Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute of Mental Health (NIMH)
New
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
None
93.242
NIMH seeks applications for pilot projects to evaluate the preliminary effectiveness of interventions targeting sustained and enhanced treatment response following acute treatment for anorexia nervosa (AN). An emphasis is placed on trials that go beyond seeking incremental gains in intervention effects, and instead take a theory-driven, empirical approach to developing and testing interventions that will have a significant impact on weight restoration and psychological symptoms associated with AN. Consistent with an effectiveness framework, studies should take a deployment-focused approach to intervention development and testing, acknowledging that many patients will receive post-acute treatment from community providers unaffiliated with specialty eating disorder centers.
April 15, 2020
September 19, 2020 and May 15, 2021
October 19, 2020 and June 15,2021
No late applications will be accepted for the Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
March 2021 and November 2021
May 2021 and January 2022
July 2021 and April 2022
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.
Rationale
Anorexia nervosa (AN) is a debilitating and life-threatening psychiatric disorder that represents the third leading cause of chronic illness in adolescents. Data continue to show a mortality rate of 5% per decade for those with AN, making it the mental disorder with the highest rate of mortality. Evidence-based, short-term interventions for AN exist and are widely used in eating disorder specialty clinics. Yet even the most promising of these interventions results in weight restoration-defined remission rates that hover around 50%. When weight-based outcomes are measured at follow-up time points, the superiority of evidence-based interventions over comparator treatments disappears. The impact of evidence-based interventions on psychological symptoms is also concerning, as evidence-based interventions appear to confer no advantage over comparator treatments at either post-treatment or follow-up time points. Seeking to build upon progress that has been made to date, this Funding Opportunity Announcement (FOA) encourages research that focuses on refining and pilot testing psychosocial, pharmacological, or somatic interventions, alone or in combination/sequence, delivered during the post-acute treatment period (i.e., following weight restoration or other study-defined clinical endpoints for the acute treatment phase, such as discharge from an inpatient program or other intensive services). During the post-acute treatment period individuals with AN who have achieved weight restoration may be more physically and cognitively capable of engaging in interventions targeting psychological symptoms, have greater insight, and present a more favorable benefit:risk ratio for pharmacotherapy or neurostimulation than when they were in a malnourished or starvation state.
Research Scope and Objectives
This FOA seeks applications to evaluate the preliminary effectiveness of interventions targeting sustained and enhanced clinical response following acute treatment for AN. In this pilot research phase, trials should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach, and to obtain preliminary data that can inform the design of a large-scale, definitive effectiveness trial. Consistent with the NIMH experimental therapeutics approach, this FOA is intended to support studies that not only test the intervention effects on outcomes of interest, but also inform understanding of the intervention’s mechanisms of action. As such, applications must (1) specify target mechanisms, (2) include measurement and analytic plans designed to assess both the intervention-induced changes in the target mechanisms and the associations between changes in the target mechanisms and the intervention outcomes. For details on the experimental therapeutics approach, see the NIMH Clinical Trials web page.
Research topics may include, but are not limited to:
Due to the post-acute focus of this FOA, all applications must include plans to characterize interventions delivered during the acute treatment phase. All applications must also clearly define the discharge criteria that patients are required to meet before terminating acute treatment and becoming eligible for post-acute interventions. Applications that do not focus explicitly on the post-acute treatment period will not be considered responsive to this FOA.
NIMH encourages a deployment-focused model of intervention design and testing that considers the perspective of relevant stakeholders and key characteristics of the settings where optimized mental health interventions are intended to be implemented. The goal of this attention to end-user perspectives and intervention setting characteristics is to ensure that the resultant interventions are acceptable, feasible, and scalable, and that the research results will have utility for end users. Accordingly, this FOA encourages development and testing in community practice settings (i.e., with typical patients and providers). All studies, regardless of setting, must include plans for substantial stakeholder and end user input throughout the process.
Novel applications of technology may be particularly useful in designing and testing scalable, service-ready interventions. Applications of technology might include: technology-assisted monitoring to detect symptom changes or measure treatment adherence, digital health approaches to promote intervention skill use or deliver just-in-time interventions, clinician-facing applications to promote measurement-based care or intervention fidelity (see NOT-MH-18-031; Notice of Information: NIMH High-Priority Areas for Research on Digital Health Technology to Advance Assessment, Detection, Prevention, Treatment, and Delivery of Services for Mental Health Conditions).
NIMH encourages intervention research that includes the assessment of suicidal behavior to advance understanding of how effective prevention and treatment of mental disorders might impact suicide-relevant outcomes. This priority is particularly relevant to AN, where one-in-five deaths is due to suicide. Where feasible and appropriate, applications should include plans to assess suicidal behavior.
Information about the mission, strategic plan, and research interests of the NIMH can be found at the NIMH website. Applicants are strongly encouraged to review this information along with details provided on the NIMH Clinical Trials site.
Potential applicants are also strongly encouraged to consult with NIMH staff as early as possible in the application development process (see Scientific/Research Contacts, Section VII). Early contact provides an opportunity to clarify NIH policies and guidelines and identify whether the proposed project is consistent with the goals of this FOA and NIMH priorities.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NIMH intends to commit $2.0M (Total Costs) in FY2021 to fund up to 8 awards.
The total project period for an application submitted in response to this funding opportunity may not exceed 3 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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.
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.
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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Email: [email protected]v
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy
Significance
Justify the practical effect of the intervention in terms of both the empirical basis for the anticipated effect size and the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.
Address the degree to which the proposed intervention is scalable and could be disseminated into practice given typically available resources, service structures, and service use patterns.
Detail how results from the proposed research will lead to a firm conclusion about the feasibility and utility of a regular research project grant (e.g., R01) or full-scale clinical trial and outline the anticipated scope and goals of the intended future work.
Innovation
Highlight how innovative research strategies and design/analytic elements (e.g., adaptive sequential randomization, equipoise stratification, technology-based assessments) are incorporated, as appropriate, to enhance the study’s potential for yielding practice-relevant information.
As relevant, highlight how applications of technology are leveraged to increase the reach, efficiency, or effectiveness of interventions.
Highlight how the proposed post-acute intervention(s) differs from typical acute treatment of AN.
Where appropriate, explain how the proposed post-acute intervention(s) is consistent with an RDoC-informed understanding of AN pathology/pathophysiology.
Approach
Detail the rationale and empirical basis for the intervention in terms of intended target population, corresponding goals and focus of the intervention (e.g., remediating residual symptoms or functional impairment; preventing relapse or re-hospitalization; promoting adherence), the key window or time frame for the intervention, and the potential scalability.
Characterize the acute treatment provided to participants and specify the remission criteria that will be used to justify the participants transition from acute care to post-acute treatment.
Consistent with NIMH's experimental therapeutics approach (http://www.nimh.nih.gov/about/director/2012/experimental-medicine.shtml), detail plans to explicitly address whether the intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes). Include the following: (1) a conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms or functional deficits the intervention seeks to improve; (2) plans for assessing engagement of the target(s)/mechanism(s) using valid measures that are as direct and objective as is feasible in the effectiveness context, including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and (3) analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in the pilot trial. In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context.
Provide a clear justification for the chosen experimental design and research methods. Note that the goal of this stage of research is to propose the most rigorous means of collecting data that will inform a larger, more definitive test of the intervention.
Describe plans to involve key stake holders (e.g., community practice partners or providers, consumers, relevant policy makers) in the project in a manner that informs the research and intervention design and helps to ensure that the results will have utility for end users.
Incorporate validated outcome measures, including stakeholder-relevant outcomes as appropriate. As appropriate, include patient measures that are consistent with NIMH common data elements efforts .
Describe provisions for feasible and valid intervention fidelity monitoring.
Justify the timing of assessments and the length of follow-up, considering both the intent of the intervention and the R34 project period.
As relevant, address how the trial contributes to advancing the personalization of mental health care, and describe the collection of clinical and/or biological variables that might be used to examine moderators or inform algorithms for more prescriptive approaches.
Describe plans for the assessment of suicidal behavior and related outcomes using strategies that can facilitate the integration and sharing of data as appropriate. Provide a rationale for the selection of suicide-related constructs, the corresponding assessment instruments, assessment time periods (e.g., lifetime, history, current), and assessment schedule, considering the target population, participant burden, etc. See NOT-MH-15-009 and the PhenX Toolkit for suicide-related constructs and corresponding assessment strategies. Note that studies must also follow the Human Subjects suicide risk-related application guidelines outlined in the PHS Human Subjects and Clinical Trials Information section below.
The following modifications also apply:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All studies must indicate (in the Human Subjects section of the application) how participants will be monitored for indications of suicidal thoughts and behavior and include a clear plan for the management of these participants should elevated suicide risk be detected. In situations where it is not appropriate or feasible to include the assessment of suicide risk, a justification for the omission that is both strong and acceptable (from a Human Subjects protections perspective) should be provided.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
How well does the application justify the practical effect of the intervention in terms of both the empirical basis for the anticipated effect size and the clinical meaningfulness of the anticipated increment in effects compared to existing approaches?
If the approach is successful, to what degree is it scalable given typically available resources, service structures, and service use patterns?
How likely is it that the proposed research will generate data that will lead to a firm conclusion about the feasibility and utility of a regular research project or full-scale clinical trial?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are innovative research strategies and design/analytic elements (e.g., adaptive sequential randomization, equipoise stratification, technology-based assessments) incorporated, as appropriate, to enhance the study’s potential for yielding practice-relevant information?
As relevant, are applications of technology leveraged to increase the reach, efficiency, or effectiveness of the interventions?
Does the application highlight how the proposed post-acute intervention(s) differs from typical acute treatment of AN?
Where appropriate, is an explanation provided for how the proposed post-acute intervention(s) is consistent with an RDoC-informed understanding of AN pathology/pathophysiology?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Are there sufficient rationale and empirical basis for the intervention in terms of intended target population, corresponding goals and focus of the intervention (e.g., remediating residual symptoms or functional impairment; preventing relapse or re-hospitalization; promoting adherence) and the key window or time frame for the intervention?
Is the acute treatment well characterized and are the remission criteria used to justify participants transition from acute care to post-acute treatment appropriate?
Is the study appropriately designed to address whether the intervention engages the mechanism(s) presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes)? Does the application include (1) a well-supported conceptual framework that clearly identifies the target(s)/mechanism(s) and the empirical evidence linking the target(s)/mechanism(s) to the clinical symptoms or functional deficits that the intervention seeks to improve; (2) well justified plans for assessing engagement of the target(s)/mechanism(s), including the specific measures, the assessment schedule, and the justification for the assessment strategy (e.g., evidence regarding the validity and feasibility of the proposed measures in the effectiveness context); and (3) appropriate analytic strategies that will be used to examine whether the intervention engages the target(s) and to conduct a preliminary examination of whether intervention-induced changes in the target(s) are associated with clinical benefit, as appropriate in the pilot trial? In the case of multi-component interventions, does the application specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the target(s)/mechanism(s) corresponding to each intervention component, as appropriate in the effectiveness context?
Does the application include a compelling justification for the choice of experimental design and research methods? Do the chosen experimental design and research methods represent the most rigorous yet feasible means of collecting data that will inform a larger, more definitive test of the intervention?
Does the application include plans to involve key stake holders (e.g., community practice partners or providers, consumers, relevant policy makers) in the project in a manner that informs the research and intervention design and helps to ensure that the results will have utility for end users?
Are outcome measures validated and generally accepted by the field? Are stakeholder-relevant outcome measures included? As appropriate, are assessments consistent with NIMH common data elements efforts included?
Does the application include provisions for feasible and valid intervention fidelity monitoring?
How well justified are the timing of assessments and the length of follow-up considering both the intent of the intervention and the R34 project period?
As relevant, to what extent will the trial contribute to advancing the personalization of mental health care and describe the collection of clinical and/or biological variables that might be used to examine moderators or inform algorithms for more prescriptive approaches?
Does the application describe plans for the assessment of suicidal behavior and related outcomes using strategies that can facilitate the integration and sharing of data as appropriate? Does the application provide a rationale for the selection of suicide-related constructs, the corresponding assessment instruments, assessment time periods (e.g., lifetime, history, current), and assessment schedule, considering the target population, participant burden, etc.? Does the application also include provisions for clinical management when suicidal behavior is reported? In situations where it is not appropriate or feasible to include the assessment of suicide outcomes, is a clear justification for the omission provided? See NOT-MH-15-009 and the PhenX Toolkit for suicide-related constructs and corresponding assessment strategies.
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis/hypothesesbeing tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
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.
Not Applicable
Not Applicable
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.
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).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 NIMH, 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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Recruitment Reporting and Trial Registration
NIMH requires reporting of recruitment milestones for participants in clinical trials as noted in NOT-MH-19-027 . While trials in response to this FOA may not seek 150 subjects or more (the level at which this reporting has been required), we expect reporting for all trials, even those with less than 150 subjects.
The NIMH expects the registration and results reporting for all NIMH-supported clinical trials in ClinicalTrials.gov, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm). We plan to include language regarding this expectation in the notice of grant award.
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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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Mary Rooney, Ph.D., ABPP
National Institute of Mental Health (NIMH)
Telephone: (301) 827-1325
Email:? [email protected]
Matthew Rudorfer, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1111?
Email: [email protected]
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]