Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Encouraging Appropriate Care Using Behavioral Economics through Electronic Health Records (R21/R33)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-17-013

Companion Funding Opportunity

None  

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.279

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing to apply behavioral economics principles to build interventions into electronic health records (EHRs) for the purpose of improving physician compliance with recommended treatment guidelines, thereby improving quality of care, health outcomes and reducing health disparities.  This FOA will support pilot research to test the feasibility of implementing and integrating EHR-based behavioral economics interventions (R21 phase) that, if successful, can transition to an R33 phase for implementation of large pragmatic trials.  

The transition from the R21 to the R33 phase of the award will be administratively reviewed and determined by successful completion of the Go/No-Go Criteria that are specified for the R21 phase.

Key Dates

 

Posted Date

September 16, 2016

Open Date (Earliest Submission Date)

December 30, 2016

Letter of Intent Due Date(s)

December 30, 2016

Application Due Date(s)

January 30, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2017

Advisory Council Review

August 2017

Earliest Start Date

October 2017

Expiration Date

January 31, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Research Objectives 

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing to apply behavioral economics principles to build interventions into electronic health records (EHRs) for the purpose of improving physician compliance with recommended treatment guidelines, thereby improving quality of care and health outcomes and reducing health disparities.  Given impressive previous successes in radically changing physicians’ behavior in antibiotics trials, behavioral economics is thought to provide potentially effective tools to enhance the adherence of clinical guidelines by health-care providers.  Behavioral economics techniques have been shown to change physician behavior in prescribing antibiotics but have not been studied adequately for implementing guidelines across diverse health conditions and clinical settings, leaving a substantial opportunity for improvements that could be met, in part, through research supported by this FOA.

Background/Need

Evidence suggests that physicians do not always adhere to recommended guidelines when treating patients.  For example, over-prescribing antibiotics has led to the evolution of drug-resistant bacterial strains and poorer health outcomes.  Improving adherence to practice guidelines may be achieved through both financial and non-financial incentives.  However, studies have shown that financial incentives alone are oftentimes unsuccessful in significantly changing the behavior of physicians.  Alerts to physicians through the EHR, reminding them to avoid over-prescribing are often ignored because doctors are already targeted with other similar and competing messages. 

For the purpose of this FOA, behavioral economics interventions will integrate principles of psychology and economics to enhance our understanding of how physician decision-making can be influenced and reinforced for development of more effective and judicious clinical behavior without affecting physician's autonomy and professional judgement. With the Federal government’s $27 billion investment to modernize EHRs, there is an opportunity for researchers to leverage this resource to improve the quality of care and health outcomes for the elderly.  Behavioral-economic interventions, including behavioral reinforcement or "nudges," can be integrated into EHRs, for example, by instituting minor adjustments to displays, menus or alerts, as well as providing more formal decision aids.  Small changes to clinical practice protocols may result in significant reduction in overuse problems (e.g., over-prescription of opioids, ordering MRIs for back pain when it is not necessary, etc.) in diverse clinical environments.  Similarly, these approaches can address underuse, which leads to disparities in health care and health outcomes.  The implementation of EHRs to change physician adherence to practice guidelines can include payments to doctors to encourage follow-ups with patients focusing on treatment adherence.  Such behavioral-economic "nudges" may influence provider decision-making and include cues requiring physician justification of non-concordant treatment plans.  Furthermore, behavioral-economic interventions might also be targeted to encourage socially-motivated performance reporting (e.g., comparing a physician’s performance with relevant peer group) and defaults. 

Purpose

The purpose of this FOA is to focus on nudges.  Although applicants can collaborate with insurers and health care facilities, incorporating payment incentives is not the focus of this FOA (i.e., this FOA will not cover incentive payments to physicians for adhering to clinical guidelines).  The opportunity exists to build nudges (e.g., peer comparison, justifications of non-concordant treatment plans, defaults, etc.) into EHRs as well as to leverage systems that already have these features, demonstrating how they affect clinicians’ behavior and patient outcomes.

Partnerships and Access to Electronic Health Records

Partnerships with health-care delivery organizations will be critical in implementing this FOA.  It is anticipated that the interventions will generally be performed with electronically-supported integrated health-care delivery organizations to establish efficiencies.  The partnership must facilitate access to all data sources relevant to the project, which may include inpatient, outpatient, imaging, clinical laboratory, pharmacy, and community data from EHRs (modifying the system when necessary).  Further, we encourage collaborations with retail EHR vendors (EPIC, eClinical, MedSeek, etc.) to deliver interventions to solo and small-group practices.

Scope of the FOA

The purpose of this FOA is to encourage appropriate care and increase patient safety through a reduction in inappropriate and overuse/underuse of therapies or diagnosis and foster the appropriate use of health care resources to improving quality of care, health outcomes and reducing health disparities.

Applications submitted to this FOA should exploit EHRs coupled with findings from behavioral economics for interventions targeting compliance with recommended treatment guidelines.  The

Program Directors/Principal Investigators (PD(s)/PI(s)) will form a multidisciplinary, collaborative research team consisting of expertise in medicine, behavioral and social science (e.g., psychology, economics, etc.), and bioinformatics to carry out the research objectives.  The FOA encourages participation of both large and small health delivery network, such as primary care physicians, specialists, or Health Management Organizations (HMOs), in order to implement interventions.  Specifically, applications are requested in the following areas:

National Institute on Aging (NIA)

The NIA seeks applications that will integrate behavioral economics techniques with EHRs to produce low-cost interventions designed to improve physician adherence to recommended treatment guidelines and reductions in inappropriate and overuse/underuse of preventive services, therapies, or diagnostic tests.  The NIA is particularly interested in interventions against common geriatric conditions.  For example, applications of the Choosing Wisely campaign focused on geriatric patients will be appropriate for this RFA, but are not limited to it.  Applications of behavioral economics encouraging appropriate care and address underuse, which leads to health disparities, is also of interest to the NIA. 

National Institute on Drug Abuse (NIDA)

The NIDA seeks applications that will integrate behavioral economics techniques with Electronic Health Records (EHRs) to produce low-cost interventions designed to improve physician adherence to recommended pain treatment guidelines and to the CDC Guideline for Prescribing Opioids for Chronic Pain (guideline http://www.cdc.gov/drugoverdose/prescribing/guideline.html).  The pain treatment guidelines incorporated must be consistent with the CDC Guideline for Prescribing Opioids for Chronic Pain.  If the pain treatment guideline included suggests treatments which are incongruent with the CDC guideline, the pain guidelines must be modified to support the recommendations of the CDC guideline.  The intervention should ‘nudge’ providers to provide enhanced pain treatment which is congruent with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The R21 Phase  (Planning Phase)

During the R21 pilot phase, researchers will test the feasibility of implementing and integrating guidelines through EHR-based interventions which, if successful, can transition to an R33 phase for implementation of pragmatic trials.  The specific activities and milestones appropriate for the R21 phase will depend on the type of intervention under study and its stage of development.  Generally, the applicant could include the following activities and milestones for the R21 phase:

  • Establish a partnership with health care provider (e.g., primary care physicians, specialists, HMOs, etc) and document commitment of the organization to the project
  • Obtain access to EHRs to modify and implement pilot interventions using behavioral economics   principles.
  • Operationalize definitions and objective measures of the intervention (i.e., the hypothesized mechanism of action of behavioral economics principle).
  • Preliminary evidence that the mechanism of action can be manipulated reliably and validly through the EHR process.
  • Assess and justify adequacy and finalize clinically-relevant outcome measures.
  • Plan adequately for pilot testing intervention(s) and produce preliminary data for R33 administrative review showing feasibility.

The R33 Phase (Implementation Phase)

During the R33 Phase, PDs/PIs shall implement the intervention in a clinical setting and general activities include:

  • Plan for intervention refinement, standardization, and further testing of feasibility, safety, and acceptability with preliminary testing of the association between interventions and clinical outcomes.
  • Plan for refining estimates of requirements based in R21 findings with guidance from NIH staff for sample size, numbers of sites, site to site heterogeneity, and the implementation timetable based on data derived from the healthcare delivery partners.
  • Studies supported by the R33 phase should be adequately powered. It is recommended that PD/PI provide power calculations for the R33 phase.
  • Development of plans for site implementation, including site staff, method of identification, randomization (as applicable), participant recruitment and acquisition.
  • Address all ethical issues and issues related to human subject safety oversight for the pragmatic trails, including the development of informed consent documents or opt-out consents (if applicable), and finalizing site of IRB review. 
  • Applicants must propose a consolidated or centralized IRB approach for trial oversight to facilitate both the appropriate and timely study implementation.
  • Replicating findings in another site.  Applicants are not required, but can identify additional implementation sites, if they choose to, in consultation with the NIH staff for replication purposes prior to beginning the R33 phase.

Milestones and R21/R33 Transition

The application must propose a well-defined set of milestones (see suggested milestones above) for the planning phase (R21) and annual milestones for the implementation phase (R33).  Specifically, the transition from the R21 to the R33 phase of the award will be administratively reviewed and determined by successful completion of the Go/No-Go Criteria that need to be clearly specified for the R21 phase.  Applicants can establish Go/No-Go Criteria as they deem fit for their application but must include the following (1) Establish partnership with health care provider (e.g., primary care physicians, specialists, HMOs, etc) and document commitment of the organization to the project; (2) Obtain access to EHRs and modify and implement pilot interventions using behavioral economics   principles; and (3) pilot test intervention(s) and produce preliminary data for R33 administrative review showing feasibility of the intervention.

At the completion of the R21 planning phase, the applicant will be required to submit a detailed transition request for the R33 implementation phase. R33 transition requests will undergo an administrative review to determine whether the milestones have been met. Unless the R21 meets Go/No-Go Criteria, the R21 may not transition to R33 phase (i.e. it is anticipated that not all funded R21 projects will transition to the R33 phase.) 

Prospective applicants should note that funding of R21 phase grant application does not guarantee support of the R33 implementation phase.  Transition to the R33 phase of the project will occur only if an administrative review process recommends that the R21 planning activities have been successful, the implementation phase of the project can proceed with confidence of success, and if funds are available.

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIA: For R21 Phase, and pending annual appropriations, NIA intends to commit $900,000 for FY 2017, and $900,000 for FY 2018 to fund up to 4 awards.  Pending administrative review and annual appropriations, NIA can potentially fund up to 4 R33 awards, totaling $2,900,000 in FY 2019, $2,900,000 in FY 2020, and $2,900,000 in FY 2021. 

NIDA: For R21 Phase, and pending annual appropriations, NIDA intends to commit $450,000 for FY 2017, and $450,000 for FY 2018 to fund up to 2 awards.  Pending administrative review and annual appropriations, NIDA can potentially fund up to 2 R33 awards, totaling $1,450,000 in FY 2019, $1,450,000 in FY 2020, and $1,450,000 in FY 2021.  

Award Budget

For the R21 planning phase, the combined budget for direct costs for the two year project period may not exceed $275,000, with no more than $200,000 requested in any single year. 

For the three year R33 implementation phase, applicants combined budget for direct costs may not exceed $1,350,000.  Applicant's budgets need to reflect the actual needs of the proposed project.

Award Project Period

The project period is limited to five years, which include 2 years of R21 phase followed by up to 3 years of R33 phase.    

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Partha Bhattacharyya, Ph.D
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: bhattacharyyap@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Applicants should budget for travel to an annual investigators meeting to be held in the Washington, DC area

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Applicants should budget for travel to an annual investigators meeting to be held in the Washington, DC area.   

Specific Aims: Separate specific aims should be presented for both the R21 and R33 phases in one page.

Research Strategy: The Research Strategy should contain separate sections that describe both the R21 and R33 phases.  Separate research design and methods could be presented as needed for the R21 and R33 phases. It is not necessary to repeat information or details in the R33 section that are described in the R21 section.

Preliminary data are not required for an R21/R33 application.  Any preliminary data that will support or justify the proposed hypothesis, rationale or development plan may be included. 

PDs/PIs should propose to follow best practices for the conduct of their randomized trial, and, in particular, to state clearly how randomization will be performed. For example, if randomization is performed at the hospital level, the applicant should describe how many effective observations will there be after accounting for intra-cluster correlation. If the randomization is at a lower level than the hospital, the PD/PI should address potential threats to validity that could occur due to contamination across treatment groups. PDs/PIs should clearly present power calculations that reflect a range of effect sizes of clinical significance. Specifically, it is recommended that PDs/PIs provide beta ranges to assess the sample size/and effect size across multiple sites.

Applicants should provide a description of how the study designs, methods and assessments are complementary such that outcomes from the planning phase will enhance the interpretation of outcomes at the implementation stage.  For example, in the planning phase the PD/PI can propose only one intervention (e.g., peer comparison) in a site and implement it in EHR to show feasibility of participation from physicians.  In the implementation phase the PD/PI can propose multiple interventions which can improve physicians following guidelines (e.g. default settings in EHR, peer-comparison within and outside the health system, etc.) across multiple sites. 

Since the intent of this announcement is to leverage findings from planning phase to implementation phase and increase the potential for translation research, the PDs/PIs are encouraged to collaborate with EHR vendors to maximize the possibility of translation.

Milestones and R21/R33 Transition

The application must include milestones they expect to achieve by the end of the R21 phase. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the specific aims for the R21 phase.  It is recommended that PDs/PIs include a section labeled "milestones" describing milestones to be achieved during the R21 phase to qualify for the transition to the R33.

It is understood that the proposed milestones for the R33 phase may be revised based on activities during the R21 planning phase.  In the event of an award, the PD/PI and NIH staff will negotiate a list of milestones for each year of support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Resource Sharing/Dissemination plans are expected.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R21/R33 phased innovation grant supports behavioral economics interventions through electronic health records to deliver appropriate care without overruling physicians’ autonomy of exercising clinical judgement.  An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however,  these may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Reviewers will focus their evaluation on the conceptual framework, the level of innovation for implementing behavioral economics concepts in EHR, and the potential to significantly advance our knowledge or understanding.  Since, implementation of behavioral economics principles through EHR is an emerging research area, investigators may not have experience working together as a team, as expertise may be necessary from multiple disciplines (e.g. medicine, bio-statistics, economics, psychology, etc.)  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

 
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

Is there a unifying and testable hypothesis that transcends both R21 and R33 phases? Does the application provide clear milestones for the R21 phase and related scientific goals for the R33 phase? Are those milestones conducive to accomplishing the study aims? Are the goals of the R33 phase based, in part, on findings collected during the R21 phase?  Did the PDs/PIs establish an appropriate partnership with health care provider (e.g., primary care physicians, specialists, HMOs, etc) and document commitment of the organization to the project?  Will the PDs/PIs be able to access EHR system to modify and implement pilot interventions using behavioral economics principles - e.g. is there an appropriate letter of support? Did the PDs/PIs provide adequate power calculations and adequate justification?

Did the PI operationalize definitions and objective measures of the intervention -  i.e., did the PDs/PIs cite evidence base to support the hypothesized mechanism of action of behavioral economics principle can be manipulated and implemented in EHR?  Did the applicant assess and justify adequacy and finalize clinically-relevant outcome measures? Will the R21 phase produce preliminary data for R33 administrative review showing feasibility - i.e. can the PD/PI show he/she make changes to the EHR system and conduct an intervention?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute on Aging, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board(e.g. NACA for NIA applications). The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Program balance.
3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Partha Bhattacharyya, Ph.D
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: bhattacharyyap@mail.nih.gov

David Thomas, Ph.D
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1313
Email: dthomas1@nida.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: Vemuri@nia.nih.gov

Financial/Grants Management Contact(s)

Richard Proper
National Institute on Aging (NIA)
Telephone:301-402-7735
Email: properr@mail.nih.gov

Suezette D. Epps
National Institute on Drug Abuse (NIDA)
Telephone: 301-617-3882
Email: eppss@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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