Midcareer Investigator Award in Patient-Oriented Research (Parent K24)

Midcareer Investigator Award in Patient-Oriented Research (Parent K24) is sponsored by NINR. Provides support to mid-career health-professional doctorates for patient-oriented research.

PA-24-187: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial 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 Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of Mental Health ( NIMH ) National Institute of Nursing Research ( NINR ) National Center for Complementary and Integrative Health ( NCCIH ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Research on Women's Health ( ORWH ) Office of Data Science Strategy ( ODSS ) National Institute of Minority Health and Health Disparities ( NIMHD ), May 20, 2024 - Participation added ( NOT-MD-24-016 ) Special Note: Not all NIH Institutes and Centers participate in Parent Announcements.

Candidates should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements at the Table of IC-Specific Information, Requirements and Staff Contacts website. ICs that do not participate in this announcement will not consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged.

Funding Opportunity Title Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required) K24 Midcareer Investigator Award in Patient-Oriented Research Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 .

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 September 4, 2024 - Notice of Correction to the Eligible Individuals (PD/PI) Section for the NIHs Parent Mentored Patient-Oriented Research Career Development Award (Parent K23s) and the Midcareer Investigator Award in Patient-Oriented Research (Parent K24s).

See Notice NOT-OD-24-168 July 1, 2024 - Notice of Correction to Funding Opportunity Purpose Language and to Extend the Renewal/Resubmission/Revision Application Due Date for PA-24-187. See Notice NOT-OD-24-148 . June 4, 2024 - Guidance Regarding Reduction of Effort for NIMHD Individual Mentored K Awards.

See Notice NOT-MD-24-017 May 20, 2024 - Notice of Participation of NIMHD in PA-24-187. See Notice NOT-MD-24-016 May 7, 2025 - Notice of Change in the NIAID K24 Allowable Application Types and Eligibility Requirements. See Notice NOT-AI-24-043 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 Midcareer Investigator Awd in Patient-Oriented Res Midcareer Investigator Awd in Patient-Oriented Res See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 846, 93. 273, 93.

361, 93. 213, 93. 866, 93.

279, 93. 113, 93. 242, 93.

310, 93. 233, 93. 837, 93.

838, 93. 839, 93. 840, 93.

313, 93. 173, 93. 855, 93.

307 Funding Opportunity Purpose The purpose of the NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is to provide support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors for junior clinical investigators pursuing POR research, such as clinical residents.

This Parent Announcement 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 NOFO ( PA-24-188) . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

Dates in bold and italics reflect changes per NOT-OD-24-148 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. 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.

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. 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 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 NIH Midcareer Investigator Award in Patient-Oriented Research (K24) is designed to enable mid-career clinician-scientists to: (a) Devote more time to augment their capabilities in Patient-Oriented Research (POR); and (b) Provide mentoring to junior clinical investigators in the conduct of POR (see below for definition).

The K24 award is intended to provide protected time to mid-career clinical investigators who are typically at the Associate Professor level or the equivalent (see Section III, Eligible Individuals) and who have their own independent, peer-reviewed research support to provide mentoring to junior clinical investigators, particularly K23 grantees, in POR and to stabilize the careers of these investigators.

The intent is to allow these investigators to continue to conduct POR and be available as mentors in POR. A K24 award recipient who continues to have an independent peer-reviewed patient-oriented research program and continues to provide mentoring to junior investigators can continue to contribute to the overall goals of the program after being promoted to Full Professor.

It is expected that K24 recipients will obtain new or additional independent, peer-reviewed funding for POR as PD/PI and establish and assume leadership roles in collaborative POR programs.

In addition, it is expected that there will be an increased effort and commitment to act as a mentor to beginning clinician investigators in POR to enhance the research productivity of both the K24 investigator and increase the pool of well-trained clinical researchers of the future.

For the purposes of the K24 award, Patient-Oriented Research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.

This area of research includes: (1) mechanisms of human disease; (2) therapeutic interventions; (3) clinical trials, and; (4) the development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues but do not deal directly with patients.

In other words, patient-oriented research is research in which it is necessary to know the identity of the patients from whom the cells or tissues under study are derived. Studies falling under Exemption 4 for human subjects research are not included in this definition.

See also the NIH Directors Panel on Clinical Research Report 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 ).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies.

NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response.

NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

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

Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PA-24-188 ).

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts , to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

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 How to Apply - Application Guide provides details on these application types.

Required: Only accepting applications that propose an independent clinical trial(s). 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. The total project period may not exceed 5 years. Other Award Budget Information The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) will provide salary for levels of effort between 3-6 person-months (or 25 and 50% full-time professional effort).

The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts ). Further guidance on budgeting for career development salaries is provided in the How to Apply - Application Guide .

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate (see http://grants. nih. gov/grants/policy/salcap_summary.

html ) and the total percent effort does not exceed 100%. See also NOT-OD-17-094 .

Other Program-Related Expenses The NIH will provide up to $50,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and/or those mentored by the PD/PI; (b) registration and/or travel to research-related courses and meetings; (c) statistical services including personnel and computer time.

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 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 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.

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 K24 award must have a health-professional doctoral degree.

Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), as well as nursing professionals holding a doctoral degree in nursing research or practice. 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.

A K24 recipient who progresses to a more advanced career stage (e.g., promoted to Full Professor or another higher academic position) may retain the award and remains eligible for renewal provided that they continues to maintain an independent, peer-reviewed patient-oriented research program, and mentor new investigators.

Candidates should typically be in the midcareer stage (e.g., at the Associate Professor level or functioning at that rank in an academic setting or equivalent non-academic setting) and must have an established record of independent, peer-reviewed patient-oriented research grant funding including at the time of application and record of publications.

This award is intended for individuals who have a record of supervising and mentoring patient-oriented researchers. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definitions 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 must be able to demonstrate the need for protected time, 3-6 person months (25-50% of full-time professional effort) for a period of intensive research focus as a means of augmenting their capabilities in POR and ability to act as a mentor to new clinical investigators in the conduct of POR during this period.

Candidates for the K24 award may not concurrently apply for any other PHS career award or have another PHS career award pending review. 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.

Depending on the policies of the sponsoring NIH Institute/Center, recipients may apply for a one-time renewal for an additional three to five years of support if the recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application. Candidates should clearly demonstrate continuing need for protected time to expand their research programs.

Peer-Reviewed Research Support Depending on the policies of the sponsoring NIH Institute/Center, candidates are expected to continue to hold independent peer-reviewed research support for the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the career award.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the candidate.. 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. 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. 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.

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, CollaboratorsEnvironment & Institutional Commitment to the CandidateOther 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 Include a summary of the research career of the candidate, documenting the ability of the candidate to conduct high quality POR and commitment to a career in POR. Document the ability of the K24 candidate to provide mentoring to new clinician investigators.

Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the stages in their professional career.

In addition, describe the types of research that were conducted by the individuals mentored, and the proportion of mentored individuals currently in academic medicine and/or directly participating in POR. Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators.

Provide an explanation as to how relief from patient care or administrative responsibilities through the protected time provided by this award will contribute to the development or expansion of the candidate’s POR program and increased level of commitment to mentoring new and early stage clinician investigators.

It is important to convey to the reviewers the reasons for needing protected time to continue a vital research program and continue to engage in the mentoring of new scientists. It should be clear that this award will permit the candidate to spend more time on research and mentoring and less time on administrative and clinical responsibilities for the institution.

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​ Provide details of the candidate’s immediate and long-term career objectives in POR and in mentoring new clinician investigators.

Describe the candidate's career goals and objectives under this award, including prior experience, and current research support. Candidates are encouraged to provide a timeline for accomplishing these goals and how this award will enhance mentoring in their career activities.

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 Describe the professional responsibilities/activities including other research projects beyond the minimum required effort commitment to the career award. Explain how these responsibilities/activities will help ensure career progression as an independent investigator.

The candidate should describe any new or enhanced research skills and knowledge to be acquired during the career award period, and how these skills and experiences will significantly enhance the ability to continue research programs as an independent scientist.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Currently supported research: There is no need to provide extensive detail with regard to ongoing, funded research.

Enough information should, however, be provided in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the extent, special features and general quality of the candidate's research activities and opportunities for mentoring.

New research to be specifically supported by this award: Describe how this award will be used to help augment the candidate’s research skills and/or develop new directions in POR. This description should include a Statement of Hypothesis and Specific Aims; Background, Preliminary Studies and Aims; Significance and Rationale; and Research Design and Methods.

Although it is not expected that this description would be as detailed as an application for an investigator-initiated research grant (e.g., R01), it is expected that sufficient detail be provided to permit an evaluation of the scientific merit of the research, and to clearly show research opportunities for mentoring.

Documentation must be provided that appropriate and adequate resources, both in terms of support and facilities are available to the candidate to conduct the research program(s). This is an important part of the application because it will provide the main rationale and justification for needing protected time for research.

The candidate must ensure that the inclusion of women, members of minority groups and their subpopulations, and children, has been addressed in the development of the design for all proposed patient-oriented research.

The Inclusion Policies for Research Involving Human Subjects (i.e., Inclusion of Women and Minorities policy and the Inclusion Across the Lifespan policy) address the participation of designated groups in NIH grant applications and progress reports. See, https://grants. nih.

gov/policy/inclusion. htm . For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The candidate must provide for each new research project proposed the information described in the PHS 398 Career Development Award Supplemental form Part 1, Section 7 of the R&R 424 instructions. Candidates must provide plans for ensuring continuing support of their POR programs preferably with them as the PD/PI.

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, scope of the project, and methods used to assign trial participants and deliver interventions. If proposing an ancillary clinical trial, provide a brief description of