Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed)

Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed) is sponsored by National Institute on Aging (NIA). Provides career development awards for emerging leaders in aging research.

PAR-27-112: Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed) Department of Health and Human Services Part 1. Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTE ON AGING ( NIA ) Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements.

Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website . ICOs that do not participate in this announcement will not consider applications for funding. Funding Opportunity Title Paul B.

Beeson Emerging Leaders Career Development Award in Aging (K76 Clinical Trial Not Allowed) K76 Emerging Leaders Career Development Award Check for any recent Notices of NIH Policy Changes that may impact application requirements. Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose The National Institute on Aging invites early-stage clinician-scientists to apply for the Beeson K76 award with the goal of advancing their research and leadership skills in their specialty and in the broader field of aging research.

Unlike other mentored K awards, candidates for this award must have received competitively awarded research support as a Program Director/Primary Investigator (PD/PI) at the faculty level or have otherwise leveraged faculty-level research support to develop an independent line of research. Candidates must show evidence of leadership in the clinical or research domain.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial . Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.

Funding Opportunity Announcement Goal(s) To encourage biomedical, social, and behavioral research and research training directed toward greater understanding of the aging process and the diseases, special problems, and needs of people as they age. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

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. Applications 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.

Required Application Instructions It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Other Award Budget 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.

Funding Opportunity Description The overall purpose of the NIH Research Career Development program is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.

NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.

More information about Career programs may be found at the NIH Research Training and Career Development website. The goal of the NIH Emerging Leaders Career Development Award (K76) is to help develop a cadre of scientists prepared to take an active leadership role in transformative change that will lead to improved research or healthcare outcomes.

This program supports basic or clinically trained faculty members who seek additional research, professional career and leadership skills essential for assuming a leadership role in an increasingly global biomedical workforce.

NIH Emerging Leaders are early-stage investigators conducting research who have shown early signs of leadership and who will use this award to further develop the tools, skills and resources to have a significant impact as leaders in their field of expertise. These skills will prepare them to assume academic leadership roles and independent careers in an emerging discipline within their professional specialty.

The small number of individuals skilled in geriatrics, and the even smaller number pursuing research on aging, are inadequate to address the burgeoning needs of the rapidly growing aging population. A key goal of this initiative, therefore, is to foster the careers of emerging clinician-scientists who possess the skills necessary for academic leadership in aging and geriatrics.

As a result, this award is intended to prepare early-stage investigators for academic research leadership, as well as provide mentoring in their scientific research area of interest. Its focus is on building a cadre of investigators and leaders to advance knowledge and skills in a new field, methodology, or approach, both through their own research and through their leadership, in the broader community of their specialty.

NIA uses the NIH Emerging Leaders Career Development Award to administer the Paul B. Beeson Emerging Leaders Career Development Award in Aging K76 program. The program is named after Dr. Paul B.

Beeson, who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University, and Professor and Distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978.

His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society.

The aims of the program are as follows: To provide support for career development and to advance the leadership skills of clinician scientists conducting clinically relevant basic, translational or clinical, and patient-oriented research (POR) in disciplines relevant to aging and geriatrics.

To deepen the commitment of research institutions to promote transformative academic research and leadership in aging and geriatric medicine by linking mentors to emerging scientists with a commitment to future leadership in aging research and policy.

This NOFO provides an opportunity for candidates to expand their research area of interest and pursue activities consistent with the expectation of future leadership in the candidate's chosen field related to aging or older adults. Awardees will be provided salary and research support for a sustained period of "protected time" (3 to 5 years) for career development and to advance the leadership skills of clinician-scientists.

NIA welcomes applications in all fields of aging research, including basic, translational, genetic, biological, neuroscientific, clinical, behavioral, and social sciences research on aging. A current high-priority topic for NIA is research on Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD).

The full range of research methods appropriate to completing the proposed investigation is encouraged, including basic and translational research and cell or computational models, provided that the application makes clear the eventual clinical relevance of the proposed work. It is expected that scholars will contribute significantly to the research and scientific literature associated with the field of aging research.

Please note that the Beeson K76 program does not support independent clinical trials. 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 Resubmission - Applications submitted to RFA-AG-24-014 or RFA-AG-24-015 The OER Glossary and the How to Apply - Application Guide provides details on these application types.

Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NIA intends to commit $1,944,000 in FY 2027 - FY 2029 to fund approximately 8 general aging awards each year. NIA intends to commit $972,000 in FY 2027 - FY 2029 to fund approximately 4 AD/ADRD awards each year. Future year amounts are contingent upon annual appropriations.

Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 5 years. Other Award Budget Information NIH will contribute up to the legislative limit per year toward the salary of the career award recipient.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. Salary must be within the overall direct cost limit of $225,000 (see NOT-OD-17-094). The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap .

Other Program-Related Expenses NIH will contribute support up to the overall direct cost limit of $225,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

These funds may be used for the following expenses: Tuition and fees related to career development; Research-related expenses, such as supplies, equipment and technical personnel; Travel to research meetings or training; and Statistical services, including personnel and computer time.

It is expected that recipients will use a portion of their research development funds to cover the costs of traveling to an annual domestic meeting for Beeson scholars. Salaries for mentors, secretarial and administrative assistants, etc. are not allowed. Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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 - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 Foreign Organizations/International Collaborations 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 not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.

3. 9. 2 Electronically Submitted Applications for additional information.

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.

Foreign organizations must obtain a NATO Commercial and Government Entity (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.

Obtaining an eRA Commons account can take up to 2 weeks. All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID.

For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help . Eligible Individuals (Program Director/Principal Investigator) Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with their mentor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

Candidates for the K76 award must have Early-Stage Investigator status at the time of application submission. Applicants whose ESI status expired in 2025 or 2026 may also be eligible on a case-by-case basis. Note that possible exceptions do not apply to applicants who no longer have ESI status due to having received an R01 or equivalent – exceptions may only be granted to those whose ESI status timed out in 2025 or 2026.

Contact NIATraining@mail. nih. gov with questions.

This initiative is targeted primarily towards individuals who have prior training in research coursework, methods, and resources related to aging. Candidates are expected to hold or have had prior competitively awarded research support, such as through small grant support from NIH , similar support from other federal agencies, or foundation funding as a PD/PI, at the faculty level.

Individuals who have leveraged faculty-level research development support to advance an independent line of research and who can provide evidence that they possess the attributes of committed and skilled leaders in their respective fields are also welcome to apply. Prior evidence of leadership can be in either clinical duties or research activities that illustrate keen engagement and commitment to moving the applicant's field forward.

Examples include organizing seminar series, conferences, or symposia at a national meeting; organizing workshops; or other activities where the candidates have played a leading role in enhancing their field's academic, medical/health, and research accomplishments and visibility.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Candidates for this award must have a clinical doctoral degree.

Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible.

Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the program contact concerning their eligibility.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Candidates for this award must have a clinical doctoral degree.

Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM. Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible.

Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the program contact concerning their eligibility. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate. 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 .

An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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.

A resubmission (A1) application that is submitted before issuance of 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 NIH Grants Policy Statement 2.

3. 9. 4 Similar, Essentially Identical, or Identical Applications ).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application.

K award recipients are encouraged to obtain funding from NIH or other Federal sources, either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065 . At the time of award, the candidate must have a "full-time" appointment at the academic institution.

Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.

See NOT-OD-18-156 and NIH Grants Policy Statement , Section 12. 3. 6.

4 Temporary Adjustments to the Percent Effort Requirement for more details. Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience.

The mentor should be an established investigator in the area of the proposed aging and/or age-related diseases and conditions research and agree to commit time to supervise and guide the candidate during the period of the award. A part of that commitment is the intent to advance the candidate both as a researcher and as an emerging leader in the field.

The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research.

The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage.

Candidates proposing to gain experience in clinical trial research should include at least one mentor who can provide opportunities for hands-on training in clinical trial design, implementation, and analysis through their own line of research.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, social science, or clinical research. Section IV. Application and Submission Information 1.

Requesting an Application Package Buttons to access the online ASSIST system or to download application forms 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 Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts).

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications .

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. Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile Expanded All instructions in the How to Apply - Application Guide must be followed.

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. All instructions in the How to Apply - Application Guide must be followed.

A central component of this award is an annual meeting for Beeson scholars and their mentors. Accordingly, recipients must attend the annual meeting. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni, and mentors.

The meetings are intended to spark collaboration and expose scholars to a wide range of exciting science on aging. Include funds in the budget to travel to an annual domestic meeting of Beeson scholars, alumni, and mentors. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections 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: Candidate Information and Goals for Career Development Describe the candidate's background as an emerging leader: how the candidate has (a) prior or current competitive external funding for research at the faculty level; (b) lead-author peer-reviewed publications; and (c) leadership either in clinical duties, or in research activities.

Provide evidence that the applicant has an area of research or clinical specialty or similar focus where they intend to show leadership in promulgating research important to the growth of knowledge within the specialty. Describe how the candidate's background shows the potential for the candidate to become a productive investigator and a leader in their chosen field.

Describe all of the candidate's professional responsibilities in the recipient institution and elsewhere and describe their relationship to the proposed activities on the career award. Describe the candidate's commitment to a health-related research career with a focus on aging, including AD/ADRD and/or other geriatric conditions.

If a candidate is requesting more than five years of combined mentored career award support with earlier years obtained from other awards (such as K12s, KL2s, or K23s) and the additional years obtained from the Beeson award, the extra time beyond five years should be clearly justified.

Career Goals and Objectives Describe the candidate's immediate, near term and long range career development goals, including plans for leadership development and enhancing the skill and capability to implement change.

Describe a systematic plan that: (1) shows a logical progression from prior and current research, and leadership experiences to the research, career development and leadership activities that will occur during the career award period and post award; (2) justifies the need for further career development to become an independent investigator and emerging leader; and (3) utilizes the relevant research and educational resources of the institution.

If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the candidate must demonstrate they will receive training in: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

The candidate must also include plans to obtain hands-on research experience in clinical trial design, implementation, and analysis through a clinical trial led by their mentor(s). Candidate's Plan for Career Development/Training Activities During Award Period The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline is often helpful.

Describe the career development plan incorporating consideration of the candidate's goals and prior experience. Include details of the plans to obtain the necessary experience to facilitate further development as an academician and leader. Describe career development activities consistent with the expectation of future leadership in the selected field(s).

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Provide a sound research project that is consistent with the candidate's level of research development and objectives of their career development plan.

The research description should demonstrate not only the quality of the candidate's research thus far but also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.

For candidates proposing patient-oriented research, complementary laboratory research directly related to patient-oriented research may be proposed in the application, thereby providing an opportunity for a career development experience in translational research. Training in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).

See How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Plans and Statements of Mentor and Co-mentor(s) The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.

The candidate may also nominate co-mentors as appropriate to the goals of the program. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.

The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; and 3) a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award.

Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.

If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meeting. The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.

If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial and appropriate expertise to guide the applicant in any proposed clinical