051������������,PA-22-051: AHRQ Mentored Career Enhancement Awards for Established Investigators in Patient

Department of Health and Human ServicesPart 1. Overview Information Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditionsstated in this announcement may differ from those used by the NIH.  Wherethis Notice of Funding Opportunity (NOFO) provides specific written guidancethat may differ from the general guidance provided in the grant applicationform, please follow the instructions given in this NOFO. Also note that AHRQhas different page limits than NIH for the application Research Strategy,which can be found within each individual NOFO.

Componentsof Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Notice of Funding Opportunity Title

AHRQ Mentored Career Enhancement Awardsfor Established Investigators in Patient-Centered Outcome Research (K18)

Activity Code

K18Career Enhancement Award

Announcement Type

New

Related Notices

October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.

August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170.

April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109.

NOT-OD-22-018  Reminder: FORMS-G Grant Application Forms& Instructions Must be Used for Due Dates On or After January 25, 2022 -New Grant Application Instructions Now Available

NOT-OD-21-170- Update: Notification of Upcoming Changein Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - ExpandingRequirement for eRA Commons IDs to All Senior/Key Personnel

NOT-OD-21-073  UpcomingChanges to the Biographical Sketch and Other Support Format Page for DueDates on or after May 25, 2021

NOT-HS-21-016  Noticeof Updated AHRQ Policy for Late Application Submission for Active Peer Reviewor National Advisory Council Service 

NOT-HS-21-015 - AHRQPolicy on the Inclusion of Priority Populations in Research

NOT-HS-21-014 - SpecialEmphasis Notice (SEN): AHRQ Announces Interest in Health Services Research toAdvance Health Equity

NOT-HS-21-007 - SalaryLimitation on AHRQ FY2021 Grants, Cooperative Agreements, and Contracts

NOT-HS-21-002 - AHRQGuide Notice on Exception to the Use of the Single IRB Review RequirementsDuring the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

NOT-OD-21-073 - UpcomingChanges to the Biographical Sketch and Other Support Format Page for DueDates on or after May 25, 2021

NOT-OD-21-095 - Extendingthe Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material PolicyDuring the COVID-19 Pandemic: January 2022 Council

NOT-HS-20-017 - Changesto the HHS Notice of Award (NoA) Beginning October 1, 2020

NOT-HS-20-011 - TheAgency for Healthcare Research and Quality Data Management Plan Policy

NOT-OD-20-077 - Reminder:FORMS-F Grant Application Forms & Instructions Must be Used for Due DatesOn or After May 25, 2020—New Grant Application Instructions Now Available

NOT-HS-20-005 - AHRQGuide Notice on Implementation of the Use of a Single Institutional ReviewBoard (IRB) for Cooperative Research at 45 CFR 46.114 (b)

NOT-HS-19-007 - AHRQAnnounces Change in Grant Recipient Purchasing of Identifiable CMS Data,effective FY2019

NOT-HS-16-018 - AHRQMultiple Program Director/Principal Investigator Policy

Notice of Funding Opportunity (NOFO) Number

PA-22-051

Companion Funding Opportunity

None

Number ofApplications

See Section III. 3.Additional Information on Eligibility.

Assistance Listing Number(s)

93.226

Funding Opportunity Purpose

This Notice of FundingOpportunity (NOFO) issued by AHRQ, invites applications for Mentored CareerEnhancement grant awards (K18) in Patient Centered Outcomes Research (PCOR).The program targets established mid-career and senior investigators who areinterested in developing new skills in comparative effectiveness researchmethodology and applying these methods to patient-centered outcome research(PCOR).

Key Dates Posted Date

December 8, 2021

Open Date (Earliest Submission Date)

December 10, 2021

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standarddates apply.

The first standard due date for this NOFO is February 12,2022.

All applications are due by 5:00 PM local time ofapplicant organization. Applications are encouraged to apply early to allowadequate time to make any corrections to errors found in the applicationduring the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

Generally, four months after the receipt date.

Advisory Council Review

Not Applicable.  

Earliest Start Date

Generally, four months after the merit review.

Expiration Date

July 13, 2025

Due Dates for E.O. 12372

Not Applicable

RequiredApplication Instructions

It is critical that applicants follow the Career Development(K) Instructions in the SF424(R&R) Application Guide, except whereinstructed 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 allapplication instructions in the Application Guide as well as any NOFO-specificinstructions noted in Section IV andfollow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/NOFOguidance/index.html.

Whenthe NOFO-specific instructions deviate from those in the Application Guide,follow the NOFO-specific instructions. Applications thatdo not comply with these instructions may be delayed or not accepted for review.

While grant awards are made to institutions rather thanindividuals, this NOFO and its instructions are written to inform individualresearchers of this funding opportunity and facilitate the submission of grantapplications by their organizations.

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.Table of Contents

Part 1. Overview InformationPart 2. Full Text of the Announcement

SectionI. Funding Opportunity DescriptionSection II. Award InformationSection III. Eligibility InformationSection IV. Application and SubmissionInformationSection V. Application Review InformationSection VI. Award Administration InformationSection VII. Agency ContactsSection VIII. Other Information

 

Part 2. Full Text of AnnouncementSection I. Funding OpportunityDescriptionPurpose 

The overall goal of the AHRQ Research Career Developmentprogram is to help ensure that a diverse pool of highly trained scientists isavailable in appropriate scientific disciplines to address the Nation's healthservices research needs. In addition to this opportunity, AHRQ supports othercareer development programs designed to foster research methodological skillsdevelopment and progression towards research independence.  Moreinformation about AHRQ's career development programs may be found at the  AHRQ Trainingand Education website.

 

Theobjective of the Research Career Enhancement Awards for EstablishedInvestigators in Patient-Centered Outcome Research (K18) is to provide supportfor experienced researchers and scientists who either wish to broaden theirscientific capabilities or to advance their research careers by acquiring newresearch skills or knowledge. The purpose of this NOFO is to provide suchinvestigators with support for an intensive period of mentored researchexperience to acquire new research capabilities in research areas supported by AHRQ.Such experiences will afford candidate investigators protected time to: 1)enrich and expand their expertise and research programs through retooling innew techniques, emerging technologies, and/or scientific areas; and/or 2)redirect their research programs in new trajectories; and/or 3) catalyzeresearch collaborations in new research directions.  It is expected that thisinitiative will lead to new and/or augmented research programs competitive for AHRQfunding.

ResearchCareer Training Objectives

The purpose of PCOR is to improve health outcomes bydeveloping and disseminating evidence-based information to patients,clinicians, policy makers, and health care administrators, responding to theirexpressed needs about which clinical and health system design interventions aremost effective for which patients under specific circumstances.  Researchcareer training objectives and candidates must focus the content on health caredelivery within the United States.

For purposes of this NOFO, PCOR is defined as the conductand synthesis of research comparing the benefits and harms of differentinterventions and strategies to prevent, diagnose, treat and monitor healthconditions, as well as the delivery of health care in “real world” settings.The purpose of this research is to improve health outcomes by developing anddisseminating evidence-based information to patients, clinicians, and otherdecision-makers, responding to their expressed needs, about which interventionsare most effective for which patients under specific circumstances.

The Patient-Centered Outcomes Research Institute MethodologyCommittee was established to develop and improve the science and methods ofcomparative clinical effectiveness research. The Committee’s recommendedmethodology standardsand subsequent updates can be found at www.pcori.org.

Example areas of methodological emphasis in applications mayinclude, but are not limited to:

Aims to help people make informed health care decisions andallows their voice to be heard in assessing the value of health care options;Assesses the benefits and harms of preventive, diagnostic,therapeutic, or health delivery system interventions to inform decision-making,highlighting comparisons and outcomes that matter to people;Is inclusive 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;Incorporates a wide variety of settings and diversity ofparticipants to address individual differences and barriers to implementationand dissemination; andInvestigates (or may investigate) optimizing outcomes whileaddressing burden to individuals, resources, and other stakeholderperspectives.

RequiredAreas of Emphasis

Candidates must focus their research and careerenhancement/development plans in one or both of the following areas:

1.  The reduction of disparities in health care outcomes andquality among racial and ethnic minority populations and underservedpopulations.

Applicant institutions that provide health care to racialand ethnic minority populations and underserved populations and/or have accessto unique data on these populations should demonstrate how K18 candidates may usethese opportuinities to design and implement research projects focusing on thereduction of specific and known disparities.

Additionally, AHRQ intends that research funded by theagency contributes to promotingequity. Accordingly, candidates are encouraged to propose projectsaddressing any healthcare delivery-related topic with demonstrated healthinequities, including but not limited to:

Maternal Healthcare DeliveryPrimary Care DeliveryPrevention of Diagnostic ErrorsCare Delivery for Persons with Multiple Chronic ConditionsDigital Healthcare Tools /MethodsIntegration of SDOH and Social Needs Care within HealthcareDeliveryNursing Home Care DeliveryBehavior and Mental Healthcare Delivery (including substanceabuse)Healthcare Policies (including changes in health insuranceaccess, coverage and payment)

2.  Evaluating and comparing health care delivery systemdesigns; developing and evaluating system redesigns; or implementing anddisseminating effective, evidence-based design practices.

Candidates may focus their research on a wide range ofissues within delivery systems research, including, but not limited to:

The organization and management of health care delivery (e.g.,primary care medical home, the development of accountable care organizations,other forms of bundling care);Strategies for increasing providers’ compliance withevidence-based guidelines;Transition support for patients with complex health care needs,including ways to reduce unnecessary re-hospitalization; Care delivery and coordination for chronic care patients; andPayment and reporting strategies for improving access, quality,and/or the value and administration of health care and its delivery.

Candidates are strongly encouraged to emphasize and addressthe following:

Novel approaches for engaging stakeholder groups (e.g.,clinicians, patients, consumers, policymakers, insurers, buyers, andadministrators) in the development of research questions, measurement ofoutcomes, the design of projects, and as appropriate and feasible, participationin the research; and specific plans for disseminating the findings andincorporating them into health care delivery at the onset of developing aresearch project.

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 prioritypopulations).  To this end, AHRQ is interested in primary and secondary researchfor which either: 1) main analyses principally center on a priority population(s)or 2) exploratory interaction (subgroup) analyses can be conducted that yieldresults stratified by priority population.

Exampleareas of CER methodological emphasis could include, but are not limited to:

 

Prospective, longitudinal cohort studies of theeffectiveness/comparative effectiveness of health care diagnoses, treatment,and services including pharmaceuticals, devices and other types ofinterventions or combination of interventions;Cluster-randomized, randomized, or practical clinical trials ofthe effectiveness/comparative effectiveness of new or existing health caretechnologies, involving wide inclusion of patients and health systems thatadequately reflect health care provision for the general population;Innovative approaches (clinical, methodological, and statistical)in the design as well as analysis of studies that more adequately identify andaccount for clinical heterogeneity of treatment effects;Integration of quantitative and qualitative analytical frameworksand techniques in the screening, synthesis, appraisal, anddissemination/implementation of evidence;The identification, role, and assessment of observational studiesin the systematic review and synthesis of evidence on comparativeeffectiveness;Meta-analysis and systematic review methodology;Decision science modeling and analysis;The design, analytical tools, and statistical techniques forreducing, confounding and mitigating the impacts of potential bias inherent inthe observational studies of comparative effectiveness;The communication of risk and benefit and contextual informationthat enhances the use of evidence in decision-making, as well as the comparativeeffectiveness of different approaches and technologies in accomplishing suchobjective;Implementation science methodology, within a comparativeeffectiveness framework;Training in use of registries, combining large-scale longitudinaldata sets, and data mining techniques (as applied to comparative effectivenessresearch questions); andThe ability to conduct interaction (subgroup) analyses todetermine which treatments and interventions work best for specificpopulations, such as underserved and underrepresented groups with the intent tofocus on reduction of disparities.

 

PCORcomponents include, but are not limited to:

Utilization of a translational framework to provide “theoreticalunderpinnings and organizing structure” to help identify appropriate analyticaldesigns and methods most suitable for addressing specific PCOR researchquestions;As necessary, utilization of any translational tool adopted byPCORI to assist with the dynamic implementation of the translational framework;Engagement of stakeholders (e.g., providers, consumers, communitygroups, payers, purchasers, policymakers, administrators) in the formulation oftheir research (in the development of research questions, measurement ofoutcomes, the design of projects, and as necessary, participation in theresearch), and to the extent necessary, the implementation and dissemination ofthe research;Demonstrated ability to collaborate with institutions andnetworks well-versed in systematic review methodologies or with research centerscapable of performing accelerated clinical effectiveness and outcomes researchand the translation, dissemination and uptake of evidentiary information forhealth care practice and decision-making;Assessment of the benefits and harms of preventive, diagnostic,therapeutic, palliative, or health delivery system interventions to informdecision making, highlighting comparisons and outcomes that matter to people;andInclusion 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.

Special Note: To ensure that applications areresponsive to AHRQ priorites as well as NOFO requirements, consultation withAHRQ staff prior to application submission is encouraged.

 

See Section VIII. OtherInformation for award authorities and regulations.

Section II. AwardInformation Funding Instrument

Grant: A support mechanism providing money, property, orboth to an eligible entity to carry out an approved project or activity.

ApplicationTypes Allowed

NewResubmission

The OERGlossary and the SF424 (R&R) Application Guide provide details onthese application types. Only those application types listed here are allowedfor this NOFO.

Clinical Trial?

 ClinicalTrials: Optional

Note:Candidates may propose to conduct a clinical trial.

Needhelp determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon budget appropriationsand the submission of a sufficient number of meritorious applications.  Futureyear funding is contingent upon the availability of funds for each year ofsupport.

Award Budget

Award budgets are composed of salary and otherprogram-related expenses, as described below.  Budget proposals must notexceed $275,000 total costs annually. Facilities and administrative (F&A)costs are included in the total cost limitation.  Facilities andadministrative costs are based on 8% of modified total direct costs (directcosts excluding tuition/fees and expenditures for equipment), or the applicant'sactual F&A rate, whichever is less. An application that requests more than$275,000 total costs in any given year, or that exceeds two years induration, will not undergo peer review.  For applications that request aduration other that 12 or 24 months, the annual total cost budget of $275,000is to be prorated accordingly (for example, a 6 month budget may not exceed$137,500 total cost).

Award Project Period

The total project period shall be between six (6) andtwenty-four (24) months.

Other Award Budget Information Salary

AHRQ will provide salary  for the K18 candidate at a rateup to the Congressionally-mandated salary limit in effect at the time ofaward. The total salary provided by the award will be prorated based on afull-time, 12-month staff appointment and the support period requested.  TheK18 requires the candidate to devote a minimum of 6 calendar months(equivalent to 50% of full-time professional effort) to conductingPCOR.  The remaining effort may be devoted to clinical, teaching, orother research pursuits and activities consistent with the objectives of theaward. 

The total AHRQ contribution to salary may not exceed thelegislatively mandated salary cap.  See: http://grants.AHRQ.gov/grants/policy/salcap_summary.htm.    

The total salary requested must be based on a full-timestaff appointment. The salary must be consistent both with the establishedsalary structure at the institution and with salaries actually provided bythe institution from its own funds to other staff members of equivalentqualifications, rank, and responsibilities in the department concerned.

For effort directly committed to the K award, thesponsoring institution may supplement the AHRQ salary contribution up to alevel that is consistent with the institution's salary scale. However,supplementation may not be from Federal funds unless specifically authorizedby the Federal program from which such funds are derived. Institutionalsupplementation of salary must not require extra duties or responsibilitiesthat would interfere with the purpose of the career award.

Fringe benefits will be provided at the institution'sfederally negotiated fringe benefit rate or, if a federally negotiated fringebenefit rate does not exist, at the actual fringe benefit rate in effect atthe time of award.

For effort not directly committed to the K award, thecandidate may derive additional compensation for effort associated with otherFederal sources or awards provided the total salary derived from all Federalsources does not exceed the maximum legislated salary rate and the totalpercent effort does not exceed 100%.

Further guidance on budgeting for career developmentsalaries is provided in the SF424 (R&R) Application Guide.See also NOT-OD-17-094. 

Research Enhancement/Development Support Costs

AHRQ will provide up to  $50,000 direct costs per year forthe following expenses:  a) tuition and fees related to careerdevelopment; b) research related costs such as supplies, equipment, andtechnical personnel working with research data; c) travel to researchmeetings or training (including local or distance travel related to trainingthat takes place at another site); d) statistical services includingpersonnel and computer time; e) mentor salary and fringe benefits (up to$6,000) annually per mentor for a maximum of two mentors per candidate. All expenses must be directly related to the proposed research careerdevelopment, not to living expenses.

Indirect Costs

Indirect Costs (also known as Facilities &Administrative [F&A] Costs) are reimbursed at 8% of modified total directcosts.

42 U.S.C. 299b-37 authorizes AHRQ to make these awards tosupport the training of researchers in the methods used to conduct comparativeclinical effectiveness research. 

All applications submitted and AHRQ grants made in responseto this NOFO are subject to 45 CFR Part 75 (Uniform AdministrativeRequirements, 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.

Section III. Eligibility Information1. Eligible ApplicantsEligible Organizations

Higher Education Institutions

Public/ or non-profit private institution such as a:

UniversityCollegeFaith-basedCommunity-based organizationUnit of local or State governmentIndian/Native American Tribal Government (Federally recognized)Indian/Native American Tribal Government (Other than Federallyrecognized)Indian/Native American Tribally Designated Organization

The following types of HigherEducation Institutions are always encouraged to apply for AHRQ support asPublic or Private Institutions of Higher Education:

Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander ServingInstitutions (AANAPISIs)

AHRQ’s authorizing legislation does not allow for-profitorganizations to be eligible to lead applications under this researchmechanism. For-profit organizations may participate in projects as members ofconsortia or as subcontractors only. Because the purposeof this program is to improve healthcare in the United States, foreigninstitutions may participate in projects as members of consortia or assubcontractors only.  Applications submitted by for-profitorganizations or foreign institutions will not be reviewed.  Organizationsdescribed in section 501(c) 4 of the Internal Revenue Code that engage inlobbying are not eligible.

HHS grants policy requires that the grant recipient performa substantive role in the conduct of the planned project or program activityand not merely serve as a conduit of funds to another party or parties. Ifconsortium/contractual activities represent a significant portion of theoverall project, the applicant must justify why the applicant organization,rather than the party(s) performing this portion of the overall project, shouldbe the grantee and what substantive role the applicant organization will play.Justification can be provided in the Specific Aims or Research Strategy sectionof the PHS398 Research Plan Component sections of the SF424 (R&R)application.  There is no budget allocation guideline for determiningsubstantial involvement; determination of substantial involvement is based on areview of the primary project activities for which grant support is providedand the organization(s) that will be performing those activities.

 

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) arenot eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligibleto apply.

RequiredRegistrations

ApplicantOrganizations

Applicant organizations must complete and maintain thefollowing registrations as described in the SF 424 (R&R) Application Guideto be eligible to apply for or receive an award. All registrations must becompleted prior to the application being submitted. Registration can take 6weeks or more, so applicants should begin the registration process as soon aspossible.

Dun and BradstreetUniversal Numbering System (DUNS) - All registrations require thatapplicants be issued a DUNS number. After obtaining a DUNS number, applicantscan begin both SAM and eRA Commons registrations. The same DUNS number must beused for all registrations, as well as on the grant application.

 System for AwardManagement (SAM) – Applicants must complete and maintain an activeregistration, whichrequires renewal at least annually. The renewal process mayrequire as much time as the initial registration. SAM registration includes theassignment of a Commercial and Government Entity (CAGE) Code for domesticorganizations which have not already been assigned a CAGE Code.

o   NATO Commercialand Government Entity (NCAGE) Code – Foreign organizations must obtain anNCAGE 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 throughtheir SAM or Grants.gov registration, but all registrations must be in place bytime of submission. eRA Commons requires organizations to identify at least oneSigning 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 tocomplete the Grants.gov registration.

Please note that a federal-wide transition from the DUN andBradstreet (D&B) Data Universal Numbering System (DUNS) number to a newgovernment-owned Unique Entity Identifier (UEI) is underway. By April 2022, thefederal government will stop using the DUNS number to uniquely identifyentities registered in the Systemfor Award Management (SAM). SAM will become the central repository for thenew UEI that will be incorporated into an institution’s SAM registration. SeeNOT-OD-21-170 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-170.html)for details.

ProgramDirector/Principal Investigator (PD/PI)

The candidate PD/PI must have an eRA Commons account and shouldwork with their organizational officials to either create a new account or toaffiliate their existing account with the applicant organization in eRACommons. If the PD/PI is also the organizational Signing Official, they musthave two distinct eRA Commons accounts, one for each role. Obtaining an eRACommons account can take up to 2 weeks.

Please note that for applications with due dates of January25, 2022, and after, all individuals listed in the SF424 R&R Senior/KeyPerson 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 thePD/PI eRA Commons account must be linked to a valid ORCID ID. For moreinformation on linking an ORCID ID to an eRA Commons personal profile see the ORCIDtopic in our eRA Commons online help.

Eligible Individuals (Program Director/PrincipalInvestigator)

Any candidate with the skills, knowledge, and resourcesnecessary to carry out the proposed research as the Program Director/PrincipalInvestigator (PD/PI) is invited to work with his/her mentor and organization todevelop an application for support. Individuals from underrepresented racialand ethnic groups as well as individuals with disabilities are alwaysencouraged to apply for AHRQ support.

Multiple PDs/PIs are not allowed.

This award is intended for mid-career and seniorinvestigators holding a research or health professional doctorate who are atthe academic rank of Associate Professor or Professor (or the equivalent innonacademic settings), who have established records of independent, peer-reviewedFederal or private research grant funding, who seek an intense, mentoredcareer development experience in comparative effectiveness methodologywhich will substantially improve their ability to pursue future researchin PCOR.  Targeted candidates are: (1) Faculty, providers orinvestigators without expertise in comparative effectiveness research, who arelocated at institutions that do not possess intensive CER programs; and (2)faculty, providers or investigators who are located at institutions thatpossess intensive CER programs, but who do not possess individual expertise inCER.

Each career enhancement program in CER must be tailored tomeet the individual needs of the candidate. The candidate and mentor arejointly responsible for the preparation of the career development plan. Thesponsoring institution must demonstrate a commitment to provide the environmentand resources needed for the candidate to perform the activities included inthe career enhancement program that maximize the use of relevant research andeducational resources and propose qualified investigators as mentors.

Degree Requirements.   Candidates for the K18 award musthave a research or health-professional doctoral degree.  Candidates should be Ph.D.,M.D., D.D.S., D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.P.H., D.N.Sc., D.P.T., Pharm.D., N.D., D.S.W., Psy.D. degree recipients or recipientsof an equivalent doctoral degree from an accredited domestic or foreigninstitution.  It is the responsibility of the grantee institution todetermine if a foreign degree is equivalent. Research training must emphasizespecialized training to meet national research priorities in PCOR.

Candidates must hold the rank of Associate Professor orProfessor, or their equivalent in non-academic settings. This award isintended for well-established investigators who have established records ofindependent, peer-reviewed Federal or private research grant funding. Candidatesare not required to have active research grant support at the time ofapplication for this award.

By the time of award, the individual must be a citizen or anon-citizen national of the United States or have been lawfully admitted forpermanent residence (i.e., possess a currently valid Permanent Resident CardUSCIS Form I-551, or other legal verification of such status).

2. Cost Sharing

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 institutionalsupport from the applicant and its collaborators indicates a greater potentialof success and sustainability of the project.  Examples of institutionalsupport would include donated equipment and space, institutional funded stafftime and effort, or other resource investments.  Applicant institutionsshould indicate institutional support by outlining the specific contributionsto the project and providing assurances that their organization and anycollaborators are committed to providing these funds and resources to theproject. This information can be included at the end of the budgetjustification section of the application, but institutional support dollars arenot to be shown/included in the detailed budget request.  

3. AdditionalInformation on Eligibility

 

Number of Applications

Applicant organizations may submit more than one application,provided that each application is scientifically distinct, and each is from adifferent candidate.

The AHRQ will not accept duplicate or highly overlappingapplications under review at the same time, per 2.3.7.4 Submission of ResubmissionApplication. An individual may not have two or more competing AHRQcareer development applications pending review concurrently. In addition, AHRQwill not accept:

A new (A0) application that is submitted before issuance of thesummary statement from the review of an overlapping new (A0) or resubmission(A1) application.

A resubmission (A1) application that is submitted before issuanceof the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with anotherapplication pending appeal of initial peer review (see  NOT-OD-18-197).

Level of Effort

The K18 requires the candidate to devote a minimum of 6calendar months (equivalent to 50% of full-time professional effort) toconducting PCOR.  The proposed duration of the award may span a minimum of sixcontinuous months to a maximum of 24 continuous months.  The amount ofeffort devoted to the program over the course of each 12-month period can vary,so long as the required minimum level of effort (i.e., 50% of full-time effortover the duration of the award) is achieved.  For example, a candidatecould propose 100% effort for a 6 month award, or 50% effort for a 12 monthaward, or 25% effort for the first 6 months and 75% effort for the final sixmonths of a 12 month award, etc., provided the overall level of effort over theduration of the project is 50%.

The allowance for a part-time commitment of professionaleffort will enable candidates to hold their ongoing research grants (ifapplicable) and/or meet their academic responsibilities in a limited capacity,as they pursue the career enhancement program.  Candidates should describeany clinical, administrative, teaching, mentoring or grant-related researchcommitments they intend to maintain during the period of the award, and thearrangements to be made with the home institution and/or the sponsoringinstitution to ensure the requisite protected time for this award period. 

In no case will a reduction of total effort below 50% overthe course of the duration of the entire project in order to accept otherFederal funding be allowed.  In addition, no redistribution of theproposed levels of effort across the duration of the course of the project willbe allowed once a grant is awarded.

At the time of award, the candidate must have a “full-time”appointment at the applicant institution.

Candidates who have VA appointments may not consider part ofthe VA effort toward satisfying the full-time requirement at the applicantinstitution. Candidates with VA appointments should contact the theScientific/Research Contact listed under Agency Contacts in Section VII of thisNOFO

prior to preparing an application to discuss theireligibility. Candidates with a full-time VA appointment are not eligible toapply.   

Candidates to this program may not concurrently apply forany other PHS award that duplicates the provisions of this NOFO.  K18 awardrecipients may hold concurrent Federal and non-Federal grant/contract supportas a PD/PI or sub-project director with this award provided the aggregateeffort does not exceed 12 calendar months (i.e.100%).  

Candidates may have one individual Career Development Awardapplication pending peer review at any time.

Mentor(s)

Before submitting the application, the candidate mustidentify a mentor who will supervise the proposed career development andresearch experience. The mentor should be an active investigator in the area ofthe proposed research and be committed both to the career development of thecandidate and to the direct supervision of the candidate’s research. The mentormust document the availability of sufficient research support and facilitiesfor high-quality research. Candidates are encouraged to identify more than onementor, i.e., a mentoring team, if this is deemed advantageous for providingexpert advice in all aspects of the research career development program. Insuch cases, one individual must be identified as the primary mentor who willcoordinate the candidate’s research. The candidate must work with the mentor(s)in preparing the application. Members of the mentoring team should have asuccessful track record of mentoring individuals at the candidate’s careerstage. Where feasible, the recruitment of women, individuals from diverseracial and ethnic groups, and individuals with disabilities as potential mentorsis encouraged, given their ability to serve as role models.

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

Consultant(s)/Collaborator(s)

Signed statements must be provided by eachconsultant/collaborator confirming their participation in the project anddescribing their specific roles.  A consultant must state their daily orhourly consulting rate and specify the number of hours or days to be devoted. Collaborators and consultants generally do not need to provide theirbiographical sketches.  However, information should be provided thatclearly documents expertise in the proposed area(s) ofconsulting/collaboration.

Section IV. Application and Submission Information1. Requesting an Application Package

The application forms package specific to this opportunitymust be accessed through ASSIST, Grants.gov Workspace or an institutionalsystem-to-system solution. Links to apply using ASSIST or Grants.gov Workspace areavailable in Part 1 of this NOFO.See your administrative office for instructions if you plan to use aninstitutional system-to-system solution.

2. Content and Form ofApplication Submission

It is critical that applicants follow the Career Development(K) Instructions in the SF424(R&R) Application Guide, exceptwhere instructed in this NOFO to do otherwise. Conformance tothe requirements in the Application Guide is required and strictly enforced.Applications that are out of compliance with these instructions may be delayedor not accepted for review.

Page Limitations

All page limitations described in the SF424 (R&R)Application Guide and the Table ofPage Limits must be followed, with the following exception:   

PHS398 Career Development Award Supplemental Form.  The CandidateSection and Research Plan Section may not exceed 15 pages combined.

Instructions for Application Submission

The following section supplements the instructions found inthe SF 424 (R&R) Application Guide and should be used for preparing anapplication to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guidemust be followed.   

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guidemust be followed.   

Other Project Information

All instructions in the SF424 (R&R) Application Guidemust be followed.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guidemust be followed. 

IMPORTANT REMINDER: The personal profile associated with theeRA 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 eRACommons personal profile see the ORCIDtopic in our eRA Commons online help.

R&R Budget

All instructions in the SF424 (R&R) Application Guide mustbe followed

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guidemust be followed, with the following additional instructions:

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form iscomprised of the following Sections:

Candidate Research PlanMentor, Co-Mentor, Consultant, CollaboratorsEnvironment & Institutional Commitment to the CandidateOther Research Plan AppendixCitizenship

All instructions in the SF424 (R&R) Application Guide mustbe followed,

Candidate Section

All instructions in the SF424 (R&R) ApplicationGuide must be followed, with the following additional instructions:

 

CandidateInformation and Goals for Career Development

Candidate’s Background

Describe the candidate's commitment to a career in PCOR. Include adescription of all of the candidate’s professional responsibilities at thegrantee institution and elsewhere and show their relation to the proposedactivities on the career development award.Describe any clinical, administrative, research, or grant relatedcommitments they intend to maintain during the period of the award, andarrangements which will be made to provide protected release time.Describe the candidate's research efforts and accomplishments in health-relatedresearch to date as an independent investigator, including publications, priorresearch interests and experience, and history of research support. Present evidence of the candidate's potential to augment his/herresearch career and to ultimately advance scientific progress through thiscareer enhancement plan.Include a description of the candidate’s professionalresponsibilities and show their relationship to the proposed activities of thecareer enhancement award.Provide evidence of the candidate's ability to interactand collaborate with other scientists, particularly those from otherdisciplines. If applicable, describe the candidate's ability to organize,manage, and implement the proposed clinical trial, feasibility or ancillaryclinical trial.If applicable, describe the candidate's prior efforts, interestsand experience clinical trials research.

Career Goals and Objectives

Discuss the candidate’s objectives and long term career plans,and how these relate to the proposed activities in the career enhancementaward, with a focus on how the proposed work will advance the candidate’smethodological skills in comparative effectiveness research and research careerin PCOR.Describe the candidate's research career trajectory to date andfuture career goals and objectives and explain how these relate to the proposedresearch career development enhancement program. Justify the need for further career enhancement in order to achievethe candidate's future research goals. Demonstrate how the proposed career enhancement program and theresearch, educational and mentoring resources of the sponsoring laboratory andinstitution will further the stated research career goals.The candidate must demonstrate they have received training orwill participate in courses such as: data management, epidemiology, studydesign (including statistics), hypothesis development, etc., as well as thelegal and ethical issues associated with research on human subjects and,ifapplicable, clinical trials.

Candidate’s Plan for CareerDevelopment During Award Period

The candidate and the mentor(s) are jointly responsible for thepreparation of the career development plan. The candidate and mentor(s) maypropose a mentoring team. A timeline for the phasing of the K18 award should be included.Describe the career development plan, tailoring it to thecandidate's goals, prior experience and career level, as well as to the intentof the K18 program. Provide a systematic plan for progression of career enhancementand research experiences for the period of the award and beyond, including atimeline for the phasing of the career enhancement and research activities. Explain how the career development plan will enhance thecandidate’s independent research career trajectory, including a description ofany cutting-edge research skills and conceptual knowledge that will be acquiredduring the career award period.Describe any clinical, administrative, teaching, mentoring orgrant-related research commitments the candidate will maintain during theperiod of the award, and the arrangements to be made with the applicantinstitution and/or the host institution to ensure the requisite protected timefor this award period.

 

Research Plan Section

All instructions in the SF424 (R&R) ApplicationGuide must be followed, with the following additional instructions:

 

Research Strategy

A research project in PCOR that is consistent with the goals ofthis NOFO and the objectives of the career enhancement must be described. Organize the research plan as indicated in the PHS 398 CareerDevelopment Award Supplemental Form, following instructions for Specific Aims,Research Plan, (Significance, Innovation, Approach), to the extent possible andappropriate. The candidate should consult with the mentor regarding thedevelopment of this section.Propose a sound research project that is consistent with thecandidate’s level of research development and objectives of his/her careerdevelopment plan. The research description should demonstrate the quality ofthe candidate’s research thus far and also the novelty, significance, creativityand approach, as well as the ability of the candidate to carry out theresearch.Consider whether there are equity issues that are relevant to theproject. Where equity issues have been identified, propose a plan to addressthese issues. The application must  describe the relationship between thementor’s research and the candidate’s proposed research plan.Although it is not expected that the description of the researchwould be as detailed as an application for an investigator-initiated researchgrant (e.g., R01), enough information should be provided to permit anevaluation of the scientific merit of the candidate's research activities andmentored research training.Data and Safety Monitoring (when applicable): Plans for data andsafety monitoring must be included as needed.    Clinical Trials, if applicable:If the applicant is proposing to gain experience in a clinicaltrial, ancillary study to a clinical trial or a clinical trial feasibilitystudy as part of his or her research career development, describe therelationship 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 clinicalquestion, provide justification why this is warranted and how it willcontribute to the overall goals of the research project including planning andpreliminary data for future, larger scale clinical trials.Describe the proposed timelines for the proposed clinical trial,feasibility or ancillary study, including any potential challenges andsolutions (e.g., enrollment shortfalls or inability to attribute causalinference to the results of an intervention when performing a small feasibilitystudy).Describe how the proposed clinical trial or ancillary study willtest the safety, efficacy or effectiveness of an intervention that could leadto a change in clinical practice, community behaviors or health care policy (Thiswould not apply to a feasibility study).

 

Trainingin the Responsible Conduct of Research

All applications must include a plan to fulfill AHRQ requirementsfor instruction in the Responsible Conduct of Research (RCR). See SF424(R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant,Collaborators Section

All instructions in the SF424 (R&R) ApplicationGuide must be followed, with the following additional instructions:

 

Plansand Statements of Mentor and Co-mentor(s)

The candidate must name a primary mentor who, together with the candidate,is responsible for planning, directing, monitoring, and executing the proposedprogram.  The candidate may also nominate co-mentors as appropriate to thegoals of the program.  The mentor should be recognized as an accomplished investigatorin their scientific domain  and have a track record of success in trainingindependent investigators. The primary mentor should have sufficient independent researchsupport to cover the costs of the proposed research project in excess of theallowable costs of this award. Include a statement that the candidate will commit at least 6 personmonths (50% of full-time professional effort) to the career development programand related career development activities. The application must include a statement from the primary mentorproviding: 1) information on his/her research qualifications and previousexperience as a research supervisor; 2) a plan that describes the nature of thesupervision and mentoring that will occur during the proposed award period.. Similar information must be provided by any co-mentor. If morethan one co-mentor is proposed, the respective areas of expertise andresponsibility of each should be described.  Co-mentors should clearly describehow they will coordinate the mentoring of the candidate. If any co-mentor isnot located at the sponsoring institution, a statement should be provideddescribing 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 annualevaluations of the candidate’s progress as required in the annual progressreport.If the candidate is proposing to gain experience in a clinicaltrial as part of his or her research career development, the mentor or co-mentorof the mentoring team must include a statement to document leadership of theclinical trial, and appropriate expertise to guide the candidate in anyproposed clinical trials research experience.The mentor or mentoring team must provide evidence of expertise,experience, and ability to guide the candidate in the organization, managementand implementation of the proposed clinical trial, ancillary or feasibilitystudy and help him/her to meet timelines.

 

Letters of Support from Collaborators,Contributors and Consultants

Signed statements must be provided by all collaborators and/orconsultants (if applicable) confirming their participation in the project anddescribing their specific roles. Collaborators and consultants do not need toprovide their biographical sketches unless also listed as senior/key personnel.However, information should be provided clearly documenting the appropriateexpertise in the proposed areas of consulting/collaboration. A consultant muststate their daily or hourly consulting rate and specify the number of hours ordays to be devoted.

Environmental and InstitutionalCommitment to the Candidate

All instructions in the SF424 (R&R) ApplicationGuide must be followed, with the following additional instructions:

 

Descriptionof Institutional Environment

The sponsoring institution must document a strong,well-established research and career development program related to thecandidate's area of interest, including a high-quality research environmentwith key faculty members and other investigators capable of productivecollaboration with the candidate. Describe how the institutional research environment isparticularly suited for the development of the candidate's research career andthe pursuit of the proposed research plan.Describe the resources and facilities that will be available tothe candidate, including any clinical trial-related resources, such asspecialized administrative, data coordinating, enrollment, andlaboratory/testing support.  If applicable, include a description of theresources and facilities available at international sites.

 

InstitutionalCommitment to the Candidate’s Research Career Development

The sponsoring institution (e.g., the institution that isproviding the training experience for the candidate) must provide a statementof commitment to the candidate’s research career development and to meeting therequirements of this award. Provide assurances that the candidate will be able to devote therequired effort to activities under this award. The remaining effort should bedevoted to activities related to the development of the candidate’s career asan independent scientist. Appropriate administrators/officials at the applicant institutionmust describe all institutional commitments the candidate will maintain duringthe research career development period and provisions which will be made toprovide appropriate release time.  This must be a clear and unambiguousstatement of assurance that during the active period of the K18 award the candidatewill be released from all administrative, teaching and/or clinical duties thatinfringe on his/her commitment to the award, and that he/she will be able todevote 6-12 calendar months (i.e. 50-100%) effort to the research careerenhancement program.Provide assurances that the candidate will have access to appropriateoffice 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 beavailable for any proposed mentor(s) and/or other staff consistent with thecareer development plan.

BudgetComponent:  Special Instructions for AHRQ applications

AHRQ is not usingthe Modular Grant Application and Award Process.  Applicants forfunding from AHRQ are to ignore application instructions concerning the ModularGrant Application and Award Process, and prepare applications usinginstructions for the Research and Related Budget Components of the SF 424(R&R). Applications submitted in the Modular format will not bereviewed.

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.

PHS Human Subjects and Clinical Trials Information              

When involving human subjects research, clinical research,(and when applicable, clinical trials research experience) follow allinstructions for the PHS Human Subjects and Clinical Trials Information form inthe SF424 (R&R) Application Guide, with the following additionalinstructions:

If you answered “Yes” to the question “Are Human SubjectsInvolved?” on the R&R Other Project Information form, you must include atleast one human subjects study record using the Study Record: PHS Human Subjects and Clinical TrialsInformation form or a DelayedOnset Study record.

StudyRecord: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guidemust be followed with the following additional instructions:

 

DelayedOnset Study

Note: Delayedonset does NOT apply to a study that can be described but will not startimmediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guidemust be followed. 

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guidemust be followed. 

 

Reference Letters

Three letters of reference are required. 

Candidates must carefully follow the SF424 (R&R)Application Guide, including the time period for when reference letters willbe accepted. Applications lacking the appropriate required referenceletters will not be reviewed. Thisis a separate process from submitting an application electronically. Referenceletters are submitted directly through the eRACommons 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.pdfconcerning letters of support. Letters of support, recommendation, oraffirmation from any entity or individual not directly participating in theproject should not be included.

3. Unique Entity Identifier and System for AwardManagement (SAM)

See Part 2. Section III.1 Required Registrationsfor information regarding therequirement for obtaining a unique entity identifier and for completing andmaintaining active registrations in System for Award Management (SAM), NATOCommercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, andGrants.gov.

 

4. Submission Dates and Times

Part I. Overview Informationcontains information about Key Dates and Times. Applicants are encouraged tosubmit applications before the due date to ensure they have time to make anyapplication corrections that might be necessary for successful submission. Whena submission date falls on a weekend or Federalholiday, the application deadline is automatically extended to the nextbusiness day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grantsacross all Federal agencies) using ASSIST or other electronic submissionsystems. Applicants must then complete the submission process by tracking thestatus of the application in the eRA Commons, NIH’s electronic system for grantsadministration. NIH and Grants.gov systems check the application against manyof the application instructions upon submission. Errors must be corrected, anda changed/corrected application must be submitted to Grants.gov on or beforethe application due date. and time.  If a Changed/Corrected application issubmitted after the deadline, the application will be considered late.  Applications that miss the due date and time are subjected to theNIH Policy on Late Application Submission.

Applicantsare responsible for viewing their application before the due date in the eRACommons to ensure accurate and successful submission.

Information on the submission process and a definition ofon-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmentalreview.

6. Funding Restrictions

For efficient grant administration, AHRQ grantadministration procedures will be used and conducted in accordance with theterms and conditions, cost principles, and other considerations described inthe HHS Grants Policy Statement. The Grants Policy Statement can be foundat http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable only as described in the HHS GrantsPolicy Statement.

A grantee may, at its own risk and without AHRQ priorapproval, incur obligations and expenditures to cover costs up to 90 daysbefore the beginning date of the initial budget period of a new award if suchcosts are necessary to conduct the project and would be allowable under thegrant, if awarded, without AHRQ prior approval. If specific expenditures wouldotherwise require prior approval, the grantee must obtain AHRQ approval beforeincurring the cost. AHRQ prior approval is required for any costs to be incurredmore than 90 days before the beginning date of the initial budget period of anew award.

The incurrence of pre-award costs in anticipation of acompeting or non-competing award imposes no obligation on AHRQ either to makethe award or to increase the amount of the approved budget if an award is madefor less than the amount anticipated and is inadequate to cover the pre-awardcosts incurred. AHRQ expects the grantee to be fully aware that pre-award costsresult in borrowing against future support and that such borrowing must notimpair the grantee's ability to accomplish the project objectives in theapproved time frame or in any way adversely affect the conduct of the project. 

7. Other SubmissionRequirements and Information

Applications must be submitted electronically following theinstructions described in the SF424 (R&R) Application Guide.  Paperapplications will not be accepted.

 

Applicants must complete all required registrationsbefore the application due date. SectionIII. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submissionprocess, visit How toApply – Application Guide.If you encounter a system issue beyond your control that threatens your abilityto complete the submission process on-time, you must follow the Dealingwith System Issues guidance. For assistance with application submissioncontact the Application Submission Contacts in SectionVII.

Important reminders:

The PD/PI must include his/her eRA Commons ID in theCredential field of the Senior/Key Person Profile Component of theSF424(R&R) Application Package. Failure to register in the Commonsand to include a valid PD/PI Commons ID in the credential field will preventthe successful submission of an electronic application to AHRQ.

 

The applicant organization must ensure that the DUNSnumber it provides on the application is the same number used in theorganization’s profile in the eRA Commons and for the System for AwardManagement (SAM). Additional information may be found in the SF424 (R&R)Application Guide.

 

See more tipsfor avoiding common errors.

Upon receipt, applications will be evaluated forcompleteness and compliance with application instructions by AHRQ. Applicationsthat are incomplete or non-compliant will not be reviewed.

Institutional Review Board (IRB) approval of human subjectsis 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 stronglyencouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receiptof an application, applicants are generally notified of the review and fundingassignment within eight (8) weeks.

Priority Populations

AHRQ’s authorizing legislation provides that AHRQ shall, incarrying out its mission, conduct and support research and evaluations, andsupport demonstration projects, with respect to the delivery of health care ininner-city and rural areas (including frontier areas); and health care forpriority populations, which include low-income groups; minority groups; women;children; the elderly; and individuals with special health care needs,including individuals with disabilities and individuals who need chronic careor end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also must ensure thatthese requirements are reflected in the overall portfolio of research conductedand supported by the Agency. 42 U.S.C. 299(c)(2).

AHRQ is committed to the inclusion of priority populationsin health services research. The overall portfolio of health services researchthat AHRQ conducts and supports shall include the populations specificallynamed in AHRQ’s authorizing legislation: inner city; rural; low income;minority; women; children; elderly; and those with special health care needs,including those who have disabilities, need chronic care, or need end-of-lifehealth care. AHRQ also includes in its definition of priority populations thosegroups identified in Section 2(a) of Executive Order 13985 as members ofunderserved communities: Black, Latino, and Indigenous and Native Americanpersons, 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 theresearch that AHRQ supports and conducts so that the portfolio of research isinclusive of all populations. AHRQ intends that these populations be includedin studies such that the research design explicitly allows conduct of validanalyses. The policy applies to all grant applications. Investigators shouldreview the document entitled, “AHRQ Policy on the Inclusion of PriorityPopulations,” which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html.Candidates under this NOFO must consider and discuss including prioritypopulations in research design as specified in this Notice. Applicants mustinclude a one-page proposed inclusion plan for priority populations in the "OtherAttachments" section of the application.

PublicAccess to AHRQ-Funded Scientific Publications

Investigators should review the document titled ‘AHRQAnnounces 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 thatAHRQ-funded authors submit an electronic version of the author’s finalpeer-reviewed accepted manuscript to the National Library of Medicine's PubMedCentral (PMC) to be made publicly available within 12 months of the publisher’sdate of publication.

 

Planfor 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 toshare the data. Applicants who are planning to share data should describebriefly the expected schedule for data sharing; the format of the finaldataset; the documentation to be provided; whether or not any analytic toolsalso will be provided; whether or not a data-sharing agreement will be requiredand, if so, a brief description of such an agreement (including the criteriafor deciding who can receive the data and whether or not any conditions will beplaced on their use); and the mode of data sharing (e.g., under its ownauspices by mailing a disk or posting data on its institutional or personalwebsite or through a data archive or enclave). Investigators choosing to shareunder their own auspices may wish to enter into a data-sharing agreement.References to data sharing may also be appropriate in other sections of theapplication.

The reasonableness of the data sharing plan or the rationalefor not sharing research data will be assessed by the reviewers. However,reviewers will not factor the proposed data sharing plan into the determinationof scientific merit or the priority score.

AHRQData Management Plan Policy

Investigators should review the document titled AHRQ Data ManagementPlan (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 researchcontracts to include a DMP for managing, storing and disseminating the primarydata, samples, physical collections and other supporting materials created orgathered in the course of research funded by AHRQ, or state why data managementis not possible, as a component of their grant application or research contractproposal.

DataConfidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requiresthat information that is obtained in the course of AHRQ supported activitiesand that identifies individuals or establishments be used only for the purposefor which it was supplied.  Information that is obtained in the course ofAHRQ-supported activities and that identifies an individual may be published orreleased only with the consent of the individual who supplied the informationor is described in it. There are civil monetary penalties for violation of theconfidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the HumanSubjects section of the application, applicants must describe procedures forensuring the confidentiality of the identifying information to be collected(see NOT-HS-18-012:Confidentiality in AHRQ-Supported Research).  The description of the proceduresshould include a discussion of who will be permitted access to thisinformation, both raw data and machine readable files, and how personalidentifiers and other identifying or identifiable data will be restricted andsafeguarded.  Identifiable patient health information collected by granteesunder this RFA will also be obtained and managed in accordance with the HIPAAPrivacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containingconfidential data have a level and scope of security that equals or exceedsthat established by the HIPAA Security Rules if applicable (see HIPAA websitein prior paragraph) and that established by the Office of Management and Budget(OMB) in OMB Circular No. A-130, Appendix III - Security of Federal AutomatedInformation Systems. The applicability and intended means of applying theseconfidentiality and security standards to subcontractors and vendors, if any,should be addressed in the application.

SharingResearch Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees maycopyright, or seek patents for, as appropriate, final and interim products andmaterials developed in whole or in part with AHRQ support, including, but notlimited to, methodological tools, measures, software with documentation,literature searches, and analyses.  Such copyrights and patents are subject toa royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce,publish, use or disseminate for any purpose consistent with AHRQ’s statutoryresponsibilities and to authorize others to do so for any purpose consistentwith AHRQ’s statutory responsibilities. In accordance with its legislativedissemination mandate, AHRQ purposes may include, subject to statutoryconfidentiality protections, making project materials, databases, results, andalgorithms available for verification or replication by other researchers.  Inaddition, subject to AHRQ budget constraints, final products may be made availableto the health care community and the public by AHRQ or its agents if suchdistribution would significantly increase access to a product and therebyproduce substantial or valuable public health benefits.  Ordinarily, toaccomplish distribution, AHRQ publicizes research findings but relies ongrantees to publish research results in peer-reviewed journals and to marketgrant-supported products.  AHRQ requests that grantees notify the Office ofCommunications (OC) when an AHRQ-funded research article has been accepted forpublication in a peer-reviewed journal. Researchers should submit manuscriptsthat have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.govat least four to six weeks in advance of the journal’s expected publicationdate.

Regulations applicable to AHRQ grantees concerningintangible rights and copyright can be found at 45 CFR 75.322.

Post Submission Materials

Applicants are required to follow the instructions forpost-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 thepolicy.

Section V.Application Review Information1. Criteria

The mission of AHRQ is to produce evidence to make healthcare safer, higher quality, more accessible, equitable, and affordable, and towork with the U.S. Department of Health and Human Services (HHS) and otherpartners 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 healthservices research which are evaluated for scientific and technical meritthrough the AHRQ peer review system.

Applications that are complete and responsive to the NOFOwill be evaluated for scientific and technical merit by an appropriateobjective group convened in accordance with standard AHRQ peer-reviewprocedures that are described in 42 CFR Part 67, Subpart A.  Incompleteand/or non-responsive applications or applications not following instructionsgiven in this NOFO will not be reviewed.  Only the review criteriadescribed below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will beevaluated for completeness by the Center for Scientific Review, NationalInstitutes of Health, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as describedbelow, will be considered in the review process.

Forthis particular NOFO, note the following: Reviewers shouldevaluate the candidate’s demonstrated capacity to carry out independentresearch, and continue to make significant contributions to the field.

Overall Impact

Reviewers should evaluate the candidate’s potential fordeveloping an independent research program that will make importantcontributions to the field, taking into consideration the years of researchexperience and the likely value of the proposed research career development asa vehicle for developing a successful, independent research program.

Scored Review Criteria

Reviewers will consider each of the review criteria below inthe determination of scientific merit, and give a separate score for each. Anapplication does not need to be strong in all categories to be judged likely tohave major scientific impact.

For projects that propose a clinical trial:  The reviewerswill consider that the clinical trial may include study design, methods, andintervention that are not by themselves innovative, but address importantquestions or unmet needs. Reviewers should also consider the scope of theclinical trial relative to the available resources, including the possibilitythat research support provided through career development awards may besufficient to support only small feasibility studies.

 

Candidate

Has the candidate provided evidence of excellence as anindependent investigator, including a record of research support andpeer-reviewed publications?Does the candidate show evidence of a high level of commitment tomeeting the program's career enhancement objectives?Does the candidate have high potential for successfullyaugmenting his/her research career capabilities and becoming an outstandingcontributor to the research field relevant to the proposed research enhancementexperience?

CareerDevelopment Plan/Career Goals and Objectives/Plan to Provide Mentoring

Is the career development plan appropriate in its content, scope,duration, and phasing for the candidate's stated career development goals?Is an appropriate level of the candidate's professional effort tothe career development plan documented in the application?If proposed, will the candidate's leadership of a clinical trialcontribute to the their research career development?

Research Plan

If applicable, are the scientific rationale and need for aclinical trial, feasibility or ancillary study well supported by preliminarydata, clinical and/or preclinical studies, or information in the literature orknowledge of biological mechanisms? Does the proposed research address a key program foci such ashealthcare equity, disparities, maternal and child health, or primary careresearch and/or evaluating health systems or dissemination and implementationof evidence-based practices?If proposing a small feasibility study, is the study warrantedand will it contribute to planning and preliminary data needed for design offuture larger scale clinical trials?Is the clinical trial or ancillary study necessary for testingthe safety, efficacy or effectiveness of an intervention, or in the case of afeasibility 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 monitoradherence to, the protocol and data collection or distribution guidelinesappropriate? Are planned analyses and statistical approach appropriate for theproposed study design and methods used to assign participants and deliverinterventions, if interventions are delivered?For trials focusing on mechanistic, behavioral, physiological,biochemical, or other biomedical endpoints, is this trial needed to advancescientific understanding?

Mentor(s) andCo-Mentor(s)

Are the qualifications of the mentor(s) in the area of theproposed research?Is there appropriate information provided to demonstrate thementor(s) qualifications in the proposed area(s)? Is there appropriate time and support available for any proposedmentor(s) and/or other staff consistent with the career development plan.If the candidate is proposing to gain experience in a clinicaltrial as part of his or her research career development, is there evidence ofthe appropriate expertise, experience, and ability on the part of the mentor(s)to guide the candidate during participation in the clinical trial?Does the mentor or mentoring team have the expertise, experience,and ability to guide the candidate in the organization, management andimplementation of the proposed clinical trial, ancillary, or feasibility studyand help him/her to meet timelines?

Environment& Institutional Commitment to the Candidate

Are the research facilities, resources and training opportunities,including faculty capable of productive collaboration, available to thecandidate?Is there clear commitment from the institution(s) to ensure thatthe candidate will devote the requisite effort directly to the research careerenhancement activities described in the application?Is there strong institutional commitment to fostering thecandidate’s advanced research career development? Are there unique features ofthe scientific environment of the institution(s) that will benefit the proposedresearch and career development plan (e.g., useful collaborative arrangements,special equipment or analytic methods, unique subject populations)?If applicable, are the administrative, data coordinating,enrollment and laboratory/testing centers, appropriate for the trial proposed?If applicable, does the application adequately address thecapability and ability to conduct the trial feasibility or ancillary study atthe proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers,as needed, appropriate?

 

Additional Review Criteria

As applicable for the project proposed, reviewers willevaluate the following additional items while determining scientific andtechnical merit, and in providing an overall impact score, but will not giveseparate scores for these items.

Inclusionof Priority Populations

Peer reviewers must include their assessment of the proposedinclusion plan for priority populations in evaluating the overall scientificand technical merit of the application and assigning the impact score.

In conducting peer review for scientific and technicalmerit, the peer review groups will:

Evaluate the application for the presence or absence of theinclusion plan based on the proposed research objectives.Evaluate the adequacy of the proposed plan for the inclusion ofpriority populations.Evaluate the proposed justification for the exclusion of prioritypopulations when a requirement for inclusion is described as inappropriate withrespect to the purpose of the research.Evaluate the plans for outreach and recruitment of studyparticipants, including priority populations, where appropriate.Evaluate the proposed plan for study design, execution andoutcome assessments so that study results will be relevant to one or morepriority populations, where appropriate.Assess the plan as being “acceptable” or “unacceptable” withregard to the appropriateness of the inclusion or exclusion of prioritypopulations in the proposed research.StudyTimeline for Clinical Trials

Is the study timeline described indetail, taking into account start-up activities, the anticipated rate ofenrollment, and planned follow-up assessment? Is the projected timelinefeasible and well justified? Does the project incorporate efficiencies andutilize existing resources (e.g., CTSAs, practice-based research networks,electronic medical records, administrative database, or patient registries) toincrease the efficiency of participant enrollment and data collection, asappropriate?

Are potential challenges andcorresponding solutions discussed (e.g., strategies that can be implemented inthe event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves humansubjects but does not involve one of the categories of research that are exemptunder 45 CFR Part 46, the committee will evaluate the justification forinvolvement of human subjects and the proposed protections from research riskrelating to their participation according to the following five review criteria:(1) risk to subjects, (2) adequacy of protection against risks, (3) potentialbenefits to the subjects and others, (4) importance of the knowledge to begained, and (5) data and safety monitoring for clinical trials.

 

For research that involves human subjectsand meets the criteria for one or more of the categories of research that areexempt under 45 CFR Part 46, the committee will evaluate: (1) the justificationfor the exemption, (2) human subjects involvement and characteristics, and (3)sources of materials. For additional information on review of the HumanSubjects section, please refer to the Guidelines for the Review of HumanSubjects see https://www.ahrq.gov/funding/policies/human-subjects/index.html.

For details regarding IRB approval, applicants mayrefer 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 foruse of single IRB for cooperative research, 45 CFR 46.114 (b)” https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

Resubmissions

For Resubmissions, the committeewill evaluate the application as now presented, taking into consideration theresponses to comments from the previous scientific review group and changesmade to the project.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers willconsider each of the following items, but will not give scores for these items,and should not consider them in providing an overall impact score.

 Data Management Plan

Thereviewers will comment on whether the Data Management Plan is reasonable.

 

AHRQ applicants are reminded to refer toNOT-HS-20-011: The Agency for Healthcare Research and Quality Data ManagementPlan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html)for additional information on how to incorporate the required data managementplan into the resource sharing plan.

  

Training in theResponsible Conduct of Research

All applications for support under this NOFO mustinclude a plan to fulfill AHRQ requirements for instruction in the ResponsibleConduct 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’scareer stage, the reviewers will evaluate the adequacy of the proposed RCRtraining 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 notacceptable); 2) Subject Matter - the breadth of subject matter, e.g.,conflict of interest, authorship, data management, human subjects and animaluse, laboratory safety, research misconduct, research ethics; 3) FacultyParticipation - the role of the mentor(s) and other faculty involvement inthe fellow’s instruction; 4) Duration of Instruction - the number ofcontact hours of instruction (at least eight contact hours are required); and5) Frequency of Instruction –instruction must occur during each careerstage and at least once every four years.  Plans and past record will be ratedas ACCEPTABLE or UNACCEPTABLE, and the summary statement willprovide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-21-152.

 

ResourceSharing Plan

Reviewers will comment on whether the ResourceSharing Plan is reasonable.

 

AHRQ applicants are reminded to refer toNOT-HS-20-011: The Agency for Healthcare Research and Quality Data ManagementPlan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html)for additional information on how to incorporate the required data managementplan into the resource sharing plan.

 

   Budgetand Period of Support

Reviewers will consider whether the budget and the requestedperiod of support are fully justified and reasonable in relation to theproposed research.

 

2. Reviewand Selection Process

Applications that are complete and responsive to the NOFOwill be evaluated for scientific and technical merit by an appropriateScientific Review Group convened in accordance with standard AHRQ peer reviewprocedures that are described in 42 CFR Part 67, Subpart A.  Incompleteand/or non-responsive applications or applications not following instructionsgiven in this NOFO will not be reviewed.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applicationsdeemed to have the highest scientific and technical merit (generally the tophalf of applications under review) will be discussed and assigned an overall impactscore.Will receive a written critique.

Applications will be assigned on the basis of establishedAHRQ referral guidelines to the appropriate AHRQ Office or Center. Applicationswill compete for available funds with all other recommended applicationssubmitted in response to this NOFO.

The following will be considered in making fundingdecisions:

Scientific and technical merit of the proposed project asdetermined by scientific peer review. Availability of funds. Responsiveness to goals and objectives of the NOFO.Proposed plan to address health equity.

 

Relevance and fit within AHRQ research priorities, as wellas overall programmatic and geographic balance of the proposed project toprogram priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, thePD/PI will be able to access his or her Summary Statement (written critique)via the eRACommons. Refer to Part 1 for dates for peerreview, advisory council review, and earliest start date.

Generally, applicants should anticipate eight months betweenthe application submission date and the earliest possible start date.

Section VI. Award Administration Information1. Award Notices

 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 generallyconsists of information on other support, any additional information necessaryto address administrative and budgetary issues, and certification of IRBapproval of the project's proposed use of human subjects.  For details regardingIRB approval, applicants may refer to the "AHRQ Revised Policy forInstitutional Review Board (IRB) Review of Human Subjects Protocols in GrantApplications" (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 forcooperative 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 providedto the applicant organization for successful applications. The NoA signed bythe AHRQ grants management officer is the authorizing document and will be sentvia email to the e-mail address designated by the recipient organization duringthe eRA Commons registration process.

Awardees must comply with any funding restrictions describedin Section IV.6. Funding Restrictions.

Selection of an application for award is not anauthorization to begin performance. Any costs incurred before receipt of theNoA are at the recipient's risk. These costs may be reimbursed only to theextent considered allowable pre-award costs.     

Any application awarded in response to this NOFO will besubject to the DUNS, SAM Registration, and Transparency Act requirements asnoted 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, AHRQ and are subject to the AHRQ-specific terms andconditions identified in the NoA. 

ClinicalTrials.gov: If an award provides for one or moreclinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the"responsible party" must register and submit results information forcertain “applicable clinical trials” on the ClinicalTrials.gov ProtocolRegistration and Results System Information Website (https://register.clinicaltrials.gov).AHRQ expects registration and results reporting of all trials whether requiredunder the law or not. 

Institutional Review Board or Independent Ethics CommitteeApproval: Recipient institutions must ensure that all protocols are reviewed bytheir IRB or IEC. To help ensure the safety of participants enrolled in AHRQ-fundedstudies, the recipient must provide AHRQ copies of documents related to allmajor changes in the status of ongoing protocols. 

Data and Safety Monitoring Requirements: The AHRQ policy fordata and safety monitoring requires oversight and monitoring of all AHRQ-conductedor -supported human biomedical and behavioral intervention studies (clinicaltrials) to ensure the safety of participants and the validity and integrity ofthe data. Further information concerning these requirements is found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html)and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device ExemptionRequirements: Consistent with federal regulations, clinical research projectsinvolving the use of investigational therapeutics, vaccines, or other medicalinterventions (including licensed products and devices for a purpose other thanthat for which they were licensed) in humans under a research protocol must beperformed under a Food and Drug Administration (FDA) investigational new drug(IND) or investigational device exemption (IDE). 

 

2. Administrative and National Policy Requirements

 

All AHRQ grant and cooperative agreement awards are subjectto AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS GrantsPolicy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm),and the terms and conditions set forth in the notice of grantaward.  

All AHRQ grants awards are subject to 45 CFR Part 75(Uniform Administrative Requirements, Cost Principles and Audit Requirementsfor 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 thatapplies the terms of 48 CFR section 3.908 to the award, and requires thatgrantees inform their employees in writing of employee whistleblower rights andprotections under 41U.S.C. 4712 in the predominant native language of theworkforce.

As necessary, additional Terms and Conditions will beincorporated into the NoA.

Should you successfully compete for an award, recipients offederal financial assistance (FFA) from HHS must administer their programs incompliance with federal civil rights laws that prohibit discrimination on thebasis of race, color, national origin, disability, age and, in somecircumstances, religion, conscience, and sex (including gender identity, sexualorientation, and pregnancy). This includes ensuring programs are accessible topersons with limited English proficiency and persons with disabilities. The HHSOffice for Civil Rights provides guidance on complying with civil rights lawsenforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.htmland https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

• Recipients of FFA must ensure that their programs areaccessible to persons with limited English proficiency. For guidance on meetingyour legal obligation to take reasonable steps to ensure meaningful access toyour 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 forserving qualified individuals with disabilities, including reasonablemodifications and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.• HHS funded health and education programs must beadministered 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 compliancewith applicable federal religious nondiscrimination laws and applicable federalconscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.htmlhttps://www.hhs.gov/conscience/conscience-protections/index.htmland https://www.hhs.gov/conscience/religious-freedom/index.html.

Health Literacy – NOFOs may benefit from providinglinks to information on health literacy. Below are available HHS resources.

HHS Health.gov: HealthLiterate Care Model

AHRQ: HealthLiteracy Universal Precautions Toolkit

 

Please contact the HHS Office for Civil Rights for moreinformation about obligations and prohibitions under federal civil rights lawsat https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697.  

The provisions that pertain to suspension and termination ofthis award are specified in 45 CFR 75.371 through 75.375.

For additional guidance regarding how the provisions applyto AHRQ grant programs, please contact the Scientific/Research Contact that isidentified in Section VII under Agency Contacts of this NOFO.

There is a prohibition on certain telecommunications andvideo surveillance services or equipment that became effective on or afterAugust 13, 2020.  

In accordance with the statutory provisions contained inSection 872 of the Duncan Hunter National Defense Authorization Act ofFiscal Year 2009 (Public Law 110-417), AHRQ awards will be subjectto the Federal Awardee Performance and Integrity Information System(FAPIIS) requirements.  FAPIIS requires Federal award making officials toreview and consider information about an applicant in the designated integrityand performance system (currently FAPIIS) prior to making an award.  Anapplicant, at its option, may review information in the designated integrityand performance systems accessible through FAPIIS and comment on anyinformation about itself that a Federal agency previously entered and iscurrently in FAPIIS.  The Federal awarding agency will consider any comments bythe applicant, in addition to other information in FAPIIS, in making ajudgement about the applicant’s integrity, business ethics, and record of performanceunder Federal awards when completing the review of risk posed by applicants asdescribed in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agencyreview of risk posed by applicants.”  This provision will apply to all AHRQgrants and cooperative agreements except fellowships.

3. Reporting

Recipients of awards under this NOFO must provide annual andfinal reports of performance in achieving the NOFO objective to preparequalified individuals for careers in patient-centered outcomes research (PCOR).

When multiple years are involved, awardees will be requiredto submit the ResearchPerformance Progress Report (RPPR) annually unless specified otherwisein 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 3months before the start date of the next budget period of the award.

In addition to the annual RPPR, recipients may be requiredto submit interim progress reports to AHRQ using the AHRQ Research ReportingSystem (ARRS).  If applicable, detailed instructions on interim reportingrequirements will be provided with the grant award.

 

Grantees are required to submit expenditure data on theFederal Financial Report (FFR; SF 425) annually.

 

Expenditure data is to be reported onthe Federal Financial Report (FFR; SF 425). AHRQ requires annual financialexpenditure reports for ALL grant programs as described in the HHS GrantsPolicy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period thatcoincides with the budget period of a particular project.  However, the duedate for annual FFRs is 90 days after the end of the calendar quarter in whichthe 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 quarterof 6/30/2020).

A final Progress Report, final Federal Financial Report, andFinal Invention Statement are required when an award ends.  All finalreports are due within 90 days of the project period end date.  Forfurther details regarding grant closeout requirements, refer to https://www.ahrq.gov/funding/grant-mgmt/closeout.html.

The Federal Funding Accountability and Transparency Act of2006 (Transparency Act), includes a requirement for awardees of Federal grantsto report information about first-tier subawards and executive compensationunder Federal assistance awards issued in FY2011 or later.  All awardeesof applicable AHRQ grants and cooperative agreements are required toreport 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) foradditional information on this reporting requirement.

In accordance with the regulatory requirements provided at45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2CFR Part 200, recipients that have currently active Federal grants, cooperativeagreements, and procurement contracts from all Federal awarding agencies with acumulative total value greater than $10,000,000 for any period of time duringthe period of performance of a Federal award, must report and maintain thecurrency of information reported in the System for Award Management(SAM) about civil, criminal, and administrative proceedings in connectionwith the award or performance of a Federal award that reached final dispositionwithin the most recent five-year period.  The recipient must also makesemiannual disclosures regarding such proceedings. Proceedings informationwill be made publicly available in the designated integrity and performancesystem (currently FAPIIS).  This is a statutory requirement under section 872of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section3010 of Public Law 111-212, all information posted in the designated integrityand performance system on or after April 15, 2011, except past performancereviews required for Federal procurement contracts, will be publiclyavailable.  Full reporting requirements and procedures are found in AppendixXII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition forRecipient Integrity and Performance Matters.

ProgramPlanning and Performance reporting requirements:

The overarching objective of this project is to preparequalified individuals for careers in patient-centered outcomes research (PCOR).The career development experience must involve a, mentored career developmentplan in comparative effectiveness research, which will substantially improvethe candidate’s ability to pursue future research in PCOR.

Recipients' performance will be measured based on success inseveral areas. Grantees must report on the following metrics and informationannually on the RPPR, Section G.1:  G.1 SPECIAL NOTICE OF AWARD TERMS ANDFUNDING OPPORTUNITIES ANNOUNCEMENT REPORTING REQUIREMENTS.

1. Process: How has the CareerDevelopment Plan been implemented?

 

Performancemeasures:

A. To what extent have each of the following training formats been employed toprovide you with CER methods training?  For each item on thefollowing list, please choose one of the following: At least monthly throughouttraining, More than twice a year but less than monthly throughout training, Nomore 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 or activities have you considered to be most importantto effective training?  For each item on the following list,please choose one of the following: Not very important, Important, Veryimportant, 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 youprogressed?

Performancemeasures:  

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; appointmentas department/division chair, dean, provost, president, or other leadershipposition; service on editorial boards, peer review panels, advisory councils;etc.).

4. Evaluation

In carrying out its stewardship of human resource-relatedprograms, the AHRQ may request information essential to an assessment of theeffectiveness of this program from databases and from participants themselves. Participantsmay be contacted after the completion of this award for periodic updates onvarious aspects of their employment history, publications, support fromresearch grants or contracts, honors and awards, professional activities, andother information helpful in evaluating the impact of the program.

Periodically, AHRQ will assess the program’s overalloutcomes, gauge its effectiveness in enhancing diversity, and consider whetherthere is a continuing need for the program.  Upon the completion of theseevaluations, AHRQ will determine whether to (a) continue the program ascurrently configured, (b) continue the program with modifications, or (c)discontinue the program. 

The overall evaluation of the program will be based onmetrics that will include, but are not limited to, the following:

Subsequent participation in patient-centered outcomes research oremployment in an environment that supports conduct of such research.   Authorship of scientific publications in patient-centeredoutcomes research.Subsequent independent research grant support from AHRQ, NIH, oranother source.  Section VII. AgencyContacts

We encourage inquiries concerning this funding opportunityand welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, applicationerrors and warnings, documenting system problems that threaten submission bythe 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: GrantsInfo@AHRQ.gov (preferredmethod of contact)

Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.govregistration and Workspace)Contact Center Telephone: 800-518-4726 Email: support@grants.gov  

Scientific/ResearchContact(s)

Division of Research EducationOffice of Extramural Research, Education, and PriorityPopulationsAgency for Healthcare Research and Quality (AHRQ)Email: PCORtraining@ahrq.hhs.gov

Peer Review Contact(s)

Nicholas Kenney, PhDDivision of Scientific ReviewOffice of Extramural Research, Education, and PriorityPopulationsAgency for Healthcare Research and Quality (AHRQ) Telephone: 301-427-1869 Email: Nicholas.Kenney@AHRQ.hhs.gov

Examine your eRA Commons account for review assignment andcontact information (information appears two weeks after the submission duedate).

Financial/Grants Management Contact(s)

Galen GregorDivision of Grants Management Office of Management Services Agency for Healthcare Research and Quality (AHRQ)Telephone: (301) 427-1457E-mail: Galen.Gregor@ahrq.hhs.gov

Section VIII. Other Information

Recently issued AHRQ policy notices may affect yourapplication submission. A full list of policy notices published by AHRQ isprovided at https://www.ahrq.gov/funding/policies/polnotice/index.html.

Authority and Regulations

This program is described in the Assistance ListingNumber(s) (formerly Catalog of Federal Domestic Assistance) at https://sam.gov/content/assistance-listings/federal andis not subject to the intergovernmental review requirements of Executive Order12372 or Health Systems Agency review.

This award is made pursuant to AHRQ's authority under 42U.S.C. 299b-37(e), in accordance with the statutory requirements generallyapplicable to research supported under Title IX of the Public Health ServiceAct. fTheseAll awards are subject to the terms and conditions, cost principles,and other considerations described in the HHS Grants Policy Statement. The HHSGrants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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