It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the AHRQ Grants Policy Notices). 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.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- 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)
- State Governments
- County Governments
- 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
- Regional Organizations
- 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 full SAM and Grants.gov registrations; 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.
- Have simultaneously submitted or have an application pending peer review for any other Federal career development award, or a research project grant (R01). However, individuals may concurrently submit an application for an AHRQ or NIH Small Grant (R03) or Exploratory/Developmental Grants (R21);
- Have simultaneously submitted or have an application pending peer review for any non-Federal research grant, contract, or cooperative agreement over $100,000 direct costs per year;
- Have been or are currently a PD/PI on any other Federal mentored career development awards. Individual scholars supported on institutional K12 grants are eligible to apply for a 2-year K08 award provided that the support is not concurrent. However, in such instances the combined support requested for the K08 award and the total time spent on the K12 grant cannot exceed five years;
- Have been or are currently a PD/PI on a Federal research grant (such as R01, R29, P01) or subproject leaders on Program Project (P01) and Center Grants (P50); and/or
- Have been or are currently a PD/PI on peer-reviewed non-Federal research grants, contracts or cooperative agreements over $100,000 in direct costs per year.
- 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.
- The K08 award recipient must be a/the named PD/PI on a competing AHRQ or NIH research grant application (R01, R03, R15, R21, R34, or equivalent application from another Federal agency) or a sub-project director on a competing multi-component research or center grant or cooperative agreement application (P01, P50, U01, U18, etc. or an equivalent application from another Federal agency). These specified grant mechanisms are for illustrative purposes and not meant to be all-inclusive. If necessary, the recipient should contact AHRQ Staff for clarification or additional information.
- The K08 award must be active when the competing research grant application is submitted.
- The K08 award must be in its final two years of a five-year individual award or the final year of a four-year individual award.
- Describe the candidate's commitment to a health services-related research career. Describe all the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award.
- Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
- Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
- Provide evidence of the candidate's potential to develop into an independent investigator.
- Describe the candidate's commitment to a career in a health services research field relevant to the AHRQ mission as a health-related research scientist.
- Include a statement that the candidate will commit the required time to the mentored clinical scientist development program and related career development activities. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award.
- Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.
- The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, etc., as well as the legal and ethical issues associated with research on human subjects.
- Describe the candidate’s career goals and objectives under this award, including prior experience, and current research support.
- Describe how the candidate plans to separate scientifically from his/her mentor and advance to research independence
- The candidate and the mentor are jointly responsible for the preparation of the career development plan. Although not required, the mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of the program of study and to monitor the candidate’s progress through the career development program. Providing a career development timeline is often helpful and including a publication plan is strongly encouraged.
- The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
- Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time professional effort) commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
- The candidate should describe any new or enhanced research skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her research programs as an independent scientist.
- A sound research project that is consistent with the candidate s level of research development and objectives of his/her 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.
- Describe the relationship between the mentor’s research and the candidate’s proposed research. Describe how the candidate will gain independence from his/her mentors and separate his/her scientific research program from that of the mentor(s).
- 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 research training.
- Data and Safety Monitoring (when applicable): Plans for data and safety monitoring must be included, as needed.
- All applications must include a plan to fulfill AHRQ requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.
- The candidate must name a primary mentor who, together with the candidate, is responsible for 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 be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
- 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.
- Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
- Include a statement that the candidate will commit at least 9 person-months (75% 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 his/her 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; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate s research, publications, and progression towards independence.
- 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 meetings.
- The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
- Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
- Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.
- The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
- Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
- Describe the resources and facilities that will be available to the candidate
- The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
- Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
- Provide assurance that appropriate time and support will be available or any proposed mentor(s) and/or other staff consistent with the career development plan.
- Provide assurance that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of his/her research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
- For NOFOs that do not allow independent clinical trials, do not complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.
- Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.
- Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.
- Does the candidate have the potential to develop as an independent and productive researcher?
- Are the candidate's prior training and research experience appropriate for this award?
- Is the candidate’s academic, clinical (if relevant), and research record of high quality?
- Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?
- Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator
- What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
- Are the candidate's prior training and research experience appropriate for this award?
- Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
- Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
- Is the career development plan appropriate in its content, scope, duration, and phasing for the candidate's stated career development goals?
- Is there a strong scientific premise for the project?
- Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
- Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in human subjects?
- Are the proposed research question, design, and methodology of significant scientific and technical merit?
- Is the research plan relevant to the candidate’s research career objectives?
- Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
- Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
- Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
- Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
- Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
- Is there evidence of the mentors, consultants, and/or collaborators previous experience in fostering the development of independent investigators?
- Is there evidence of the mentor's current research productivity and peer-reviewed support?
- Is active/pending support for the proposed research project appropriate and adequate?
- Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
- Does the mentor provide an appropriate plan that addresses the candidate’s training needs, and that is likely to foster the candidate s continued development and transition to independence?
- Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
- Is the institutional commitment to the career development of the candidate appropriately strong?
- Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
- Is the environment for the candidate’s scientific and professional development of high quality?
- Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
- Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
- Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
- Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
- Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
- Evaluate the proposed plan for study design, execution and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
- Assess the plan as being acceptable or unacceptable with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.
- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Responsiveness to goals and objectives of the NOFO.
- Proposed plan to address health equity
- Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
- The funds may be expended by the grantee institution in accordance with the policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
- The funds may be used for health-related research purposes.
- The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, AHRQ and forwarded to the Director, Division of Financial Management, 5600 Fishers Lane, Rockville, Md, 20857. Checks must identify the relevant award account and reason for the payment.
- A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by AHRQ staff.
- The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee’s research program.
- All conditions of the award are met at the new institution.
- The period of support requested is no more than the time remaining within the existing award.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award 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
The award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in health services research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous health services research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.
Applications must be responsive to AHRQ’s mission, which is to produce evidence to make health care safer, higher quality, more accessible, equitable and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Within the mission, AHRQ’s specific research priority areas of focus are described at: http://www.ahrq.gov/funding/policies/foaguidance/index.html.
The research sponsored and conducted by AHRQ develops and presents scientific evidence regarding all aspects of health care in the United States. It addresses issues of organization, delivery, financing, utilization, patient and provider behavior, outcomes, effectiveness and cost. It evaluates both clinical services and the system in which these services are provided. These scientific results improve the evidence base to enable better decisions about health care, including such areas as disease prevention, appropriate use of medical technologies, improving diagnosis and treatment in cost-effective ways, long-term care, and reducing disparities based on race, ethnicity, gender, or socioeconomic status. AHRQ welcomes any area of health services research relevant to AHRQ's priority areas as a mentored K08 research project topic.
Applicants are strongly encouraged to focus on topical areas unique to AHRQ, demonstrating how expected results can be used or made available for use to enhance healthcare quality. Results should be directly relevant to stakeholders, such as providers and practitioners, administrators, payers, consumers, policymakers, and insurers.
Candidates are encouraged to address health services research issues critical to AHRQ priority populations, as defined in section IV.7.
Promoting equity is an important societal goal. AHRQ intends that research funded by the agency contribute to this goal by addressing equity. Candidates are encouraged to include a focus on the reduction of disparities in healthcare outcomes and quality among underserved populations in their research training.
Candidates must conduct mentored K08 research projects which focus on health care delivery in the United States. AHRQ will not accept international health care research projects.
Special Note: To ensure that applications are responsive to AHRQ's priorities as well as NOFO requirements, consultation with AHRQ scientific/research contact prior to application submission is encouraged.
See Section VIII. Other Information for award authorities and regulations.
These projects are being funded pursuant to 42 U.S.C. 299a(b)(1), which provides that AHRQ may provide training grants in the field of health services research.
All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 ) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Governments
Federal Governments
Other
AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.
HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not
eligible to apply.
Applicant Organizations
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.
Program Director/Principal Investigator (PD/PI)
All PD/PI must have an eRA Commons account. PD/PI 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.
Project Director/Principal Investigator (PD/PI): 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 his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. Multiple PDs/PIs are not allowed.
The K08 award is also available to promote research workforce diversity by providing enhanced research career development opportunities. This funding opportunity may support individuals who propose to embark in health services research training. Eligible individuals who have had a hiatus in their research career because of illness or pressing family circumstances may also apply.
Citizenship and Residency: By the time of award, the candidate 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). Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.
Degree Type: Candidates for the K08 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 AHRQ concerning their eligibility for a K08 award.
Individuals are eligible for a K08 award if they have been, or currently are, the PD/PI of an NIH or AHRQ R03 or R21 grant or a Federal or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.
Individuals are NOT eligible if they:
AHRQ Maximum Federal Career Development (K) Award Term:
All candidates for AHRQ individual mentored career development grants are limited to a total of five years of mentored career development support. If the candidate has been a scholar appointed to any Federally-funded institutional mentored career development program (including, but not limited to, the K12 and KL2 award mechanisms), the time appointed to these grants counts toward the AHRQ five-year total time limitation for mentored career development support. For example, an individual who has been appointed to an NIH or AHRQ K12 or KL2 institutional mentored career development grant for three years can request only two years of individual career development support on an AHRQ K08 grant. The minimum allowable time requested for all other applicants to AHRQ’s individual mentored career development grants remains at three years per instructions in this announcement.
This NOFO does not require cost sharing.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
AHRQ will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing AHRQ career development applications pending review concurrently. In addition, AHRQ will not accept:
At the time of award, the candidate must have a full-time appointment (normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own consistently-applied policies) at the applicant institution. Candidates are required to commit a minimum of 75% of a full-time appointment (i.e., 9 person months of effort, or 30 hours per week) to their program of career development. Candidates may engage in other duties as part of the professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Exception to level of effort requirement: Applicants for the AHRQ individual mentored career development award who have had three years of a mentored experience on another Federally-funded career development grant, such as those noted above, can request two years of support at a minimum of 50% full-time professional effort (i.e., 6 person-months, or 20 hours per week). The remaining professional effort not covered by this award may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award.
Information for candidates with VA appointments: 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 a full-time VA appointment are not eligible to apply.
Salary supplementation for the candidate: The recipient institution may supplement the AHRQ salary contribution on "K" awards up to a level that is consistent with the candidate's institutional base salary. For effort directly committed to the "K" award, salary supplementation is allowable, but must be from non-Federal sources (including institutional sources). Non-Federal or institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the goals of the "K" award. For effort not directly committed to the "K" award, "K" award recipients may devote effort, with compensation, on Federal or non-Federal sources as the Program Director/Principal Investigator (PD/PI) or in another role (e.g., co-Investigator), as long the specific aims of the other supporting grant(s) differ from those of the "K" award.
Candidates obtaining support as a PD/PI from Federal sources during final two years of K support: K08 award recipients are encouraged to obtain funding from AHRQ or other Federal sources either as a named PD/PI on a competing research grant award or cooperative agreement, or as sub-project director on a competing multi-project award, during the final two years of the K08 award under certain circumstances.
To be eligible for salary support from peer-reviewed research awards from any Federal agency, the following criteria must be met:
At the time the competing research grant is awarded, the grantee may request that effort devoted to the K08 award be reduced to no less than six person-months (50% full-time professional effort) at the grantee organization and replaced by effort from the research award so that the total level of research commitment remains at a minimum of nine person-months (75% full-time professional effort) for the duration of the K08 award. AHRQ prior approval is required before effort may be reduced on the K08. Note that a reduction in effort on the K08 will result in recalculation of salary provided by the K08 award.
The candidate must identify and name in the application a primary 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 for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (or advisory committee), 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. Women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors.
The primary mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.
Reference Letters: A minimum of three and a maximum of five letters of reference are required. These letters are distinct from mentor letters, and are submitted by individuals (referees) who are familiar with the candidate and his/her previous experience/research, but are not involved in the execution of the proposed K08 application. The letters should address the qualities of the candidate as well as his/her potential for becoming an independent health services researcher. They must be submitted directly through the eRA Commons Reference Information link and not as part of the electronic application that goes through Grants.gov. Applications lacking the required reference letters will not be reviewed. Please note that the specified format must be used. Details on the requirements for these letters can be found in Section 7.3 of the SF 424 (R&R). They are due on the application receipt date.
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 health services research. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator and be willing to allow the protected time needed by the applicant. The candidate, mentor, and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.
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.
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF 424 (R&R) 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) 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 (candidate) 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 SF424 (R&R) Application Guide must be followed, with the following additional instructions:
AHRQ is not using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.
Applicants who propose the use of identifiable Centers for Medicare and Medicaid Services (CMS) data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.
All instructions in the SF424 (R&R) Application Guide must be followed.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
1. Candidate
2. Research Plan
3. Other Candidate Information
4. Mentor, Co-Mentor, Consultant, Collaborators
5. Environment & Institutional Commitment to the Candidate
6. Other Research Plan Sections
7. Appendix
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
Candidate’s Background
Career Goals and Objectives
Candidate’s Plan for Career Development During Award Period
Research Plan Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Training in the Responsible Conduct of Research
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)
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Appendix
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.
When involving human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide and this NOFO, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.
Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the eRA Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
The applicant should pay particular attention to the SF424 (R&R) application guide instructions (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-g/general-forms-g.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.
Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Priority Populations
AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.
AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html. Applicants under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.
Public Access to AHRQ-Funded Scientific Publications
Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.
AHRQ Data Management Plan Policy
Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Data Confidentiality
The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.
The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.
Sharing Research Resources: Rights in Data
Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to [email protected] at least four to six weeks in advance of the journal’s expected publication date.
Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-19-083 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-083.html). Any instructions provided here are in addition to the instructions in the policy.
The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.
AHRQ's priority areas of focus are available at https://www.ahrq.gov/funding/policies/nofoguidance/index.html.
Applications that are complete and responsive to the NOFO will be evaluated for overall impact within the original objectives of the award by an appropriate objective group convened in accordance with standard AHRQ peer-review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed. Only the review criteria described below will be considered in the review process.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects:
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicants should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.
Inclusion of Priority Populations
Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations.
Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.
In evaluating the overall impact of the application, the review groups will:
Degree of Responsiveness
Reviewers will assess how well the application addresses the purpose and objectives of this NOFO and how responsive the application is to the special eligibility criteria.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
The reviewers will comment on whether the Data Management Plan is reasonable.
All applications for support under this NOFO must include a plan to fulfill AHRQ requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with AHRQ Review Policy, using the stated Review Criteria in Section V. AHRQ K08 applications are assigned to the AHRQ Health Care Research Training (HCRT) study section (https://www.ahrq.gov/funding/process/study-section/peerdesc.html). If there is a conflict of interest, the AHRQ Referral Officer will make an alternate AHRQ study section assignment. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html) Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.
If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this NOFO will be subject to the SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at
https://www.ahrq.gov/funding/grant-mgmt/index.html.
All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award. As necessary, additional Terms and Conditions will be incorporated into the award statement.
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.
Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.
All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the K08 award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:
Funds budgeted in an AHRQ-supported research grant for salaries and fringe benefits, but freed as a result of a K08 award, may not be re-budgeted and must be returned to the Federal government. AHRQ will give consideration to approval for the retention and use of released funds only under unusual circumstances, but does not routinely allow retention. Any proposed retention of funds released as a result of a K08 award must receive prior written approval from AHRQ.
Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leaves does not exceed three months. For longer periods, prior written approval from AHRQ is required. Details on the process for submission of prior approval requests can be found in the HHS Grants Policy Statement (rev. 1/07), OPDIV Prior Approval .
A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K08 award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of AHRQ and will be granted only in unusual situations.
Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible
Policy on Temporary Adjustments to Full-Time Appointments or to Percent Effort devoted to the project: With AHRQ prior approval, K08 awardees may reduce the full-time appointment required to less than full-time (but not less than three-quarter time) for a period not to exceed 12 continuous months during the K08 award project period. Note: This option is only available once a K application has been awarded. At the time of application, all candidates must meet the full-time appointment requirement as well as the minimum 75% annual effort requirement.
If requesting approval to change to a part-time appointment status, the awardee must continue to commit at least 75% effort of the part-time appointment to research and career development activities.
The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to change appointment status or percent effort will not be approved to accommodate job opportunities, clinical practice, or clinical training.
The grantee institution must submit written documentation supporting the need for reduced faculty appointment status or percent effort along with assurance of a continuing commitment to the scientific and research career development of the awardee. The K awardee should justify the request to reduce either his/her appointment to less than full-time status or to less than 75% effort and must describe the anticipated impact of the requested change on his/her career progression during the remainder of the K08 award period. In addition, the awardee must submit assurance of his/her intention to return to a full-time faculty appointment or to at least 75% effort and provide an estimated date on which this will occur. The mentor must provide a revised plan for mentoring and specifically describe updated milestones for the awardee’s progression to independence. Lastly, a revised statement of institutional commitment to the awardee must ensure continued protected time and describe additional support that will assist the K08 grantee to continue to make progress toward his/her goals during the requested period of reduced time/effort devoted to the award. During the period of reduced appointment status or percent effort, the salary and other costs supported by the award will be reduced accordingly.
Prior approval requests must be submitted at least 30 days in advance of the proposed date of reduction and be submitted by an authorized institutional official of the grantee institution to the attention of the AHRQ Grants Management Specialist named on the most recent NoA. AHRQ grants management and program staff will consider such requests on a case-by-case basis.
Changes in Research or Career Development Program: Consultation with AHRQ program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered. Individual awards are made for career development in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval by AHRQ. Prior approval requests are to be submitted to the AHRQ Grants Management Specialist named on the most recent NoA. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by AHRQ staff to ensure the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.
Change of Mentor: In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor’s qualifications for supervising the program, and the level of support for the PD/PI’s continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. AHRQ staff will review the request and will notify the institution of the results of the evaluation.
Change of Institution or Termination: Consultation with AHRQ staff is strongly encouraged when either change of institution or termination is being considered. A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, AHRQ will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, AHRQ may require peer review or may disapprove the request and, if appropriate, terminate the award. If the K08 awardee is moving to another eligible institution, career award support may be continued provided:
See FAQs on the AHRQ website for detailed information about requesting a change of grantee institution: https://info.ahrq.gov/
When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NOA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. AHRQ may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, AHRQ shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award.
For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.
In addition to the annual RPPR , recipients may be required to submit interim progress reports to AHRQ using the AHRQ Research Reporting System (ARRS). If applicable, detailed instructions on interim reporting requirements will be provided with the grant award.
Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.
Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2022, the annual FFR is due 9/30/2022 (90 days after the end of the calendar quarter of 6/30/2022).
A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
Program Planning and Performance reporting requirements:
The objective of the AHRQ Mentored Clinical Scientist Research Career Development Award (K08) is to support an intensive mentored research career development experience, comprised of didactic study and/or mentored research opportunities in health services research. Recipients performance will be measured based on success in several areas. Grantees must report on the following metrics and information annually on the RPPR, Section G.1: G.1 SPECIAL NOTICE OF AWARD TERMS AND FUNDING OPPORTUNITIES ANNOUNCEMENT REPORTING REQUIREMENTS.
1. Productivity: How have you progressed?
Performance measures:
A. Number of project-related publications.
B. Number of project-related presentations.
C. Number of new funded grant applications.
D. What career landmarks have you achieved (e.g., receipt of tenure; appointment as department/division chair, dean, provost, president, or other leadership position; service on editorial boards, peer review panels, advisory councils; etc.).
In carrying out its stewardship of human resource-related programs, the AHRQ may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application
errors and warnings, documenting system problems that threaten submission by
the due date, and post submission issues)
Finding Help Online: http://grants.nih.gov/support/
(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions,
application processes, and NIH grant resources)
Email: [email protected] (preferred
method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Tamara Willis, PhD, MPH
Division of Research Education
Office of Extramural Research, Education and Priority
Populations
Agency for Healthcare Research and Quality
Telephone: 301-427-1011
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Armaz Aschrafi , Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Email: [email protected]
Galen Gregor
Agency for Healthcare Research and Quality)
Telephone: 301-427-1457
Email: [email protected]
Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices
This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at https://beta.sam.gov/help/assistance-listing and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
and Human Services (HHS)
