Participating Organization(s) |
National Institutes of Health (NIH) |
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM) |
|
Funding Opportunity Title |
Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) |
Activity Code |
R34 Planning Grant |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-14-182 |
Companion Funding Opportunity |
PAR-17-215 , U01 Research Project-Cooperative Agreements |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.213 |
Funding Opportunity Purpose |
The goal of this funding opportunity is to support early phase clinical trials of mind and body approaches for conditions that have been identified by NCCAM as high priority research topics. This funding opportunity is intended to support exploratory clinical trials, which will provide data that are critical for the planning and design of a subsequent controlled cohort study, clinical efficacy or effectiveness study, or a pragmatic trial. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial. This FOA is not appropriate for support of randomized clinical trials to test or determine efficacy or effectiveness. Applications that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial are not appropriate for this announcement. The subsequent larger trial should have the potential to make a significant impact on public health. |
Posted Date |
April 18, 2014 |
Open Date (Earliest Submission Date) |
September 10, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
New Dates October 10, 2014, February 10, 2015, June 10, 2015, October 9, 2015, February 10, 2016, June 10, 2016, October 11, 2016, February 10, 2017, June 10, 2017, October 18, 2017, by 5:00 PM local time of applicant organization.
Additional due dates for resubmissions: 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. |
AIDS Application Due Date(s) |
Standard dates apply by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
New Dates February-March 2015, June-July 2015, October-November 2015, February-March 2016, June-July 2016, October-November 2016 February-March 2017, June-July 2017, October-November 2017, February-March 2018 |
Advisory Council Review |
New Dates May 2015, October 2015, January 2016, May 2016, October 2016, January 2017, May 2017, October 2017, January 2018, May 2018 |
Earliest Start Date |
New Dates July 2015, December 2015, April 2016, July 2016, December 2016, April 2017, July 2017, December 2017, April 2018, July 2018 |
Expiration Date |
New Date January 8, 2018 per issuance of NOT-AT-17-014 . (Original Expiration Date: September 8, 2017 ) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
There is a critical need for research studies to evaluate these practices as they are used and delivered to determine whether or not they provide benefit, as the public believes, or if they have any deleterious side effects. For larger trials to be impactful, they must be well designed and test hypotheses that will guide decisions about their inclusion into the delivery of health care. A series of early-phase clinical trials can be conducted to gather the multiple types of preliminary data needed to design large and rigorous efficacy and effectiveness studies. This FOA will support early-phase clinical trials in the area of mind and body research.
Mind and body research encompasses a wide variety of interventions which are based in physical procedures or techniques administered or taught to others by a trained practitioner or teacher. Although the scientific literature may provide the rationale for conducting a clinical trial, investigators often lack critical information about the intervention, the outcome, or recruitment strategy necessary to design an efficacy or effectiveness trial. Exploratory clinical trials can fill this information gap, thereby improving study design and knowledge of trial feasibility. For more information about what NCCAM recommends for the multi-staged process for mind and body intervention development and testing, see the NCCAM website (http://nccam.nih.gov/grants/mindbody/stages). In order to elucidate the optimal research strategy, a number of steps may be necessary, such as adaptation of the intervention to a specific patient population; refinement of the intervention to determine the appropriate duration or frequency of treatment; or determination of the appropriate outcome measure.
Exploratory intervention trials submitted to this FOA should not be scaled down randomized controlled trials (RCTs) that propose to primarily test the efficacy of the intervention on clinical outcomes. It is expected, however, that results obtained under this NCCAM R34 FOA could lead to submission of subsequent grant applications for support of such studies. Indeed, as described below, depending on the stage of intervention development, the R34 project might not involve randomization, but rather might focus on earlier stages, such as operationalizing an intervention protocol and corresponding manual and/or pilot testing the experimental intervention in a sample drawn from the target population.
Most importantly, the R34 should propose the developmental work to be performed that would enhance the probability of reaching more definitive outcomes in a larger trial. This is best done by working out the details of the experimental protocols, including the assessment protocol, the experimental intervention protocol, as well as the comparison intervention protocol and randomization procedures (if appropriate); examining the feasibility of recruiting and retaining participants into the study conditions (including the experimental condition and the comparison condition, if relevant); and developing supportive materials and resources. Investigators should keep in mind the future planned trial and then design the R34 to provide the necessary preliminary data for a future efficacy, effectiveness, or pragmatic trial; or controlled cohort or case-control study.
Accordingly, collection of preliminary data regarding feasibility, acceptability, safety, tolerability, and target outcomes is appropriate. Given the limited sample sizes that can be supported under this exploratory R34 grant mechanism, proposing the use of a comparison group for conducting fully powered tests of outcomes (i.e., efficacy) or attempting to utilize the highly variable point estimate of an effect size for power calculations would not be appropriate. Power calculations for subsequent larger studies should be based on an achievable, clinically meaningful improvement due to the intervention in the research population. A comparison group could be proposed for some aspects of the exploratory study, such as for determining the acceptability and feasibility of group assignment.
The goal of this FOA is to provide support to investigators for such early phase clinical trials on mind and body approaches that have been identified as priority areas of research for NCCAM (see below). Applicants are encouraged to submit R34 grant applications that focus on exploratory clinical trials of mind and body approaches, using a variety of study designs (e.g., intervention refinement, feasibility testing, or assessing acceptability and adherence to various doses of the intervention).
Potential applicants are encouraged to contact Scientific/Research staff as far in advance as possible to discuss the match between potential research applications and current NCCAM priorities.
Research Scope
As NCCAM's mind and body clinical research portfolio matures, NCCAM is identifying targeted areas of investigation for complementary health approaches as part of the clinical research program. There are many areas of research with scientific promise and potential. However, for this funding opportunity applications will be considered of high programmatic priority if they meet the following two criteria:
- The mind and body or integrated approach must include one or more of the following: spinal manipulation, mobilization, massage, tai chi, qi gong, yoga, acupuncture*, hypnosis, guided imagery, light therapy, breathing activity, progressive relaxation, meditation, biofeedback, or mindfulness techniques. Integrated approaches to care could include one or more of these complementary health approaches added to standard care or other interventions such as a natural product, pharmacological approach, and/or another conventional behavioral approach (e.g. health coaching, physical activity or nutritional recommendations).
- In addition, proposed projects must study a mind and body or integrated approach for one of the following high priority topic areas: symptom management, particularly for chronic pain syndromes; reduction of prescription drug (opioid) use or abuse in patients with chronic pain; medication adherence; post-traumatic stress (disorder); traumatic brain injury; sleep disorders or disturbances; anxiety; depression; promotion of psychological resilience; weight loss and weight loss maintenance; smoking cessation; and promotion of healthy eating and physical activity.
*Applicants proposing acupuncture as an intervention should consult the NCCAM website (http://nccam.nih.gov/grants/acupuncture/priorities) to determine if the proposed projects are aligned with NCCAM's updated priorities for acupuncture research
Examples of research projects include but are not limited to the following:
- Mind and body intervention refinement to assess acceptability and adherence to dose, frequency and/or duration for testing in a future clinical trial.
- Intervention refinement to address challenges with intervention fidelity, participant adherence, or participant retention.
- Development and feasibility testing of a mind and body or integrated approach to be tested in pragmatic trials within a health care system.
- Assess acceptability or feasibility of randomization or other aspects of trial design.
- Develop an appropriate control/comparison intervention for a future larger study.
- Extend observational studies to elucidate relevant patient or practice characteristics (e.g., demographics, beliefs, attitudes, patient-provider information) to facilitate design of future controlled cohort or case-control studies.
- Extend observational studies to demonstrate feasibility, identify characteristics of patients who adhere to specific interventions, and test methods for outcome collection in practice-based settings, which would facilitate design of future controlled cohort or effectiveness studies.
NCCAM encourages applications to this FOA that meet the above criteria and also address health disparities, symptom management in patients with HIV/AIDS, utilize special populations such as older adults, children, individuals in the military, or veterans.
This NCCAM R34 FOA will not support studies of experimental models of disease or animal studies; studies to discover or validate biomarkers; studies to elucidate potential mechanisms of mind and body approaches; or fully-powered randomized clinical trials designed to test efficacy or effectiveness. Randomization may be employed as a methodological approach for addressing the feasibility of recruiting and retaining participants into study conditions and for meeting other goals of this FOA. Other FOAs should be considered for applications with these aims. Applications proposing research in topics not identified above as high programmatic priority will be considered of low programmatic priority, which reduces the likelihood of funding.
Optional Administrative Period
In view of the preliminary work required to initiate research activity for exploratory clinical testing of mind and body interventions, this NCCAM R34 can provide support for an early administrative period of the award, prior to implementation of the preliminary clinical trial. This early administrative period of the award can be up to 12 months in length and could include support for, but is not limited to, developing tools for data management and clinical safety oversight (including the Data and Safety Monitoring Plan [DSMP]), finalizing the clinical protocol and informed consent documents, developing the manual of operations/procedures, and obtaining appropriate regulatory approvals (e.g., IRB, FDA). Investigators are encouraged to review the NCCAM Clinical Research Toolbox (http://nccam.nih.gov/grants/toolbox) to learn more about NCCAM's requirements for clinical trials. Successful achievement during the early administrative period will be a requirement for initiating clinical testing and continued support of the project.
Subsequent Studies
The objective of this NCCAM R34 funding opportunity is to increase the quality of clinical trials that evaluate mind and body approaches. Investigators are encouraged to include relevant stakeholders (e.g. patients, providers, health care systems, etc.) in the planning and execution of exploratory and larger clinical trials. The products of a successful R34 award period are the data necessary to design and carry out a well-executed clinical trial, a decision whether a subsequent study is feasible or justified, and/or evidence that additional studies must be completed before proceeding to a full-scale trial. If warranted by the studies conducted, R34 awardees may prepare and submit an application for a full-scale trial during the final year of the R34 award period. Please note that issuance of the R34 award does not guarantee or imply that the NCCAM will accept or fund a subsequent full-scale clinical trial application.
Consultation with NCCAM:
Applicants are encouraged to consult with NCCAM Scientific/Research staff as plans for an application are being developed (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NCCAM policies and guidelines for clinical trials.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Applicants may request up to $100,000 in direct costs for the optional initial administrative period (up to 12 months) of the award. This R34 is limited to direct cost requests of up to $450,000 over the entire project period. Although variations from year to year are permissible, in no case may any year be more than $225,000 in direct costs. |
Award Project Period |
The maximum project period is 3 years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
For more information, see NCCAM's statement on International Interventional Clinical Studies: NCCAM Special Considerations (http://nccam.nih.gov/grants/internationalclinicaltrials).
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
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, with the following additional instructions:
Provide a listing of all clinical sites, pharmacies, and laboratories to be used in the clinical trial.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Facilities and Other Resources: Applicants are encouraged to provide strong evidence of the availability of appropriate institutional resources, and suitable patient populations. Documentation of availability of eligible subjects at clinic sites, presented in tabular format should be provided. The application should include relevant information that addresses the feasibility of recruiting participants who are eligible for the clinical trial. Specifically, applicants must provide evidence that each recruiting center in the trial has access to a sufficient number of study participants who meet the eligibility criteria as defined in the submitted protocol. For multi-site applications, information must be provided for each site participating in the trial.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketches: Documentation of the Program Director s/Principal Investigator’s experience in leading clinical trials and expertise in the content area of the trial. Biographical sketches for all key study personnel must be provided. Even exploratory clinical trials will require a multidisciplinary team (clinician, biostatistician, data manager, study coordinator, etc.) 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, experienced investigative team members, and previous investigative experience in related clinical trials.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 http://nccam.nih.gov/grants/policies/data-safety-monitoring).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: The specific aims of the exploratory clinical trial must be clearly and concisely presented. The primary and major secondary hypotheses to be evaluated must be clearly stated.
Research Strategy:
Clinical Significance and Biological Relevance: Applicants must provide a clear and compelling rationale for pursuing the proposed early-phase clinical trial and development of the intervention, as well as for other critical aspects of the research design (e.g., frequency or schedule of intervention, duration of treatment, choice of endpoints of interest, feasibility and acceptability of the intervention, retention and adherence estimation, fidelity of the intervention etc.). There must be a strong rationale as to why the specific intervention proposed is likely to be beneficial for the clinical condition under study.
The clinical significance and, when applicable, the biological relevance of the future clinical trial must be clearly stated. The importance of the proposed exploratory trial must be described and why it is necessary to plan the subsequent future trial. It is particularly important that there be discussion of how the proposed early-phase trial will test the primary hypothesis and how the results of the trial (positive or negative) will guide decisions about whether a subsequent study is feasible or justified, and/or evidence that additional studies must be completed before proceeding to a full-scale trial.
Prior Studies and Rationale for Development: The major findings of the preclinical and clinical studies that led to the proposed clinical trial should be described. Justification for the study from preliminary data may be presented as results from previous clinical studies conducted by the investigative team or from the scientific literature. Pilot studies that show the need for, and the feasibility of, the trial should also be discussed. Study conceptualization and planning must be at a stage sufficient to allow for an assessment of the likelihood of trial success.
Applications should address the reasons for consideration of the intervention. This may include public health impact if subsequent efficacy trials are conducted and positive; 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 that peer reviewers may evaluate the strength of the supporting evidence. The applicant should also discuss the limitations of those data.
Study Design: A summary of the proposed exploratory trial protocol should be presented in the Research strategy and must include the items listed below.
- A description of the study design (e.g., assessment of various doses for acceptability and adherence, iterative intervention development, etc.) and the rationale for this choice.
- Preliminary data to justify the choice of intervention for the indication being proposed for study.
- A description of the intervention to be tested and how it will be administered.
- A description of the target population, and why it is an appropriate group to address the proposed hypotheses and how results will generalize to the population at large.
- A list of participant eligibility criteria or group eligibility criteria.
- Participant recruitment and retention plans, including a discussion of the availability of participants for the proposed study and the ability of enrollment sites to recruit and retain the proposed number of participants, including women and minority participants. Data supporting recruitment and retention estimates must be provided.
- A description of all assessments including clinical, laboratory, physiological, behavioral, patient-centered, or other outcomes addressing the primary and secondary research questions. Use of patient reported outcomes, including those available through PROMIS, NIH Toolbox, and NeuroQoL, as well as non-traditional data collection approaches (e.g., telephone, mobile devices, or web-based systems) should be considered.
- Statistical Methods: Discussion of sample size justification; study outcome measures; plans for interim (if any) and final analyses; methods of bias control; and methods for handling missing data.
- Data Management and Quality Control: Details of efficient data management and methods for monitoring quality; methods for monitoring the quality and consistency of intervention administration; and methods for ensuring participant confidentiality.
- Discussion of the challenges expected in implementing the trial and how these might be overcome.
- Design and Implementation: Applicants must provide a clear description of the outcome measures; participant eligibility criteria; procedures to minimize bias in allocation of participants to treatment and in assessment of outcomes; the treatment regimen; and participant follow-up procedures. Statistical methods should be proposed that are appropriately matched to the study design. Sample size justifications, and plans for analyses, data management, and quality control must be included. Given the page limit for the Research Strategy in applications, applicants are encouraged to concisely state the scientific relevance and potential impact of the proposed research. The approach should be summarized clearly in the application, with specific references to the protocol to be submitted as an appendix, where methodological details should be described (see "Appendix" under Section IV.2).
- Timeline: Applicants should include a proposed timeline for reaching important study milestones such as: (a) obtaining regulatory approval of the final protocol; (b) establishing agreements with participating industry partners, if indicated; (c) finalizing the study procedures and training participating clinical site staff; (e) enrolling 25%, 50%, 75%, and 100% of the targeted sample size; and (f) completing all subject follow-up and data collection activities.
- Descriptions of the organization of the study and how the trial will be managed.
- If an administrative period is proposed, a timeline and milestones during this period should be provided.
- Future Clinical Trial: A concise summary of the subsequent proposed trial should be provided including the study design (efficacy, effectiveness, pragmatic, controlled cohort, or case-control study).
Human Subjects Protections: Applications that propose a clinical trial must include a Data and Safety Monitoring Plan (DSMP) that is commensurate with the study size, complexity and risks posed to study participants (see https://grants.nih.gov/grants/guide/notice-files/not98-084.html). The DSMP provides a general description of a monitoring plan that will serve as the overall framework for data and safety monitoring of the study. The DSMP must be included in the study protocol and address the following elements:
- Who will perform the monitoring?
- What data will be monitored?
- What is the planned frequency of monitoring?
- What policies and procedures will be implemented to ensure confidentiality of subject identifiers and accuracy/ completeness of accumulating data throughout the monitoring process?
- What are the timeframes for reporting unanticipated problems and serious adverse events to NCCAM and applicable regulatory agencies?
As part of general oversight and scientific leadership of the study, the study’s PD/PI is expected to play an integral role in the data and safety monitoring of the study. In addition, NCCAM 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 NCCAM Guidelines for Data and Safety Monitoring http://nccam.nih.gov/grants/policies/data-safety-monitoring.
Letters of Support: 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.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
- Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. The following additional documents must be included in the Appendix as separate files.
- Draft Clinical Protocol. A study protocol must be included as Appendix I. Applications that do not include a draft protocol are incomplete and will not be reviewed.
- Draft informed consent form(s) (ICFs) and, if applicable, assent form(s). The applicant should consider including language in the ICF to allow broad data and specimen access for subsequent research in order to maximize the value of subject samples and data and accelerate progress beyond the trial itself.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
For more information, see NCCAM's statement on International Interventional Clinical Studies: NCCAM Special Considerations (http://nccam.nih.gov/grants/internationalclinicaltrials).
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
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 Applying Electronically.
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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow our Post Submission Application Materials policy.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? 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?
Does the applicant describe how the results of the pilot and feasibility studies will lead to the development of a larger more definitive study? Does the applicant provide justification as to why it is important to perform the future larger clinical study in the context of the present knowledge on clinical research on mind and body therapies? Is there a sufficient body of preclinical or clinical research of high scientific rigor to support the study rationale? Is it clear why the proposed exploratory trial is essential to inform the design and implementation of subsequent steps in the evaluation of the intervention? Is the proposed project likely to yield clear answers needed to proceed to the next step of the therapeutic development of the intervention as proposed in this application?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application provide strong evidence of necessary experience and expertise with the intervention, the study population, and the research methods to be employed? Does the investigative team have a track record of publishing the results of clinical trials previously completed? Has the investigative team successfully recruited the study population in previous clinical trials?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the proposed trial have the potential to advance the field (e.g., by breaking ground for future trials in this area) even if (a) the proposed study design, methods, and intervention are not innovative, and/or (b) the results of the trial indicate that further clinical development of the intervention is unwarranted?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
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?
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
children, justified in terms of the scientific goals and research strategy
proposed?
Does the applicant describe how the proposed study relates to a larger strategy for research and development on the intervention, and will it provide pilot and feasibility data needed to advance that strategy? Does the application demonstrate the feasibility of methods for developing tools for data management and study oversight, finalizing protocol documents and manuals, as well as addressing appropriate regulatory requirements (IND, IRB)? Are the outcome measures, dose/duration of study, appropriateness of inclusion/exclusion criteria, and sample size, clearly justified and explained in the application? Is the proposed design feasible and adequate to provide interpretable results? Is the proposed timeline feasible and appropriate for the timely completion of the trial (particularly regarding participant accrual goals)?
Are the plans for recruitment outreach appropriate and are there follow-up procedures to ensure collection of data at stated intervals? Are the retention plans and practices described?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Does the information provided in the application give reasonable assurance that the target sample size can be enrolled in the timeframe proposed? Does the application document the availability of the requisite eligible subject pool in proposed clinical center(s)? Is there documentation of the commitment of any subcontractors and consultants, as well as service agreements for personnel and facilities?
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.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six 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 six 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 Children
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 children 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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) Genome Wide Association Studies (GWAS).
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 NCCAM, 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:
- 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.
- Will receive a written critique.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
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 grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, 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.
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 registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-945-7573
TTY 301-451-5936
Email: [email protected]
Wendy Weber, N.D., Ph.D., M.P.H.
National Center for Complementary and Alternative Medicine
(NCCAM)
Telephone: 301-402-1272
Email: [email protected]
Dale L. Birkle Dreer, Ph.D.
National Center for Complementary and Alternative Medicine
(NCCAM)
Telephone: 301-451-6570
Email: [email protected]
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH) (Previously NCCAM)
Telephone: 301-594-3788
Email: [email protected]
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 Parts 74 and 92.
