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Grant Details

https://www.grants.gov/search-results-detail/355206

Grant Analysis

Purpose & Target

• Core objective: Support the career development of individuals with clinical doctoral degrees to become new, well-trained, independent investigators in clinical pain management research. • Target recipient type: Individual clinician-scientists holding clinical doctoral degrees (e.g., MD, DDS, DVM, PhD in clinical disciplines) who are affiliated with eligible U.S. organizations. • Target size: Not applicable in terms of organization size for the individual applicant, but the grant supports the individual's career progression. • SECTOR-SPECIFIC: Clinical Pain Management Research and broader Biomedical/Behavioral Research within the NIH HEAL Initiative. • Geographic scope: United States only. Applicants must be citizens or permanent residents of the U.S., and apply through U.S.-based organizations. • Key filtering criteria: Applicant must possess a clinical doctoral degree, commit to pain research, propose an independent clinical trial (or feasibility/ancillary study), and seek career development to achieve research independence. Prior experience with major NIH research grants may disqualify. • Grant frequency: Recurring, with multiple application deadlines available annually through June 2027. Program context: Part of the NIH HEAL Initiative to address the chronic pain and opioid public health crisis.

Financial Structure

• Annual salary support: Up to $125,000 per year per K08 recipient. • Annual research development costs: Up to $50,000 per year. These funds may cover tuition/fees, research expenses (supplies, equipment, technical personnel, participant incentives), travel to meetings/training, and statistical services. • Total maximum funding per awardee: Up to $175,000 per year, for a total of up to $875,000 over the maximum 5-year project period. • Eligible costs: Candidate's salary, tuition and fees related to career development, research-related expenses (supplies, equipment, technical personnel, participant incentives), travel to research meetings or training (up to $2,000 per year for the PURPOSE Annual Meeting), statistical services (personnel and computer time), and costs to ensure manuscripts are immediately publicly available upon publication. • Ineligible costs: Salary for mentors, secretarial, and administrative assistants. • Matching fund requirements: Cost sharing is not required. • Indirect costs: Reimbursed at 8% of modified total direct costs. • Currency: USD.

Eligibility Requirements

Individual Applicant Requirements
  • Must possess a clinical doctoral degree (e.g., MD, DO, DDS, DMD, OD, DC, PharmD, ND, or PhD in clinical disciplines like clinical psychology, nursing).
  • Must be a citizen or non-citizen national of the United States, or have been lawfully admitted for permanent residence (possess a valid Permanent Resident Card USCIS Form I-551 or other legal verification), by the time of award.
  • Must commit a minimum of 75% of full-time professional effort (9 person-months) to the career development program.
  • Must identify a primary mentor who is an active investigator in the proposed research area and committed to the candidate's development.
  • Current or former Principal Investigators (PD/PIs) on NIH research project (R01), program project (P01), center grants (P50), or other major individual career development awards (e.g., DP5, K01, K07, K08, K22, K23, K25, K76, K99/R00) are not eligible.
  • PD/PIs of smaller grants (R03, R21, R33, R34, R36, SBIR/STTR) or institutional K programs (K12, KL2) are eligible.
  • Must propose a project where the applicant serves as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial.
Organizational Requirements
  • Must be an eligible U.S.-based organization, including:
    • Higher Education Institutions (Public/State Controlled, Private)
    • Nonprofits with or without 501(c)(3) IRS Status
    • For-Profit Organizations (Small Businesses, Other)
    • Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal - Federally Recognized or Other)
    • Federal Governments (Eligible Agencies, U.S. Territory or Possession)
    • Other entities (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations).
  • Must have a 'full-time' appointment for the candidate at the academic institution by time of award.
  • Must demonstrate a strong, well-established record of research and career development activities and faculty qualified to serve as mentors.
  • Must have sufficient research support and facilities documented by the mentor.
  • Must complete and maintain required registrations (System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, Grants.gov) prior to application submission.
Exclusion Criteria
  • Foreign organizations or non-U.S. components of U.S. organizations are not eligible.
  • Applications with substantial overlap with other NIH career development applications pending review concurrently are not accepted.
  • This specific NOFO (PAR-24-217) is only for applicants proposing an independent clinical trial or clinical trial feasibility/ancillary study. Those not planning such a trial must apply to a companion NOFO.

Application Process

Application Submission
  • Applications must be submitted electronically. Options include NIH ASSIST system, institutional system-to-system (S2S) solution, or Grants.gov Workspace.
  • All applications are due by 5:00 PM local time of the applicant organization.
  • The latest application due date for new submissions is June 12, 2027.
  • The Funding Opportunity (NOFO) has an expiration date of July 13, 2027.
Required Documentation and Materials
  • SF424(R&R) Forms: Includes Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded (ensure PD/PI eRA Commons ID links to a valid ORCID ID).
  • R&R Budget Form.
  • PHS 398 Cover Page Supplement.
  • PHS 398 Career Development Award Supplemental Form, which includes:
    • Candidate Section: Detailed information on the candidate's background, commitment to health-related research, prior training/experience, potential as an independent investigator, and commitment to clinical pain management.
    • Career Goals and Objectives: A systematic plan showing logical progression to independent investigator status.
    • Candidate’s Plan for Career Development/Training Activities: Designed to develop necessary knowledge and research skills, including professional responsibilities beyond the minimum effort commitment.
    • Research Plan Section: A sound research project consistent with the candidate's experience and career goals, demonstrating rigor, significance, creativity, and addressing the biopsychosocial nature of pain. Must describe timelines for the proposed clinical trial or study.
    • Training in the Responsible Conduct of Research (RCR) plan.
    • Mentor, Co-Mentor, Consultant, Collaborators Section: Includes plans and statements from the primary mentor and any co-mentors, describing supervision, career progression plans, and monitoring. Signed statements from collaborators/consultants are required.
    • Environmental and Institutional Commitment to the Candidate: Description of the institutional environment, resources, facilities, and a statement of commitment to the candidate's development.
    • Other Plan(s): Specifically, a Data Management and Sharing Plan must be included, adhering to NIH and HEAL Initiative-specific requirements.
  • Appendix: Limited items allowed as per the 'How to Apply - Application Guide'.
  • PHS Human Subjects and Clinical Trials Information form: Required if human subjects research is involved.
  • PHS Assignment Request Form.
  • Reference Letters: Submitted directly through eRA Commons by referees, separate from the main application. Applications lacking required letters will not be reviewed.
Review and Award Process
  • Applications undergo scientific and technical merit evaluation by Scientific Review Groups.
  • Highly meritorious applications will be discussed and scored.
  • Recommended applications receive a second-level review by a National Advisory Council or Board.
  • Funding decisions prioritize scientific and technical merit, fund availability, and relevance to program priorities.
  • Applicants will receive a Summary Statement (written critique) via the eRA Commons after peer review.
  • Successful applicants will receive a formal Notice of Award (NoA).
Project Implementation Timeline
  • The total project period may not exceed 5 years.
  • K08 recipients are required to attend the Annual PURPOSE Meeting for Pain Research (HEAL R24 Annual National Pain Scientist Career Development Meeting).
  • Participation in the annual HEAL Scientific Meeting and other HEAL activities is encouraged.
Reporting Obligations
  • Annual Research Performance Progress Report (RPPR).
  • Annual financial statements.
  • Final RPPR, invention statement, and expenditure data are required for closeout.
  • Subaward reporting via the Federal Subaward Reporting System (FSRS) if applicable.
  • Semi-annual disclosures regarding civil, criminal, and administrative proceedings if cumulative federal awards exceed $10,000,000.
  • The Mentor’s Report (part of the annual RPPR) must include an evaluation statement of the candidate’s progress.
Post-Award Requirements
  • Compliance with all terms and conditions outlined in the Notice of Award (NoA) and the NIH Grants Policy Statement.
  • Registration and results reporting for applicable clinical trials on ClinicalTrials.gov.
  • Protocols must be reviewed and approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Adherence to NIH policies for data and safety monitoring for human biomedical and behavioral intervention studies.
  • Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.

Evaluation Criteria

Overall Impact
  • Reviewers will assess the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in clinical pain management.
Candidate
  • Potential to develop as an independent and productive researcher in clinical pain management.
  • Appropriateness of prior training, research experience, and community engagement experience.
  • Quality of academic, clinical (if relevant), and research record.
  • Evidence of commitment to program objectives and becoming an independent investigator.
  • Ability to organize, manage, and implement the proposed clinical trial, feasibility, or ancillary study.
  • Possession or plans for training in data management and statistics relevant to clinical trials.
  • Appropriate background and experience to pursue a career as a pain clinician scientist.
Career Development Plan/Goals
  • Contribution to candidate's scientific development and logical progression to scientific independence.
  • Appropriateness of content, scope, phasing, and duration given prior training/experience and stated objectives.
  • Adequacy of plans for monitoring and evaluating candidate's research and career development progress.
  • Suitability of mentor(s) or mentorship team for the proposed research project and career development program.
  • Effectiveness in preparing the candidate to transition to an independent pain clinician-scientist.
  • Contribution of the proposed clinical trial experience to the applicant's research career development.
Research Plan
  • Rigor of prior research serving as key support for the proposed project, and plans to address weaknesses.
  • Strategies to ensure a robust and unbiased approach, as appropriate for the proposed work.
  • Adequate plans to address relevant biological variables (e.g., sex) in studies.
  • Scientific and technical merit of proposed research question, design, and methodology.
  • Relevance to the candidate's research career objectives and appropriateness for their stage of research development.
  • Clarity on ownership of research areas (candidate vs. mentor) and areas of overlap.
  • Potential to lead to an independent line of research for the candidate.
  • Scientific rationale and need for the proposed clinical trial, ancillary clinical trial, or feasibility study, supported by preliminary data, clinical/preclinical studies, or literature.
  • Justification for a small feasibility study and its contribution to future larger-scale clinical trials.
  • Necessity of the clinical trial for testing intervention safety, efficacy, or effectiveness, or establishing feasibility.
  • Appropriateness of the study design for tested hypotheses.
  • Adequacy of plans to standardize, assure quality of, and monitor adherence to the protocol and data collection guidelines.
  • Appropriateness of planned analyses and statistical approaches.
  • Potential to answer meaningful questions in translational pain science or pain management, and appreciation for the biopsychosocial nature of pain.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
  • Qualifications and appropriate expertise in the area of the proposed research.
  • Clear distinction of research areas belonging to the candidate versus mentor(s), and areas of overlap.
  • Expertise in clinical pain research.
  • Plan describing how the mentoring team will work together to support the candidate and the research plan.
  • Adequate address of the candidate's potential, strengths, and areas needing improvement.
  • Quality and extent of the proposed role in providing guidance and advice.
  • Adequacy of description of elements of research career development activities, including formal coursework.
  • Evidence of previous experience in fostering the development of independent investigators.
  • Current and previous research productivity and peer-reviewed support.
  • Adequacy and appropriateness of support to the research project for the candidate's career development.
  • Adequacy of plans for monitoring the recipient's progress toward independence.
Institutional Environment and Commitment
  • Clear commitment of the sponsoring institution to ensure the required minimum of 75% effort is devoted to the award activities.
  • Strength of institutional commitment to the candidate's career development.
  • Adequacy and appropriateness of research facilities, resources, and training opportunities, including faculty for collaboration.
  • Quality of the environment for the candidate's scientific and professional development.
  • Assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator.
  • Appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers for the trial.
  • Adequate addressing of the capability and ability to conduct the trial at proposed site(s), including international sites if applicable.
  • Institutional oversight and mechanisms for fair resolution of disputes and protection from mistreatment.

Compliance & Special Requirements

Data Management and Sharing Requirements
  • All applicants must comply with the 2023 NIH Policy for Data Management and Sharing.
  • All HEAL Initiative award recipients must also comply with the HEAL Public Access and Data Sharing Policy, requiring broad and rapid data sharing and immediate open access to publications.
  • HEAL-specific data sharing mandates:
    • Select a HEAL-compliant data repository for data submission.
    • Register the study with the HEAL platform within one year of award.
    • Submit HEAL-specific study-level metadata within one year of award.
    • Submit data and metadata (and code, if applicable) to the HEAL-compliant repository upon study completion or final deposits.
    • Submit data dictionaries to the HEAL data ecosystem if applicable.
  • For HEAL clinical research/human subjects studies:
    • Register trials in ClinicalTrials.gov and reference HEAL Initiative support.
    • Use core questionnaires required by the HEAL Clinical Data Elements (CDE) Program.
    • Obtain licenses for copyrighted questionnaires before data collection.
    • Integrate broad data sharing consent language into informed consent forms.
  • All data collected under a Certificate of Confidentiality.
Ethical and Rigor Standards
  • Proposed experiments must be designed to minimize bias and ensure validity; rationale must be based on rigorous and robust supporting data.
  • K08 recipients are expected to receive training in technical, operational, professional, and communication skills for research rigor.
  • All applications must include a plan for Responsible Conduct of Research (RCR) instruction, which must include face-to-face instruction, cover broad subject matter (e.g., conflict of interest, data management, research misconduct), involve faculty, be at least 8 contact hours, and occur at least once every four years.
  • Projects involving human subjects must detail protections against risks, potential benefits, importance of knowledge gained, and data/safety monitoring.
  • Plans for inclusion of women, minorities, and individuals across the lifespan must be justified.
  • For studies involving vertebrate animals, detailed procedures, justification for species, and measures to limit discomfort/distress are required.
  • Assessment of biohazards and proposed protections is required.
Institutional and Legal Compliance
  • Compliance with all applicable nondiscrimination laws, including submitting an Assurance of Compliance (HHS-690).
  • Applicant organizations must maintain active registration in the System for Award Management (SAM.gov).
  • All awards are subject to the Federal-wide Standard Terms and Conditions for Research Grants.
  • Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment applies.
  • Acknowledgment of Federal Funding is required.
  • Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is mandatory.
  • Compliance with the Federal Funding Accountability and Transparency Act (FFATA) for subaward reporting is required.
Special Project Requirements
  • The proposed research must involve the applicant serving as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial.
  • Applicants are strongly encouraged to engage people with lived experience of pain as advisors/partners in their research, with appropriate compensation budgeted.
  • Project planning should address potential challenges such as enrollment shortfalls or limitations in attributing causal inference in small feasibility studies.
  • K08 recipients are required to attend the Annual PURPOSE Meeting for Pain Research and encouraged to participate in other HEAL Initiative events.

Grant Details

nih heal initiative paincare clinician training program pctp mentored clinical scientist developm k08 clinical trials pain management chronic pain opioid crisis biomedical research behavioral research translational research clinician scientist career development medical research public health neurological disorders aging research alcohol abuse arthritis musculoskeletal diseases skin diseases biomedical imaging bioengineering child health human development diabetes digestive diseases kidney diseases complementary medicine integrative health cancer research research training postdoctoral early career researcher us government funding grant research grant healthcare workforce data sharing responsible conduct of research human subjects research clinical data elements
NIH HEAL Initiative PainCare Clinician Training Program (PCTP): Mentored Clinical Scientist Development Awards (K08 - Clinical Trials Required)
PAR-24-217
NIH HEAL Initiative
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US
HEALTHCARE
DEVELOPMENT
OTHER
SDG3
FUNDING MENTORSHIP TRAINING_EDUCATION RESEARCH_DEVELOPMENT OPERATIONAL_SUPPORT CAPACITY_BUILDING
None
125000.00
875000.00
USD
100.00
June 12, 2027, 5 p.m.
November 2027 - January 2028