Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Person-Centered Outcomes Research Resource (U2C)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

New

Related Notices

  • July 3, 2013 - See Notice NOT-MH-13-018. Notice of NIMH's Participation.

Funding Opportunity Announcement (FOA) Number

RFA-CA-13-008

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.395; 93.837; 93.853; 93.866; 93.846; 93.213; 93.847; 93.173; 93.279; 93.313; 93.361; 93.242

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the creation of a research resource infrastructure for the administration of research investigations using person-centered health outcomes, further referred to as the Person-Centered Outcomes Research Resource (PCORR). The overarching goal for the PCORR will be to facilitate person-centered outcome research by supporting the use and enhancements of the following four measurement information systems, currently funded as separate NIH programs: the Patient Reported Outcomes Measurement Information System® (PROMIS®: http://www.nihpromis.org/); the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox: http://www.nihtoolbox.org/); the Quality of Life (QOL); Outcomes in Neurological Disorders (Neuro-QOL: http://www.neuroqol.org/); and the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me: http://www.air.org/files/4_pager_AIR_Health_Polict_2011_V10F.pdf).

The NIH plans to support the PCORR only for a limited time to facilitate its transition to sustainability. Therefore, the proposed integrated and centralized resource be designed and operated in a way that will facilitate and enable its sustainable functioning in the near future.

Accordingly, PCORR applicants are expected to have appropriate psychometric, statistical, informatics, and software/hardware expertise and capabilities compatible with the relevant measurement information systems. Previous involvement in PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me may be advantageous but is not required, and this FOA is open to all qualified applicants.    

Key Dates
Posted Date

June 19, 2013

Open Date (Earliest Submission Date)

August 26, 2013

Letter of Intent Due Date(s)

August 26, 2013

Application Due Date(s)

September 26, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November - December 2013

Advisory Council Review

January 2014

Earliest Start Date

July 2014

Expiration Date

September 27, 2013

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the creation of a research resource infrastructure for the administration of research investigations using person-centered health outcomes (i.e., those that are reported or performed by the individual research participant or patient), further referred to as the Person-Centered Outcomes Research Resource (PCORR). The PCORR will be expected to support the use and enhancement of the following four measurement information systems, currently funded as separate NIH programs: the Patient Reported Outcomes Measurement Information System® (PROMIS®: http://www.nihpromis.org/); the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox: http://www.nihtoolbox.org/); the Quality of Life (QOL) Outcomes in Neurological Disorders (Neuro-QOL: http://www.neuroqol.org/); and The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me: http://www.air.org/files/4_pager_AIR_Health_Polict_2011_V10F.pdf). PCORR applicants are expected to have appropriate psychometric and statistical expertise and capabilities compatible with the relevant measurement information systems.

The main goal for the PCORR is to provide an integrated platform for automated use of the mentioned four measurement information systems. This platform must be compatible with various modes of information collection (including web/mobile-based entry, non-digital paper source data, and others). The PCORR platform must also be designed to allow resource users (i.e., external researchers and clinicians unaffiliated with the resource) to access and use any of the four systems together or in isolation and tailor use to meet the specific study needs, while capturing and transmitting participant data securely.

Previous involvement in these systems is not required to be eligible to apply for the PCORR award. All qualified investigators/teams are encouraged to apply as long as they have appropriate informatics, software, hardware, psychometric, statistical, and dissemination/implementation expertise and capabilities compatible with the relevant measurement information systems.

Background and Rationale

As life expectancy rises, an increasing number of individuals with chronic diseases require long-term management. For many chronic illnesses, a major goal of treatment becomes not only lengthening a patient’s life but also maximizing their ability to function normally, reducing symptom burden, and improving patient quality of life. Self-reported data from both clinical care and research indicate that respondents often put high significance on functional outcomes, such as symptom amelioration (e.g., reduced pain), elimination of emotional distress, and optimal physical and social functioning. However, research on such outcomes is challenging. Assessing person-centered outcomes is time-consuming and creates excessive burden to individuals participating in such research. Moreover, many of the existing assessment tools do not have adequate reliability, validity, and sensitivity to detect changes in individuals’ functioning across diseases or due to developmental changes over the lifespan, disease progression, remission, or treatment.

To address these needs, the NIH has funded the development of four health outcome measurement systems:

These measurement systems were developed using modern psychometric theory for question development, test construction, and scoring. For example, PROMIS, Neuro-QOL, ASCQ-Me, and NIH Toolbox (when relevant) used Item Response Theory (IRT) to develop “item banks,” or groups of questions that measure a variety of health areas referred to as “domains” (e.g., physical functioning, pain, fatigue, depression, motor, sensory, and cognitive performance). In contrast to classically developed measures, item banks allow the creation of research instruments using any number of questions (items) in any order and ensuring greater consistency across the range of domains. All systems use a comparable metric to measure health domains in the general population as well as across various chronic diseases, and facilitate data harmonization with existing gold-standard scales (e.g. SF-36). These systems have also used computer adaptive testing to reduce response burden by allowing researchers to obtain precise scores with a minimal number of items. All four information measurement systems utilize an individually tailored computer-based platform for automated item bank, functional test, or scale administration that allows researchers to create study-specific measurement protocols for capturing participant data securely. These assessment systems can be used by researchers and clinicians in a variety of settings, with a particular emphasis on measuring outcomes in longitudinal and epidemiologic studies and prevention or intervention trials.

To date, investigators creating these systems, together with researchers using them, have developed, evaluated, and released approximately 100 reliable, validated item banks and performance-based measures assessing outcomes in a variety of health domains for child and/or adult respondents. Instruments are available in English and Spanish, with many translated into multiple other languages. The current web-based platform supporting PROMIS, NIH Toolbox, and Neuro-QOL has supported the work of additional investigators funded through other mechanisms, with over 800 active research studies using these measurement systems, and approximately 6.5 million participant responses collected. ASCQ-Me currently resides separately from the other three systems, and during this period of support, the PCORR will ensure the migration and integration of ASCQ-Me into the shared web-based platform used by the other three systems.

Definitions

In the context of this FOA, several key terms are used as defined below.

Item(s) and instrument(s): the broad class of measurement tools and groups of questions utilized in these systems. This term includes items, items banks, measures, and instruments.

Perspectives and Challenges for NIH-Supported Resources for the Measurement of Person-Centered Outcomes

The four person-centered outcomes informatics systems are currently at a crossroads facing two major challenges.

Challenge 1: Transition from Methods Development to Widely Accepted Research Applications

The initial goal of the NIH-supported efforts on person-centered outcomes measurement systems was to develop core sets of validated, standardized metrics that could be calibrated across diverse populations and research designs. These core sets are now available to the research community.

Currently, the main challenge is to expand the use of these informatics systems by researchers and clinicians examining health outcomes across multiple populations and disease conditions. The widespread, long-term availability of validated, precise, efficient, standardized person-centered measures, such as those developed in PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me, is essential to increasing their use as endpoints in clinical and observational research. The increased adoption of these measurement systems in clinical research and health care settings is important because it will greatly enhance the capacity to compare and interpret research findings across multiple study designs and populations. It should also strengthen our national capacity to survey and monitor population health over time and advance our ability to evaluate the effectiveness of alternative interventions and treatments. Ultimately, these advances should improve patient-provider communication and decision-making in healthcare delivery.

Challenge 2: Need for Integrated and Sustainable Resource

PROMIS has been developed and is currently funded under a cooperative agreement award; NIH Toolbox, Neuro-QOL, and ASCQ-Me have been developed and supported as contracts. To effectively address Challenge 1, these four separate systems need to be integrated and made available to the scientific community under an umbrella of one entity, which will then require approaches to be developed for them all to be sustainable beyond the previous and current funding efforts.

It is expected that creating a centralized resource for outcomes research will facilitate broader adoption of these systems and increase their use in clinical research and health care. NIH supports the need to increase accessibility and widespread adoption of these measurement systems over the long-term.

It is essential that the integrated, centralized resource needs to be designed and operated in a way that will enable its sustainable functioning in the near future.

Specific Research Objectives

This FOA will support the creation of a centralized research resource that will integrate under a single platform all the functionalities of PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me and make these systems available to researchers for studies and/or clinical settings utilizing person-centered outcomes.

The key required attributes/activities expected from the PCORR include:

Main Applicant Capabilities

To perform the functions outlined above, applicants responding to this FOA are expected to have the following scientific and technical capabilities along with necessary resources:

Priority on Sustainability. The NIH plans to support the PCORR only for a limited time to facilitate its transition to sustainability. Accordingly, the NIH support will be gradually phased out during the funding period (reduced budget cap for Year 3 and 4 of the Project Period, see “Funds Available” below). It is expected that the PCORR and the awardee institution will find other sources of funding and/or cost recovery (e.g., usage fees) to maintain full operation.  

Plans and resource designs should assume that there will be no designated NIH support for the PCORR after the end of the funding period indicated in this FOA. Therefore, the ultimate financial sustainability of PCORR is of high priority. Vigorous, credible, and well-documented steps in that direction (with appropriate metrics) are essential for favorable assessment of application merit.

Section II. Award Information
Funding Instrument

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

New

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

Funds Available and Anticipated Number of Awards

NIH intends to fund one award, corresponding to a total of up to $3.2 million per year, for fiscal years 2014 and 2015; funding amounts will be reduced to no more than $2.4 million in year 3 and $1.85 million in year 4.

Award Budget

Application budgets must not exceed $3.2 million per year in total costs for Years 1 and 2 of the funding period, $2.4 million for Year 3, and $1.85 million for Year 4.

Award Project Period

Award project period must be 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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) and component Project Leads that are not yet registered in eRA Commons must work with their institutional officials to register. Also, institutional officials at the applicant organization should ensure that the eRA Commons account for the contact PD/PI is affiliated with their organization.

eRA Commons accounts are necessary to use ASSIST to prepare and submit applications.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

The letter of intent should be sent to:

Ashley Wilder Smith, Ph.D., M.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Telephone: 240-276-6714
Email: smithas@mail.nih.gov


Page Limitations


Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Research Resource

12

Admin Core (Use this component for the Administrative Core)

6

Core (Use this component for the Statistical Core and Outreach Core)

6


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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.

The application must consist of the following components:

Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: Applicants may provide additional materials supportive of their application.

The following information should be uploaded as individual files.   The filename provided for each attachment will be the name used for the bookmark in the application image.

The following materials (and corresponding filenames) are strongly encouraged:

A) Documentation for technical and statistical capabilities and expertise (file name: "Capabilities"), including:

B) Documentation regarding commitments to maintain full operation of the resource in Years 3 & 4 when NIH funding is reduced and specific plans for the long-term sustainability of the PCORR (filename "Sustainability". Document, as appropriate, institutional commitment to the resource, any other sources of funding (and amounts) expected to be available to maintain full operation, business plans for actions related to cost recovery, documentation of relevant partnerships, etc. 

C) Documentation for the administrative skills and infrastructure necessary to negotiate for appropriate rights (e.g., intellectual property) to maintain, manage, modify, and distribute items and instruments, consistent with achieving the goals of this program (filename: "IntellectualProperty").

D) Other documentation as appropriate - summary tables,other overview documentation of relevant studies previously administered through measurement systems, etc. (filename: "OtherDocumentation").

Collectively, "Other Attachments" are expected not to exceed 20 pages.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Biographical Sketch: All instructions in the SF 424 Application Guide for the preparation of Biographical Sketches for the PD(S)/PI(s) must be followed except for the instructions for Section C. “Selected Peer-reviewed Publications,” which are modified as indicated below.

C. Selected Peer-reviewed Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. For those publications that are identified as important to the field, you may choose to include a short narrative explanation of the findings and how those findings have advanced scientific understanding. You also may wish to describe the impact of those findings on our understanding of disease, standards of medical care, public policy, inventions, the development of commercial products, and any other related advancement.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material).

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Outline the overall aims of the proposed PCORR.

Research Strategy: Comprehensively address the main objective of the PCORR, which is to create a research resource that will provide a scientific center for automated administration of the PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me measurement information systems. The PCORR provides the technical infrastructure of the four measurement systems and supports the continued management of these systems.

As part of this section, describe the following elements:

Background:

Overall mission/vision for the PCORR, including:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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.

Research Resource

When preparing your application in ASSIST, use Component Type ‘Research Resource.’

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

SF424 (R&R) Cover (Research Resource)

Complete only the following fields:

PHS 398 Cover Page Supplement (Research Resource)

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

Research & Related Other Project Information (Research Resource)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Research Resource)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Resource)

Biographical Sketch: All instructions in the SF 424 Application Guide for the preparation of Biographical Sketches for all individuals listed as Senior/key Personnel and Other Significant Contributors must be followed except for the instructions for Section C. “Selected Peer-reviewed Publications,” which are modified as indicated below.

C. Selected Peer-reviewed Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. For those publications that are identified as important to the field, you may choose to include a short narrative explanation of the findings and how those findings have advanced scientific understanding. You also may wish to describe the impact of those findings on our understanding of disease, standards of medical care, public policy, inventions, the development of commercial products, and any other related advancement.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material).

Budget (Research Resource)

Applicants must provide a detailed budget, including justification for all expenditures, for the Research Resource component.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Resource)

Specific Aims: Applicants responding to this FOA must comprehensively address operational aims that will help accomplish the main objective of the PCORR, which is to serve as a resource to the research community by providing a scientific center for automated administration of the PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me measurement information systems. The PCORR will provide the technical infrastructure of the four measurement systems and support the continued management of these systems, in addition to dissemination and implementation expertise to ensure optimal uptake by the user community. Applicants should outline specific aims to address these goals.

Research Strategy: The PCORR is intended to serve as a resource to the research community by providing scientific and technical expertise to researchers with person-centered outcomes studies and clinicians seeking to measure person-centered outcomes in their research or clinical settings. Applicants must outline the technical functions of the PCORR. The PCORR will be organized around the technical work (i.e. software, hardware) required to support the four measurement systems.

Indicate how the Research Resource will use the three required Cores for its functions. Define interactions with these Cores, including the coordination of efforts and lines of responsibilities.

In this section, applicants must describe how the central objectives of the PCORR will be accomplished. Address the following aspects:

It is expected that the applicants have access to relevant, existing software that is already developed for the purpose of providing automated administration of item banks via both static (fixed-length) short forms and dynamic computer adaptive testing, as well as software and related materials for administration of instruments.

Note: Development of new software to administer person-centered outcome instruments remains beyond the scope of this FOA. Applications proposing such activities will be considered non-responsive. Non-responsive applications will not be reviewed.

The Research Resource will provide strategic oversight to ensure that daily activities help advance the overarching aims of the resource. Applications should describe how the efforts of each core will be integrated, and describe the overall operations management of the PCORR. The Resource itself is expected to function as a scientific hub/center and is intended to be located at the institution of the PD(s)/PI(s)' institution. The PD(s)/PI(s) are expected to lead the Research Resource; as appropriate. PD(s)/PI(s) may also serve as core leads but are not required to do so.

As part of this section, the applicant should address plans for the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide

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.

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administrative Core)

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

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Project Narrative is not required for this component. 

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

Biographical Sketch: All instructions in the SF 424 Application Guide for the preparation of Biographical Sketches for all individuals listed as Senior/key Personnel and Other Significant Contributors must be followed except for the instructions for Section C. “Selected Peer-reviewed Publications,” which are modified as indicated below.

C. Selected Peer-reviewed Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. For those publications that are identified as important to the field, you may choose to include a short narrative explanation of the findings and how those findings have advanced scientific understanding. You also may wish to describe the impact of those findings on our understanding of disease, standards of medical care, public policy, inventions, the development of commercial products, and any other related advancement.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material).

Budget (Administrative Core)

Applicants must provide a detailed budget, including justification for all expenditures, for the Administrative Core.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the Research Resource.

As part of this section, the applicant should address the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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.

Statistical Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Statistical Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Statistical Core)

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

Research & Related Other Project Information (Statistical Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Statistical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Statistical Core)

Biographical Sketch: All instructions in the SF 424 Application Guide for the preparation of Biographical Sketches for all individuals listed as Senior/key Personnel and Other Significant Contributors must be followed except for the instructions for Section C. “Selected Peer-reviewed Publications,” which are modified as indicated below.

C. Selected Peer-reviewed Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. For those publications that are identified as important to the field, you may choose to include a short narrative explanation of the findings and how those findings have advanced scientific understanding. You also may wish to describe the impact of those findings on our understanding of disease, standards of medical care, public policy, inventions, the development of commercial products, and any other related advancement.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material).

Budget (Statistical Core)

Applicants must provide a detailed budget, including justification for all expenditures, for the Statistical Core.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan  (Statistical Core)

Specific Aims: Identify general objectives planned for the Statistical Core along with the main benchmarks that would indicate the accomplishment of these objectives..

Research Strategy: The Statistical Core will provide statistical and psychometrical support to the Research Resource.

Applications should describe how the proposed Statistical Core will complete the following primary functions:

As part of this section, the applicant should address the following specific aspects:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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.

Outreach Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Outreach Core)

Complete only the following fields:

PHS 398 Cover Page Supplement (Outreach Core)

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

Research & Related Other Project Information (Outreach Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete.

Project /Performance Site Location(s) (Outreach Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Outreach Core)

Biographical Sketch: All instructions in the SF 424 Application Guide for the preparation of Biographical Sketches for all individuals listed as Senior/key Personnel and Other Significant Contributors must be followed except for the instructions for Section C. “Selected Peer-reviewed Publications,” which are modified as indicated below.

C. Selected Peer-reviewed Publications. NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. For those publications that are identified as important to the field, you may choose to include a short narrative explanation of the findings and how those findings have advanced scientific understanding. You also may wish to describe the impact of those findings on our understanding of disease, standards of medical care, public policy, inventions, the development of commercial products, and any other related advancement.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available publications are not acceptable as appendix material).

Budget (Outreach Core)

Applicants must provide a detailed budget, including justification for all expenditures, for the Outreach Core.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Outreach Core)

Specific Aims: Identify general objectives planned for the Outreach Core along with the main benchmarks that would indicate the accomplishment of these objectives..

Research Strategy: The Outreach Core needs to be capable of supporting the Research Resource through the following primary functions:

Provide detailed descriptions of plans for customer support, user training, and outreach for PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me, as well as examples of previous experience with such activities for these or similar measurement systems.

As part of this section, the applicant should address the following:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

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.

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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.

5. 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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:
All PD(s)/PI(s) and component Project Leads 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.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete 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-10-115.

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.

Overall Impact - Overall

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 - Overall

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? 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?

Specific for this FOA: Does the proposed plan provide for a resource that will allow accessibility of these measurement systems by researchers examining health outcomes across multiple populations and disease conditions? Will the proposed plan increase uptake of the measurement systems for use in trials and clinical settings? Are future directions and needs of the research field addressed with appropriate consideration to adapting, modifying, replacing, or adding tools? 

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?

Specific for this FOA: How advanced is the investigators’ experience with PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me, and/or other similar systems?

Research Resource:

Do the investigators have sufficient software and hardware expertise to support PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me?

Statistical Core:

Do the investigators have psychometric and statistical expertise relevant to supporting PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me?

Training and Outreach Core:

Do the investigators have experience with user training, support, and outreach on PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me, and/or other similar systems? 

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?

Specific for this FOA: What novel approaches will be used by the investigators to capture relevant information for research purposes (e.g., from clinical settings or integration into electronic health records)? Does the proposed plan allow for technological advances (i.e. upgrades to relevant software or development of new software) during the project period? What innovative outreach and/or user interface approaches will be used to ensure extensive use of the PCORR by the scientific community?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the resource? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA: Does the proposed plan create a sufficiently high likelihood of successful transition from methods development to research application by engaging investigators from academic centers and other research settings? How appropriate and realistic are the plans for partial resource sustainability in the final 2 years of the funding period and ultimate strategy to attain full sustainability beyond the PCORR award? Are the strategies and methods proposed for attaining sustainability optimally balanced, e.g., in the context of preserving facile and affordable resource usage for academic investigators? Are the plans for Outreach consistent with obtaining maximal use of the resource and with plans for sustainability?   

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?

Specific for this FOA: Is the existing hardware and software capacity (servers, web-based portals) adequate for continued support and expansion of PROMIS, NIH Toolbox, Neuro-QOL, and ASCQ-Me? Does the proposed plan include adequate privacy and security protections? Are there sufficient commitments of facilities, infrastructure, and other resources  to allow for the full scale operation under reduced NIH support in Years 3 and 4 and, ultimately, foster resource sustainability?  

Additional Review Criteria - Overall

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

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 - Overall

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) Genome Wide Association Studies (GWAS).

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 convened by the NCI, 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:

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

Applications will be assigned to the NCI.. 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. The following will be considered in making funding decisions:

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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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 recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides 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:

Intellectual Property Considerations

 Awardees will be responsible for relevant intellectual property oversight that will include:

The PD(s)/PI(s) assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of research conducted with or through the PCORR in accordance with terms and conditions of the award.

The PCORR will be subject to external evaluation (coordinated by the NIH). The PCORR awardee will be expected to participate in such evaluations.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One or more designated NIH Program Director(s) and/or Science Officer(s), acting as Project Scientist(s), will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Additional NIH scientific staff members with relevant expertise may also become substantially involved in PCORR activities as Projects Scientists or Coordinators.

The NIH Project Scientist(s) and other substantially involved NIH program staff members will assist PCORR by:

NIH staff members who are substantially involved in the scientific activities (e.g., publications) of the PCORR will not attend peer review meetings of renewal and/or supplemental applications.

In addition, an NIH Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice. If this individual becomes substantially involved in the PCORR activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NIH waiver if such participation is essential.

The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to the PCORR awardee and/or member institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of Joint Responsibility include:

PCORR Steering Committee. The PCORR Steering Committee will serve as the main governing board for the PCORR Initiative. The Steering Committee will consist of the following voting members:

NOTE: Each voting member noted above representing PCORR will have one vote (including those individuals who may have multiple responsibilities).

All NIH representatives will collectively have one vote.

Additional individuals may be added to the PCORR Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., Centers for Disease Control and Prevention, U.S. Food and Drug Administration). PD(s)/PI(s) of grants using the PCORR research resource may also be invited when their presence is needed.

The PCORR Steering Committee will meet twice per year in person and monthly via phone conference. Applicants should budget for in-person meetings to occur in the Washington, D.C., metropolitan area.

The PCORR Steering Committee will have primary responsibility for:

The PCORR Steering Committee will also form subcommittees, each with a specific functional area of oversight as defined in the application. Whether or not a business sub-committee exists, the awardee must include an expert in business management to either the PCORR Steering Committee or the Scientific Consulting Panel.

Scientific Consulting Panel. A Scientific Consulting Panel will operate as a subcommittee to the Steering Committee, advising the Steering Committee and providing technical expertise to the entire PCORR. This panel will comprise scientific experts not affiliated with the PCORR institutions and may include scientists from academic and other research institutions as well as from NIH, clinicians and clinical staff, and relevant stakeholders for non-traditional research methods. Members of the Scientific Consulting Panel will be selected by the Steering Committee in consultation with the NIH Project Scientist. The Scientific Consulting Panel will be charged with the following activities:

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress Reports

NIH will require reports on the PCORR processes for effective and efficient outreach and dissemination of these measurement systems and the impact of adoption and implementation by the research community. Proximal data includes but is not limited to: 1) number of new researcher registrations; 2) number of downloads; 3) number of new protocols launched and the number of protocols completed; 4) number of respondents evaluated in each protocol; and 5) number of customer service contacts (emails, calls). A successful applicant should plan to substantively assess and report the number of scientific publications that utilize these systems. Further, their use in clinical encounters with health care practitioners and uptake in electronic health records will provide additional evidence of accomplishment. PCORR applicants should account for any staff and monetary resources needed to produce these reports when providing a budget plan.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Ashley Wilder Smith, Ph.D., M.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Telephone: 240-276-6714
Email: smithas@mail.nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: 240-276-6390
Fax: 240-276-7682
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Benjamin Sakovich
Office of Grants Administration
National Cancer Institute
Telephone: 240-276-6298
Email: sakovichbj@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 Parts 74 and 92.


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