Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
R24 Resource-Related Research Projects
New
RFA-DA-21-030 - HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
93.279, 93.213, 93.846, 93.273, 93.242
The National Institutes of Health (NIH) intends to establish an Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network consisting of clinical research centers, which will be supported by a single Coordination and Dissemination center. This network is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain (CP) and opioid use disorder (OUD) or opioid misuse. The network will be part of the NIH’s Helping to End Addiction Long-term (HEAL)SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management.
This FOA seeks applications for a single Coordination and Dissemination Center for the IMPOWR network. Key responsibilities include coordination and communication to support the research centers within this network and other HEAL funded projects of relevance to CP and OUD/misuse, data harmonization on common data elements, providing educational infrastructure, stakeholder and patient engagement and information dissemination, and creating novel tool assessments.This FOA runs in parallel with a companion FOA that seeks applications to develop collaborative research projects on approaches, models, delivery, and implementation of care for co-occurring chronic non-cancer pain and OUD/misuse (RFA-DA-21-030).
30 days prior to the application due date
March 26, 2021
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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
June 2021
August 2021
September 2021
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
The National Institutes of Health (NIH) intends to establish an Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network consisting of clinical research centers, which will be supported by a single Coordination and Dissemination center. This network is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain (CP) and opioid use disorder (OUD) or opioid misuse. The network will be part of the NIH’s Helping to End Addiction Long-term (HEAL)SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. Applicants interested in pursuing research examining comorbid OUD and other health conditions with or without suicide risk are encouraged to respond to NOT-MH-21-005.
This FOA seeks applications for a single Coordination and Dissemination Center for the IMPOWR network. Key responsibilities include coordination and communication to support the research centers within this network and other HEAL funded projects of relevance to CP and OUD/misuse, data harmonization on common data elements, providing educational infrastructure, stakeholder and patient engagement and information dissemination, and creating novel tool assessments. This FOA runs in parallel with a companion FOA that seeks applications to develop collaborative research projects on approaches, models, delivery, and implementation of care for co-occurring chronic non-cancer pain and OUD/misuse (RFA-DA-21-030).
Background
The ongoing opioid epidemic and the chronic pain (CP) crisis represent significant public health problems with unmet needs. The opioid epidemic was fueled by three waves of opioid use: (1) the overprescribing of prescription opioids to manage pain; (2) the increased use of illicit opioids, such as heroin; and (3) the increased number of overdose deaths involving powerful synthetic opioids, like fentanyl. As a result, an estimated 2 million individuals have an opioid use disorder (OUD), and to date, approximately 450,000 people have died from an overdose involving prescription or illicit opioids. In addition, nearly 10 million Americans misuse opioids, using them differently than prescribed or for the euphoric effects of the drug, which may elevate the risk for developing OUD. More than 50 million Americans suffer from chronic pain, and approximately 20 million individuals have severe CP that interferes with life or work activities. CP treatment and loss of productivity are estimated to cost $635 billion annually in the United States. Both opioid over-prescribing and restrictions on opioid prescribing have led to unintended consequences for many who have CP. People with pain may rely on opioids for pain relief in the absence of other effective treatments, and some turn to misuse or to illicit drug use for pain relief as health care professionals reduce or eliminate access to opioids for pain management. In addition, a subset of individuals with OUD may go on to develop acute or chronic pain. As a consequence, too many people suffer from both CP and OUD. These complex patients often do not respond well to current treatments for pain or OUD, face challenges of stigma, and often have limited or no access to quality care. Evidence-based integrated treatments and models of care that are effective and accessible for patients with co-occurring conditions are urgently needed.
Care for patients who have co-occurring CP and OUD may be further complicated by additional comorbid mental health or substance use disorders. A significant number of individuals self-medicate for pain with alcohol and/or have Alcohol Use Disorder. Furthermore, the prevalence of General Anxiety Disorder and Major Depressive Disorder is high among individuals with co-occurring OUD and CP. Patients who have co-occurring mental health or substance use diagnoses often have worse pain outcomes and may complicate effective management of comorbid CP and OUD. For this reason, the development of integrated treatments, integrated care delivery models, and implementation strategies should not ignore these comorbidities and opportunities may exist to attend to these psychiatric comorbidities in order to treat the whole patient.
Health care services for patients with both CP and OUD are fragmented in the United States. Providers in pain clinics and primary care clinics have evidence-based pain management treatments for patients with CP, such as opioid or non-opioid medications, interventional treatments, and non-pharmacological pain management strategies. They also have tools to assess and monitor patient responses to opioid analgesics, compliance with treatment agreements to assure safe and effective opioid prescription use, and monitor behaviors indicative of misuse while managing their pain. However, if a patient exhibits opioid misuse, the patient may be discharged from a pain clinic or a primary care clinic and referred to substance use or OUD treatment programs. While skilled at treating OUD, these programs often lack the expertise and resources to manage co-occurring CP. Healthcare providers lack tools and treatment guidelines and therefore, experience great difficulty treating patients with co-occurring CP and OUD. There is limited research on how to effectively and concurrently treat a patient’s CP and OUD. For example, there is a lack of evidence regarding which medications and/or dosages can be used safely and effectively to treat these patients. There also is a lack of evidence about how best to integrate and dose pharmacotherapies with non-pharmacological behavioral approaches and complementary interventions to treat patients with CP and OUD. The overall goal of these companion FOAs is to develop, evaluate, disseminate, and implement patient-centered and integrated treatments and models of care that are safe, effective, and accessible to complex patients with both CP and OUD.
While challenging, strategies can be pursued to safely and effectively respond to the needs of this complex patient population. Opportunities exist to leverage the effective treatment modalities targeting CP or OUD alone by integrating them to address the needs of individuals with both conditions. Medications for OUD (MOUDs; e.g. buprenorphine, methadone, and naltrexone) can effectively treat OUD and are often used in combination with behavioral approaches to improve treatment adherence and recovery outcomes. Pharmacological treatments and complementary medicine approaches such as mindfulness, cognitive behavioral therapy, acupuncture, exercise, and physical therapy can be effective for treating CP. Despite scientific evidence for effectiveness of such approaches for OUD or pain, we have little knowledge of how best to leverage, integrate, and deliver these treatments for co-occurring CP and OUD/misuse. Access to quality care for many, especially underserved populations, who have CP or OUD presents even greater challenges for care delivery to people with both conditions. Effort is needed to address the barriers that lead to fragmented health care delivery for CP and OUD. Best models for integrated care and best approaches to implementation need to be explored and evaluated to maximize sustained access to quality care. Bringing together scientists, patients, and practitioners with the appropriate expertise to develop data-driven best practices to manage CP and OUD is an important part of the formula needed to improve the health of this population.
This FOA seeks applications for a single Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) Coordination and Dissemination Center. This FOA runs in parallel with a companion FOA that seeks applications for multidisciplinary and collaborative research centers to develop, evaluate and implement effective patient-centered and integrated approaches to treat complex patients with CP can OUD and to evaluate best delivery models and implementation strategies for access to quality care (IMPOWR Research Centers: RFA-DA-21-030). The Coordination and Dissemination Center is expected to develop a communication plan, enhance collaboration and coordinate activities across the network and with relevant NIH initiatives (e.g., NOT-MH-21-005, and other HEAL programs on pain and OUD). The center will develop, evaluate and provide essential shared assessment tools and facilitate harmonization of data collected across the network. It also will develop and support educational activities in support of the program goals. This initiative encourages innovative, multidisciplinary approaches.
HEAL Initiative
This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
Network Structure and Objectives
The network will support multidisciplinary research centers to develop and evaluate integrated interventions, models of care, and implementation strategies that will provide an evidence base for safe, effective, patient-centered treatments and facilitate access to quality care for individuals who have co-occurring CP and OUD. To accomplish this objective, NIH intends to establish a network of investigators at multiple sites and with broad expertise in the areas of CP and OUD/misuse treatment and service delivery which are linked together through a central Coordination and Dissemination center that serves to promote collaboration and communication and to provide shared research resources across the network.
Applicants also are encouraged to review a related FOA that will optimize multi-component service delivery interventions for people with OUD and co-occurring conditions (NOT-MH-21-005). Interaction is expected between the IMPOWR network and those from NOT-MH-21-005 and applicants should anticipate the potential for overlapping populations of interests across the studies. The purpose of the related initiative is to support studies that will test (1) overall effectiveness of multi-component interventions for OUD and co-occurring conditions and (2) examine the relative contribution of constituent components to overall effectiveness. This research will streamline service packages so they only include components that drive clinical improvements for complex conditions. Studies are to be highly pragmatic and practice relevant, with designs that balance rigor with time-to-practice urgency. Projects will seek to a) identify constituent components that drive improvements in access, continuity, quality, value, and outcomes of care, for service delivery interventions with previously demonstrated effectiveness as a bundled package; and b) simultaneously test overall effectiveness of the package and its subcomponents, for widely implemented service delivery packages without previously demonstrated effectiveness. Please review NOT-MH-21-005 for detailed information.
A summary of the synergistic and distinct elements between these inter-related FOAs is provided below:
Title |
HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required): RFA-DA-21-030 |
HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional) |
HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional): NOT-MH-21-005 |
Target Patient Population |
Patients must have CP and OUD/opioid misuse; may have AUD, GAD, MDD |
Patients must have CP and OUD/opioid misuse; may have AUD, GAD, MDD |
Patients must have OUD and Mental Health Disorders and/or Suicide; may have CP |
Program goals |
Identify targeted interventions for both CP and OUD/opioid misuse via:
|
Provide support to the network, including:
|
Optimize existing multi-component, evidence based strategies to manage OUD + MH +/- suicide
|
.
IMPOWR research centers, the IMPOWR Coordination and Dissemination center and NOT-MH-21-005 awardees are expected to participate in shared executive committee meetings, which will meet quarterly and an annual in-person 2-day meeting throughout the life of the award. These meetings provide a forum to discuss (1) research updates; (2) opportunities of synergy and collaboration (e.g., data harmonization, protocol modifications); (3) develop a bidirectional pipeline between the research projects to facilitate practice-based research and improve early identification, intervention effectiveness, service delivery, and optimal components that are driving integrated care delivery for CP and OUD. It is also expected that IMPOWR research centers, the IMPOWR Coordination and Dissemination center and, NOT-MH-21-005 awardees will participate in workgroups that arise to support synergistic activities across these networks (e.g., publication policy, data policy, stakeholder and patient engagement, biostatistics, and subject recruitment). Finally, IMPOWR research centers, the IMPOWR Coordination and Dissemination center and NOT-MH-21-005 awardees are expected to participate in break-out sessions with other HEAL programs of relevance to this initiative (e.g., PRISM, ERN, BACPAC, BRIM, etc) at the annual HEAL Investigator meeting.
IMPOWR Coordination and Dissemination Center: Scope of Activities and Purpose
Applicants responding to this FOA must carefully review the companion FOA for IMPOWR research centers (RFA-DA-21-030) and NOT-MH-21-005 to understand the full mission of this network.
The Coordination and Dissemination center is expected to provide coordination, infrastructure and other supports for the network. Key responsibilities for the Coordination and Dissemination center include:
A. Administrative coordination and communication.
B. Data harmonization.
C. Patient and stakeholder engagement and information dissemination. Each research center within this network must include PWLE/patient organizations and key stakeholders relevant to their research projects. Relevant stakeholders, in addition to PWLE/patient organizations, may include, but are not limited to payors, care takers, health care providers from multiple disciplines, policymakers, advocacy groups, or professional organizations that create clinical care guidelines. The Coordination and Dissemination center is expected to translate broader network findings into resources of interest to external stakeholders. Responsibilities include:
D. Research education infrastructure. Applicants should propose a robust infrastructure of educational activities designed to enhance treatment of concurrent CP and OUD. User-friendly, and audience-appropriate, educational activities and materials include, but are not limited to: a workshop series on diverse topics of interest relevant to CP, OUD, and attendant psychiatric comorbidities (e.g., AUD, MDD, GAD) aimed at key stakeholders, advanced seminars on methodology, web resources, pocket guidelines, any other products that bridge OUD and CP expertise, or short term educational opportunities (intensive workshops, summer institutes, or visiting scholar programs, etc.). Educational content on reducing stigma and health disparities in OUD and CP is required. Applicants are encouraged to be thoughtful about competency assessments of the educational content generated by this center. Resources that educate a wide range of audiences are encouraged and are expected to be facilitated by the stakeholder engagement and information dissemination efforts developed in the Coordination and Dissemination center.
If excellent research education resources currently exist that address CP and OUD and/or stigma associated with this population, but do not have educational accreditation, considerable thought should be given towards professional training accreditation and include a plan to address this issue. Of note, if applicants have identified existing meritorious resources that address the training and education needs specified in this FOA, applicants may propose a multi-pronged approach to disseminate existing resources as appropriate and develop new activities to address any remainingresearch education gaps. Applicants are encouraged to be thoughtful about competency assessments of the exiting educational content.
The Coordination and Dissemination center should plan to track educational metrics throughout the life of the grant award (e.g., quantity of educational content generated, quantity of medical professionals, patients, and stakeholders engaged, competency evaluations, etc.).
E. Create innovative research resources appropriate to co-occurring CP and OUD, composite outcomes measures, and screening tools for both OUD and CP. Currently, health care providers must use separate assessment and screening tools and outcomes measures for CP and OUD. Applicants must propose to develop a single composite outcomes measure tool for both CP and OUD to be used across the network. An option to include AUD, MDD, and GAD could be considered. In addition, the Coordination and Dissemination should create other assessment tools of high priority as a research and potential clinical resource for this population. Examples of these tools include, but are not limited to:
The Coordination and Dissemination center should include plans for psychometrically validating these tools, if needed, and include plans for disseminating the tools for use in awarded research centers within this network and to the broader research field/clinical community. These plans should consider approaches to facilitate integration into multiple digital platforms (e.g., REDcap, qualtrics, etc.) to increase uptake.
Points to Consider Regarding Racial Diversity in Multidisciplinary Team Science: 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. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce and health care system is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific workforce. Therefore, applicants are strongly encouraged to include as research and healthcare staff, and key contributors, individuals who are underrepresented in biomedical research including individuals of diverse racial/ethnic, gender, rural and low-income backgrounds.
Points to Consider Regarding Early Stage Investigators: Pain treatment in individuals with OUD and other co-occurring substance use and psychiatric conditions is identified as an under-resourced medical need and has received limited research attention. To assure a sustained workforce and effort toward identifying and developing effective pain treatment for these vulnerable populations in the future, applicants are strongly encouraged to indicate how they will include early stage investigators in this funding opportunity.
Special Considerations:
Applications with the following specifics will be considered non-responsive and will not be reviewed:
On June 1-2, 2020, NIH held a workshop on Managing Chronic Pain in Individuals with Co-occurring OUD, and Other Psychiatric Conditions. A recording and summary of this meeting's proceedings are available at https://apps1.seiservices.com/HEALPainOUDWorkshop/Default.aspx. NIH issued a Notice of Intent to Publish a Funding Opportunity Announcement for the Coordination and Dissemination center (NOT-DA-20-077). Applicants are encouraged to participate in a future technical assistance webinar related to the FOA, which is anticipated to occur December 2020/January 2021. The date for this webinar will be published in a Notice associated with this RFA.
Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.
Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
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The HEAL Initiative intends to commit $575,000 direct costs in FY 2021 to fund 1 award.
Application budgets are limited to $575,000 per year in direct costs. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
Local Governments
Federal Governments
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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: NIDALetterofIntent@mail.nih.gov.
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:
Office of Extramural Policy and Review
National Institute on Drug Abuse
3WFN 9th Floor, MSC 6021
301 North Stonestreet Ave
Bethesda, MD 20892
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
With the following additional instructions:
PD/PIs are required to expend at least 2.0 person-months effort annually on the award over the entire period of support. In a multi-PI application, at least one PD/PI is required to commit a minimum of 2.0 person-months annually over the life of the grant award.
Senior/Key Personnel biosketches should describe recent experience and participation in coordinating a network consisting of multisite research projects. Applicants are expected to provide evidence of their unique strengths, accomplishments and capabilities to contribute to shared activities across the network. Applications should include a diverse set of expertise to provide multidisciplinary perspectives on CP and OUD. For example, the perspectives of patients, OUD healthcare provider, and CP healthcare provider, OR a healthcare provider with subject matter expertise in both conditions are encouraged to be a part of the multidisciplinary team. Since the awarded research centers will included stakeholders relevant to their research projects, applicants for the Coordination and Dissemination center should describe a plan for engaging a diverse range of audiences to broadly disseminate the products and findings of the awarded research centers within this network to wider audiences.
All instructions in the SF424 (R&R) Application Guide must be followed.
With the following additional instructions:
The Coordination and Dissemination center is expected to engage stakeholders in order to disseminate knowledge and products generated by the awarded research centers. Applicants are NOT instructed to pre-identify stakeholders in the application, but may elect to engage stakeholders based on the research centers. Applications are encouraged to include budgetary support for these stakeholders and/or the PWLE/representatives from patient advocacy organizations. Budgetary support might include allowable salary support or honorarium, travel, and per diem costs.
Requirements for Participating in Network Activities
Budgets should include funds for travel for the PD(s)/PI(s), and up to three additional project staff to participate in in-person executive committee meetings once per year, every year of the award, in Rockville, MD. An additional in-person kickoff meeting to be held in Rockville, MD should be included in the year one budget of the award to discuss data harmonization policies and procedures. In the event in-person gatherings are not possible due to the COVID-19 pandemic, applicants should plan to conduct these meetings virtually.
In addition to the annual in-person executive committee meeting, representatives from the Coordination and Dissemination are expected to participate in virtual meetings that will occur quarterly. At least one PI should be present from the Coordination and Dissemination center at these virtual meetings, with the option to include additional stakeholder partners as appropriate.
Stakeholder and PWLE partners from each awarded research center will form a community workgroup to provide guidance on network activities. Engagement with these individuals will bolster information dissemination efforts executed by the Coordination and Dissemination center. Time and support should be budgeted for these individuals to participate in such activities.
At least one PI should also be present at the annual HEAL Investigators meeting that convenes annually. Awardees are expected to participate in break-out sessions with other HEAL programs of relevance to this initiative (e.g., PRISM, ERN, BACPAC, BRIM, etc.) at the annual HEAL Investigator meeting. Coordination with these programs may continue on a regular basis beyond the annual HEAL Investigators meetings. Time and support should be budgeted to participate in such activities.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Specific Aims describing all of the key responsibilities are required.
Research Strategy:
The Coordination and Dissemination center should be viewed as a resource center that provides support to individual research centers, to the network as a whole, and to the greater community of stakeholders engaged in working with individuals with CP and OUD. Applicants should describe the overall structure of their proposed Coordination and Dissemination Center. This should include unique advantages or capabilities of the proposed center and how it will interact with the broader network of funded research centers and HEAL programs of relevance to this network (e.g., BRIM, BACPAC, PRISM, ERN, etc.). Applicants should address how the specified responsibilities will be executed to establish the research resources, and include details on workflow plans and timelines. Applications should include a diverse set of expertise to provide multi-disciplinary perspectives on pain and OUD. For example, the perspectives of PWLE/patient organizations, OUD healthcare provider, and CP healthcare provider, OR a healthcare provider with subject matter expertise in both conditions as part of the multidisciplinary team. Since the awarded research centers will include stakeholders relevant to their program projects, applicants for the Coordination and Dissemination center should describe a plan for engaging a diverse range of audiences to broadly disseminate the products and findings generated by the research centers to wider audiences. It is recommended that applications include personnel with expertise in attendant psychiatric conditions, such as GAD, MDD, and AUD. The types of stakeholders involved in the Coordination and Dissemination center may be dependent on the scope of projects proposed in the research centers. Rather than identifying specific stakeholder groups, applicants should describe a plan for engaging with diverse stakeholder groups.
If the application includes activities that span multiple institutions, applicants must explain how those activities will be coordinated across institutions, and how the proposed activities will effectively engage and collaborate with other relevant activities at participating institutions. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the network. Applications should include the following categories as subheadings in the applications: Administrative Coordination and Communication; Data harmonization; Stakeholder engagement and information dissemination; Research education infrastructure; Innovative tool development.
The application should describe the Coordination and Dissemination center's ability to conduct the following required tasks:
A. Administrative Coordination and Communication
B. Data harmonization
C. Patient and stakeholder engagement and information dissemination
D. Research education infrastructure
E. Create innovative research resources appropriate to co-occuring CP and OUD, composite outcomes measures, and screening tools for both OUD and CP
Letters of support:
Letters of support should not be included from potential stakeholder groups. Rather, a plan for identifying and engaging these groups should be included in the Research Strategy Section, as specified above. Include letters of support/agreement for any collaborative arrangements, subcontracts or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.
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:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
HEAL Central Data Sharing Platform Requirements
The award recipient and its collaborators must comply with all NIH HEAL Initiative Data Sharing policies established during the project period. This includes compliance with the NIH HEAL Initiative central data platform requirements and timelines developed through the HEAL consortium. It is expected that all data collected by award recipients and their collaborators, as part of the NIH HEAL Initiative, will be shared with the NIH HEAL Initiative central data platform.
All data collected as part of the NIH HEAL Initiative are so collected under a Certificate of Confidentiality and entitled to the protections thereof. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution’s NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d). Failure to adhere to this criterion may result in enforcement actions.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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.
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 through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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.
Significance
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: Does the application include plans to effectively disseminate research findings to targeted audiences of relevance to the proposed research projects and engage in a meaningful manner with stakeholders/PWLE? Does the application address plans to reduce stigma for OUD and CP and attend to barriers in health equity in a meaningful manner?
In addition, for applications involving clinical trials:
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
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: Is there clear description of roles for all key personnel involved in the Coordination and Dissemination center? Are investigators experienced in treating CP, OUD, and attendant psychiatric conditions such as GAD, MDD, and AUD? Is the patient voice represented and are there clear plans for integrating their perspective into executing the key responsibilities of the Coordination and Dissemination center? Does the team have experience in supporting networks and engaging with other investigators executing research on this comorbid population? Do the key personnel understand the issues surrounding education and information dissemination in treating CP and OUD? Do the key personnel understand the challenges in addressing stigma and health disparities in patients with comorbid CP and OUD? Is there a commitment to promoting early stage investigators and diversity (e.g., racial, ethnic, gender, individuals with disability) among the investigative team?
In addition, for applications involving clinical trials:
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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 to this FOA: Does the research plan include novel or appropriate strategies for capturing, monitoring, and displaying metrics data on performance from the awarded research centers? Are there state of the art and novel web-based platforms or tools for collaboration and communication? Are there innovative approaches to communicating between research sites and with all their relevant stakeholder partners? Are there innovative strategies or approaches for disseminating findings and best practices applicable for relevant PWLE and stakeholder partners? Are there innovative approaches for engaging with a diverse range of stakeholders? Does the application include development of diagnostic and measurement tools that are innovative?
In addition, for applications involving clinical trials:
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
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?
Specific to this FOA: Are a clear communication plan and state of the art technology proposed to facilitate collaboration between research centers, their stakeholders and PWLE, the Executive Committee, network workgroups, HEAL funded programs of relevance (e.g., BRIM, PRISM, ERN, BACPAC), the NIH, and other relevant entities? Is there a clear plan to keep abreast of emerging findings relevant to CP and OUD treatment, including initiatives internal to the HEAL initiative and broader NIH/HHS funded programs? Is there a clear vision or framework for working with research sites and other involved key personnel to coordinate all study-related activities? Is there a conceptually driven dissemination plan for study findings that include various audiences across the country dealing with the OUD and CP crisis? Does the application include plans to develop screening tools, including a single integrated diagnostic screening tool for measuring changes in OUD and CP? For new tool development, does the application include details on how best to validate and disseminate these products to health care providers? Does the dissemination plan address key actions that could translate research findings into practice? Does the approach include a plan for identifying and convening relevant stakeholder groups? Does the plan for stakeholder engagement include a wide, representative array of stakeholder groups? Is there a strong plan for developing research education infrastructure, including approaches to address stigma and health disparities relevant to this patient population? If applicants have identified existing meritorious resources that address theeducational needs specified in this FOA, does the application propose a multi-pronged approach to develop new activities to address any remaining gaps and disseminate existing resources as appropriate? If appropriate, does the application address professional accreditation? Is there a clear vision for how the center will facilitate data harmonization and sharing? Are there plans to interface between the funded research centers and other relevant initiatives funded by HEAL and more broadly by NIH/HHS? Do the proposed measurement tools for development address high priority research and practice for populations with comorbid CP and OUD?
Are the data sharing plans consistent with the HEAL Data Sharing policy?
In addition, for applications involving clinical trials:
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
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 to this FOA: Does the application demonstrate a track record of collaborating with the relevant stakeholders and PWLE/patient organizations in research and is there information about the nature and extent of collaborations between the researchers and stakeholder/PWLE partners? Does the application list the infrastructure necessary to deliver project coordination activities for a large multi-site study? Does the application describe an environment with experience conducting or coordinating research related to CP, OUD, and attendant psychiatric conditions?
In addition, for applications involving clinical trials:
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
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.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
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) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, 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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
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.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions 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: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Shelley Su, Ph.D.
National Institute on Drug Abuse
Telephone: 301-402-3869
Email: IMPOWR@nih.gov
Maribeth Champoux, Ph.D.
Center for Scientific Review
Telephone: 301-594-3163
Email: champoum@mail.nih.gov
Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email:pfleming@mail.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.
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