Department of Health and Human Services
Funding Opportunity Title
Testing Multi-Level Interventions to Improve Blood Pressure Control in Minority Racial/Ethnic, Low Socioeconomic Status, and/or Rural Populations (UH2/UH3)
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
This funding opportunity announcement (FOA) solicits applications to fund up to two patient-centered comparative effectiveness clinical trials using a UH2/UH3 cooperative agreement mechanism. This initiative is supported by the Hypertension Disparities Reduction Program Partnership (HDRPP), a research partnership between NHLBI, NINDS, and the Patient-Centered Outcomes Research Institute (PCORI), with funds provided by PCORI to the NIH. The research initiative aims to reduce disparities in hypertension, a leading cause of cardiovascular disease that disproportionately affects certain populations including racial and ethnic minorities, individuals with low socioeconomic status, and rural communities. Approximately 30% of adults in the U.S. have hypertension, and of these, more than half have uncontrolled hypertension. The purpose of the FOA is to compare alternative, evidence-based approaches to reduce inadequate control of hypertension among high risk populations, including racial/ethnic minority groups, patients with low socioeconomic status (SES), and individuals residing in rural geographical areas with an above average lifetime risk of cardiovascular disease (CVD).
December 8, 2014
Open Date (Earliest Submission Date)
January 13, 2015
Letter of Intent Due Date(s)
January 13, 2015
Application Due Date(s)
New Date February 19, 2015 per issuance of NOT-OD-15-057. (Original Expiration Date: Feburary 13, 2015), 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.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date
New Date February 20, 2015 per issuance of NOT-OD-15-057. (Original Expiration Date: Feburary 14, 2015)
Due Dates for E.O. 12372
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
This NIH Funding Opportunity Announcement (FOA), funded by the Patient-Centered Outcomes Research Institute (PCORI), invites applications to fund up to two new patient-centered comparative effectiveness clinical trials, with the goal of comparing alternative, evidence-based ways to reduce inadequate control of hypertension and disparities in outcomes among high-risk populations, including racial/ethnic minority groups, patients with low socioeconomic status (SES), and individuals residing in rural geographical areas with an above average lifetime risk of cardiovascular disease (CVD). For this FOA, high risk populations are those with an elevated risk of fatal and non-fatal cardiovascular disease outcomes and for whom it has been challenging to achieve a high rate (>75%) of blood pressure control. Despite evidence-based strategies, it has been difficult to achieve a high rate (>75%) of blood pressure control in these populations.
This initiative is supported by the Hypertension Disparities Reduction Program Partnership (HDRPP), a research partnership between NHLBI, NINDS and PCORI, with funds provided by PCORI to the NIH. PCORI was authorized by the Patient Protection and Affordable Care Act of 2010 as a nonprofit, nongovernmental organization charged with helping patients, clinicians, purchasers, and policy makers make informed health and healthcare decisions by advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor, and manage diseases, disorders, and other health conditions. It does this by funding and disseminating high-quality, useful, evidence-based information produced through comparative clinical effectiveness research guided by patients, caregivers, and the broader healthcare community. The law noted the importance of taking into account the potential for differences in the effectiveness of healthcare options for various subpopulations and required PCORI to consider the prevalence and burden of disease, with an emphasis on practice variations and health disparities, in its research priority setting. PCORI’s Addressing Disparities program focuses on funding comparative effectiveness research that aims to reduce disparities in healthcare outcomes and advance equity in health and healthcare. This research initiative aims to reduce disparities in hypertension—a leading cause of cardiovascular disease that affects 30% of adults in the U.S. Of these individuals, more than half have uncontrolled hypertension. In advancing its research agenda, PCORI is committed to transparency and a rigorous stakeholder-guided process that focuses on patient-centeredness and emphasizes meaningful engagement by a broad range of healthcare stakeholders. More information is available at www.pcori.org .
This FOA seeks applications that propose to compare alternative, evidence-based approaches to reduce inadequate control of hypertension among high risk populations, including racial/ethnic minority groups, patients with low SES, and individuals residing in rural geographical areas with an above average lifetime risk of CVD. The project's overall aims are to improve clinical practice and lead to improvement in blood pressure control and other related patient-centered outcomes in disparities populations. For the purposes of this FOA, high risk populations are those with an elevated risk of fatal and non-fatal cardiovascular disease outcomes and for whom it has been challenging to achieve a high rate (>75%) of blood pressure control. Many high risk populations are served in health care facilities such as Federally Qualified Health Centers (FQHCs), and community clinics. Many of these populations include a significant proportion of patients insured through Medicaid. Planning, implementation, recruitment, retention, and dissemination, and other aspects of the trials will involve patients and key stakeholders in meaningful ways to assure the trial success.
The FOA uses the UH2/UH3 cooperative agreement mechanism. Although applications for the UH2 and UH3 activities must be submitted and will be reviewed simultaneously, funding for the UH3 phase is contingent on achieving pre-specified milestones during the UH2 phase. These milestones will ensure sufficient progress during the UH2 to provide feasibility and scientific rationale for the conduct of research proposed in the UH3. Milestones must be identified in the application, and these may be negotiated based on comments of the peer review panel.
To be responsive to this FOA:
- The trials must be based on comparative study designs and must not include cost-effectiveness analyses. The applicant must carefully justify their trial design and these designs must be practical with high likelihood of success based on past experience or feasibility studies.
- The trial’s intervention arms must target one or more of the high risk patient populations with hypertension which include racial/ethnic minority groups, patients with low SES status, and individuals residing in rural geographical areas with an above average lifetime risk of CVD.
- The active intervention arm(s) must involve a multi-level and multi-component intervention involving the management of the health care system, the providers, patients with hypertension, and appropriate community-based organizations. Components of the active intervention must be based on evidence, and be feasible for broad future implementation, and address system/facility, physician/provider, and patient barriers. A stepped approach should be used so that patients who remain uncontrolled will get additional interventions in order to overcome lack of progress.
- The trial must have a well-defined comparator arm(s).
- The trial must have important patient centered secondary outcome measures including important potential adverse effects of anti-hypertensive treatment.
- The primary outcome of the trial must be a measure of improvement in blood pressure control between the beginning of intervention and the end of the follow-up period. The minimum duration of the follow-up period is one year.
- The applicant must propose to recruit a diverse sample of sufficient size to provide adequate power to detect a substantial improvement in the blood pressure control rate.
- In both the UH2 and UH3 phases, the trial must collaborate with the separately funded, companion Research Coordination Unit (HL-15-031 ). This can include such activities as sharing trial performance metrics such as recruitment and retention data and quality control data with the coordinating function.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The awards are contingent upon the submission of a sufficient number of meritorious applications.
PCORI intends to authorize $2,000,000 total costs in FY 2015 to fund up to 2 UH2 (Planning Phase) awards. PCORI intends to authorize $21,500,000 total costs in FY2016-FY2019 for up to 2 UH3 (Implementation Phase) awards. The UH3 transition is contingent upon satisfactory progress and availability of funds.
The UH2 Phase is limited to $650,000 direct costs for a one year period. The UH3 Phase is limited to $1,800,000 direct costs for each subsequent year (2 to 5)
Award Project Period
The UH2 phase will be one year in length and the UH3 phase may be up to 4 years.
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.
1. Eligible Applicants
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:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits 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)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
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.
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.
An applicant institution may apply to both companion announcements. However, the PD/PI for this FOA must be a different PD/PI from RFA-HL-15-031.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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).
In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
1. Requesting an Application Package
Applicants must download 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.
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:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
- For this specific FOA, the Research Strategy section is limited to 30 pages.
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.
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. For the UH3 implementation phase (conduct of clinical trial), clearly defined clinical settings involved in the trial may:
- Consist solely of primary care settings
- Include a majority of primary care settings with some additional selected specialty care settings, such as neurology, cardiology, endocrinology, or nephrology clinics as appropriate.
- Recruit participants from the primary and/or specialty clinical sites and from other participating community organizations (i.e., recruiting individuals who are not current patients in the trial clinical sites is acceptable); community members with uncontrolled hypertension who do not seek care for hypertension or who rarely do so, may be among the highest CVD risk group and have the most difficult patient barriers to address successfully.
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. For the UH3 implementation phase (conduct of clinical trial), applicants are expected to have expertise in conducting patient-centered research and patient stakeholder engagement.
All instructions in the SF424 (R&R) Application Guide must be followed. The applicants should budget for three two day face-to-face meetings per year. Each meeting should involve at least two investigators from the trial. These meeting will be held in the Washington, D.C. metro area. The application should include appropriate compensation for patients and other relevant stakeholders who must be engaged in all phases of conducting the study, including design, implementation, evaluation and reporting of results. The applicant should budget for the cost of a study chair for two and half years. Each trial will pay the cost of the independent program steering chair for two and half years, if the awards are five years in length.
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:
Specific Aims: Applicants should include separate specific aims for each phase of the application (UH2 and UH3).
Research Strategy: The project's overall goals are to improve clinical practice and lead to improvement in blood pressure control and other related patient-centered outcomes in disparities populations. Trials must be based on comparative study designs and must not include cost-effectiveness analyses. The overall active intervention strategy should be based on a comprehensive model of the remedial causes of disparities in hypertension among these high risk populations and the health care system in which these trials will occur. Projects must be for patient-centered, comparative effectiveness research that specifically targets disparities in hypertension management. To avoid duplication, encourage innovation, and enhance utility of future research findings, the proposed trials must be innovative and different from previous and ongoing research by the proposing research team and past trials by other investigators.
For the UH2 planning phase, applicants must describe plans for:
- Protocol development, including plans for developing collaborations and refining the protocol based on results of the one-year planning period activities
- Any other activities, examples of which include:
- Conducting small pilot studies testing recruitment and retention strategies.
- Finalization of plans for outcome measurements.
- Finalization of data analysis plans.
- Engaging patient and other key stakeholders as research partners in the conduct of the study.
- Ascertainment and integration of forms into existing electronic resources.
For the UH3 implementation phase (conduct of clinical trial), applicants are expected to describe in detail a proposed trial design. Proposed trials should include the following or its equivalent:
- The primary outcome of the trial must be the improvement in blood pressure control between the beginning of intervention and the end of the follow-up period. The hypothesized improvement in the rate of blood pressure control between the control arm and the active intervention arm should be substantial, such as greater than 15%.
- The minimum duration of the follow-up period is one year.
- A detailed description of the specific components of the intervention(s) in each arm of the trial and must include plans to monitor the implementation of these components during the course of the trial.
- At least one active intervention arm and one or more well-defined comparator arms or groups.
- Active intervention arm(s) must:
- Be comprised of multi-level and multi-component interventions that include involvement of leadership of the health care system, practitioners, patients with hypertension, and appropriate community-based organizations.
- Be based on evidence and lessons from previous trials.
- Be able to engage patients and families.
- Be feasible for broad future implementation.
- Address system/facility, community, clinician, and patient barriers.
- Be tailored to patient factors that increase adherence and engagement such as context, preferences, and language.
- Include specified components to address major obstacles that are more common among high risk populations.
- One comparator arm must consist of individuals receiving current standard of care in the health care system(s). In order to encourage recruitment of health care systems, some changes in standard of care even in the comparator arm may be required.
- Innovative interventions, such as combining changes in care team structure or function with innovative uses of technology, may be included. Different components of the multi-component intervention may be directed at different levels such as the leadership of the health care system, providers, patients, and appropriate community groups or resources.
- Applicants are encouraged to determine whether there are specific subgroups for which specific components of the intervention are ineffective for controlling hypertension.
- Research design should be appropriately patient-centered to engage providers and integrate community based resources to address patient or family barriers.
- Clearly defined trial features may consist of the following:
- Cluster randomized designs.
- Adaptive or other trial designs to address inadequate response to the active intervention or its components, especially among population subgroups.
- Randomization at the individual patient level.
- Restriction to participants with uncontrolled blood pressure
- Clearly defined trial features must include the following:
- A stepped approach so that patients who remain uncontrolled will receive additional interventions that are flexible and tailored to the individual; this approach should have decision rules with sufficient specificity to allow the protocol to be adopted by other providers after the study.
- The type of trial design carefully justified.
- A primary outcome of improving blood pressure control between the beginning of the intervention and the end of the follow-up period.
- Health facilities/systems in the trial with extensive experience with minority racial/ethnic, low SES, and/or low income rural patients, families, health systems, and communities.
- A research team that possesses the following characteristics:
- Extensive research experience with the proposed health disparities populations.
- Extensive experience in conducting research with minority racial/ethnic, low SES, and/or low income rural patients.
- Extensive experience in working with the health care organizations serving these populations and relevant experience engaging patients and stakeholders in clinical trial research and conducting randomized trials.
- Each funded trial will be conducted by a different research team and specific elements of the interventions may be different, each study team will be responsible for the analysis of their trial data.
A goal of this FOA is to determine the type of interventions which will lead to the achievement of a control rate of 75% or greater by the end of the trial in the clinical sites in the active intervention arm. Comparing changes in the distribution of blood pressure control rates between the arms of the trial, and across subgroups within each arm, at the end of the follow-up period are important secondary outcome measures. In addition to assessing improvements in blood pressure control rates, the trial will assess important patient-centered outcomes, intervention acceptability, feasibility, fidelity, and sustainability metrics, and clinical outcomes that have a recognized impact on quality of life such as potential adverse effects of anti-hypertensive treatment, including injurious falls and episodes of renal dysfunction.
Milestones and UH2/UH3 transition
The UH2 section must include a description of the milestones that will be reached at the end of the UH2 phase. To successfully transition to the UH3 phase, the project must substantially achieve the following milestones in addition to any trial-specific ones outlined in the application:
- Develop and document all collaboration and partnerships necessary for conduct of the clinical trial. These may include selection of clinical sites, selection of study champions in relevant delivery locations, and execution of data use agreements, and subcontracts.
- Finalize study protocol, manual(s) of procedures, and data collection forms by nine months of award issuance. If data collection forms are to be integrated into an existing electronic record, demonstrate the integration. If data will be collected from existing electronic sources, demonstrate validated methods to collect such data.
- Obtain all necessary human subject protection approvals and procedures including IRB approval, review and approval of final informed consent documents or waiver of informed consent, and selection of medical/data safety monitors. Applicants should plan on one NHLBI DSMB for these trials.
- Document a potential study population adequate to meet the sample size of the trial.
- Demonstrate ability to recruit potential participants to enroll in the clinical trials.
- Demonstrate ability to retain study participants for the duration of the intervention and any follow-up measurement time period.
- Document the roles and the decision-making authority of patients and other stakeholders in the design, monitoring, and dissemination of the study.
- Document that the research addresses patient-centered issues in the design and execution of the trial such as what the patients do to control their hypertension, work successfully with their health care providers, and make the best decisions about their healthcare. Patient-centered trials incorporate individual preferences, attention to health-related quality of life, and consider stakeholder perspectives throughout the research process. http://www.pcori.org/content/research-we-support
- Describe different randomization options and assess impact on the feasibility of implementing the trial effectively and their impact on the statistical power of the trial.
- Describe the monitoring and quality control methods for the recruitment of sites and participants, and for ensuring the quality and fidelity of the components of the intervention.
- Describe the training needed for the study’s providers to successfully implement the protocol. This training should be readily scalable for use with other providers after the study.
- At the end of the UH2 phase, the manual (s) of procedure, and data collection forms for the trial must be completed.
- Ensure that most of the clinical settings have functional electronic health records (EHRs) that can be used to identify individuals in these practices who have hypertension and describe the clinical blood pressure measurements at individual and system levels. Also ensure that the health care system will support the timely generation of this data for submission to the trial. If data collection forms are to be integrated into an existing electronic record, demonstration of the integration must be provided. For critical data that will be collected from existing electronic sources, demonstration of validated methods to collect such data should be provided, particularly for key trial endpoints like blood pressure measurements and changes in anti-hypertensive medication and patient-centered outcomes.
- Work collaboratively with the steering committee to ensure that the final trial protocol is consistent with the relevant PCORI methodological standards. The program steering committee and the protocol review committee will review the protocol with regard to the appropriate PCORI methodological standards. Each of these standards is organized into 11 categories. There are both categories that are relevant to all studies such as Category 5 (Standards for the Heterogeneity of Treatment Effects) and categories that are relevant only to particular study designs and methods such as Category 9 (Standards for Adaptive and Bayesian Trial Designs) (http://www.pcori.org/content/pcori-methodology-report).
- Work collaboratively with patient and stakeholder partners in all aspects of the study in the UH2 (e.g., study design, identification of patient-centered outcomes, development of study tools and materials.)
- Work collaboratively with the Steering Committee to develop a protocol with key common elements, including the primary outcome measure and some common secondary outcome measures and interim data analysis plan and intent-to-treat analysis.
- Work collaboratively with the separately funded Research Coordination Unit (HL-15-031) to share trial performance metrics such as recruitment and retention data and quality control data with the coordinating function.
- The final trial protocol must be approved by an NHLBI protocol review committee of extramural scientists.
- Provide analysis of the trial’s ability to succeed in minority/ethnic, low SES, and/or rural populations, and the health organizations/systems participating in the trial.
Each applicant must submit additional milestones that are specific to their proposed clinical trial. These should be quantifiable and the metrics to measure success fully explained in the application. Additional milestones may be negotiated before and after funding decisions have been made.
Proposed trials should build on the findings of previous trials and interventions. However, not all factors should have been previously addressed or tested in trials. All applicants should provide a thoughtful analysis of obstacles for testing their interventions in the patient and provider populations and study organizations they intend to target. Applicants should provide realistic solutions about how they plan to address these obstacles and challenges to help assure successful trials. For example, factors which might present obstacles to implementation and conduct of the trial could include: challenges patients face to complete participation in the trial; turnover of clinicians, staff and leadership in health care organizations; lack of Information Technology (IT) infrastructure to provide electronic feedback and information needed for the trial.
To achieve the project goals, applicants should provide information about expertise of team members in:
- Clinical trials, including the staffing and infrastructure necessary to conduct a multi-site trial in real-world practices.
- Recruiting and retaining the target study population and sample size, including expertise in following up with research participants who do not complete the intervention (Underserved populations are often challenging to recruit and retain.)
- Engaging patients and other relevant stakeholders to participate actively in all phases of the study, including design, implementation, evaluation, and reporting of results.
- Ensuring the provision, with high fidelity, of all elements of health care identified in the study protocol, including:
- Qualified teams and access to the services of other required professionals in other organizations or in the community.
- Robust processes for monitoring and ensuring the quality of the clinical services and their fidelity to the protocol.
- Access to a sufficient number of practices and participants to ensure adequate statistical power.
Projection of the interventions sustainability in the study organization(s)
To increase the potential of adoption and uptake of the findings by other health care providers/systems, we urge applicants to leverage available staff, facilities, and community resources that are representative of real-world (present and potential) linkages to the practices engaged in the trials. Areas of research focus should be generalizable to other settings and clinical practice sites. Trials that include community resources to augment healthcare are permissible, but the community resources must be well integrated into healthcare delivery. Referral alone, without active follow-up, to community programs by the healthcare system or staff is not, in itself, adequate as a response to this funding announcement. There should be some evidence that the community program or policy is directly linked to healthcare delivery through a formal agreement, reimbursement, and regular communication about patient progress and outcomes. In this FOA, there is particular interest in applications involving organizations or programs that can help researchers design, implement, disseminate, and sustain effective interventions. Applicants are strongly encouraged to collaborate with appropriate institutions or organizations to achieve this end.
The anticipated start date for the project is September 2015 and the total funding period will be five years. The applicant should, therefore, project a schedule for implementing interventions in a sufficient number of participants by the end of September 2016.
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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
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.
Planned Enrollment Report
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
3. Submission Dates and Times
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
4. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
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.
6. 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.
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 the instructions for post-submission materials, as described in NOT-OD-13-030.
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.
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.
Does the project address an important problem or a critical barrier to progress in the field? 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?
If the aims of the project are achieved, will improvements in clinical practice likely lead to widespread improvements in outcomes that matter to patients? What is the likelihood that successful completion of the aims of the clinical trial will directly improve clinical practice and produce outcomes that are important to patients?
Does the application demonstrate patient-centeredness at every stage of the research? Does the application address the following
- Is the research focused on questions that affect outcomes of interest to patients and their caregivers?
- Does the research address one or more of the key questions mentioned in PCORI’s definition of patient-centered outcomes research?
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?
What is the likelihood that this project will improve the care of patients in this population?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?
Does the application adhere to all relevant PCORI Methodology Standards? Does the UH2 phase propose required activities for the development of the protocol in this study population? Is the timetable feasible? Is there a strong likelihood that the UH2 will be completed as proposed and will be ready for full implementation in the UH3 phase?
Are the proposed staff’s level of effort, expertise, roles and responsibilities sufficient to complete concurrently the multiple parallel activities that will be required in order to test and refine the protocol, both during the protocol development and refinement of the UH2 phase, and during the protocol implementation of the UH3 phase?
Will the trial address multiple levels of interventions and is the intensity of each realistic to achieve the project aims? Does the intervention address determinants of health that are feasible to intervene upon? Is the effect of the project’s planning and implementation on the healthcare operations and workflow addressed? Does the application discuss factors such as differential adherence to chosen treatments (or participation in intervention programs) that could create or explain apparent differences in the effectiveness of the alternative interventions being compared in clinical populations? Are the study outcomes meaningful to patients and clinicians?
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?
Patient and Stakeholder Engagement
- Does the application demonstrate that people representing the population of interest and other relevant stakeholders are engaged in ways that are appropriate and necessary in a given research context?
- Are patients and other stakeholders engaged in:
- Formulating research questions
- Defining essential characteristics of study participants, comparators, and outcomes
- Identifying and selecting outcomes that the population of interest notices and cares about (e.g., survival, function, symptoms, health-related quality of life) and that inform decision making relevant to the research topic
- Monitoring study conduct and progress
- Designing/suggesting plans for dissemination and implementation activities
- Are the roles and the decision-making authority of all research partners clearly stated?
- Does the application identify, recruit, and retain trial participants representative of the spectrum of the population of interest and ensure that data are collected thoroughly and systematically from all study participants?
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.
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?
How strong is the expertise of the PD(s)/PI(s) or key personnel in design and implementation of a clinical trial, including recruitment, retention, and outcomes assessment? How strong is the experience of PD(s)/PI(s) or key personnel with performing the activities proposed in the Planning Phase and conducting research with minority racial/ethnic, low SES, and/or low income rural patients? How strong is the evidence that the PD(s)/PI(s) or key personnel have worked closely with health delivery organizations that serve this population? Do the PD(s)/PI(s) or key personnel have existing and substantive relationships with patient and stakeholder groups targeted in the study?
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?
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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
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
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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Heart, Lung and Blood Institute, 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 National Heart, Lung and Blood Advisory Council. 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.
- Lack of overlap with any grant funded under the Agency for Healthcare Research and Quality (AHRQ) FOA on the dissemination and implementation of patient-centered outcomes research (PCOR), RFA-HS-14-008, Accelerating the Dissemination and Implementation of PCOR findings into Primary Care Practice.
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by NIH involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept and the Hypertension Disparities Reduction Program Partnership, the dominant role and prime responsibility reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
- PCORI's authorizing law requires PCORI to "ensure that there is a process for peer review of primary research" that meets the requirements of the authorizing law. The awardee will collaborate with NIH in working with PCORI to ensure that primary research is peer reviewed to meet this statutory directive.
- The award recipient will work with Offices of Public Liaison and Communication in NHLBI and NINDS and, at the request of NHLBI and NINDS, with the communications liaisons in PCORI, as well as institutional press offices to disseminate findings to physicians, other clinicians and to the general public. These activities will occur in advance of publications from the study.
- If requested by IC, the award recipient will consult with the expert advisory panels for clinical trials and rare diseases established pursuant to PCORI’s authorizing law.
- PCORI's authorizing law provides that PCORI "shall, not later than 90 days after the conduct or receipt of research findings…make such research findings available to clinicians, patients, and the general public…" The awardee will collaborate with NIH in working with PCORI to ensure that research findings from this study are made available to meet this statutory directive.
- Award recipient will ensure that NIH and PCORI are appropriately acknowledged as funders of the study under this cooperative agreement in any material produced by or on behalf of Award recipient that relates to the study funded under this cooperative agreement, consistent with applicable NIH and PCORI requirements. NIH will develop suggested language to be used in acknowledging support from this award and will forward the language to the awardees.
- Receipt of the request for transition to the UH3 phase in a PHS 2590 application. The application should include, but not be limited to, an outline of UH2 progress; how UH2 milestones have been met; detailed plans, budget, and annual milestones for the UH3 implementation phase; final study protocol; an operational plan for implementation, enrollment plan, and statistical plans; data safety monitoring plan: resources and data sharing plans; a plan for how the trial-specific Steering Committee of investigators and stakeholders will be organized.
- Additional milestones may be negotiated after funding decisions have been made.
- The awardee agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study including those outlined under "NIH Responsibilities" including all aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.
- Awardees will participate in steering committee meetings will support any committees, task forces, and advisory panels as needed.
- Upon implementation of the protocol, each field center, whether a single institution or a consortium of institutions, will follow the procedures required by the protocol regarding study conduct and monitoring, patient management, and data collection.
- Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by NIH Program Officer to ensure objectivity of research.
- Obtaining prior written approval of the NIH Grants Management Specialist in consultation with the NIH Program Officer for a change in any of the key personnel identified in the Notice of Award.
- Award recipients will own the rights in any tangible work products created under the terms of the cooperative agreement. Work products may include such things as research reports, papers, research findings, training curricula, data sets, books, patient tools, and other materials. All such products shall be made accessible to the public and are subject to Government rights of access, as appropriate, in accordance with NIH’s legal directives and authorities.
- Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- The decision to advance each trial under the NIH/PCORI Hypertension Disparities Reduction Program Partnership (HDRPP) from the UH2 phase to UH3 phase and to commit the additional funds necessary for the UH3 phase will require an administrative review. If it is determined that the trial will not be advanced to the UH3 phase, NIH will notify the recipient that no further funding will be provided.
- The NIH Project Scientist will have access to the data and work with the PD(s)/PI(s) to ensure the objectives of the program are being met. The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH Project Scientist.
- The NIH reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting. If the application is assigned to NHLBI, NHLBI support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding. The Grantee is expected to demonstrate best effort compliance in accord with the NHLBI Milestone Accrual Policy (http://www.nhlbi.nih.gov/studies/index.htm). Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and or negotiating an orderly close-out of this study.
- NIH staff will act as a resource and facilitator for activities of the awardee with non-HCS researchers and other NIH, DHHS, or other federally-sponsored research networks that may be relevant to this effort.
- Serve as a resource to provide scientific/programmatic support during the accomplishment of the clinical trial by participating in the design of the activities, advising in the selection of sources or resources, advising in management and technical performance, or participating in the preparation of publications.
- Participate in the monitoring of issues relating to recruitment, retention and follow-up of study participants, and monitoring of data integrity and quality control through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting as needed to the administration and evaluation core.
- Assist in the development and modification of study protocols.
- NIH staff will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(S) and his staff, periodic site visits for discussion with the awardees’ research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
- Reporting periodically on progress of the program to the interested IC Directors.
- Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
- A Steering Committee will be formed to serve as the primary high-level decision-making body for the program. Members of the Steering Committee will include the PIs for each trial, a site investigator from each trial, a representative of PCORI, an NHLBI staff member, and a Chairperson. Each member will have one vote. The Committee will approve the study goals and methods (including applicable PCORI Methodological Standards, as adopted by the PCORI Board of Governors), provide support for patient and stakeholder engagement, monitor the study’s progress, and approve revisions to the study protocols. Awardee members of the Steering Committee will be required to accept and implement all policies governing the study conduct approved by the Steering Committee. The Steering Committee will meet either in-person or via teleconference every three (3) months or more often, as needed. NIH and PCORI will each have the option of naming a representative to each of the working group and sub-committees. These working groups and sub-committees will be predominantly comprised of study investigators and experts named in the grant application. Working groups and sub-committees are advisory and have no decision-making authorities unless the steering committee delegates areas of specific authority to a subcommittee."
- The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
- Awardees and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions.
- All awardees and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research in health care settings.
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff or the PCORI representative voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
For funded applications, the PD/PI will submit a progress report to the Program Officer upon completion of the UH2 milestones. Receipt of this progress report will trigger an administrative program review which will be conducted by NHLBI Program Officials to determine whether UH2 goals, as proposed and peer-reviewed, are complete including the final study protocol approved by an extramural protocol review committee. The primary purpose of the UH2 goals is to ensure that the trial can be successfully completed in the UH3 phase. The RPPR should also address how the final study protocol is innovative and distinctive from any grant funded by the Agency for Healthcare Research and Quality (AHRQ) FOA on the dissemination and implementation of patient-centered outcomes research (PCOR), RFA-HS-14-008, Accelerating the Dissemination and Implementation of PCOR findings into Primary Care Practice. Insufficient progress will result in termination of the award and the project will not be allowed to transition to the UH3 phase. During the UH3 phase, recruitment and other trial metrics such as retention will be monitored and trials which are not performing well can be asked to implement close-out plans. In both the UH2 and UH3 phases, each trial must be willing to share trial performance metrics and to be collaborative in making decisions for the overall program.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Lawrence J. Fine, MD DrPH
National Heart, Lung, and Blood Institute (NHLBI)
Salina Waddy, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Peer Review Contact(s)
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Financial/Grants Management Contact(s)
National Heart, Lung, and Blood Institute (NHLBI)
Tijuanna DeCoster, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
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 Parts 74 and 92
This initiative is funded through the Hypertension Disparities Reduction Program Partnership of the NIH and the Patient-Centered Outcomes Research Institute (PCORI). NIH’s involvement in the funded study or studies will be in collaboration with PCORI pursuant to Public Law 111-148, section 6301, which amends both Title XI of the Social Security Act (SSA) (6301(a) and (c)) and Title IX of the Public Health Service Act (PHSA) (6301(b)) to provide legal authority to assist PCORI in carrying out its statutory research agenda through agreements for the management of funding and the conduct of comparative clinical effectiveness research. In particular, 42 U.S.C. §1320e(d)(2)(B) authorizes PCORI to enter into agreements with federal agencies for this purpose, and 42 U.S.C. §299-b-37(g) authorizes federal agencies to enter into agreements with PCORI and to accept and retain funds from PCORI for the conduct and support of research. This unique authority also directs certain conditions for such agreements (including those specified at 42 U.S.C. §1320e(d)(2)(B)(ii)), which are incorporated here, with the understanding that additional terms may be incorporated into a revised Notice of Award, if necessary and appropriate to fulfill these legal directives .