Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) (R03 Clinical Trial Optional)

Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) (R03 Clinical Trial Optional) is sponsored by NIH. Supports early medical/surgical specialists' transition to aging research.

Expired RFA-AG-25-021: Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) (R03 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Funding Opportunity Title Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) (R03 Clinical Trial Optional) 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 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The goal of the Grants for Early Medical/Surgical Specialists' Transition to Aging Research (GEMSSTAR) program is to provide support for early-career physician-scientists trained in medical or surgical specialties and early-career dentist-scientists to launch careers as future leaders in aging- or geriatric-focused research.

In support of the program's goal, this GEMSSTAR notice of funding opportunity (NOFO) invites applications that propose to conduct transdisciplinary aging research that will yield pilot data and experience for subsequent aging research projects.

The GEMSSTAR program encourages candidates to seek out a supportive research environment to further the program's objectives of fostering the development of early-career physician- and dentist-scientists in aging- or geriatric-focused research, particularly as it applies to their clinical specialty/discipline.

Toward this end, GEMSSTAR candidates should include a Professional Development Plan that reflects this supportive research environment. In selecting GEMSSTAR awardees, the National Institute on Aging (NIA) will consider the extent to which a candidate's environment is supportive of aging- or geriatric-focused research.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization's time zone. 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description With the growing number of older adults with complex health challenges, there is an equally growing need for medical, surgical, and dental clinician-scientists with training and experience in research focused on optimizing the care of older patients.

A pivotal point in the development of clinician-scientists is the completion of specialty training and the first faculty appointment. At this early stage, limited research experience and publication record preclude competitiveness for many kinds of advanced research opportunities.

This transition stage may be particularly difficult for physicians or dentists focusing on aging-related aspects of their specialty/discipline, as multidisciplinary research entails training that is rarely available in conventional programs.

Thus, mechanisms that allow these clinicians to initiate research projects and establish research track records are critical for cultivating the next generation of clinician-scientists at the interface of aging and medical, dental, and surgical specialties.

The goal of the GEMSSTAR program is to provide support for early-career physician-scientists trained in medical or surgical specialties and early-career dentist-scientists for small, transdisciplinary research projects on questions relevant to aging and/or the aged to launch careers as future leaders in aging- or geriatric-focused research.

This GEMSSTAR NOFO invites applications proposing to conduct transdisciplinary aging research that will yield pilot data and experience for subsequent aging research projects.

The GEMSSTAR program encourages candidates to seek out a supportive research environment that will further the program's objectives of fostering the development of early-career physician- and dentist-scientists in aging- or geriatric-focused research, particularly as it applies to their clinical specialty/discipline.

In selecting GEMSSTAR awardees, NIA will consider the extent to which a candidate's environment is supportive of aging- or geriatric-focused research. The GEMSSTAR program is intended to support an early-career physician's or dentist's first independent research project.

The program also provides an opportunity for physicians and dentists who are funded in non-aging-related fields to refocus their research efforts on aging- or geriatrics-related topics. Thus, the program seeks applicants who aspire to continue or shift their research focus to bridge their specialty/discipline and the clinical care of older adults. The GEMSSTAR program provides two years of funding.

Applicants should emphasize integration of gerontologic or geriatric research with the candidate’s clinical specialty/discipline. Proposed projects may involve pilot or feasibility studies, secondary analyses of existing data, development of research methodology, development of new research technology, or other similar approaches.

Projects may span the breadth of scientific domains, including basic, translational, clinical, genetic, or epidemiologic science. Human subjects, animal models, and in vitro systems are all acceptable as appropriate to the research questions. Projects should be appropriate to the background and level of experience of the applicant.

Potential research topics may include, but are not limited to, the following: Characterization of an aging-related disease, condition, syndrome, or phenomenon relevant to a clinical specialty/discipline Elucidation of mechanisms underlying specialty/discipline-related diseases in older age Identification of predictors and/or outcomes of specialty/discipline-related interventions specific to older populations Pilot investigation of a specialty/discipline-related intervention in older adults Development of strategies to address and/or integrate important complexities common in older patients typically seen within a clinical specialty/discipline, such as multiple chronic conditions; polypharmacy; multispecialty guideline integration; and preservation of function, cognition, and independence Multidisciplinary care strategies, such as palliative care, to improve outcomes in older patients within or across care settings Specific diagnostic, management, and/or decision-making and communication strategies pertaining to older adults with Alzheimer's disease (AD) or AD-related dementias (ADRD) within or across medical and/or surgical specialties and primary care/geriatrics Strategies for screening, primary prevention, and/or secondary prevention of specialty/discipline-related diseases in older adults Initial development of tools to assess the risk and/or prognosis of a specialty/discipline-related disease and/or interventions in older adults Please refer to Section III.

Eligibility Information, Eligible Individuals (Program Director/Principal Investigator) for clarification on eligibility. It is expected that applicants will have expertise in their clinical specialty/discipline, but may be less experienced in geriatric/gerontologic science or in other areas.

As such, applicants should include participation of a senior collaborator with complementary expertise in aging-related research and, if needed, other collaborators and/or consultants in additional areas appropriate to the proposed project.

Geriatricians proposing a research project that integrates their geriatrics expertise with a specific clinical problem that is typically embraced by another specialty should involve a senior collaborator with expertise in that clinical problem as it relates to older patients.

For example, a geriatrician researcher proposing a project focused on chronic kidney disease is encouraged to involve a senior nephrologist or other relevant specialist.

In addition to the research project, candidates must also include a Professional Development Plan that describes an individualized plan to garner resources, activities, collaborations, and/or didactic or practical experiences concurrent with the R03 research project that will 1) lead to enhanced knowledge and skills in aging/geriatrics science, and 2) increase the applicant's likelihood of successful completion of their proposed GEMSSTAR project.

This plan would complement the GEMSSTAR R03 award and would need to be supported independent of the R03 research plan and funding. More details about the Professional Development Plan and other details can be found on the NIA GEMSSTAR webpage . Prospective applicants are strongly encouraged to visit this webpage for answers to frequently asked questions and to learn more about the GEMSSTAR program.

NOTE TO APPLICANTS CONSIDERING A CLINICAL TRIAL: The limited time and budget provided by this NOFO will constrain the types of clinical trials that can be proposed. In general, only mechanistic trials or small pilot trials are likely to be feasible. Applicants considering a clinical trial are highly encouraged to contact NIA program staff early to discuss the feasibility of doing so.

Refer also to the NIH's policies and requirements for clinical trials . Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Clinical Research Operations Management System NIA uses a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research.

NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021, including clinical trials funded as pilots, exploratory studies, or other projects through this Consortium, and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017 .

Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4. 1. 15.

7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website . When applicable, all NIA grantees must ensure: 1.

The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46. 116 , all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.

” If using the NIA informed consent template , please see Section 6: Statement of Confidentiality. 2. An assigned NIH ClinicalTrials.

gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials. gov. NIA's Commitment to Inclusivity in Research Involving Human Subjects NIA is committed to supporting and conducting research on aging that improves the health and well-being of all people.

Therefore, NIA will prioritize the advancement of science that represents, in terms of race, ethnicity, sex, age, and comorbidity, the population affected by the condition being studied.

Applicants should ensure as applicable that they 1) include proposed planned enrollment tables identifying the population(s) affected by the disease/condition, and 2) address the NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities , as appropriate; as well as other populations that experience health disparities. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards Funds Available: $3. 8 million in fiscal year 2025 Anticipated Number of Awards: 15 general awards and 4 Alzheimer’s disease (AD) or AD-related dementias (ADRD) awards.

Application budgets are limited to $125,000 in direct costs per year. Indirect costs are those for a common or joint purpose across more than one project and that cannot be easily separated by project. Learn more at 45 CFR 75.

414 , Indirect Costs. To charge indirect costs applicants can select one of two methods: Method 1 – Approved rate. The applicant organization currently has an indirect cost rate approved by the applicant organization’s cognizant federal agency.

Method 2 – De minimis rate. Per 45 CFR 75. 414(f) , if the applicant organization has never received a negotiated indirect cost rate or is awaiting approval of an indirect cost proposal, they may elect to charge a de minimis rate.

If choosing this method, costs included in the indirect cost pool must not be charged as direct costs. This rate is 10% of modified total direct costs (MTDC). See 45 CFR 75.

2 for the definition of MTDC. Organizations can use this rate indefinitely. The project period is limited to 2 years.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed. The applicant organization must be registered in SAM.

gov, Grants. gov, and eRA Commons before submitting an application. While applicants can review the requirements and start developing applications before registrations are complete, applicants should complete these steps early.

Failure to complete required registrations before the due date is not a valid reason for a late submission. Please reference NIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applications for more information. System for Award Management (SAM) – Applicant organizations must have an active account with SAM.

gov. This includes having a Unique Entity Identifier (UEI). SAM. gov registration can take 6 weeks or longer.

Begin that process today. To register, go to SAM. gov Entity Registration and select Get Started.

Select the Entity Registration Checklist on the same page to view a list of the information needed to need to register. Organizations must maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration.

After registering in SAM, organizations can register with Grants. gov and eRA Commons. 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 registrations; 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.

Make sure the organization uses the same UEI on the application, in SAM. gov, and in eRA Commons. Grants.

gov – Applicant organizations must also have an active account with Grants. gov. See step-by-step instructions at the Grants. gov Quick Start Guide for Applicants .

Program Directors/Principal Investigators (PD(s)/PI(s)) Every 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. All other personnel listed on the SF424 (R&R) Senior/Key Person Profile must have an eRA Commons account. Eligible Individuals (Program Director/Principal Investigator) NIH invites anyone who has the skills, knowledge, and resources needed to carry out the proposed research as a program director or principal investigator (PD/PI) to work through their organization to apply.

Individuals from diverse backgrounds, including 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 and organizations who are proposing multiple PDs/PIs, visit the Senior/Key Person Profile (Expanded) component of the Research Instructions and look for submission details. Eligibility is limited to individuals aiming to focus on aging research within their specialty/discipline who are: Physicians (i.e., those with M. D.

, D. O. , or equivalent degrees) who have completed training in their medical or surgical specialty.

Physician specialties include, but are not limited to, the traditional medical and surgical specialties, anesthesiology, emergency medicine, family medicine, general internal medicine, general surgery, geriatrics, hospital medicine, neurology, obstetrics/gynecology, palliative medicine, physiatry/rehabilitation medicine, and psychiatry; or Dentists and dental specialists (i.e., those with either a D. D. S.

, D. M. D.

, or equivalent dental degree). This award is not intended for individuals with substantial experience in aging research. It is generally expected that applicants will not have had prior research funding as an independent PD/PI on a major NIH grant (e.g., R01, P01), though they may have had support through institutional awards, such as institutional career development awards (e.g., K12, KL2) or NIA Center research education awards.

Note that NIH policy now allows investigators with K awards to receive salary compensation from Federal or non-Federal sources for effort not directly supported by their K award (see NOT-OD-17-094 ). Candidates who have received individual mentored K-awards from NIA (excluding K38 and K99) are generally ineligible.

Early-career clinician-scientists who have had a previous NIH individual mentored career development award in a non-aging-related field and who wish to refocus their research efforts on aging-related science are eligible to apply for a GEMSSTAR award.

However, such individuals must provide strong justification in their application explaining how their proposed research will entail a meaningful shift towards aging-related science within their clinical specialty or discipline. Such applicants are strongly encouraged to discuss their eligibility with NIA program staff early in the application process.

Applicants considering applying for a mentored K award and a GEMSSTAR award concurrently are strongly encouraged to contact NIA program staff to ensure their plans are consistent with NIH policy and NIA programmatic interests. The aims of the two applications must not overlap per NIH submission policies. NIA will weigh an applicant's funding from other NIA and NIH awards in making GEMSSTAR funding decisions.

Eligibility is limited to candidates who have, or will have, a faculty appointment at the start of GEMSSTAR funding. Candidates in the last year of training should provide documentation of institutional commitment for a faculty appointment as described in Letters of Support in Section IV. Faculty appointments that are contingent on receiving a GEMSSTAR award are not acceptable.

It is expected that GEMSSTAR applications will have a single PD/PI and that other personnel will be listed as collaborators or consultants. Answers to frequently asked questions regarding GEMSSTAR eligibility can be found on NIA's GEMSSTAR webpage . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.

2 Definition of Terms. 3. Additional Information on Eligibility Applicant organizations may submit more than one application if each is scientifically distinct.

NIH will not accept duplicate or highly overlapping applications under review at the same time. See the policy on Submission of Resubmission Application . This means that NIH will not accept: A new (A0) application submitted before NIH issues the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application submitted before NIH issues the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review. See the policy on Similar, Essentially Identical, or Identical Applications .

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 Applicants must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide unless this NOFO says otherwise.

NIH strictly enforces these requirements. If the applicant does not follow them, NIH may delay or not accept the application for review. NIH encourages organizations to submit applications in advance of deadlines.

NIH asks that applicant organizations let us know if they plan to apply for this opportunity. The purpose is to plan for the number of expert reviewers needed to evaluate applications. It is not required.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity The funding opportunity number and title Participating institution(s) The name(s), phone number, and email address of all the PD(s)/PI(s) Names of other key personnel Please email the optional letter of intent to: National Institute on Aging (NIA) All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed.

Other attachments : Applicants must include an attachment titled "Professional Development Plan" that describes an individualized plan to garner resources, activities, collaborations, and/or didactic or practical experiences concurrent with the R03 research project that will 1) lead to enhanced knowledge and skills in aging/geriatrics science, and 2) increase the applicant's likelihood of successful completion of their proposed GEMSSTAR project.

This plan would complement the GEMSSTAR R03 award and would need to be supported independent of the R03 research plan and funding. This section is limited to 5 pages. The elements of a Professional Development Plan may differ for each applicant based on career stage, research experience, institutional resources, or other factors.

Applicants are encouraged to tailor their plans to meet their individual professional development needs in relation to their proposed GEMSSTAR project. Moreover, applicants are encouraged to describe specific activities that will augment their skills in geriatrics and/or aging research in order to develop into independent researchers in aging science.

Additional information on designing a Professional Development Plan, including answers to frequently asked questions, can be found on NIA's GEMSSTAR webpage . SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. Applicants should use the biographical sketch of the principal investigator to illustrate how this award will advance the investigator's career in aging research.

Applicants should use biographical sketches of all investigators to illustrate complementary and integrated expertise in aging and/or geriatrics among the research team, and the appropriateness of each person's role to advance the specific aims of the project. All instructions in the How to Apply - Application Guide must be followed.

Applicants should budget for travel to the annual GEMSSTAR grantees meeting supported by the Clin-STAR Coordinating Center . Except in unusual circumstances, only the PD/PI may be supported by R03 funds to travel to the grantees meeting. There is no specific line item in the Modular Budget format in which to list travel costs; instead, the proposed travel should be described in the budget justification section.

Answers to frequently asked questions regarding travel to the grantees meeting can be found on NIA's GEMSSTAR webpage . All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Research Strategy: In accordance with the goals of the GEMSSTAR program, the Research Strategy should emphasize how the candidate's proposed research will advance the understanding of aging- or geriatrics-related science in the candidate’s specialty/discipline, as well as facilitate the candidate’s transition specifically into aging research.

Applicants should address to what extent the proposed project introduces aging-related research questions to the applicant’s clinical specialty/disciplinary area, as well as its potential contribution to new and meaningful knowledge of geriatric or gerontologic science related to the applicant’s clinical specialty/discipline.

Clinical Trials: Without duplicating information in the PHS Human Subjects and Clinical Trials Information Form, applicants proposing a clinical trial, ancillary, or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, project scope, and methods used to assign trial participants and deliver interventions.

If proposing an ancillary study to an ongoing clinical trial, applicants should provide a brief description of its relationship to the larger clinical trial.

If proposing a feasibility study to begin to address a clinical question, applicants should provide justification as to why this is warranted and how it will contribute to the overall goals of the research project, including planning and preliminary data for future, larger-scale clinical trials.

Applicants should describe the proposed timelines for the proposed clinical trial, feasibility, or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).

Letters of Support: Letters of support from department or division chairs, other institutional leaders, senior collaborators, and other contributors should describe, where appropriate, the following: Support from the applicant's institution, department, or division for the applicant's successful completion of the proposed research project Efforts from the letter's author to promote transdisciplinary aging research within the author's specialty/discipline Scientific roles of senior collaborator(s) or other contributors to the applicant's professional development For applicants in their last year of training, documentation of the institution's commitment to the applicant's faculty appointment, which should commence no later than the start of the GEMSSTAR R03 award Letters of support associated with a Professional Development Plan, if included, should be placed in the Letters of Support section.

Applicants are encouraged to visit NIA's GEMSSTAR webpage for additional information regarding letters of support. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions: If the answer to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form is yes, include at least one human subjects study record. Use either of the following parts of the PHS Human Subjects and Clinical Trials Information form: Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Section 2 - Study Population Characteristics Applications in response to this funding opportunity must provide a rationale supporting eligibility criteria that are 1) representative of the population affected by the disease/condition, and 2) address the populations outlined in the NIH Inclusion Policies for Research Involving Human Subjects and