FAQs

1. What types of research do National Center for Complementary and Integrative Health (NCCIH) clinical trial funding opportunities support?

NCCIH clinical trial funding opportunities fund investigator-initiated natural product, mind and body, and multicomponent intervention studies, and they are designed to support all phases of clinical intervention development and testing.

In addition to funding fully powered efficacy or effectiveness trials, we support investigators working to establish “building blocks” that bridge the gap from basic research to high-impact clinical trials of complementary and integrative health interventions. Examples include feasibility testing, assessment of outcome measures, and intervention fidelity testing. NCCIH also funds multisite clinical trials to assess the efficacy or effectiveness of a complementary or integrative health intervention. NCCIH supports dissemination and implementation research of evidence-based interventions through parent funding opportunities. 

2. How do I decide if NCCIH is the best fit for my proposal versus other National Institutes of Health (NIH) Institutes, Centers, or Offices (ICOs)?

We strongly encourage you to review the NCCIH strategic plan, including the top scientific priority areas listed in the plan, to see if your research interests align with the Center’s. You may also review the Center’s active funding opportunities and clinical trial funding opportunities for any funding opportunities of interest and the specific priorities described within them. If NCCIH is one of several NIH ICOs that are participating in a funding opportunity, pay attention to statements about our Center’s research interests. Also, look for NIH Guide Notices listed in the funding opportunity itself.

We encourage you to contact the NCCIH program director listed in the funding announcement to discuss your potential application. Please include a short summary of the specific aims of your study with your initial email to facilitate the conversation.

3. Why does NCCIH offer separate clinical trial funding opportunities for mechanistic studies and clinical outcome studies?

NCCIH recognizes a difference between clinical trials that are designed to answer specific questions about the clinical effect(s) of interventions and mechanistic studies that have the primary goal of understanding how an intervention works.

• A clinical outcome study is defined as one with the objective of determining the clinical safety, tolerability, feasibility, efficacy, and/or effectiveness of pharmacologic, nonpharmacologic, behavioral, biologic, surgical, or device (invasive or noninvasive) interventions.
• A mechanistic study is defined as one designed to understand the mechanism of action of an intervention, a biological or behavioral process, or the pathophysiology of a disease.
• NCCIH utilizes parent NIH funding opportunities and has created specific funding opportunities to support mechanistic research focused on understanding how a mind and body or natural product intervention works. NCCIH has also created a suite of separate clinical trial funding opportunities to support clinical research to develop and test the clinical safety, tolerability, feasibility, efficacy, and/or effectiveness of mind and body or natural product interventions for particular conditions. We encourage investigators to choose which research question they wish to focus on first: How does this intervention work? or Does this intervention work for a given condition? Investigators can then select an appropriate funding opportunity.

If you’re not sure which funding opportunity best suits your research, please contact nccihderinquiries@mail.nih.gov or the appropriate NCCIH program director for your research topic/question(s).

4. I did preliminary research with a different funding source but want to conduct my follow-up study with NCCIH. Is this allowed?

Yes. NCCIH welcomes applications aligned with the priorities stated in our funding opportunities. Please be sure that your previous pilot data can satisfy the preliminary data requirements outlined in the funding opportunity you select.

5. I received a good score on my clinical trial application at another NIH ICO, but they aren’t going to fund it. My research includes a complementary health intervention. Can my application be transferred to NCCIH?

In some cases, NIH applications can be transferred from one ICO to another. NCCIH must be a participating component on the funding opportunity for which the application was submitted for NCCIH to accept transfer. Additionally, the NIH ICO that accepted your application must be willing to allow the transfer of the application to NCCIH. Applicants are encouraged to begin this conversation with the program official assigned to the application before contacting NCCIH.

6. Is a foreign site for clinical trials permitted and within the scope of NCCIH clinical trial Notices of Funding Opportunities (NOFOs)?

No, NCCIH will not consider applications involving interventional clinical trials outside of the United States and Canada. NCCIH clinical trial NOFOs do permit foreign components to allow foreign collaborators on a project, but foreign sites outside of Canada may not propose any data collection. Please discuss any foreign collaboration with an NCCIH program officer prior to applying to ensure your application aligns with NCCIH policy (nccih.nih.gov/research/international-health-research).

For any NOFO, look carefully at the Foreign Institutions section, which will specify whether foreign organizations and components are allowed. Foreign institutions are only eligible for funding through direct mechanisms when specified in the NOFO.

1. How do I decide which NCCIH funding opportunity to apply for?

NCCIH has developed separate independent clinical trial funding opportunities for (1) natural product studies and (2) studies of mind and body interventions, so be sure you’re looking at the series best suited for your area of research. 

When the appropriate series of funding opportunities has been identified, choose the funding opportunity that most closely matches the stage of research that your project represents. Each series includes funding opportunities for early-phase trials, intermediate trials, and full-scale efficacy, effectiveness, or pragmatic trials. Each funding opportunity describes what type of preliminary data is needed for the stage of research that the funding opportunity supports.

If you are not sure which funding opportunity is most suitable for your research, please contact nccihderinquiries@mail.nih.gov or the appropriate NCCIH program director for your research topic/question(s).

2. How do I decide what funding opportunity to use for multicomponent interventions?

We recommend using one of the mind and body NOFOs when the multicomponent intervention includes a natural product formulation that has demonstrated efficacy for the condition being studied and there is peer-reviewed and published data from at least one fully powered placebo-controlled trial of the natural product. In contrast, use of one of the natural product NOFOs is best for a multicomponent intervention when efficacy data for the natural product is lacking, but the proposed mind-body component has demonstrated efficacy in at least one fully powered trial for the condition and population being studied.

3. What kinds of human subject research will NCCIH accept through the Parent R01?

NIH now offers three options for the Parent R01 (see comparison of funding opportunity types by clinical trial allowability):

• Parent R01 Clinical Trial Not Allowed (PA-20-185): NCCIH will accept human subjects applications to this NOFO for observational studies, such as survey studies, cohort studies, or case-control studies, as well as secondary analyses of existing datasets or banked samples. This NOFO can also be used for all non-human research, including basic science, laboratory, or animal research.
• Parent R01 Clinical Trial Required (PA-20-183): NCCIH will only accept applications that propose human mechanistic trials/studies (see NOT-AT-20-001); no applications will be accepted that include specific aims proposing to assess efficacy or effectiveness of an intervention.
• Parent R01 Basic Experimental Studies With Humans Required (PA-20-184): NCCIH will accept applications that propose basic science experimental studies involving humans, defined as “studies that meet both the definition of basic research and the NIH definition of a clinical trial.” These studies assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application toward processes or products in mind.

If you are not sure which funding mechanism to use, please contact nccihderinquiries@mail.nih.gov or the appropriate NCCIH program director for your research topic/question(s).

4. I want to apply to NCCIH for funding to conduct a prospective observational study of patients being treated in real-life practice settings. Could I use a Parent R01 Notice of Funding Opportunity? 

Yes. In prospective observational studies, participants are not assigned to receive a treatment or intervention, so the study is not a clinical trial. The Parent R01 Clinical Trial Not Allowed Notice of Funding Opportunity (PA-20-185) may be used.

5. I want to apply to NCCIH for funding to analyze an existing clinical trial database to address questions that are beyond those originally addressed in the primary analyses of the trial. Could I use a Parent R01 Notice of Funding Opportunity?

Yes. Because new participants will not be enrolled and past participants will not be recontacted, the Parent R01 Clinical Trial Not Allowed Notice of Funding Opportunity (PA-20-185) may be used.

6. What will happen to my application if I submit a clinical trial focused on clinical outcomes to the Parent R01 (Clinical Trial Required) and ask for it to be assigned to NCCIH?

NCCIH won’t accept your application (see NOT-AT-20-001). The Center for Scientific Review (CSR) might be able to find another NIH ICO that will accept the application, but if other ICOs won’t accept it because it doesn't align with their research priorities, the application will be withdrawn without review. To avoid this possibility, it is recommended that applicants contact NCCIH program directors for advice prior to submission and use NCCIH clinical trial-specific funding opportunities, when appropriate.

7. What is a cooperative agreement (U award)?

A cooperative agreement (U) is a support mechanism we frequently use for high-priority research areas that require substantial involvement from NIH program or scientific staff. Once an award has been made, NCCIH will assign a program official, similar to all awards, and a program scientist, who will be more actively involved in the project, to support and stimulate the research (e.g., by participating in steering committee meetings). NIH staff will not take primary responsibility for awardee activities.

8. What is the difference between a Request for Applications (RFA) and a Program Announcement (PA, PAR, or PAS)?

Program announcements (PA) are ongoing solicitations, usually with multiple receipt dates. A PAR is a PA with special receipt, referral, and/or review considerations. A PAS is a PA that includes specific set-aside funds. RFAs are solicitations in a well-defined scientific area and are meant to achieve specific program objectives. RFAs usually have a single receipt date, are reviewed by a review group convened only for that RFA, and have set-aside funds for awarding grants. More information can be found on the NIH Office of Extramural Research website (grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/understand-funding-opportunities.htm).

1. What does NCCIH mean by a “similar” population or intervention?

In the context of feasibility trials (PAR-24-084 and PAR-24-083), the term “similar” is used to describe populations or interventions for which findings from previously conducted studies could be reasonably applied such that additional research to demonstrate the feasibility of applying the intervention under consideration to the population under consideration is not necessary. For example, a study proposing to examine vinyasa yoga in adults with anxiety could cite pilot work demonstrating the feasibility of conducting a trial evaluating hatha yoga for adults with depression and anxiety. The pilot study, which had an intervention of the same duration, could be cited for demonstrating 85 percent adherence and 90 percent participant retention at the primary outcome time point.

The applicant will need to decide and justify in their application whether the intervention and population in the proposed study are similar enough to those involved in prior work such that findings from the prior study can be applied to the proposed study or, conversely, that they are not similar enough and that a de novo study to establish feasibility is justified.

2. Are efficacy aims allowed in an application whose primary purpose is to understand the mechanism(s) of action of an intervention, a biological or behavioral process, or the pathophysiology of a disease/condition?

No, applications to the Parent R01 or R21 funding opportunity will not be accepted by NCCIH if they include any specific aims that propose to assess efficacy or effectiveness of an intervention on a health outcome (see NOT-AT-20-001). 

3. Are mechanistic aims allowed in a feasibility or clinical efficacy/effectiveness application? 

Single or multisite feasibility trials submitted under PAR-24-084 or PAR-24-083 should not include any specific aims that assess the impact/efficacy of an intervention on a mechanism of action or evaluate mediational effects. Mechanistic measures may be included in feasibility trials for the purpose of determining if collecting the mechanistic measure is feasible, which can inform whether mediation or moderation aims could be included in a future, fully powered efficacy or effectiveness trial. NCCIH uses other funding mechanisms to support basic, mechanistic and translation research (see NOT-AT-21-006). For applications submitted to the funding opportunities that accept fully powered efficacy or effectiveness trials, mechanistic outcomes could be included if a strong rationale is provided, such as the need to assess whether the effect of the intervention is mediated or moderated via the measured mechanism.

4. Are multisite trials allowed?

Yes, UG3/UH3 funding opportunities encourage the submission of multisite trials to assess efficacy or effectiveness of complementary health approaches; the NCCIH R01 PAR-24-083 funding opportunity will support multisite feasibility studies; and the NCCIH mHealth R01 PAR-24-086 funding opportunity allows the utilization of multiple sites or remote methods for regional or national recruitment. Please discuss your proposed trial with the appropriate NCCIH program director before submitting your application.

All UG3/UH3 clinical trial proposals require the submission of a companion data coordinating center application (U24). Current examples: (PAR-24-090 and PAR-24-087)

5. Are multisite trials expected to have a single Institutional Review Board (IRB)? Who will organize a single IRB?

NIH issued a policy in 2016 that establishes the expectation that a single IRB of record will be used for multisite research. You can find an introduction to this policy on NCCIH’s Research Blog and the full policy on the NIH website. Special exceptions to the single IRB rule are available for certain studies involving U.S. Department of Veterans Affairs and U.S. Department of Defense sites. 

6. How is “geographic diversity” defined for multisite and remotely delivered interventions?

NCCIH requires investigators who are proposing multisite feasibility studies or fully powered efficacy or effectiveness trials to implement their interventions across geographically diverse sites/regions to enhance the generalizability of results. “Geographic diversity” is defined as not being limited to a single city or location. Investigators will need to justify how the selected sites and/or regions provide geographic diversity and results that are generalizable to the patient population being studied.

7. Do I need a control group? Can I propose to use a waitlist control?

Investigators applying to any NCCIH clinical trial funding opportunity should propose at least one randomized controlled trial design with at least one intervention arm and one comparator arm. There should be strong rationale for the comparator condition (e.g., time and attention control, usual care, standard of care, sham condition, and/or active comparator(s)), based on the research question you plan to address in the powered trial (or future powered trial, in the case of feasibility studies).

Due to lack of rigor and potential expectancy effects, NCCIH will not support studies proposing a waitlist comparator condition. In some situations, an open label pilot may be informative as part of a series of studies, to gather qualitative feedback about an intervention and its acceptability before a randomized trial is conducted. However, applications to all NCCIH clinical trial funding opportunities must include at least one randomized trial that includes a comparator condition.

8. Should I include an interim analysis in my application?

NCCIH recommends that applications for fully powered efficacy or effectiveness trials should include at least one planned interim analysis. Plans for interim analyses should be described in detail and include plans to assess futility based on the inability of successfully completing the trial due to poor enrollment or poor adherence to the intervention; conditions for early stopping due to such futility or early achievement of primary clinical outcomes; plans to assess safety; and while not common, any plans to reassess or recalculate power, or modify sample size (e.g., to confirm an expected event rate during the trial or to confirm the expected intra-class correlation (ICC) for cluster-randomized trials). In the rare situation when an application does not propose interim analyses, the application should justify why they are not planned.

9. How much preliminary data is needed to propose a pragmatic clinical trial?

When pragmatic trials are conducted in a health care setting, it is important that scientific evidence exists that demonstrates the efficacy of the intervention under ideal settings. This evidence can come from fully powered single or multisite efficacy trials, which should provide the foundation of evidence needed to convince health care settings that they should participate in a trial to evaluate the effectiveness of the intervention in the real world setting of their health care system. Health care systems are complex organizations, and burdening the clinical staff with complex or difficult research data collection is often untenable. 

10. If preliminary data is required, does it need to be published?

Yes. If preliminary data is required, only published data will be accepted. In preparing your grant application, please carefully read the preliminary data requirement section of the funding opportunity to obtain specifics regarding the required pilot feasibility data.

11. Is a recruitment plan required? Will NCCIH monitor progress of the trial? Are there consequences for failing to meet the recruitment milestones?

Yes, yes, and yes. Please consult NCCIH’s policy on Study Accrual and Retention for Human Subject Research for details. This policy provides transparency on how NCCIH carries out oversight of study accrual and retention. Corrective actions, up to and including cessation of recruitment for a study, are outlined in this policy.

12. What is a Data Safety and Monitoring Plan?

A complete description can be found on the NCCIH website: Data and Safety Monitoring of NCCIH-Funded Clinical Research. The website includes sample templates that applicants may use.

13. How does an applicant decide what the appropriate level of data and safety oversight is?

You can learn more from the documents in the NCCIH Clinical Research Toolbox and from the NCCIH policy on Data and Safety Monitoring of NCCIH-Funded Clinical Research.

NCCIH requires independent monitoring of all human subject research, including observational designs. A Data and Safety Monitoring Board (DSMB) is required for all Phase III trials and should be considered for other clinical trials with elevated safety risks.

14. What kind of expertise is needed on an Independent Monitoring Committee or Data and Safety Monitoring Board?

In general, the committee should have several members, and we recommend that at least one of the independent monitors has expertise in each of the following areas: human subject research monitoring, relevant disease expertise, expertise with the intervention or observation technique under study, and a biostatistician. NCCIH strongly encourages applicants to ensure that all independent monitors have an advanced graduate-level degree (e.g., Ph.D. or M.D.). Additional information for data and safety monitoring for NCCIH-funded clinical trials can be found at nccih.nih.gov/grants/policies/data-and-safety-monitoring-of-nccihfunded-clinical-research. The NCCIH Data and Safety Monitoring Board Charter Sample Document can be downloaded at files.nccih.nih.gov/nccih-dsmb-charter-template-august-2019-508.docx. 

15. Why do I need an independent Data Coordinating Center for a multisite efficacy/effectiveness trial?

For multisite efficacy/effectiveness trials, NCCIH requires investigators to submit paired applications for a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC). The CCC is in charge of implementing the clinical trial across multiple sites. The DCC provides data coordination and management across sites as well as safety monitoring and reporting. The DCC also prepares interim data reports for the DSMB, conducts study analyses, and assists with dissemination of findings. An independent DCC helps to enhance the integrity of data collection and analyses by ensuring appropriate blinding of staff handling the data. 

16. Is it necessary to register all clinical trials with clinicaltrials.gov?

Yes, investigators must register all clinical trials with clinicaltrials.gov. Your study may meet the NIH definition of a clinical trial even if you are studying healthy participants, your study does not have a comparison group (e.g., placebo or control), your study is utilizing a behavioral intervention, or only one aim or sub-aim of your study meets the clinical trial definition. For more details, review the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.

1. Do I need a control group in a feasibility study? Can I propose to use a waitlist control?

Investigators applying to any NCCIH clinical trial funding opportunity, including one that supports feasibility work, must propose at least one randomized controlled trial design with at least one intervention arm and one comparator arm. There should be strong rationale for the comparator condition (e.g., time and attention control, usual care, standard of care, sham condition, and/or active comparator(s)), based on the research question you plan to address in the powered trial (or future powered trial, in the case of feasibility studies). 

Due to lack of rigor and potential expectancy effects, NCCIH will not support studies proposing a waitlist comparator condition. In some situations, an open label pilot may be informative as part of a series of studies, to gather qualitative feedback about an intervention and its acceptability before a randomized feasibility trial is conducted. However, applications to all NCCIH clinical trial funding opportunities must include at least one randomized trial that includes a comparator condition.

2. Do I need a biostatistician on my application for a pilot feasibility study?

NCCIH strongly encourages that all clinical trials, including pilot feasibility studies, include a biostatistician as part of the key personnel. A biostatistician is highly beneficial in planning study design, monitoring data completeness, and conducting data analysis. Investigators should consult the NCCIH website (nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses) for more information on the uses and misuses of feasibility studies.

3. What is the appropriate use of statistics in feasibility studies? Can I estimate preliminary efficacy or an effect size?

Pilot or feasibility studies are carried out in preparation for future large-scale, adequately powered studies and therefore, should address key issues of process (e.g., recruitment, retention, feasibility, adherence, and/or fidelity) and/or outcomes assessment (e.g., feasibility of the method; frequency, burden, and duration of data collection). Applicants should define feasibility/acceptability with quantitative benchmarks corresponding to each assessment category. Statistical methods should be mainly descriptive to assess feasibility and acceptability benchmarks.

Proposing to conduct fully powered tests of clinical outcomes (i.e., efficacy) or underpowered tests of outcomes (i.e., preliminary efficacy) or attempting to utilize the highly variable point estimate of an effect size for future power calculations is not appropriate. Applications to the R34 and multisite feasibility R01 that propose to estimate effect sizes or measure efficacy are noted as nonresponsive and will be withdrawn. Investigators should consult the NCCIH website (nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses) for more information on the uses and misuses of feasibility studies.

4. How do I determine a sample size for pilot feasibility studies?

Scientific, practical, and/or statistical justification should be provided to demonstrate that the sample size is sufficient to make a feasibility/acceptability determination in accordance with pre-specified benchmarks. Sample size calculation could be performed based on precision of estimating feasibility benchmarks (i.e., confidence interval of feasibility measures). A sample of at least 30 per arm (intervention and control) is generally recommended, but this can vary. Investigators should consult the NCCIH website (nccih.nih.gov/grants/pilot-studies-common-uses-and-misuses) for more information on the uses and misuses of feasibility studies.

5. Is it necessary to register a feasibility clinical trial with clinicaltrials.gov?

Yes, investigators must register all clinical trials with clinicaltrials.gov. Feasibility trials meet the NIH definition of a clinical trial if any clinical outcomes are collected. Your study may meet the NIH definition of a clinical trial even if you are studying healthy participants, your study does not have a comparison group (e.g., placebo or control), your study is utilizing a behavioral intervention, or only one aim or sub-aim of your study meets the clinical trial definition. For more details, review the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.

1. What NCCIH funding opportunities can I use for remotely delivered or mHealth interventions?

NCCIH welcomes research on remotely delivered or mHealth interventions in all of our NOFOs. Choosing the right funding opportunity depends on the stage of intervention development, the approaches included in your intervention (i.e., mind and body, natural product, or multicomponent), and whether any in-person contact with research participants is proposed. Please see our Funding for mHealth and Remotely Delivered Interventions webpage for more information.

2. Can I adapt an in-person intervention for the mHealth R01 Funding Opportunity (PAR-24-086)?

Adaptation of an in-person intervention to a virtual intervention is not appropriate for PAR-24-086. The mHealth R01 (PAR-24-086) is best utilized when there is a compelling rationale, a rigorous empirical basis, strong feasibility and safety data, and scientific premise to conduct a fully powered, remotely delivered efficacy, effectiveness, or pragmatic clinical trial. For investigators interested in adapting an in-person intervention for remote delivery, establishing single or multisite feasibility for an adapted mHealth intervention, or providing partial remote delivery of a multicomponent intervention, the R34 Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (PAR-24-084) and the R01 Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (PAR-24-083) are recommended.

3. Can I develop an app as part of an mHealth clinical trial?

New app development requires significant time and resources and is outside the scope of NCCIH clinical trial funding opportunities. For investigators interested in app development, NCCIH and NIH Institutes fund scientists and entrepreneurs interested in research and development via Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant funding opportunities. 

4. Are mobile health apps and devices subject to U.S. Food and Drug Administration (FDA) regulations?

For applications that propose the use of an app or clinical decision support software, applicants must consult with their IRB to determine whether the approach may qualify as a medical device. If so, applicants must contact the FDA prior to applying to determine whether investigational device exemption (IDE) approval is necessary for the proposed clinical research (fda.gov/medical-devices/software-medical-device-samd/your-clinical-decision-support-software-it-medical-device).

5. How is “geographic diversity” defined for remotely delivered interventions?

NCCIH requires investigators who are proposing multisite feasibility studies or fully powered efficacy or effectiveness trials to implement their interventions across geographically diverse sites/regions to enhance the generalizability of results. “Geographic diversity” is defined as not being limited to a single city or location. Investigators will need to justify how the selected sites and/or regions provide geographic diversity and results that are generalizable to the patient population being studied.

1. What other attachments are required with an application?

In preparing your grant application, it is important to note that other attachments may be required. The table below provides a listing of other attachments that may be required for NCCIH clinical trial funding opportunities. Please read the funding opportunity carefully to note which of the following Other Attachments you will need to include with your application. If you include an attachment that is not requested by the funding opportunity, your application will be rejected before review. Similarly, if you fail to include a required attachment, your application will not be reviewed.

 2. If required by the NOFO, how many Clinical Trial Experience Tables should I include? Can I submit a table for each of the key personnel?

If requested in the funding opportunity to which you are applying, one table must be provided that includes all key personnel, and it must not exceed three pages. If your application includes more than one clinical trial (i.e., more than one study record), you may submit one table per study record, with a unique filename for each study record (e.g., “Clinical Trial Experience1.pdf”, “Clinical Trial Experience 2.pdf”), as attachments. For two or more study records, it will be helpful to include more than one Clinical Trial Experience Table if key personnel are different for each trial (i.e., study record).

3. If required by the NOFO, should I only include those clinical trials in the Clinical Trial Experience Table where all the key personnel have collaborated in the past?

The Clinical Trial Experience Table does not have to be collaborative (i.e., you could list trials that a single key person worked on, where others were not involved), but you are only allowed one table to summarize the experience of all key personnel involved.

4. If required by the NOFO, how many years of experience should I report in the Clinical Trial Experience Table?

The Clinical Trial Experience Table should demonstrate experience of key personnel in clinical trial conduct/coordination over the past 5 years.

5. If required by the NOFO, what information should be included in the Milestone Plan? Is there a template for the Milestone Plan that I could follow?

The Milestone Plan should describe the key milestones that need to be met throughout the lifecycle 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 need to be included in the plan. Some sample milestones can be found in the NCCIH Clinical Trials Toolbox.

6. Is data sharing required?

Yes, data sharing is now required by NIH. All applications are subject to the 2023 NIH Data Management and Sharing Policy (nccih.nih.gov/grants/policies/data-management-and-sharing-policy). 

7. How flexible is the recommended budget limit?   

Part 2, Section II of every NOFO describes the direct cost limit of the entire award, as well as per year or per phase direct cost limits for multi-year awards. Budgets in excess of these limits require NCCIH approval in advance of application submission as outlined here (nccih.nih.gov/grants/policies/nccih-policy-applications-for-large-budget-clinical-trials-over-500000-in-direct-costs-in-any-year).

1. Who will review applications submitted in response to NCCIH clinical trial funding opportunities?

Applications submitted to the Notice of Special Interest in Fundamental Science Research on Complementary and Integrative Health Approaches via the Parent R01 and R21 Notices of Funding Opportunities (NOT-AT-21-006), whether for natural products or mind and body interventions, are reviewed by standing study sections in the NIH Center of Scientific Review. Applications submitted to the Dissemination and Implementation Research in Health R01 (PAR-22-105) or R21 (PAR-22-109) are also reviewed by a standing study section in the NIH Center of Scientific Review. 

Most applications to NCCIH clinical trial funding opportunities will be reviewed by NCCIH special emphasis panels with expertise in both clinical trials and complementary health approaches. The panels will include experts familiar with the unique challenges faced by this research community. Panel members also provide valuable advice to NCCIH and constructive feedback to investigators. 

2. I’ve heard that applications may be returned without review if they don't contain the required elements or aren’t compliant with the funding announcement instructions. Is this true, and how can I be sure that my application is complete and compliant?

Yes. It’s standard procedure at NIH to review applications for completeness. The NCCIH clinical trial funding opportunities describe attachments and information that must be included for your application to be considered responsive and complete. If your application does not include these required elements, it will be returned to the submitting institution. Please check for “Related Notices” in the funding opportunity in case there have been any changes to required elements.

In addition, the funding opportunities indicate what stage of research will be supported by each funding opportunity. Each funding opportunity provides a list of clinical trials that are not responsive to that specific funding opportunity. If your proposed trial is not responsive to the funding opportunity (for example, if you submit an application for an efficacy trial to an early phase clinical research funding opportunity), your application will be deemed nonresponsive and will not be reviewed.

3. Does NCCIH have a payline?

The Center uses funding zones for most grant mechanisms, and these can provide investigators with an idea about the likelihood that their application may be funded. Each grant mechanism has its own funding zone. The most up-to-date funding zones are located at nccih.nih.gov/grants/funding-strategy.