) indicated no group differences (PLA: 422.26 min, SE = 13.41; CR: 431.83 min, SE = 11.06) in total sleep on non-workout days (t(17.89) = 0.55, p = 0.588); however, compared to the PLA group (M = 396.70 min, SE = 13.89), the CR group (M = 444.60 min, SE = 11.62) experienced an increase in their total sleep duration on workout days (t(30.92) = 2.65, p = 0.013; Figure 2 ). There were no other group differences or effects by workout for deep sleep, REM sleep, and light sleep duration.

Model-estimated means (and standard errors) of total sleep duration as a function of workout and group status. Note: The thick lines represent the average effect estimated by the fixed effect and the thinner lines represent the effects by participant (i.e., the random effect).

3.2. Participant Demographics

Of the 27 participants enrolled, 2 withdrew prior to beginning the study and 4 withdrew at various points during the study following pre-testing. Data reflect participants who completed both pre- and post-testing and were >80% compliant regarding supplementation and exercise training. Participant demographics at baseline are displayed in Table 1 . There were no significant differences between groups.

Participant demographics at baseline.

Data reported as mean ± SD. cm, centimeters; kg, kilograms; m, meters; F, follicular; L, luteal. Note: Not all participants had a confirmed menstrual cycle phase at baseline.

3.3. Strength

TONAL ® strength score improved from pre- to post-intervention for both groups (F(1,19) = 125.57, p < 0.001); however, there were no group differences or group × time interaction in strength score.

3.4. Body Composition

There were no significant group differences in DXA body composition metrics; however, both groups significantly increased absolute FM but not relative fat mass (kg; F(1,19) = 8.83, p = 0.008), TBW (F(2,28) = 5.09, p = 0.013), ICW (F(2,28) = 5.49, p = 0.010), and ECW (F(2,28) = 3.49, p = 0.041; Table 2 ). Although there were significant differences in TBW, ICW, and ECW from pre-intervention to ovulation testing, there were no differences in these metrics from ovulation to post-intervention.

Body Composition Metrics.

Data reported as mean ± SD. BM, body mass; FM, fat mass; LST, lean soft tissue; VAT, visceral adipose tissue; ALSTI, appendicular lean soft tissue index; BCI, body composition index; TBW, total body water; ICW, intracellular water; ECW, extracellular water; kg, kilograms; cm, centimeters; m, meters. ^ Indicates statistical significance from pre to post p < 0.05. # Indicates statistical significance from pre to ovulation p < 0.05.

3.5. Dietary Intake Assessment

There were no significant group differences in dietary behaviors or changes from pre- to post-intervention. Across both groups, there was a significant reduction in the following from pre- to post-intervention: total calories ( p = 0.039), protein ( p = 0.018), and fat ( p = 0.036). Relative protein ( p = 0.009; g/kg) and carbohydrate ( p = 0.023; g/kg) significantly decreased from pre- to post-intervention ( Table 3 ).

Dietary Intake.

Data reported as mean ± SD. kcal, kilocalories; g, grams; kg, kilograms; ^ Indicates statistical significance from pre to post p < 0.05.

4. Discussion

Unique and important results of this study included greater sleep duration (quantity) the night following resistance training exercise bouts with CR supplementation compared to resistance training exercise without CR. These results are consistent with previous research among sleep-deprived participants, which has shown restorative effects of CR supplementation with and without exercise on cognitive performance and mood improvement [ 7 , 26 ]. However, these results contradict those identified in a rat model, in which total sleep duration decreased following 4 weeks of CR supplementation [ 27 ]. These results have not been reproduced in a human model and warrant further investigation. Current evidence suggests that CR supplementation may have greater effects on the brain under stressful conditions such as exercise and sleep deprivation and that CR may decrease the effects of sleep deprivation [ 28 ]. In the present study, it is possible that resistance training provided a great enough stimulus to stress the body and therefore enhance the effects of CR supplementation. While the precise mechanism for this change is unknown, CR has been shown to decrease oxidative stress and inflammation and improve brain bioenergetics, which may have favorable effects on sleep [ 28 ]. Furthermore, these findings are important given that young females typically experience greater sleep disturbances and poorer sleep quality compared to males [ 11 , 12 ].

Although there is a dearth of CR supplementation and sleep research, several studies have investigated the impact of resistance training on sleep [ 29 , 30 , 31 , 32 , 33 , 34 ]. Findings vary, with one study reporting no effects of acute resistance training on sleep assessed via polysomnography [ 31 ]. It is possible that lab-based sleep assessments fail to capture real-life sleep among participants when free-living conditions (e.g., the habitual sleep environment) are removed. At-home sleep assessment using ŌURA ® or similar daily sleep-tracking devices may better capture participants’ sleep responses to resistance training exercise. Other research findings suggest subjective sleep quality improves following 12–16-week resistance training programs; however these findings have been observed among clinical and older male and female populations [ 32 , 34 ]. Moreover, many studies report subjective sleep quality only using the PSQI before and after exercise intervention. In the present study, there were no differences in perceived sleep quality using the PSQI over time or between groups, indicating a need for future research to include both sleep quality and quantity measures in dietary and exercise interventions that are short in duration (e.g., 6–10 weeks).

In the present study, both groups significantly improved TONAL ® strength score, while no significant changes in relative LST and FM were identified. It is likely that the improvements in TONAL ® strength scores are attributed to improved neural function [ 35 ]. Our findings do not suggest that CR supported these improvements during the short 6-week intervention as all participants improved over time. It is possible that the training period was too short to elicit significant changes in LST and FM, and it may require a training program longer in duration and higher intensity to yield changes previously demonstrated in other female-specific exercise intervention studies [ 36 , 37 ]. The small samples size likely limited the ability to detect small changes between CR and PLA. A previously reported perceived mild side effect of CR supplementation is bloating [ 38 ], which may be more prominent among women. Participants did not report any perceived negative side effects with CR supplementation, and no significant changes in TBW, ICW, and ECW between groups suggest that cellular fluid did not change as a result of CR supplementation. However, significant changes in TBW, ICW, and ECW were observed between pre-testing and ovulation, indicating cellular fluids may change specifically during ovulation. These results are limited and warrant follow-up in future investigations given the small number (n = 16) of participants reporting a positive ovulation test during the present 6-week intervention.

Estimated habitual CR consumption was low for non-vegetarians/vegans where participants consumed less than 0.5 g/day at pre- and post-testing, when 2–4 g would be expected from a habitual omnivore diet [ 1 ]. This could partly be attributed to low total estimated energy intake below 2000 calories at both pre- and post-testing. Interestingly, all participants experienced significant decreases in total calories consumed, relative protein and carbohydrate intake, and absolute fat intake. The reasons for these changes among all participants are unclear. The food frequency questionnaire used in this study (DHQ III) captured the previous 30 days, so these changes represent the difference in diet behavior 30 days prior to the study and 30 days during the study. It is possible that the significant decreases in relative protein below the recommended dietary allowance (<0.8 g/kg/day) also impacted participants’ ability to stimulate muscle protein synthesis, thus impacting our body composition findings. Research has indicated that 0.8 g/kg/day is insufficient at stimulating muscle protein synthesis for those engaging in resistance training, and at least 1.2 g/kg/day protein should be consumed to stimulate muscle protein synthesis [ 39 ]. To mitigate significant dietary changes in future research, it may be beneficial to incorporate a nutrition education session prior to an intervention to maximize potential benefits of additional CR.

Key strengths of the present study include the use of an at-home sleep-monitoring device to assess sleep quantity throughout the 6-week intervention in addition to sleep quality. The study employed double-blinding and randomized, placebo-controlled methods where participants reported to the laboratory daily and submitted weekend videos to ensure supplement compliance. The study also included naturally menstruating women; a population that has historically been excluded from research. Despite these strengths, there are a few limitations to address. Given that total saturation of CR stores takes approximately 28 days [ 40 ] it is possible that a 6-week intervention was too short to produce significant changes in LST and may impact our sleep-related findings. Future sleep and CR research should employ CR loading phases and experiment with greater CR dosages that may have greater effects on the brain and sleep [ 28 ]. The resistance training intervention utilized new and innovative resistance training equipment, TONAL ® . The study relied on TONAL ® programming and strength testing and it is possible that the intensity of the programming was insufficient to produce LST changes compared to standard resistance training. Greater than two days per week of resistance exercise would have likely yielded difference results, however, the study was designed to standardize exercise across all participants to observe the additive effects of creatine supplementation.

Future research should explore the effects of CR supplementation, both alone and in combination with varying types of exercise, on cognitive performance, mood, and its relationship to sleep quantity using daily measurement devices such as ŌURA ® . Due to individual menstrual differences and the fact that ovulation was not detected for some participants we were unable to determine a precise menstrual cycle phase for all participants in our study. There is a strong need to include women in research, and the inability to determine menstrual cycle phase should not necessarily deter researchers from including female participants. Additionally, studies should investigate a similar intervention using females on hormonal birth control to explore the potential interaction of hormonal birth control and CR on sleep following exercise.

5. Conclusions

This study demonstrated that CR supplementation may increase acute total sleep when combined with resistance training among naturally menstruating women. These findings may be particularly important for those consuming a diet habitually low in creatine sources even if they follow an omnivore diet. While much research has investigated the impact of resistance training on sleep, the additive effect of resistance training and creatine supplementation on sleep quality and quantity is further warranted.

Acknowledgments

We wish to acknowledge the many undergraduate and graduate students working in the Human Performance Laboratory for the duration of this intensive intervention study who met daily with participants to ensure strong compliance and monitored exercise training. We would also like to acknowledge TONAL ® for gifting the equipment for this study.

Funding Statement

A.A.B.C., C.J.B., and A.F.B. were supported by an Institutional Development Award (IDeA) from the National Institute of General Medical Sciences of the National Institutes of Health under Grant # P20GM152304 during preparation of this manuscript. The contents are solely the responsibility of the authors and do not necessarily reflect the official views of NIH.

Author Contributions

Conceptualization, A.F.B., S.J.B. and D.G.C.; methodology, A.F.B., S.J.B. and D.G.C.; formal analysis, A.J.A.B.C. and C.J.B.; investigation, A.J.A.B.C., K.K., S.J.B. and A.F.B.; resources, D.G.C. and A.F.B.; data curation, A.J.A.B.C., K.K. and G.L.I.; writing—original draft preparation, A.J.A.B.C., M.G.S., C.J.B. and A.F.B. writing—review and editing, A.J.A.B.C., C.J.B., M.G.S., D.G.C. and A.F.B.; visualization, A.J.A.B.C., C.J.B. and A.F.B.; supervision, A.F.B. and S.J.B.; project administration, A.F.B. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of University of Idaho (22-216; 6 January 2023).

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

Data Availability Statement

Conflicts of interest.

D.G.C. has conducted industry-sponsored research involving CR supplementation and received CR donations for scientific studies and travel support for presentations involving CR supplementation at scientific conferences. In addition, D.G.C. serves on the Scientific Advisory Board for Alzchem (a company that manufactures CR) and as an expert witness/consultant in legal cases involving CR supplementation. All other authors declare no conflicts of interest.

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