Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

National Cancer Institute (NCI)

Tribal Health Research Office (THRO)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
Palliative Care Research Across the Lifespan: Leveraging the Palliative Care Consortium (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices
Funding Opportunity Number (FON)
PAR-27-090
Companion Funding Opportunity
None
Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.866, 93.242, 93.393, 93.307, 93.853, 93.865, 93.361
Funding Opportunity Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to invite R01 applications proposing research on palliative care across the lifespan for persons with serious illnesses and/or their care partners relevant to the missions of participating NIH Institutes, Centers, and Offices (ICOs), including projects focused on palliative care access, use, and quality. Applications may propose hypothesis-driven, milestone-defined palliative care traditional efficacy (Stage II), real-world efficacy (Stage III), effectiveness (Stage IV), and/or dissemination and implementation (Stage V) clinical trials in alignment with the NIH Stage Model (Stages II-V) and relevant Institute or Center policies. Applications may propose non-clinical trial palliative care research, such as health services research, methodologic research, natural experiments, or observational studies. Recipients will become members of the research community facilitated by the NIH-funded Advancing the Science of Palliative Care Across the Lifespan (ASCENT) Consortium.

NOTE: This NOFO is not appropriate for applications proposing new intervention generation, refinement, modification, adaptation, and/or pilot testing (Stage I of the NIH Stage Model) clinical trial research. The intervention(s) to be tested must be in a developed and testable form, with Stage I activities already completed and demonstrated.

Funding Opportunity Goal(s)

To seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Key Dates

Posted Date
October 14, 2026
Open Date (Earliest Submission Date)
January 05, 2027
The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
February 05, 2027 * March 05, 2027 * Not Applicable July 2027 October 2027 December 2027
June 05, 2027 * July 05, 2027 * Not Applicable November 2027 January 2028 April 2028
October 05, 2027 * November 05, 2027 * Not Applicable March 2028 May 2028 July 2028
February 05, 2028 * March 05, 2028 * Not Applicable July 2028 October 2028 December 2028
June 05, 2028 * July 05, 2028 * Not Applicable November 2028 January 2029 April 2029
October 05, 2028 * November 05, 2028 * Not Applicable March 2029 May 2029 July 2029
February 05, 2029 * March 05, 2029 * Not Applicable July 2029 October 2029 December 2029
June 05, 2029 * July 05, 2029 * Not Applicable November 2029 January 2030 April 2030
October 05, 2029 * November 05, 2029 * Not Applicable March 2030 May 2030 July 2030

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date
November 06, 2029
Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Palliative care is holistic interdisciplinary care focused on improving quality of life for persons with serious illness across the lifespan and their families and care partners. Serious illness includes conditions such as cancer, heart disease, chronic kidney disease, and Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), for which palliative care is associated with improved care quality and, in some cases, length of life. The core elements of palliative care include:

  • Treating symptoms, such as pain, nausea and vomiting, shortness of breath, and psychological and spiritual distress for individuals and their care partners.
  • Eliciting goals of care and promoting care concordant with those goals.
  • Facilitating coordination of care. 

Palliative care may occur alongside other care intended to cure or delay progression of underlying disease and may be initiated as early as the time of diagnosis. Palliative care teams can include members from a range of medical and surgical specialties (e.g., internal medicine, pediatrics, oncologic surgery, psychiatry, neurology) and disciplines (e.g., physician assistants, nurse practitioners, social workers, chaplains).

Toward the final months or weeks of life, an individual may elect to discontinue curative treatment while maintaining focus on quality of life and relief of suffering. This focused care may be provided in hospice settings or via hospice services in the home when a patient has an expected survival of 6 months or less. Hospice care is a subset of palliative care delivered at the end of life. In this NOFO, the term "palliative care" includes, but is not limited to, advance care planning, end-of-life care, and hospice care.

Access to reliable high-quality palliative care for a range of serious illnesses across the life span is a growing public health priority. It is estimated that about 12 million adults and hundreds of thousands of children are living in the U.S. with serious illnesses, and many are living longer with disease. The problem of limited access to palliative care is worsened by the projected increase in the population of older adults, the majority of whom live with multiple chronic conditions.

Purpose and Scope

The purpose of this NOFO is to invite R01 applications proposing research on palliative care across the lifespan for persons with serious illnesses and/or their care partners relevant to the missions of participating NIH Institutes, Centers, and Offices (ICOs), including projects focused on palliative care access, use, and quality. Applications may propose hypothesis-driven, milestone-defined palliative care efficacy, effectiveness, and/or implementation and dissemination clinical trials in alignment with the NIH Stage Model (Stages II-V) and relevant Institute or Center policies. Applications may propose non-clinical trial palliative care research, such as health services research, methodologic research, natural experiments, or observational studies. Recipients will become members of the research community facilitated by the NIH-funded ASCENT Consortium.

Applications with and without proposed clinical trials may be submitted to this NOFO. Refer to the NIH definition of a clinical trial to determine whether your application includes a clinical trial.

Research areas of interest include, but are not limited to:

  • Addressing and alleviating symptoms, including pain and other physical concerns (e.g., dyspnea, disability, cognition), psychosocial issues (e.g. depression, anxiety, loneliness), or spiritual concerns (e.g., loss of meaning, existential distress) of people with serious illness and their care partners across the lifespan.
  • Improving communication between healthcare teams and persons with serious illness and their care partners across the lifespan and across settings.
  • Evaluating novel care delivery models addressing the needs of people with serious illness and their care partners across the lifespan.
  • Assessing cost, quality, access, use, and outcomes of palliative care for people with serious illness and their care partners across the lifespan.
  • Developing and/or testing new methodological approaches (e.g., causal inference, trial design, incorporating artificial intelligence) or measures (e.g., pain, depression, spiritual distress) in palliative care research.
  • Understanding individual-, provider-, or systems-level palliative care practice patterns, capacity, and coordination. This includes needs, characteristics, and outcomes across varied settings, populations, and diseases.
  • Understanding the societal context for palliative care and its impact on health outcomes, including research on health systems, and the palliative care workforce.
  • Understanding and addressing differences in palliative care use and outcomes among different groups. See Advancing NIH's Mission Through a Unified Strategy | National Institutes of Health (NIH) for more information on solutions-oriented research priorities at NIH. 

Scope of this NOFO: Clinical Trials Applications

The palliative care literature underscores the need for rigorous, well-powered, replicable clinical trial research addressing issues of intervention fidelity, efficacy, and potential intervention mechanisms, prior to dissemination and implementation on a wide scale. Applicants are encouraged to review and reference palliative care intervention research priorities from the existing literature and consensus documents and intervention research priorities identified by the ASCENT Consortium, if available.

NIH will accept applications to this NOFO that propose rigorous efficacy, effectiveness, and/or implementation intervention research (i.e., Stages II – V of the NIH Stage Model), for which a rigorous planning and feasibility demonstration phase (i.e., Stage I) has already been completed. Applicants seeking to propose a Stage I clinical trial may wish to visit the ASCENT Consortium for pilot funding opportunities.

The NIH Stage Model

The NIH Stage Model offers a framework to: 

  • Support development of efficacious interventions that are defined by their mechanisms or principles.
  • Ensure that these efficacious interventions can be implemented sustainably in the settings where they are needed and for the people who need them. 
  • Provide a common language to facilitate discussion of intervention development research by applicants, reviewers, and funders. 

This NOFO solicits mechanism-focused palliative care intervention development research at Stages II through V of the NIH Stage Model, which has the ultimate goal of creating efficacious, implementable interventions defined by their principles.   

Stage II – V research invited via this NOFO is described below:

  1. Stage I: Not appropriate for this NOFO (see below).
  2. Stage II: Traditional Efficacy Testing. Stage II studies test efficacy under highly controlled ideal conditions (e.g., in a research setting), where internal validity is maximized.
  3. Stage III: Efficacy in the "Real World:" Like Stage II, Stage III studies test efficacy. However, Stage III studies involve the delivery of the intervention by an individual, or a group of individuals, in a real-world context, and are conducted with as high internal validity as possible within this real-world setting:
    • Stage III efficacy testing of an intervention consists of the experimental testing of an intervention while maintaining as high a level of control as possible in a real-world setting, with community-based interventionists/providers.
    • Stage III studies testing the efficacy of training materials for real-world providers are often necessary to ensure an intervention can be delivered with fidelity prior to progression to Stages IV and V.
  4. Stage IV: Effectiveness Testing: Stage IV research tests the effectiveness of an intervention. Stage IV tests intervention effectiveness, where the intervention is delivered in community settings by community interventionists (e.g., under actual conditions in the "real world"). Stage IV research strives for maximal external validity.
  5. Stage V: Dissemination & Implementation: Stage V research is focused on strategies to disseminate and implement interventions, rather than modifying or testing the intervention itself. Specifically, Stage V seeks to create, modify, and test implementation and dissemination strategies, to achieve an understanding of the principles (or mechanisms) that govern effective dissemination and implementation strategies. Stage V research testing an implementation strategy is sometimes combined with Stage IV effectiveness testing. This is sometimes referred to as a "Type 2 Hybrid."

Stage 1 intervention development research as defined below is not appropriate for this NOFO.

Stage I: Creation, Adaptation, Modification & Pilot-Testing (CAMP) of the full intervention, including procedures for teaching providers to deliver the intervention correctly:

  • CAMP of the Intervention: All studies that seek to create or change (adapt, modify, tailor or refine) and pilot test the feasibility and acceptability of an intervention are Stage I studies. Stage I studies can be conducted in controlled research settings or in community settings.
  • CAMP of a Training Procedure: Training procedures may be needed to ensure an interventionist (e.g., a nurse, peer counselor, psychotherapist, social worker, physician, etc.) can deliver the intervention correctly (with "fidelity"), and the testing of training procedures can be considered interventions in their own right. The development and pilot feasibility and acceptability testing of provider-friendly training procedures (and associated materials) are included in Stage I studies.

Clinical trial conduct is expected to implement the scientific and operational tools developed prior to the research proposed in this application or during a planning phase of the proposed work. Applications proposing Stage I work to develop a new behavioral intervention or to adapt an existing behavioral intervention, to establish acceptability and feasibility of the intervention, and to develop interventionist training and supervision materials de novo are not within scope of this NOFO.

In addition to clearly aligning intervention research questions with study methods (and stages of intervention development research), this NOFO expects tests of hypothesized intervention mechanisms of action and heterogeneity of intervention effects. Tests of hypothesized mechanisms of action are often (but not only) tested via mediation analyses, and heterogeneity of intervention effects are often (but not only) tested as moderation effects. For heterogeneity of intervention effects analyses, this includes the identification of specific individuals who are more or less likely to benefit from the intervention(s) based on genetic profiles, individual differences, behavioral factors, sociocultural, and/or clinical and demographic factors. Heterogeneity of intervention effects may elucidate different causal mechanisms at work for different populations or individuals.

Clinical trials that propose the testing of pharmacologic agents or devices that have a therapeutic indication for symptom reduction/control may be within scope, however the agent or device should not be at a stage of therapeutic development that requires an Investigational New Drug (IND) application. In addition, a trial testing a pharmacologic agent or device is expected to have pilot data and/or proof-of-principle data that confirm a direct mechanistic link between the agent or device and improved symptom outcomes, and should also have mitigation of the targeted symptom(s) as its primary endpoint. Trials designed to primarily address the dose, schedule, delivery route, safety, or side effects of the pharmacologic agent or device are not within scope of this NOFO.

Applicants are strongly encouraged to discuss proposed clinical trials with an NIH scientific contact prior to applying.  

Before commencing, the clinical trial will be expected to meet all applicable NIH and Office of Human Research Protections (OHRP) policy requirements, including the NIH policy for Single IRB for Multi-Site or Cooperative Research | Grants & Funding, if applicable, and have NIH and IRB approval. Less than satisfactory progress towards clinical trial milestones may lead to phasing out the award. 

Scope of this NOFO: Non-Clinical Trials Applications

This NOFO encompasses non-clinical trial research projects focused on palliative care or aspects of palliative care as defined in the Background section. Applicants are encouraged to review and reference research priorities from the existing literature and consensus documents and research priorities identified by the ASCENT Consortium.

Proposed study designs may include, but are not limited to:

  • Observational, epidemiological, health services or health systems research
  • Natural experiments
  • Quasi-experimental studies 
  • Methods or data infrastructure development
  • Secondary data analyses (including analyses using data from completed randomized clinical trials)
  • Qualitative research
  • Other relevant non-clinical trial research designs/methods 

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

  • Applications proposing research not specific to or in the context of palliative care for persons with serious illness or their care partner(s).
  • Applications proposing a clinical trial at Stage I of intervention development (Creation, Adaptation, Modification & Pilot-Testing (CAMP) of the full interventions, including procedures for teaching providers to deliver the intervention correctly) as defined by the NIH Stage Model.
  • Applications proposing a clinical trial that is not consistent with Stages II (traditional efficacy), III (real-world efficacy), IV (effectiveness), or V (dissemination and implementation) as defined by the NIH Stage Model.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal
Resubmission
Revision

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. 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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 

Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

Applications must budget for required interactions with the NIH-funded ASCENT Consortium, as defined below in the PHS 398 Research Plan section. Applications must budget for any optional ASCENT Consortium services or interactions the applicant proposes to use. Applicants must contact the ASCENT Consortium prior to applying to discuss planned interactions and their costs. 

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

For all applications, the Research Strategy must describe how the proposed project will meet required interactions with the NIH-funded ASCENT Consortium. Required interactions with the ASCENT Consortium include:

  1. At least one member of the study team must attend the annual ASCENT Consortium research conference.
  2. Applications must include plans to collect the relevant and appropriate minimum common data elements as agreed upon with the ASCENT Consortium.
  3. Applications must include a Data Management and Sharing (DMS) Plan using the 2026 DMS Plan Format in accordance with NIH Guide Notice NOT-OD-26-046, Updated Elements of an NIH Data Management and Sharing Plan. Applicants must be prepared to share the relevant and appropriate de-identified qualitative and quantitative study data with the ASCENT Consortium's Data Coordinating Center as determined between the applicant and the ASCENT Consortium. 

Applicants must contact the ASCENT Consortium prior to application submission to discuss the required interactions.

Applicants may wish to propose using additional, optional services offered by the ASCENT Consortium cores and should discuss these with ASCENT Consortium staff prior to applying to this NOFO.

For applications proposing a Clinical Trial

Before commencing, the clinical trial must meet all applicable NIH and Office of Human Research Protections (OHRP) policy requirements, including the NIH policy for Single IRB for Multi-Site or Cooperative Research | Grants & Funding, if applicable, and have NIH and IRB approval. 

The research strategy must:

  • Clearly align the intervention research questions with study methods and NIH Stage Model stage(s) of intervention development research (e.g., traditional efficacy (Stage II), real-world efficacy (Stage III), effectiveness (Stage IV), and/or dissemination and implementation (Stage V)).
  • Articulate a clear specification of hypothesized intervention principles and how these will be tested with adequate statistical power in the clinical trial. Tests of hypothesized mechanisms of action are often (but not only) tested via mediation analyses, and heterogeneity of intervention effects are often (but not only) tested as moderation effects. For heterogeneity tests, this includes the identification of specific individuals who are more or less likely to benefit from the intervention(s) based on genetic profiles, behavioral factors, sociocultural, and/or demographic factors. Heterogeneity of intervention response may elucidate different causal mechanisms at work for different populations or individuals.
  • Include a Milestone Plan (see below).

Milestone Plan

All applications proposing a clinical trial must include a Milestone Plan.

  • The milestone plan must describe the key milestones that need to be met throughout the life cycle of the clinical trial to ensure its success, the processes that will be used to reach the milestones, and a timetable identifying when each of these key milestones will be met.
  • All applicants must use the following definition of a milestone in their application: a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be relevant, achievable, and measurable. The plan must include anticipated challenges to meeting milestones and propose potential mitigation or corrective actions strategies.

Planning Phase: Milestones must include, at a minimum:

  1. Demonstration feasibility of study procedures
  2. Finalization of agreements for use of resources available within CTSAs, Centers, practice-based research networks, patient registries, etc., as applicable
  3. Finalization of the clinical protocol and other required study documentation
  4. Development and validation of intervention fidelity procedures
  5. Development and validation of interventionist training procedures
  6. Development of the data management system and data quality procedures

Active Trial Phase: Milestones must include, at a minimum:

  1. Completion of regulatory approvals and site activation
  2. Enrollment of the first participant
  3. Registration of clinical trial in ClinicalTrials.gov within 21 days of enrollment of first participant
  4. Ongoing monitoring and remediation (if needed) of intervention fidelity
  5. Ongoing participation in NIA's clinical trials policies and procedures
  6. Timely enrollment of the projected study sample
  7. Completion of data collection
  8. Completion of primary study analyses, including adequately powered tests of hypothesized intervention principles
  9. Completion of the final study report

If applicable to the proposed clinical trial, the research strategy should include a Co-Enrollment Plan

If applicable to the proposed clinical trial, applicants must describe any planned or reasonably anticipated co-enrollment for participants. Information should include but is not limited to:

  • Assessment and justification for permitting or excluding co-enrollment.
  • Ethical implications and the risks, burdens, and benefits of co-enrollment to the participants and the scientific validity of the study.
  • Confirmation that anticipated co-enrollment is included in the protocol provided to the IRB, and the DSMB (if applicable).
  • Actions taken to ensure participants are fully informed about the risks, burdens, and benefits that may result from co-enrollment in the studies.
  • Actions taken to reduce potential confusion about the differentiation between clinical care and research or individual research studies (for example, consider who conducts the informed consent).
  • Mitigative actions taken to address concerns or risks that may arise from co-enrollment (e.g., adjustments to exclusion criteria). 

Trials testing a pharmacologic agent or device

Trials testing a pharmacologic agent or device must have pilot data and/or proof-of-principle data that confirm a direct mechanistic link between the agent or device and improved symptom outcomes. The trial of a pharmacologic agent or a device must also have mitigation of the targeted symptom(s) as its primary endpoint.

For applications proposing use of CMS data linkages:

The NIA Data Linkage Program (LINKAGE) is available for use by the NIH grantee community. The purpose of the Program is to link NIH-funded study data with existing datasets from Centers for Medicare & Medicaid Services (CMS) and other sources and establish a virtual environment to support data accessibility and sharing. LINKAGE reduces resource cost and time barriers while promoting data access for researchers. The program provides three primary services including a linkage service, technical assistance, and a cloud-based platform (enclave) for investigator use.

The program has successfully linked CMS claims data to more than 30 studies including multi-disciplinary NIH-funded studies that focus on caregiving, disability, mortality, dementia diagnosis and more. The enclave offers Medicare Parts A, B, C and D data, Medicare enrollment and assessment data, and Medicaid data. 

Applications proposing to link CMS data must:

  1. Describe the CMS data sets that will be linked with study data.
  2. Describe limitations of CMS data and study data, and how the investigator will account for data limitations in the analyses.
  3. Describe current grant timeline in response to the responsiveness criteria.
  4. Describe plans to obtain consent from study participants for CMS data linkage and analysis or a waiver of consent based on IRB review.
  5. Indicate in the DMS Plan how the applicant will share linked data sets generated under this supplement to approved researchers as per NIHGPS 8.2.3.2.
  6. Provide budget justification.

Applicants must articulate a plan to complete the following steps within the first 150 days of their award and provide a milestone (Gantt) chart in their grant application. Applications must describe how the following steps will be incorporated in the research plan and timeline:

  1. Obtain requisite documents to gain access to the enclave and linked data for analysis including the NIA Data Use Agreement approval.
  2. Complete orientation trainings, including trainings to operate and use the enclave. These virtual, free trainings are provided by the LINKAGE Team and may take each team an average of five hours to complete.
  3. Establish a workplan for conducting linkages and submit a final finder file to the LINKAGE Program.

For more information, please contact support@linkagesupport.zendesk.com with questions.

Letters of Support: The Research Plan must include a letter of support from the ASCENT Consortium. Applications proposing to leverage NIH-supported trial networks (e.g., NCI Community Oncology Research Program (NCORP), NIH Pragmatic Trials Collaboratory, IMPACT Collaboratory) must demonstrate that pre-application approvals to use network resources have been secured. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

 Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Data Management and Sharing Plan

  • A Data Management and Sharing (DMS) Plan is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.
  • The DMS Plan must include plans to share the relevant and appropriate de-identified qualitative and quantitative study data, as determined between the applicant and the ASCENT Consortium, with the ASCENT Consortium's Data Coordinating Center. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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 How to Apply - Application Guide must be followed.

Section 2 - Study Population Characteristics 

2.5 Recruitment and Retention Plan

Without duplicating information in the attachments to the PHS Human Subjects and Clinical Trials Information form, applications in response to this funding opportunity must provide further rationale supporting eligibility criteria and study population characteristics. Applicants should propose innovative and proactive recruitment strategies as applicable and justified by the scientific goals. Applicants should ensure that they address the populations appropriate and relevant to the proposed research and scientific goals. Recruitment and retention plans should demonstrate an understanding of the participant burden involved in research participation and strategies for minimizing this burden, as well as leveraging community partners and outreach efforts.

The recruitment and retention plan must:

  • Describe the process for identifying and screening potential study participants, primary and back-up recruitment strategies, implementation of the consent process, the expertise and track record of the individual(s) responsible for screening, approaching and consenting potential participants, and strategies for participant retention. The plan must describe how the proposed types and number of recruitment and other study implementation staff are both necessary and sufficient to achieve satisfactory recruitment and retention. The study budget must include sufficient funds to support the proposed recruitment and retention activities.
  • Describe 1) if there are known participant or study-related barriers to accrual or participation (based on literature or prior experience), please list these barriers and describe plans to address them to optimize success; 2) contingency plans for participant accrual if enrollment significantly lags behind accrual benchmarks; 3) participant retention and adherence strategies; and 4) possible competition from other trials for study participants.
  • Describe the study population and why it is the most appropriate group to answer the question, and how or if results will generalize to a broader population.
  • Include a justification for the proposed number of sites, explaining why the requested number is both sufficient and necessary for the conduct of the trial. This requirement applies to single-site trials as well as multi-site trials. The justification must describe how all participants for the trial will be enrolled in the allotted timeline.
  • Describe a plan to leverage existing relationships with and/or conduct outreach to a broad range of community groups

In addition, applicants should provide rationale supporting eligibility criteria and study population characteristics that are representative of the population affected by the disease/condition as well as other populations relevant to the proposed research and scientific goals.

Where applicable, study teams should also demonstrate that they have critically evaluated whether eligibility criteria from an earlier phase trial should be carried forward into a later phase trial. Further rationale supporting eligibility criteria and study population should explain how the rationale for selected eligibility criteria justifies the level of restriction in the study compared to clinical practice

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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the  How to Apply – 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 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the  How to Apply – 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. 

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

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 through the NIH peer review system.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

 

Significance

  • Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
  • Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

  • Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
  • Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

 

Approach

  • Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

  • Evaluate the potential to produce unbiased, reproducible, robust data.
  • Evaluate the rigor of experimental design and whether appropriate controls are in place.
  • Evaluate whether the sample size is sufficient and well-justified.
  • Assess the quality of the plans for analysis, interpretation, and reporting of results.
  • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
  • For applications involving human subjects or vertebrate animals, also evaluate:
    • the rigor of the intervention or study manipulation (if applicable to the study design).
    • whether outcome variables are justified.
    • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
    • whether the study population appropriately models the target population.
  • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

  • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
  • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain a study population that appropriately models the target population. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, race, ethnicity, and sex.
  • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

 

Investigator(s)

Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.


Additional Review Criteria

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

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.


 

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.


 

As applicable, evaluate the full application as now presented.


 

As applicable, evaluate the progress made in the last funding period.


 

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.


Additional Review Considerations

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

 

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


 

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


2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIH Center for Scientific Review, in accordance with NIH peer review policies and practices, 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.

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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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: Recipient 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 recipient 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).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  • ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  • receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

  • Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
    • Identify:
      • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
    • Protect:
      • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
      • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
      • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
      • Regularly backup sensitive data and test backups.
    • Detect:
      • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
    • Respond:
      • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
      • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
    • Recover:
      • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

Recipients of both Clinical Trial Required and Clinical Trial Optional awards subject to this term shall report standardized clinical trial activation and enrollment performance data for any interventional clinical trial supported under the award. These metrics are intended to assess trial startup efficiency, site activation, and post-activation performance and to support continuous quality improvement in clinical trial operations (see supplemental guidance). Recipients shall report required data annually at the time of Research Performance Progress Report (RPPR) submission on clinical trial activation and enrollment performance milestone dates as calendar dates; NIH will calculate standardized interval metrics from these dates.

Institutions are expected to maintain capabilities that support efficient clinical trial startup, participant enrollment, and performance monitoring, including streamlined workflows and systems for electronic tracking of milestones.  Recipients are encouraged to implement and evaluate approaches that improve trial efficiency and the participant experience.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

  • Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
  • Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
  • NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 
Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

4. 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Clinical Research Operations Management System

NIA uses a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021, including clinical trials funded as pilots, exploratory studies, or other projects through this Consortium, and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (NIHGPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website. 

When applicable, all NIA recipients must ensure:

1. The study's Informed Consent Document (ICD) lists "The National Institutes of Health (NIH) and its authorized representatives" as one of the organizations that may look at or receive copies of information in participants' study records. According to DHS HHS OHRP 45 CFR 46 §46.116, all ICDs must contain "A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained." If using the NIA informed consent template, please see Section 6: Statement of Confidentiality.  

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.  

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

5. Evaluation

Recipients will be expected to collaborate with and respond to requests for information from the ASCENT Consortium as part of the ASCENT Consortium's evaluation plans.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Scientific/Research Contact(s)

National Institute on Aging (NIA)
NIAPalliativeCareResearch@nih.gov

National Institute of Neurological Disorders & Stroke (NINDS)
Email: NINDS-PalliativeCare@ninds.nih.gov

National Institute of Mental Health (NIMH) 
Email: DTRcommunications@nih.gov 

Division of Cancer Control and Population Sciences and the Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-6929
Email: NCIPalliativeCare@mail.nih.gov

National Institute of Nursing Research (NINR)
Email: NINRProgram@mail.nih.gov

Tribal Health Research Office
Email: throinfo@od.nih.gov

National Institute on Minority Health and Health Disparities (NIMHD)
Scientific Program Contact:
NIMHDDCHSRinquiries@mail.nih.gov  

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichd_ptcib_nofos@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

National Institute on Aging (NIA)
NIA-NOFO-Grants@nih.gov
Please include the NOFO number in the subject line when emailing.

National Institute of Neurological Disorders & Stroke (NINDS)
Chief Grants Management Officer
ChiefGrantsManagementOfficer@ninds.nih.gov 

National Institute of Mental Health (NIMH)
Email: NIMHNOFOGrantsManagement@mail.nih.gov

Office of Grants Administration
National Cancer Institute (NCI)
Email: NCIFinancialContact@nih.gov

National Institute of Nursing Research (NINR)
Email: NINRProgram@mail.nih.gov

National Institute on Minority Health and Health Disparities (NIMHD)
Grants Management Contact: 
NIMHD-CGMO@mail.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: nichdgrantsmanagement@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.