EXPIRED
National Institutes of Health (NIH)
U24 Resource-Related Research Projects Cooperative Agreements
NOT-TR-22-018 - Notice of Availability of Application Information for RFA-TR-22-012 Emergency Awards: HEAL Initiative-Limited Competition: HEAL Initiative Resource Centers for the Pain Management Effectiveness Research Network (ERN) (U24 Clinical Trial Not Allowed)
RFA-AT-22-005 - HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
NCATS is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS. Please see Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis as renewed in Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis.
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to continue support of Resource Center activities funded under RFA-TR-15-002 and RFA-TR-15-004; thus only applicants funded by RFA-TR-15-002 and RFA-TR-15-004 are eligible to apply for this FOA. Applications to this FOA will support Resource Centers (RCs) for clinical trials funded through the HEAL Pain Management Effectiveness Research Network (ERN) initiatives, including those funded under RFA-NS-19-021 and RFA-NS-20-028. Applicants are expected to continue provision of the existing HEAL ERN infrastructure to support comparative effectiveness clinical trials/studies with a shared common theme of improving pain management and reducing the reliance on opioid medications when appropriate. The RCs will provide clinical and data coordination, biostatistical resources, and recruitment and retention support. They will also continue working with other HEAL Data Coordination Resource Centers (DCRCs) to harmonize data elements creating valuable combined data sets that can be used for future meta-analyses or to add to our knowledge of under-studied pain conditions.
15 days prior to the application due date
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
March 15, 2022 | Not Applicable | Not Applicable | Not Applicable | Not Applicable | July 2022 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
NCATS is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS. Please see Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis as renewed in Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis.
This Funding Opportunity Announcement (FOA) invites cooperative agreement applications from current National Center for Advancing Translation Sciences (NCATS) Trial Innovation Network (TIN) recipients, funded under RFA-TR-15-002 and RFA-TR-15-004, that propose to serve as Resource Centers (RCs) for clinical trials/studies within the HEAL Pain Management Effectiveness Research Network (ERN) program. This program, initiated in 2019, is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to: (1) improve treatment for opioid misuse and addiction, and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.
Background
The Nation faces a crisis of opioid use disorder and overdose deaths, which often is associated with long-term administration of an opioid for the treatment of chronic non-cancer pain. More than 20% of adults in the U.S. experience chronic pain and need safe, non-addictive methods to manage their pain (2019 National Health Interview Survey data). Many groups report a relatively high prevalence of chronic pain and high-impact chronic pain including women, older adults, previously but not currently employed adults, adults living in poverty, adults with public health insurance, and rural residents. Reducing the burden of pain nationwide is a significant unmet need.
Severe pain is often associated with diseases and chronic conditions such as diabetes, cancer, endometriosis, and sickle cell disease, and it may persist as chronic pain following many surgical procedures or trauma. Chronic pain conditions such as complex regional pain syndrome, migraine, and fibromyalgia are diseases themselves, and many chronic pain conditions co-occur in individuals. Current strategies for managing chronic pain outlined in the CDC Guideline for Prescribing Opioids for Chronic Pain and AHRQ’s Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review include non-pharmacologic treatments for specific chronic pain conditions, non-opioid drugs, and opioid therapy with various methods for initiating and titrating opioid dosing. However, the strength of evidence supporting these strategies is considered to be low to moderate and is primarily based on clinical studies with significant limitations, observational studies, and case reports. More studies are needed to inform evidence-based treatments for chronic pain and effective, non-addictive opioid dosing regimens.
To generate this needed evidence, the HEAL ERN was established in 2019. HEAL ERN awardees conduct clinical trials to test the comparative effectiveness of existing therapies for prevention or management of pain while reducing risk of addiction. Studies that inform providers and patients on best practices to manage acute or chronic pain in the primary care, emergency department, hospital or dental settings are priority areas of interest. The studies must evaluate methods and approaches to manage pain. Strategies tested might include safe use of medications including appropriate use of opioids, biologics, devices or delivery systems, and/or behavioral interventions or multimodal approaches. The overall goal is to provide clinicians with robust evidence to best manage patients with acute or chronic pain.
HEAL Effectiveness Research Network Organization
The HEAL ERN was established using the existing NCATS TIN infrastructure and contains four unique Resource Centers: 1) Clinical Coordinating Resource Center (CCRC), 2) Data Coordinating Resource Center (DCRC), 3) Statistical and Safety Resource Center (SSRC), and 4) Recruitment Resource Center (RRC). This combined TIN infrastructure provides clinical trial scientific guidance, clinical and data coordination, biostatistical support, unique recruitment and retention strategies and additional clinical sites for enrollment if needed. Clinical trials are conducted at the Clinical and Translation Science Award (CTSA) Program hubs and/or any other non-CTSA clinical sites selected by the investigator. Currently, TIN Resource Centers can support approximately seven independent trials, but more trials may be added in the future.
The TIN Resource Centers work with Principal Investigators who have been awarded an independent HEAL grant to develop and execute a clinical trial, as described in RFA-NS-19-021 and RFA-NS-20-028. Briefly, the trial Principal Investigators determine the clinical question and the research approaches for their subsequent trials. Most trials are awarded in two phases: a planning phase during which the design and statistical analysis are finalized, the protocol is completed and reviewed by the single Institutional Review Board and any Data and Safety Monitoring Boards; and an implementation phase when the study enrolls subjects. Only studies approved by NIH leadership transition to the implementation phase.
Additionally, Principal Investigators of the clinical trials and TIN Resource Centers form the ERN Program Steering Committee, which meets once a year and at additional times if needed throughout the program. The Program Steering Committee will recommend the frequency of other in-person and teleconference meetings as needed. All award recipients agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study as stated in the terms and conditions of their cooperative agreement awards. NIH Program staff ensure that standardized and consistent pain and other relevant outcome measures and common data elements are used appropriately in studies to ensure translation of shared data across HEAL supported clinical studies.
The NIH HEAL Initiative will require a high level of coordination and sharing among investigators. It is expected that NIH HEAL Initiative recipientswill cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.
Research Objectives:
This FOA will organize the infrastructure of the Trial Innovation Network (TIN), dedicated to HEAL activities, into discrete Resource Centers referred to as HEAL ERN Resource Centers moving forward to optimize the coordination of individual HEAL ERN clinical trials/studies and to facilitate the dissemination of strategies and best practices for conducting pain management studies that result from the collaborative activities of the TIN and HEAL ERN.
The specific objectives of the HEAL ERN Resource Centers are to:
Award recipients will continue to support existing HEAL ERN clinical trials and must be flexible enough to incorporate future HEAL trials/studies if needed. Separate FOAs will solicit and provide support for any future HEAL ERN clinical trials/studies.
Applicants responding to this FOA may propose to act as only one of the following HEAL ERN Resource Centers. Applicants should clearly identify which resource center they are applying for in the application.
Data Coordination Resource Center (DCRC). The DCRC will utilize robust methods and systems to enable data collection, provide sound data management, and assure data quality. They will also work with other HEAL DCCs to harmonize data elements to create valuable combined data sets that can be used for future meta-analyses or add to our knowledge of under-studied pain conditions.
Significant responsibilities include:
Clinical Coordinating Resource Center (CCRC). The Clinical Coordinating Resource Center oversees clinical operations for the trials/studies, developing detailed project management plans, training study teams, monitoring sites, developing and implementing project-specific problem resolution and improvement plans, implementing continuous quality improvement across the trials/studies, and helping trial/study clinical investigators identify additional sites.
Significant responsibilities include:
Statistical and Safety Resource Center (SSRC). The SSRC will provide biostatistical support over the duration of the trials/studies. They will also assist ERN trial awardees with the design and implementation of protocols, safety monitoring, reporting and adjudication procedures. They will develop DSMB charters and processes and create DSMB reports in conjunction with the DCC as needed for the oversight committees.
Significant responsibilities of the SSRC include the following:
Recruitment Resource Center (RRC). The RRC will provide expertise in recruitment and retention of participants including community and stakeholder engagement and other strategies that cover the entire continuum of recruitment and retention in clinical trials/studies. They will be responsible for development and finalization of recruitment and retention plans, working with the specific study investigators, to identify barriers and facilitators to recruitment and retention and offering mitigation strategies that result in effective clinical trial/study recruitment and retention plans. In addition, the RRC will be responsible for utilizing innovative information technologies to identify potential additional clinical trial/study sites for HEAL ERN trials/studies.
Significant responsibilities of the RRC include the following:
The exact boundaries of the activities of the HEAL ERN Resource Centers, the individual HEAL ERN clinical trial/study teams and NIH may vary across time and will depend in large part on the settings, designs and approaches of the individual trials/studies within the Network.
Applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.
Applications that propose the following will be considered non-responsive and will not be reviewed:
See Section VIII. Other Information for award authorities and regulations.
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. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The NIH HEAL Initiative intends to commit up to $10,000,000 in FY 2022 to fund four unique Resource Center awards.
Application budgets are limited as follows:
Data Coordination Resource Center (DCRC):
Year 1: Not to exceed $2,000,000 direct costs; Total Direct Costs for 5 years not to exceed $8,000,000.
Clinical Coordinating Resource Center (CCRC):
Year 1: Not to exceed $2,000,000 direct costs; Total Direct Costs for 5 years not to exceed $6,500,000.
Statistical and Safety Resource Center (SSRC):
Year 1: Not to exceed $1,500,000 direct costs; Total Direct Costs for 5 years not to exceed $4,500,000.
Recruitment Resource Center (RRC):
Year 1: Not to exceed $750,000 direct costs; Total Direct Costs for 5 years not to exceed $2,500,000.
The total project period may not exceed five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Eligibility to apply to this FOA is limited to current NCATS TIN recipients supported under RFA-TR-15-002 and RFA-TR-15-004. This limited competition will allow for continued support and completion of ongoing HEAL ERN clinical trials as well as incorporation of any future HEAL ERN clinical trials/studies if needed.
Other
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
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.
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.
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
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide 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.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:
Carol Lambert, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0814
Email: lambert@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Years 1 5:
Years 2 5:
Funding requested through this FOA should not duplicate committed costs currently approved for the TIN. All applicants must justify all costs relevant to the scope of work and provide a statement confirming that the budget requested does not duplicate currently approved TIN commitments.
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:
The Research Strategy should indicate the type of HEAL ERN Resource Center the applicant is proposing to provide. Applicants should describe prior experience in the design, conduct, data analysis, and management of major collaborative clinical research projects, preferably in pain management, and provide evidence of successful performance supporting multi-site studies within the past three to five years.
All applicants, regardless of the type of HEAL ERN Resource Center application, should provide the following:
Applicants proposing to act as the Data Coordination Resource Center (DCRC) should describe:
Applicants proposing to act as the Clinical Coordinating Resource Center (CCRC) should describe:
Applicants proposing to act as the Statistical and Safety Resource Center (SSRC) should describe:
Applicants proposing to act as the Recruitment Resource Center (RRC) should describe:
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.
The following modifications also apply:
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:
HEAL Data Sharing
NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem.
To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:
The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.
Recipients conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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.
In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at NCATSReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applications Involving the NIH Intramural Research Program
The requests by NIH intramural scientists will be limited to the incremental costs required for participation.As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit.
Review Process
Applications will be evaluated for scientific and technical merit by an appropriate merit review panel convened by NIH staff, in accordance with the review criteria specified in the FOA.
For this particular announcement, note the following:
These awards will support the completion of ongoing HEAL ERN clinical trials as well as support of new HEAL ERN clinical trials/studies. Thus, review criteria will focus on capabilities of each Resource Center to provide the needed chosen Resource Center expertise for the completion of ongoing HEAL trials and the planning, implementation, and completion of new HEAL ERN clinical trials/studies. Reviewers will also consider the ability of the proposed HEAL ERN Resource Centers to work collaboratively with each other as well as with ERN clinical trial study teams to accomplish these objectives.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
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? Is the prior research that serves as the key support for the proposed project rigorous? 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 to this FOA: For all proposed Resource Centers:
For the Data Coordination Resource Center (DCRC) only:
For the Clinical Coordinating Resource Center (CCRC) only:
For the Statistical and Safety Resource Center (SSRC) only:
For the Recruitment Resource Center (RRC) only:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 to this FOA: Do key personnel have appropriate expertise and experience in the conduct of multi-center trials or analysis of clinical data to achieve the scientific objectives of the HEAL Effectiveness Research Network?
Have applicants articulated prior experience in the design, conduct, data analysis, and management of major collaborative clinical research projects? Do they have the experience and expertise needed for the Resource Center specified in their application?
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 to this FOA: Does the application provide evidence to suggest that the proposed Resource Center could institute novel and innovative procedures that would increase efficiency and/or quality of clinical trials designed to improve management of acute or chronic pain?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? Does the proposed DCRC include a plan to comply with the HEAL Initiative Public Access and Data Sharing Policy?
Specific to this FOA: For All Proposed Resource Centers:
For the Data Coordination Resource Center (DCRC) only:
For the Clinical Coordinating Resource Center (CCRC) only:
For the Statistical and Safety Resource Center (SSRC) only:
For the Recruitment Resource Center (RRC) only:
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?
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.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable.
Not Applicable.
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) ) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 review group using the stated review criteria.
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 assessment score.
Appeals of initial merit review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
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 recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for the HEAL Pain Management Effectiveness Research Network (ERN) Resource Centers will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by 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, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below. Recipient will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. The Project Scientist(s) will have the following substantial involvement:
In addition, 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. The NIH Program Official will be responsible for the following:
Prior to funding an application, the Program Official will contact the applicant to discuss any changes suggested by NIH staff or the NIH review panel. The Program Official and Project Scientist will negotiate with the applicant and agree on a final set of approved changes that will be specified in the Notice of Award. Any additional future changes must be approved in writing by the Program Official.
In addition, the assigned Program Official may also serve as an NIH Project Collaborator. The Project Collaborator will have the combined responsibilities of a Project Scientist and of a Program Official as described above with the exception that the Project Collaborator will be a non-voting member of the Steering Committee.
NIH reserves the right to withhold funding or curtail an award in the event of:
Areas of Joint Responsibility include:
The HEAL ERN Program Steering Committee will be responsible for coordinating the activities conducted by the program and is the committee through which the individual NIH HEAL ERN Clinical Trials Steering committees will formally interact. The HEAL ERN Program Steering Committee membership will include PD(s)/PI(s) of each HEAL ERN award, other staff as needed, the NIH Project Scientist(s), and the dedicated pain and clinical trial experts from the ERN CCRC, DCRC, SSRC, and RRC. The HEAL ERN Program Steering Committee may add additional members, and other government staff may attend the HEAL ERN Program Steering Committee meetings as desired.
The HEAL ERN award recipient agrees to work collaboratively to:
Dispute Resolution:
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. The three members will be: a designee of the HEAL ERN Program Steering Committee chosen without NIH staff 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 recipient. This special dispute resolution procedure does not alter the recipient'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.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
Funds awarded using appropriations provided by the Extending Government Funding and Delivering Emergency Assistance Act-September 20, 2021 will be issued in unique subaccounts in the HHS Payment Management System, and will require separate financial reporting from any other funds awarded.
A final RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Yolanda F. Vallejo, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-1751
Email: yolanda.vallejo@nih.gov
Pete Murray, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-496-4054
Email: peter.murray@nih.gov
Leslie K Derr, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: (301) 594-8174
E-mail: derrl@mail.nih.gov
Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: devon.oskvig@nih.gov
Carol Lambert, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0814
Email: lambert@mail.nih.gov
Matthew Zeback
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-8309
Email: matthew.zeback@nih.gov
Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov
Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov
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.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.