NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Required)

NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Required) is sponsored by National Institutes of Health. Enables established investigators to acquire new research skills to answer questions relevant to hearing, balance, smell, taste, voice, speech, and language sciences.

PAR-24-142: NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Department of Health and Human Services NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Deafness and Other Communication Disorders ( NIDCD ) Funding Opportunity Title NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required) K18 Career Enhancement Award Notices of Special Interest associated with this funding opportunity April 06, 2026 - Implementation of Changes for Basic Experimental Studies with Humans.

See Notice NOT-OD-26-067 . January 29, 2026 - Basic Experimental Studies With Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH. See Notice NOT-OD-26-032 March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 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 Notice of Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences.

This Notice of Funding Opportunity is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants. ” These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.

Types of studies that should be submitted under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

Applicants not planning an independent clinical trial or basic experimental study with humans, or proposing to gain research experience in a clinical trial or basic experimental study with humans led by another investigator, must apply to the 'Independent Clinical Trial Not Allowed' companion NOFO.

The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development.

Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFOs PAR-24-140 and PAR-24-143 Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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. New Date May 25, 2026 per issuance of NOT-OD-26-067 .

(Original Expiration Date: May 08, 2027) 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 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. 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. 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 1. Requesting an Application Package 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 goal 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 objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge.

The purpose of this FOA is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in research areas supported by the sponsoring NIH Institute(s)/Center(s).

Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions.

It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

The objective of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to provide support for experienced scientists to remain current in state-of-the-art techniques, evolving technologies, and the fundamental, translational, and clinical research frontiers related to the hearing, balance, smell, taste, voice, speech, and language sciences.

Established investigators often express an urgent need for compensated protected time and mentored training to augment their research capabilities and to keep their research programs in-step with emerging technologies and evolving scientific frontiers and, thereby, competitive for continued NIH funding.

This initiative provides candidates with protected time and mentored guidance to augment or redirect their research career trajectories within the NIDCD research mission. It focuses on established investigators holding the academic rank of Associate Professor or Professor, or the equivalent in non-academic research settings, who have records of scientific accomplishment and independent research support (past and/or present).

The purpose of this NOFO is to provide such investigators with support for short-term, intensive periods of mentored research experience over a period of six- to twenty-four months to acquire new research capabilities in the study of hearing, balance, smell, taste, voice, speech, or language sciences.

Such experiences, typically undertaken during an academic sabbatical year, will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; 2) redirect their research programs in new trajectories within the NIDCD scientific mission; and/or 3) catalyze research collaborations in new research directions.

It is expected that this initiative will lead to new and augmented research programs competitive for NIH funding.

In addition to serving as a short-term career development vehicle for investigators within the NIDCD Extramural research community, this program is also intended for investigators working outside of the hearing, balance, smell, taste, voice, speech, and language sciences who wish to add research direction within the NIDCD scientific mission to their overall research programs.

The research career enhancement experience shall take place in a host laboratory, whether in the applicant institution (i.e., in which the candidate holds his/her primary appointment) or in another institution with the appropriate resources to provide the proposed research career development experience. In both cases, the tutelage of a well-qualified host/mentor (or team of mentors/hosts) is required.

In most cases, the applicant and proposed mentor(s) and host laboratory will not have had previous research collaborations. The research career development experience proposed must have the potential to substantially augment the research capabilities of the candidate at the applicant institution, and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s).

The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate, and will generally incorporate two components: 1) didactic (e.g., directed study/tutorials, semester-long courses, short courses, seminar series, journal clubs) and/or laboratory-based instruction in the new discipline, techniques or technologies; and, 2) a small-scale research project at the host site.

The research enhancement experience may comprise translational or clinical/patient-oriented research (including epidemiologic, outcomes and health services research).

All applications submitted to this Notice of Funding Opportunity must propose basic science experimental studies involving humans, otherwise referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” that fall within the NIH definition of a clinical trial and also meet the definition of basic research.

NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. ” ( 32 CFR 272. 3 ).

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." ( NOT-OD-15-015 ).

Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

For the purposes of this NOFO, “specific application towards processes or products” refers to the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.

Basic experimental studies in which participants are prospectively assigned to experimental conditions and receive an intervention or experimental manipulation where the effect will be assessed for the purpose of understanding fundamental aspects of phenomena may submit under this NOFO.

Please refer to the table comparing Funding Opportunity Types by Clinical Trial Allowability for additional guidance on the most appropriate NOFO for the type of study.

Prospective studies with humans conducted with specific applications towards processes or products in mind, including FDA Phase 0 or 1 studies, mechanistic clinical trials (e.g., those that examine the mechanisms by which an intervention works or the processes that account for an intervention's effects on clinical outcome), and safety and efficacy studies should submit under the a ' Clinical Trials Required' or Clinical Trial Optional’ NOFO, but not under this NOFO.

Observational studies involving humans should submit under the ‘Clinical Trials Not Allowed’ NOFO. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. 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 SF424 (R&R) Application Guide provide details on these application types. Required - Basic Experimental Studies with Humans: Only accepting applications that propose independent clinical trial(s) that also meet the definition of basic research. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budgets are composed of salary and other program-related expenses, as described below. Generally, the research experience shall span a contiguous period of six months to two years.

Other Award Budget Information NIDCD will contribute up to the legislatively mandated salary cap in effect at the time of award 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. See also NOT-OD-17-094.

The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants. nih.

gov/grants/policy/salcap_summary. htm . Other Program-Related Expenses NIDCD will contribute $40,000 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.

Salary for mentors, secretarial and administrative assistants, etc. is 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 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) U.S. Territory or Possession 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. 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. 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.

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. 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 Program Director/Principal Investigator (PD/PI) is invited to work with their mentor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

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 the K18 award must have a research or health-professional doctoral degree.

This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Candidates are not required to have active research grant support at the time of application for this award. 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 ).

At the time of award, the candidate must have a "full-time" appointment at the academic institution that is the applicant organization. The candidate is required to devote at least 6 calendar months (50% of full-time professional effort) to the K18 program, but may devote their full-time (12 calendar months) effort to it.

For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. The allowance for a part-time commitment of professional effort will enable candidates to hold their ongoing research grants (if applicable) and/or meet their academic responsibilities in a limited capacity, and in accordance with NIH policy, as they pursue the career enhancement program.

However, the total effort cannot exceed 100%, and all other activities must be consistent with the goals of the K18 award. Generally, the research experience shall span a contiguous period of six months to two years. However, a six-month research experience may be apportioned over two successive summer semesters (of three months each), provided the experience is pursued on a full-time (100%) basis during these periods.

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 active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research.

The mentor must document the availability of sufficient research support and facilities. 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.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and Mentor(s) The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

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, or clinical research. 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 Career Development (K) 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 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 SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Include a description of your current research and the research you propose to continue in the independent phase. SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Candidate Information and Goals for Career Development Describe the candidate's commitment to a career as a health related research scientist.

Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support. Present evidence of the candidate's potential to augment their research career and to ultimately advance scientific progress through this career enhancement plan.

Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines. If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial. If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​ Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed research career development enhancement program. Justify the need for further career enhancement in order to achieve the candidate's future research goals.

Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

The candidate must demonstrate they have received training or will participate in courses such as: 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.

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. The candidate and mentor may propose a mentoring team. Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program.

Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities.

Explain how the career development plan will enhance the candidate’s independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.

Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided.

The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research. The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.

Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored career development plan.

Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, 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).

Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

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 SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section All instructions in the SF424 (R&R) 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.

Include a statement that the candidate will commit at least 6 person months (50% of full-time professional effort) to the career development program and related career development activities.

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