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 Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/nofoguidance/index.html
When NOFO-specific instructions deviate from those in the Application Guide, follow the NOFO-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.
- Maternal healthcare delivery
- Primary care delivery
- Prevention of diagnostic errors
- Care delivery for persons with multiple chronic conditions
- Digital healthcare tools/methods
- Integration of social determinants of health (SDOH) and social needs within healthcare delivery
- Nursing home care delivery
- Behavior and mental healthcare delivery (including substance abuse)
- Healthcare policies (including changes in health insurance access, coverage and payment)
- The organization and management of healthcare delivery (e.g., primary care medical home, the development of accountable care organizations, other forms of bundling care);
- Strategies for increasing providers compliance with evidence-based guidelines;
- Transition support for patients with complex healthcare needs, including ways to reduce unnecessary re-hospitalization;
- Care delivery and coordination for chronic care patients; and
- Payment and reporting strategies for improving access, quality, and/or the value and administration of healthcare and its delivery.
- Novel approaches for engaging stakeholder groups (e.g., clinicians, patients, consumers, policymakers, insurers, buyers, and administrators) in the development of research questions, measurement of outcomes, the design of projects, and as appropriate and feasible, participation in the research;
- Specific plans for disseminating the findings and incorporating them into healthcare delivery at the onset of developing a research project.
- Prospective, longitudinal cohort studies of the effectiveness/comparative effectiveness of healthcare diagnoses, treatment, and services including pharmaceuticals, devices and other types of interventions or combination of interventions;
- Cluster-randomized, randomized, or practical clinical trials of the effectiveness/comparative effectiveness of new or existing healthcare technologies, involving wide inclusion of patients and health systems that adequately reflect healthcare provision for the general population;
- Innovative approaches (clinical, methodological, and statistical) in the design as well as analysis of studies that more adequately identify and account for clinical heterogeneity of treatment effects;
- Integration of quantitative and qualitative analytical frameworks and techniques in the screening, synthesis, appraisal, and dissemination/implementation of evidence;
- The identification, role, and assessment of observational studies in the systematic review and synthesis of evidence on comparative effectiveness;
- Meta-analysis and systematic review methodology;
- Decision science modeling and analysis;
- The design, analytical tools, and statistical techniques for reducing, confounding and mitigating the impacts of potential bias inherent in the observational studies of comparative effectiveness;
- The communication of risk and benefit and contextual information that enhances the use of evidence in decision-making, as well as the comparative effectiveness of different approaches and technologies in accomplishing such objective;
- Implementation science methodology, within a comparative effectiveness framework;
- Training in use of registries, combining large-scale longitudinal data sets, and data mining techniques (as applied to comparative effectiveness research questions); and
- The ability to conduct subgroup analyses to determine which treatments and interventions work best for specific populations, such as underserved and underrepresented groups with the intent to focus on reduction of disparities.
- Utilization of a translational framework to provide theoretical underpinnings and organizing structure to help identify appropriate analytical designs and methods most suitable for addressing specific PCOR research questions;
- As necessary, utilization of any translational tool adopted by PCORI to assist with the dynamic implementation of the translational framework;
- Engagement of stakeholders (e.g., providers, consumers, community groups, payers, purchasers, policymakers, administrators) in the formulation of their research (in the development of research questions, measurement of outcomes, the design of projects, and as necessary, participation in the research), and to the extent necessary, the implementation and dissemination of the research;
- Demonstrated ability to collaborate with institutions and networks well-versed in systematic review methodologies or with research centers capable of performing accelerated clinical effectiveness and outcomes research and the translation, dissemination and uptake of evidentiary information for healthcare practice and decision-making;
- Assessment of the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health delivery system interventions to inform decision making, highlighting comparisons and outcomes that matter to people; and
- Inclusion of an individual’s preferences, autonomy and needs, focusing on outcomes that people notice and care about such as survival, function, symptoms, and health related quality of life.
- University
- College
- Faith-based
- Community-based organization
- Unit of local or State government
- Indian/Native American Tribal Government (Federally recognized)
- Indian/Native American Tribal Government (Other than Federally recognized)
- Indian/Native American Tribally Designated Organization
- 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)
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
-
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.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.
- Candidate
- Research Plan
- Mentor, Co-Mentor, Consultant, Collaborators
- Environment & Institutional Commitment to the Candidate
- Other Research Plan Sections
- Appendix
- Describe the candidate's commitment to a health-related research career. Describe all the candidate's professional responsibilities in the recipient 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. Usually this is evident from publications, prior research interests and experience, and reference letters.
- Describe the candidate's commitment to a career in CER applied to PCOR
- If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
- If applicable, describe the candidate's prior efforts, interests and experience clinical trials research.
- Describe a systematic plan that: (1) 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; (2) justifies the need for further career development to become an independent investigator; (3) utilizes the relevant researchresearch and educational resources of the institutions; and (4) is focused on CER methods as applied to PCOR.
- The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.
- The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful.
- 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 commitment to the career award. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
- Propose 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.
- Identify healthcare equity, disparities, maternal and child health, and/or pimary care research issues relevant to their project and propose a plan to address these issues.
- The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
- If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.
- If proposing an ancillary study to an ongoing clinical trial, provide a brief description of its relationship to the larger clinical trial.
- If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.
- Describe the proposed timelines for the proposed clinical trial, feasibility or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
- Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or healthcare policy (This would not apply to a feasibility study).
- 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(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
- The mentor(s) should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
- The application must include a statement from the primary 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 primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
- If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or co-mentor of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.
- The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.
- Signed statements must be provided by all collaborators and/or consultants (if applicable) 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.
- 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, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.
- 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 be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.
- 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 as applicable) to carry out the proposed research plan.
- Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.
- 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?
- Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?
- 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?
- If proposed, will the clinical trial experience contribute to the applicant’s research career development?
- Is the prior research that serves as the key support for the proposed project rigorous?
- Does the proposed research address a key program foci such as healthcare equity, disparities, maternal and child health, or primary care research and/or evaluating health systems or dissemination and implementation of evidence-based practices?
- 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?
- How likely is it that the proposed research will lead to an independent line of research for the candidate?
- Is the research plan, including the research question, specific aims, design and methods, of high scientific and technical merit?
- Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
- If applicable, are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
- If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
- Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
- Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
- Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
- Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
- For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
- 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?
- Are the mentor’s previous research qualifications, scientific stature, experience, and mentoring track record appropriate for the candidate's research career development needs toward- becoming an independent investigator?
- Are the nature and extent of the proposed mentorship adequate and appropriate, and is the commitment of the mentor(s) and/or the team to the candidate's advanced research career development appropriate?
- Does the mentor(s) have a history of research productivity and support?
- If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?
- 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 or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study (if applicable) and help him/her to meet timelines?
- Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s full-time professional effort will be devoted directly to the research 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?
- Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed (if applicable)?
- Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
- 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 with 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 your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals. SeeSee 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 your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, 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 guidance on administering your program in compliance with applicable federal religious nondiscrimination laws and 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.
- Subsequent participation in patient-centered outcomes research or employment in an environment that supports conduct of such research
- Authorship of scientific publications in patient-centered outcomes research
- Subsequent independent research grant support from AHRQ, NIH, or another source
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 overall goal of the AHRQ Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's health services research needs. In addition to this opportunity, AHRQ supports other career development programs designed to foster the transition of new investigators to research independence. More information about AHRQ career development programs may be found at the AHRQ Training and Education website.
The objective of the AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Scientist Career Development Award (K08) is to provide salary and research support for a sustained period of protected time (3-5 years) to support didactic study and/or mentored research for individuals with clinical doctoral degrees (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines). The K08 provides support for an intensive, mentored research career development experience in patient-centered outcomes research. The expectation is that, through this sustained period of research career development, recipients will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.
PCOR is defined as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions, as well as the delivery of health care in real world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.
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.
The training of research scientists will focus on the generation and translation of new scientific evidence and analytic tools. In particular, the emphasis is on developing and enhancing the research and methodological capacities for conducting patient-centered outcomes research and for the integration of evidence into practice and decision-making in the healthcare system. The training program will incorporate the recommendations of the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee to guide the development of CER methodological skills in candidates, who will then apply these skills to PCOR. Of central importance will be the inclusion of stakeholders (patients, providers, administrators, policy makers) in the selection of research questions, execution of the research, and dissemination/implementation of research findings.
Methodological Training
The Patient-Centered Outcomes Research Institute Methodology Committee was established to develop and improve the science and methods of comparative clinical effectiveness research. The Committee’s recommended methodology standardsand subsequent updates can be found at www.pcori.org.
Candidates must focus their research and career enhancement/development plans in one or both of the following areas:
1. The reduction of disparities in healthcare outcomes and quality among racial and ethnic minority populations and underserved populations. 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 propose projects addressing any healthcare delivery-related topic with demonstrated health inequities, including but not limited to:
2. Evaluating and comparing healthcare delivery system designs; developing and evaluating system redesigns; or implementing and disseminating effective, evidence-based design practices. Candidates may focus their research on areas from a wide range of issues within delivery system research, including:
Candidates are strongly encouraged to emphasize and address the following:
Pursuant to its authorizing legislation, see 42 U.S.C. 299(c), AHRQ conducts and supports research for AHRQ priority populations (see Section IV.7 for a list of priority populations). AHRQ is interested in research that includes a focus on priority populations such that meaningful subgroup analysis can be conducted and results can be produced that are stratified by priority population subgroups.
Recipients of awards under this NOFO must provide annual and final reports of performance in achieving the NOFO objective to build capacity of early career research scientists in comparative effectiveness research methods, applied to patient-centered outcomes. (see Section VI.3 Reporting).
Research Career Training Objectives
Section 937(e) of the Public Health Service Act 42 U.S.C. 299b-37(e), authorizes AHRQ to build capacity for comparative effectiveness research by establishing grant programs that provide training for researchers in methods used to conduct such research. [At] a minimum, such training shall be in methods that meet the methodological standards adopted [by PCORI]. 42 U.S.C. 299b-37(e).
As noted above, this NOFO solicits applications which apply CER methods to PCOR. The purpose of this focus is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which clinical and health system design interventions are most effective for which patients under specific circumstances. Research career training objectives and candidates must focus the content on healthcare delivery within the United States.
Each proposed career development plan must: (1) have intrinsic research importance in the area of PCOR; (2) serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained PCOR researcher; (3) ensure high research productivity; and (4) sufficiently prepare the candidate for PCOR research using CER methodology that is responsive to and involves stakeholders in the development of the research and/or in the dissemination and implementation of research findings. Research projects conducted must be designed to provide a strong foundation for conducting PCOR.
Example areas of CER methodological emphasis could include, but are not limited to:
Example PCOR components include, but are not limited to:
Special Note: To ensure that applications are responsive to AHRQ priorites as well as NOFO requirements, consultation with AHRQ staff prior to application submission is encouraged.
See Section VIII. Other Information for award authorities and regulations.
42 U.S.C. 299b-37 authorizes AHRQ to make these awards to support the training of researchers in the methods used to conduct comparative clinical effectiveness 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
Public/ or non-profit private institution such as a:
The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:
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.
Please note that a federal-wide transition from the DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number to a new government-owned Unique Entity Identifier (UEI) is underway. By April 2022, the federal government will stop using the DUNS number to uniquely identify entities registered in the System for Award Management (SAM). SAM will become the central repository for the new UEI that will be incorporated into an institution’s SAM registration. See NOT-OD-21-170 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-170.html) for details.
Program Director/Principal Investigator (PD/PI)
The PD/PI must have an eRA Commons account. The PD/PI should work with his.her organizational official 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.
Please note that for applications with due dates of January 25, 2022, and after, all individuals listed in the SF424 R&R Senior/Key Person Profile (Expanded) Form will be required to have an eRA Commons username (Commons ID). See NOT-OD-21-109 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html) for details.
The PD/PI 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.
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(s) 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.
By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).
Candidates for the 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 the scientific/research contact concerning their eligibility for a K08 award.
Individuals who apply for the PCOR K08 award can also apply or possess an AHRQ or NIH Small Grant (R03) or Exploratory/Developmental Grant (R21) but may not receive salary support from that award if the K08 is awarded.
Individuals are not eligible if they have simultaneously submitted or have an application which is pending peer review for any Federal or non-Federal research grant, contract, or cooperative agreement on which they are named PD/PI which exceeds $100,000 direct costs per year; or are the proposed subproject leader on Program Projects (P01) or Center Grants (P50) or cooperative agreements. Lastly, individuals cannot have been or currently be a PD/PI on peer-reviewed Federal or non-Federal research grants, contracts or cooperative agreements over $100,000 direct costs per year; or be or have been a subproject leader on Program Projects (P01) or Center Grants (P50) or cooperative agreements.
Individuals who have been or are currently a PD/PI on any other individual Federal mentored career development awards are not eligible to apply.
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 (from mechanisms including, but not limited to, the K12 and KL2), the time appointments on these grants count toward the total five year AHRQ time limitation. For example, an individual who has been appointed to an AHRQ K12 or NIH 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.
While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The AHRQ will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing AHRQ career development applications pending review concurrently. In addition, AHRQ will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
Level of Effort
At the time of award, the candidate must have a full-time appointment at the applicant institution. A full-time appointment is generally considered to be 40 hours per week, unless otherwise specified and consistently-applied by the applicant instution. 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.
Candidates (with one exception noted below) must be able to commit a minimum of nine person-months (75% of full-time professional effort) annually conducting research career development activities associated with this awardfor up to five years. The remaining three months (25% effort) annual effort can be divided among other research, clinical, and teaching activities but only if these activities are consistent with the goals of the Award, i.e., the candidate’s development into an independent investigator.
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 a minimum of 50% effort for two years. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award.
Salary support for research effort over and above that devoted to the K08 may not be obtained from Federally-funded projects unless authorized by the Federal program from which such funds are derived See also NOT-OD-17-094 via https://grants.nih.gov/grants/guide/notice-files/not-od-17-094.html.
The sponsoring institution may supplement the AHRQ salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award. Under expanded authorities, however, institutions may re-budget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap.
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 under certain circumstances. To be eligible for salary support from peer-reviewed research awards from any Federal agency, the following criteria must be met: First, the K08 award recipient must be the 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, 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. Second, the K08 award must be active when the competing research grant application is submitted. Third, 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.
At the time the research grant is awarded, the effort required on the K08 award may be reduced, with prior AHRQ approval, 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 nine person-months (75% full-time professional effort) or more for the duration of the K08 award. A reduction in effort will result in recalculation of salary provided by the K08 grant.
Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. Members of the mentoring team should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, the recruitment of women, individuals from diverse racial and ethnic groups, and individuals with disabilities as potential mentors is encouraged, given their ability to serve as role models.
The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed research and, if applicable, clinical trial.
The 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.
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 Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
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:
Clinical Trials, if applicable:
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
Budget Component: Special Instructions for AHRQ applications
AHRQ is not using the Modular Grant Application and Award Process. Applicants 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.
Appendix
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-098.html.
When involving human subjects research, clinical research, (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, 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 a 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 Reference Information link and not through Grants.gov.
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-f/career-forms-f.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.
See Part 2. Section III.1 Required Registrations 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. NIH 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. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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 Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
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:
The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions 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.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
AHRQ’s authorizing legislation provides that AHRQ shall, in carrying out its mission, conduct and support research and evaluations, and support demonstration projects, with respect to the delivery of healthcare in inner-city and rural areas (including frontier areas); and healthcare for priority populations, which include low-income groups; minority groups; women; children; the elderly; and individuals with special healthcare needs, including individuals with disabilities and individuals who need chronic care or end-of-life healthcare. 42 U.S.C. 299(c)(1). AHRQ also must ensure that these requirements are reflected in the overall portfolio of research conducted and supported by the Agency. 42 U.S.C. 299(c)(2).
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 healthcare needs, including those who have disabilities, need chronic care, or need end-of-life healthcare. 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. Applicants must include a one-page proposed inclusion plan for priority populations in the "Other Attachments" section of the application.
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.
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.
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.
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 grantees under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.
The grantee 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 grantees 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 healthcare 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 grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that grantees 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 grantees 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 healthcare 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 detailed here: https://www.ahrq.gov/funding/policies/nofoguidance/index.html . As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.
Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit 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.
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.
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 should evaluate the candidate s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.
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.
For projects that propose a clinical trial: The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
Clinical Trial, as applicable
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.
Not Applicable
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 see https://www.ahrq.gov/funding/policies/human-subjects/index.html.
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.
Inclusion of 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 conducting peer review for scientific and technical merit, the peer review groups will:
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
Not applicable.
Not applicable.
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.
AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html) for additional information on how to incorporate their data management plan into the resource sharing plan.
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 21-152.
Reviewers will comment on whether the following Resource Sharing Plans, is reasonable.
AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html) for additional information on how to incorporate the required data management plan into the resource sharing plan.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit by an appropriate Scientific Review 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.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO.
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.
Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.
If the application is under consideration for funding, AHRQ Division of Grants Management staff 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.
Awardees 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 DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.
Individual awards are based on the application submitted to, and as approved by, the AHRQ and are subject to the AHRQ-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). AHRQ expects registration and results reporting of all trials whether required under the law or not.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in AHRQ-funded studies, the recipient must provide AHRQ copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The AHRQ policy for data and safety monitoring requires oversight and monitoring of all AHRQ-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.htmand in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.
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.
All AHRQ grants awards 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), 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.
All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.
As necessary, additional Terms and Conditions will be incorporated into the NoA.
Should you 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. 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.
https://www.hhs.gov/ocr/about-us/contact-us/index.html
Health Literacy NOFOs may benefit from providing links to information on health literacy. Below are available HHS resources.
HHS Health.gov: Health Literate Care Model
AHRQ: Health Literacy Universal Precautions Toolkit
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.
The provisions provisions that pertain to suspension and termination of this award are specified in 45 CFR 75.371 through 75.375.
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.
There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.
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.
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 4/30/2020, the annual FFR is due 9/30/2020 (90 days after the end of the calendar quarter of 6/30/2020).
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 https://www.ahrq.gov/funding/grant-mgmt/closeout.html.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 overarching objective of this project is to build capacity of early career research scientists in comparative effectiveness research methods, applied to patient-centered outcomes. 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. Process: How has the Career Development Plan been implemented?
Performance measures:
A. To what extent have each of the following training formats employed to provide you with CER methods training? For each item on the following list, please choose one of the following: At least monthly throughout training, More than twice a year but less than monthly throughout training, No more than twice a year throughout training, Not at all, or N/A.
1. Research mentorship
2. Clinical mentorship
3. Webinars
4. Workshops
5. Coursework
6. Research collaborations
7. Community engagement activities
B. Which CER training modalities/activities have you considered to be most important to effective training? For each item on the following list, please choose one of the following: Not very important, Important, Very important, Essential, or N/A.
1. Research mentorship
2. Clinical mentorship
3. Webinars
4. Workshops
5. Coursework
6. Research collaborations
7. Community engagement activities
2. 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.
Periodically, AHRQ will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of these evaluations, AHRQ will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:
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: https://era.nih.gov/need-help(preferred
method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions,
application processes, and AHRQ 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]
Division of Research Education
Office of Extramural Research, Education, and Priority
Populations
Agency for Healthcare Research and Quality
Email: [email protected]
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]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Galen Gregor
Division of Grants Management
Office of Management Services
Agency for Healthcare Research and Quality (AHRQ)
Telephone: (301) 427-1457
E-mail: [email protected]
Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided at https://www.ahrq.gov/funding/policies/polnotice/index.html.
This program is described in the Assistance Listing Number(s) (formerly Catalog of Federal Domestic Assistance) at https://sam.gov/content/assistance-listings/federal and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.
Awards will be funded pursuant to AHRQ's authority under 42 U.S.C. 299b-37(e), in accordance with the statutory requirements generally applicable to research supported under Title IX of the Public Health Service Act. 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)
