Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
This Funding Opportunity Announcement (FOA) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site feasibility clinical trial to assess whether the intervention can be delivered with fidelity across sites; demonstrate feasibility of recruitment, accrual, and randomization of participants across sites; demonstrate participant adherence to the intervention, as well as retention of participants throughout the study across sites; and/or demonstrate feasibility of data collection across sites in preparation for a future fully powered, multi-site efficacy/ effectiveness trial. The need for multi-site feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. This FOA will not support clinical trials that determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multi-site clinical trial that has the potential to make a significant impact on public health
Prior to submitting to this FOA, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 20, 2021 | July 20, 2021 | July 16, 2021 | November 2021 | January 2022 | April 2022 |
| October 20, 2021 | October 20, 2021 | November 15, 2021 | March 2022 | May 2022 | July 2022 |
| February 18, 2022 | February 18, 2022 | March 11, 2022 | July 2022 | October 2022 | December 2022 |
| June 20, 2022 | June 20, 2022 | July 22, 2022 | November 2022 | January 2023 | April 2023 |
| October 19, 2022 | October 19, 2022 | November 14, 2022 | March 2023 | May 2023 | July 2023 |
| February 21, 2023 | February 21, 2023 | March 10, 2023 | July 2023 | October 2023 | December 2023 |
| June 20, 2023 | June 20, 2023 | July 22, 2023 | November 2023 | January 2024 | April 2024 |
| October 20, 2023 | October 20, 2023 | November 14, 2023 | March 2024 | May 2024 | July 2024 |
| February 20, 2024 | February 20, 2024 | March 11, 2024 | July 2024 | October 2024 | December 2024 |
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
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.
Background
The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of promising complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions). These mind and body interventions are widely used by the public, and they are increasingly recognized as a nonpharmacologic approach to symptom management (e.g., chronic pain, mild depression, anxiety, etc.). These approaches can be used by individuals to help prevent, treat, or self-manage various conditions, as well as be complementary to treatment offered by conventional health care.
There is a need for research to evaluate mind and body approaches as they are used and delivered to determine whether they are safe and efficacious or effective for given conditions or disorders. For clinical trials to address this need they must be well designed and test hypotheses that will guide decisions about the inclusion of these interventions or approaches in the delivery of health care for a given condition or disorder. Investigators need to cite published literature or conduct a series of early-phase clinical trials to gather the multiple types of preliminary data needed to design subsequent large and rigorous efficacy or effectiveness studies. Although the scientific literature may provide the rationale for conducting an efficacy or effectiveness trial, investigators may lack critical information about key elements needed to design and implement such a trial. Some key aspects that may need further investigation to plan the future trial could include refining or adapting the intervention to specific populations; assessing the feasibility, acceptability and adherence to protocolized multi-modal interventions; or finalizing the intervention delivery method, the most appropriate outcome(s), or recruitment strategy. Early phase clinical trials can fill this information gap, thereby improving study design and knowledge of trial feasibility. Multi-site feasibility trials can provide information regarding whether the intervention can be delivered with fidelity by multiple providers across sites; demonstrate feasibility of recruitment, randomization, and retention procedures; and test methods for consistent collection of follow up data from sites to minimize missing data. Preliminary data about the intervention as well as the research team's experience conducting clinical trials are important elements for successful conduct of fully powered efficacy, effectiveness, pragmatic, or implementation trials.
For more information about NCCIH recommendations for the multi-stage process of developing and testing physical and/or psychological therapeutic inputs (mind and body interventions), see the NCCIH website (https://nccih.nih.gov/research/blog/clinical-mind-body; https://nccih.nih.gov/grants/funding/clinicaltrials).
Overview of NCCIH Mind and Body Clinical Trials Research Funding Opportunities
NIH defines a clinical trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
NCCIH has designed its Clinical Trials Program to support a range of investigator-initiated studies with funding mechanisms tailored to address different scientific questions and levels of study complexity from early stage discovery research through large-scale efficacy or effectiveness trials. For complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body approaches), this pipeline of research is supported under funding opportunities that include the following options:
i) Pre-clinical/animal studies (which may use Parent R21 or R01 FOAs).
ii) Mechanistic studies focused on the fundamental science of mind and body approaches (which may use Parent R21 or R01 FOAs).
iii) Human feasibility and intervention refinement studies to obtain preliminary data on novel interventions, new multicomponent interventions that need to be protocolized, or existing interventions requiring substantial adaptations; to assess the ability to recruit/randomize and accrue participants; to evaluate the fidelity of delivering the intervention; to assess participant adherence to the intervention and study procedures; to reliably collect outcomes data for follow-up durations; and to assess retention of participants (which may use R34 PAR-21-240). Feasibility studies are not needed when published literature or previous studies by the investigators demonstrate the feasibility of a similar interventional trial in a similar population.
iv) Multi-site feasibility clinical trials to demonstrate delivery of the intervention with fidelity across at least two geographically distinct sites; to assess adherence to the study protocol across sites; to evaluate the ability to recruit and retain participants consistently across sites; to perform minimal intervention adaptation when needed; and to collect data with consistency across sites (which may use this R01 PAR-21-241). Multi-site feasibility studies are not needed when published literature or previous studies that demonstrate that a similar intervention in a similar population can be delivered with fidelity across sites, and the investigative team has experience conducting multi-site trials.
v) Multi-site clinical trials to determine efficacy or effectiveness of an intervention in a fully powered clinical trial. Trials must be conducted across at least three distinct geographic regions and adhere to NIH policy for enrollment of diverse populations in Phase III trials. An independent Data Coordinating Center is required for multi-site trials (which may use UG3/UH3 for Clinical Coordinating Center PAR-21-243with companion U24 for Data Coordinating Center PAR-21-242).
vi) Remotely delivered and conducted clinical trials to determine efficacy or effectiveness of complementary and integrative health interventions in a representative sample (which may use R01 PAR-20-154).
vii) Dissemination and implementation science trials to support innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based complementary and integrative health interventions, tools, policies, and guidelines. Hybrid Type 1 and Type 2 effectiveness-implementation studies should use the multi-site clinical trial pathway described above in item v. Hybrid Type 3 effectiveness-implementation studies should use the NIH-wide FOAs (R21 PAR-19-275 or R01 PAR-19-274).
Research Objectives of the Mind and Body Multi-Site Feasibility Clinical Trial (R01)
This FOA invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this FOA are expected to propose a multi-site feasibility clinical trial to gather the preliminary data to demonstrate the ability to conduct a future fully powered multi-site trial (see examples below). The need for multi-site feasibility trials is expected to be justified by sufficient preliminary data from previous single site trial(s) or the published literature including: demonstration of feasibility of single site recruitment and accrual of the same or similar participants; demonstration of participant adherence to the same or similar intervention as well as retention of participants throughout the study; completion of final data collection from any related studies; and evidence that the intervention does not cause frequent or severe adverse events. This FOA will not support randomized clinical trials to determine efficacy or effectiveness. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive, fully powered, multi-site clinical trial that has the potential to make a significant impact on public health.
For this FOA, multi-site feasibility clinical trials are defined as trials that enroll from at least two sites that are geographically diverse and are likely to recruit diverse participants. Demonstrating the ability to deliver an intervention with fidelity across sites is critical to justify the ability to perform a fully powered multi-site efficacy or effectiveness clinical trial. Multiple sites are necessary in efficacy trials to increase the generalizability of the findings, representativeness of the participants, and size and diversity of the pool of eligible participants to enhance recruitment efforts. Given the limited sample sizes that can be supported under this multi-site feasibility grant mechanism, proposing to conduct fully powered tests of clinical outcomes (i.e., efficacy), or underpowered tests of outcomes (i.e., "preliminary efficacy") or attempting to use the highly variable point estimate of an effect size for future power calculations would not be appropriate or supported by this funding mechanism. Power calculations for subsequent larger studies should be based on achievable, clinically meaningful improvement in the research population due to the intervention. A comparison group is usually needed in multi-site feasibility trials to determine the acceptability and feasibility of group assignment. Investigators should consult the NCCIH website (https://www.nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses) for more information on the uses and misuses of pilot studies.
Appropriate goals for multi-site feasibility clinical trials proposed in response to this FOA include but are not limited to:
Preliminary data requirements
This FOA is appropriate when there is a clear and compelling rationale, rigorous empirical basis, and scientific premise to conduct a multi-site feasibility trial. The following preliminary data from previous human studies (preferably published in peer-reviewed literature) on the complementary or integrative health intervention in a similar patient population and age group as proposed in the current application will provide a strong justification for the proposed work:
All of the following preliminary data about the intervention (from published literature or the team’s previous research):
All of the following preliminary data demonstrating the collective team’s experience conducting clinical trials:
Additionally, it is highly encouraged, although not required, that:
Timeline
It is important that clinical trials have a realistic timeline that explicitly addresses the time from award to first participant accrual. NCCIH has an oversight process for clinical trials that may require revising and submitting a detailed study protocol, a data and safety monitoring plan, case report forms, and a study accrual and retention plan for NCCIH and single institutional review board (IRB) approvals. NCCIH has an on-site monitoring program for some multi-site trials. Applicants will be notified prior to an award if their trial will have on-site monitoring, and the study should not begin enrollment until the study initiation visit has been conducted.
Investigators should design a timeline for completion of the clinical trial and provide contingency plans to proactively confront potential delays or disturbances to the planned trial. Investigators should specify predetermined increments and dates for the study's accrual targets. Investigators are encouraged to review the NCCIH policy: Study Accrual and Retention for Human Subject Research (https://www.nccih.nih.gov/grants/policies/nccih-policy-study-accrual-and-retention-for-human-subject-research).
Continuation of the award is conditional upon satisfactory progress and subject to availability of funds. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NCCIH will consider ending support and negotiating an orderly phase-out of the award and retains, the option to periodically conduct external peer review of progress. NCCIH staff will closely monitor progress including milestones, accrual, retention, and safety, at all stages.
Information to guide investigators for preparation of clinical trial implementation can be obtained from NCCIH program staff. NCCIH clinical research policy and guidance information as well as NCCIH templates for the protocol, study accrual and retention plan, and data and safety monitoring plan are available at the following website: https://www.nccih.nih.gov/research/nccih-clinical-terms-of-award-for-human-subjects-research . Investigators are encouraged to review the NCCIH Clinical Research Toolbox (https://www.nccih.nih.gov/grants/toolbox) to learn more about NCCIH's requirements for clinical research. Clinical trials supported by this FOA will be required to adhere to the NIH Policy on Good Clinical Practice Training (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).
NCCIH Priorities for Clinical Trials of Mind and Body Interventions
As NCCIH's clinical research portfolio matures, NCCIH has identified targeted areas of investigation to align with the NCCIH Strategic Plan (https://www.nccih.nih.gov/about/strategic-plans-and-reports). For this funding opportunity, applications will be considered of high programmatic priority if they meet at least one element in each of the following criteria:
NCCIH strongly encourages applications to this FOA that conduct studies in diverse settings1, or the inclusion of health disparity and vulnerable populations.2
1Examples of diverse settings include families, schools, Federally Qualified Health Centers, child welfare and juvenile justice systems, and homeless shelters.
2NIH-designated health disparity populations include racial and ethnic minorities (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians, and Other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, and under-served rural populations. Other vulnerable populations include high-risk pregnant women; homeless youth, individual with disabilities; children who have experienced abuse, older adults; veterans, military personnel, and military families)
*Applicants proposing acupuncture as an intervention should consult the NCCIH website (https://www.nccih.nih.gov/grants/acupuncture-research-areas-of-high-and-low-programmatic-priorities) to determine whether the proposed study is aligned with NCCIH's updated priorities for acupuncture research.
Applications proposing research topics not identified above as high programmatic priority can be submitted but are likely to be considered of lesser or low programmatic priority, which will significantly influence programmatic relevance and reduce the likelihood of funding. Applications proposing research studies using an intervention and patient population that are the same as or very or similar to those used in studies already in progress, conducted, or published and published by other groups are likely to belower programmatic priority.
Types of Clinical Trials Not Responsive to this FOA
The following types of clinical trials are not responsive to this FOA and applications proposing such activities will be deemed non-responsive and not reviewed:
Design, Analysis, and Sample Size for Studies to Evaluate Group Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/. For this FOA, investigators should consider their proposed study design when justifying proposed sample sizes to assess feasibility and acceptability metrics.
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.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project. However, it is strongly recommended that applicants not request a budget of more than $350,000 in direct costs per year.
The scope of the project should determine the project period, but it is strongly recommended that applicants do not request a project period of more than 3 years. 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 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.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
Biographical Sketches: Document the Program Director s/Principal Investigator’s experience in leading clinical trials and expertise in the content area of the trial (e.g., intervention, study population, research methods). Even feasibility clinical trials will require a multidisciplinary team (e.g., clinician, biostatistician, data manager, study coordinator) and the application should reflect their hands-on involvement in the design and implementation of the study protocol. Applicants are encouraged to provide strong evidence of the study team's qualifications and ability to conduct the proposed as well as future research, experience as investigative team members, and previous investigative experience in related clinical trials.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget for the first year of the grant should reflect the time needed for trial startup.
Applicants are strongly encouraged to request no more than $350,000 Direct Costs per year for up to 3 years of support. The request of a longer project period or higher per-year costs must be extremely well-justified, specifying why the costs exceed those of a typical multi-site feasibility trial. The budget for the number of participants included in the trial should be based on the number of participants needed to demonstrate feasibility outcomes, not on the power for assessing efficacy on a clinical outcome, which will not be supported by this FOA.
If parts of the costs of the trial are to be provided by sources other than NIH, these contributions must be presented in detail in the budget justification. Include budget support for the publication and dissemination of findings. Applicants should budget for the services of appropriate safety monitoring, e.g. Medical Safety Monitor, Independent Medical Monitor, or Safety Monitoring Committee, as indicated (see https://www.nccih.nih.gov/grants/policies/data-and-safety-monitoring-of-nccihfunded-clinical-research).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
The Research Strategy should be organized in a manner that will facilitate peer review. The body of the application should present a concise overview of the state of the science, the current status and relevance of the trial, a discussion of the specific protocol, and the approach to data collection, analysis, and dissemination.
The following criteria should be addressed:
Significance: The significance of the proposed clinical trial and importance of the question must be clearly stated. It is particularly important to include a discussion of how the trial will test the proposed hypotheses and how or why there is clinical equipoise. The application should clearly state the need for and timeliness of the study, emphasizing how the results will address an evidence-gap and therefore advance knowledge of theory and practice in this area. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance.
The clinical significance and, when applicable, the biological relevance of the future fully powered clinical trial should be clearly stated. The application should describe the importance of the proposed multi-site feasibility trial and why a subsequent trial is necessary. It is particularly important that the application include a discussion of how the proposed early-phase trial will test the primary hypothesis, how the results of the trial (positive or negative) will guide the study team's decisions about whether a subsequent study is feasible, and/or evidence that additional studies must be completed before proceeding to a full-scale trial.
Applications should address the reasons for selection of the intervention. This may include public health impact if subsequent efficacy trials are conducted and achieve positive results, ethical dimensions, and patient perspectives on acceptability of the proposed intervention. Characteristics of any preliminary research results provided in support of the proposed project, whether conducted by the applicant or others, should be described in the application so peer reviewers may evaluate the strength of the supporting evidence. The applicant should also discuss the limitations of those data.
Innovation: Explain how the application challenges and seeks to shift current research or clinical practice paradigms or guidelines.
Approach: The research approach section should include a description of the supporting data, clinical trial experience, and the experimental approach.
Supporting data: The studies that led to the proposed clinical trial should be presented. Data from pilot studies that show the need for and feasibility of the trial should also be presented. Additional supporting data from other research should be included so the approach chosen is clearly justified and adequately framed. Applications must include the following preliminary data from human studies (preferably published in the literature) that used a mind and body approach or intervention and a clinical population similar to the one proposed in the current study:
All of the following preliminary data about the intervention (from published literature or the team’s previous research):
All of the following preliminary data demonstrating the collective team’s experience conducting clinical trials:
Additionally, it is highly encouraged, although not required, that:
Experimental Approach: A summary of the proposed multi-site feasibility trial protocol should be presented in the Research Strategy and should include the items listed below.
Letters of Support:
Letters of Support from clinicians or clinical department chairs whose support is necessary to the successful conduct of the trial should be provided from all participating sites or community organizations. Applicants are also encouraged to include documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel or facilities. Letters of commitment must be co-signed by the business official of the collaborating center.
If parts of the costs of the trial are to be provided by sources other than NCCIH, provide Letter(s) of Support signed by an authorized representative.
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.
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.
Section 2 - Study Population Characteristics
2.4 Inclusion of Women and Minorities
Describe strategies for outreach to minorities and women.
2.5 Recruitment and Retention Plan
Describe the following: (1) planned remote recruitment methods, including use of contact lists, databases, other pre-screening resources, advertisements, outreach, media/social media, and referral networks or groups; (2) any known (based on literature or prior experience) participant or study-related barriers to accrual or participation (list the barriers and describe plans to address them to optimize success); (3) contingency plans for participant accrual if enrollment significantly lags behind accrual benchmarks; (4) participant retention and adherence strategies; and (5) possible competition from other trials for study participants. Investigators are encouraged to review NCCIH Policy: Study Accrual and Retention for Human Subject Research ( https://www.nccih.nih.gov/grants/policies/nccih-policy-study-accrual-and-retention-for-human-subject-research).
Applicants must provide strong evidence of the availability of appropriate institutional resources and suitable patient populations. Documentation of the availability of eligible participants must be provided. The application must provide relevant information that addresses the feasibility of recruiting a diverse sample of eligible participants to demonstrate feasibility of meeting the NIH requirements for a representative sample in the future, fully-powered efficacy of effectivneness trial.
Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan
In addition to the NIH application requirements for data and safety monitoring for clinical trials, NCCIH requires independent monitoring for research involving human subjects. Applicants should refer to NIH’s policy on data and safety monitoring (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html), as well as the NCCIH's Guidelines for Data and Safety Monitoring (https://www.nccih.nih.gov/grants/policies/data-and-safety-monitoring-of-nccihfunded-clinical-research). The data and safety monitoring plan must explicitly describe plans to remotely monitor participant safety with appropriate safeguards to minimize risk. The Independent Monitoring Committee (IMC) or Data and Safety Monitoring Board (DSMB) will have the responsibility to review interim and final data, recommend whether the protocol should be modified, and, at each meeting, recommend whether the study should continue or be terminated early. Thus, its ethical responsibilities to the participants as well as to the integrity of the study, are of paramount importance to NCCIH. The IMC/DSMB will meet in person or by phone at least twice a year. To avoid conflicts of interest in peer reivew, applicants should not appoint IMC/DSMB members in advance of peer review, or even inquire about possible DSMB members.
Section 4 - Protocol Synopsis
4.5. Will the study use an FDA-Regulated intervention?
4.5.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status
If the proposed clinical trial will use a device, natural product (e.g., botanical, herb, dietary supplement, probiotic, vitamin, or mineral), or drug, this attachment should describe correspondence from the Food and Drug Administration (FDA) indicating whether the proposed study will require an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Investigators should describe the process and the associated timeline that will be used toattain all FDA or other applicable regulatory agency approvals necessary to the conduct of the trial. For trials using an FDA-regulated product that requires an IND or IDE application, the grant application must include evidence regarding the outcome of a pre-IND meeting, or other evidence of communication with the FDA. If the protocol is being conducted under a non-U.S. regulatory agency, the applicant should submit a plan for attaining those regulatory approvals. If the protocol is exempt from an IND or IDE, a copy of the exemption letter from the FDA should be provided as part of the PDF file attachment. The FDA has provided guidance indicating that forsubstances that are Generally Recognized as Safe (GRAS) that areused in a clinical trial to evaluate the product's ability to diagnose, cure, mitigate, treat, or prevent disease it may require an IND under part 312 (https://www.fda.gov/media/79386/download). If the FDA requires an IND application for the proposed clinical trial, the IND application must be submitted to the FDA, with no clinical-hold imposed by the FDA before the application is funded.
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
The following attachments must be included as a part of the application. Attachments permit expansion of certain elements that cannot be appropriately described in the Research Strategy. All attachments listed below must be provided or the application will not be peer reviewed.
1. Clinical Trial Experience
Applicants must provide a detailed table listing the characteristics of trials that demonstrate Key Personnel experience in trial coordination in the past 5 years. One table must be provided for each study record, with a unique filename for each study record as an attachment (e.g. "Clinical Trial Experience1.pdf" , "Clinical Trial Experience 2.pdf", etc) and must not exceed three pages.
The table columns should include:
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.
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 components of participating organizations, NIH. Applications that are incomplete, non-compliant, and/or non-responsive will not be reviewed.
To expedite review, applicants are requested to notify the NCCIH Referral Office by email at Schmidma@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Requests of $500,000 or More for Direct Costs in Any Year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
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.
In addition to the post-submission materials allowed by NIH Policy and described in NOT-OD-19-083 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-083.html), the following post-submission materials are allowed:
Clinical Trial Experience Table (e.g. due to updated enrollment numbers, publication of trial results, or newly started clinical trials).
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
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 justify the need for this multi-site feasibility trial? Will the future efficacy or effectiveness trial of the mind and body intervention be impactful? Does the applicant provide justification for why performing the future larger clinical study is important in the context of the present knowledge on clinical mind and body research?
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?
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:Does the investigative team have a track record of completing and publishing the results of clinical trials? Based on the clinical experience attachment, has the investigative team successfully recruited a similar study population in previous single- or multi-site clinical trials? Does the team have experience delivering a similar intervention with fidelity in previous single- or multi-site 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?
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: Have the investigators sufficiently justified how the proposed clinical trial will inform the design of the future efficacy trial? Does the proposed research have the potential to advance the field even if the proposed study design, methods, and intervention are not innovative?
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?
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?
Specific to this FOA:Does the proposed study relate to a larger program of research for the intervention? How strong is the evidence for equipoise for the future trial? Is the proposed design feasible? Is the mind and body intervention appropriately described? Does the recruitment and retention plan provide evidence that the accrual goals are likely to be reached within the proposed timeline? Does the application address appropriate regulatory requirements (e.g., IND, IRB)? Are adverse events appropriately captured and monitored?
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?
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 document the availability of the requisite eligible subject pool in proposed clinical sites? Is there documentation for any subcontractors or consultant commitments, as well as service agreements for personnel and facilities?
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.
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) 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 NCCIH , 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.
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 National Advisory Council for Complementary and Integrative Health. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
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.
NCCIH requires independent monitoring for research involving human subjects. Applicants should refer to the NCCIH Guidelines for Data and Safety Monitoring (http://nccih.nih.gov/grants/policies/data-safety-monitoring). The IMC or DSMB will have the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and, at each meeting, whether the study should be continued or should be terminated early. Thus, its ethical responsibilities, to the participants as well as to the integrity of the study, are of paramount importance to the NCCIH. The IMC/DSMB will meet in person or by phone at least twice a year. Applicants should not appoint IMC/DSMB members in advance of the peer review, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer reviewer committee that will evaluate the applications for scientific merit.
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) if required by the FDA.
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 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).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 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
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Peter Murray, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-4054
Email: peter.murray@nih.gov
Martina Schmidt, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3456
Email: SchmidMa@mail.nih.gov).
Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@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.
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.