Part 1. Overview Information

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.

Key Dates

Posted Date July 31, 2024 Open Date (Earliest Submission Date) October 01, 2024 Letter of Intent Due Date(s)

October 01, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
November 01, 2024 November 01, 2024 Not Applicable March 2025 May 2025 July 2025

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).

Expiration Date November 02, 2024 Due Dates for E.O. 12372 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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.

Purpose

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.

Program Description

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:

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.

Clinical Research

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.