Department
of Health and Human Services
Participating
Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National
Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Innovative
Trials for the Treatment of Anorexia Nervosa in Late Adolescence and Adulthood (R01)
Announcement
Type
New
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For Applications (RFA) Number: RFA-MH-07-090
Catalog of Federal Domestic Assistance Number(s)
93.242
Key
Dates
Release/Posted Date: March 22, 2007
Opening Date: April 23, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 23, 2007
NOTE: On time
submission requires that applications be successfully submitted to Grants.gov
no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): May 23, 2007.
AIDS Application Submission/Receipt Date(s): Not
Applicable
Peer Review Date(s): July/August 2007
Council Review Date(s): August 2007
Earliest Anticipated Start Date(s): September
30, 2007
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration Date: May 24, 2007
Due Dates for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1.
Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Anorexia Nervosa (AN) is a serious eating disorder characterized, in part, by
severe self-imposed food restriction, maintenance of an abnormally low body
weight, an intense fear of gaining weight even though underweight, and an
excessive influence of body weight and shape on self-evaluation. This eating
disorder is also associated with serious medical complications, substantial
psychiatric comorbidities, and has a mortality rate as high as any psychiatric
illness. AN usually begins during mid- to late-adolescence or early adulthood,
frequently persists for several years before treatment is sought, and often
runs a chronic course resulting in the majority of individuals with AN being
older adolescents and adults.
Although there are substantial gaps in knowledge regarding evidence-based treatments for both adolescent and adult AN populations, family based therapy appears to be a promising treatment for younger adolescents who have been ill for a relatively short period of time. Currently there are both large and small scale NIMH supported intervention studies assessing the effectiveness of different treatment modalities, including family therapy, for adolescents with AN.
In the adult AN population many of the standard treatments (cognitive behavioral therapy, interpersonal therapy, selective serotonin reuptake inhibitors, etc) have not proven to be sufficient for treating the core symptoms of this disorder, and it is well-documented new treatments for late adolescent and adult AN patients are needed.
In a recent NIH workshop1 convened to address the research priorities for the treatment of AN a number of areas were identified as critical for establishing effective evidence-based interventions for this disorder. One of the areas identified was supporting novel small-scale intervention studies that could be used to guide future larger scale AN treatment studies. In recognition of the clear need to address the aforementioned challenges the purpose of this FOA is to solicit high-risk/high potential innovative psychosocial and/or pharmacological intervention development studies focusing on late adolescent and adult AN populations. This FOA is not intended to solicit applications involving minor modifications to fine tune treatment approaches that have been developed. It is not that these types of studies are not potentially important or warranted, but rather that they are not the focus of this initiative. Below are types of approaches for which applications are being solicited. The list is not exhaustive, and it is expected that additional important research topics might be identified by applicants.
Clearly research efforts directed toward furthering the understanding of the etiology, pathophysiology, treatment, and services of AN are needed for adolescent and adult populations, and for a broad description of the NIMH research areas of interest for eating disorders please refer to the following standing NIMH program announcement “Translational Research on Eating Disorders” (http://grants1.nih.gov/grants/guide/pa-files/PA-07-285.html).
1 For the report describing the proceedings of the NIH workshop focusing on the development of research priorities for AN please see Agras, W.S., Brandt, H., Bulik, C., Dolan-Sewell, et al. (2004). Report of the National Institutes of Health on Overcoming Barriers to Treatment Research in Anorexia Nervosa. International Journal of Eating Disorders, 35, 509-521.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This Funding Opportunity Announcement (FOA)
will use the NIH Research Project Grant (R01) award mechanism. The applicant will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement.) Specifically, if you are a U.S. organization, use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
At this time, it is not known if competing renewal (formerly “competing continuation”) applications will be accepted and/or if this FOA will be reissued.
2.
Funds Available
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for this RFA. Direct costs are limited to $450,000 over a three-year period, with no more than $225,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $450,000 for the combined three-year award period.
The NIMH intends to commit approximately 1.5 million dollars in FY2007 to fund approximately 3 applications.
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.
Facilities and Administrative (F&A)
costs requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004,
November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more than
one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget as appropriate (See Section IV.6.,
“Special Instructions,” regarding appropriate required budget component.)
(Research
& Related Budget required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic (non-U.S.)
Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found
in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3.
Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 23, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 23, 2007
Application
Submission/Receipt Date(s): May 23, 2007
Peer Review
Date(s): July/August 2007
Council Review
Date(s): August 2007
Earliest
Anticipated Start Date(s): September 30, 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Mark
Chavez, Ph.D.
Division
of Adult Translational Research and Treatment Development
National
Institute of Mental Health
6001
Executive Boulevard, Room 7101, MSC 9632
Bethesda,
MD 20892-9632
Telephone:
(301) 443-8942
Fax:
(301) 443-4611
Email: mchavez1@mail.nih.gov
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the NIMH Referral Office by email NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at
his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs: are necessary to conduct
the project, and would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other
Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
PHS398 Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements:
Although preliminary data are not required for this FOA, they may be included.
Items 2-5 of the Research Plan may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by
mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing
Research Resources
NIH policy expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
“Reporting.”
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the
review process.
2. Review and
Selection Process
Applications that are complete and responsive to the
FOA will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIMH in
accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
This FOA initiative is designed to support the development and/or pilot testing of new interventions for late adolescent and/or adult anorexia nervosa. Because of the purpose and goals of this FOA R01 initiative, applications need not have extensive background material or preliminary information as one might normally expect in a more standard R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of more standard R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for this specific R01 initiative; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in
all categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.
Significance: Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge or clinical practice be advanced?
What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics? For applications designating
multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient
coordination and communication among the PDs/PIs? Are the administrative
plans for the management of the research project appropriate,
including plans for resolving conflicts?
For applications intending to develop new treatments is there a clear conceptual link between the nature of the psychopathology, the treatment components proposed, and their relationship to the outcome variables being targeted? Does the application describe how the new adaptation will enhance responding for subgroups of patients that previously experienced partial remission, relapse or dropped out from the existing therapy?
For applications intending to develop new treatments is there an adequate description of which stage of intervention development best characterizes the application and is a clear rationale provided for the choice of methods proposed? In the absence of a controlled design, do such applications describe the use of other, innovative (e.g., single case, quasi experimental or uncontrolled) designs that best take into account the ethical and methodological considerations that arise when using small sample sizes (e.g., the statistical concerns that arise when comparing 2 active treatments, the risks of withholding treatment from seriously ill patients, the availability of alternative effective treatments in the community, etc.)? Does the application adequately consider these issues in choosing the most appropriate research design and providing a clear explanation for their decision? Whenever possible, are mechanisms of action that are hypothesized to have an effect on patient outcome, articulated?
Innovation: Is the project original and innovative? For example:
Does the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers? Does the PD/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will
be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
Special Review Criteria:
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the “Human Subjects Sections” of
the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the “Human Subjects Sections” of the PHS398
Research Plan component of the SF424 (R&R).
2.B. Additional Review Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Sharing Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
2.D. Sharing Research Resources
NIH policy expects
that grant recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
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. See Section
IV.5., “Funding Restrictions.”
2. Administrative and National Policy Requirements
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.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1.
Scientific/Research Contacts:
Mark
Chavez, Ph.D.
Division of
Adult Translational Research & Treatment Development
National
Institute of Mental Health
6001 Executive
Boulevard, Room 7101, MSC 9632
Bethesda, MD 20892-9632
Telephone:
301-443-8942
Email: mchavez1@mail.nih.gov
Rebecca
DelCarmen-Wiggins, Ph.D.
Division of
Pediatric Translational Research and Treatment Development
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6191, MSC 9617
Bethesda, MD 20892-9632
Telephone:
301-443-5944
Email: rdelcarm@mail.nih.gov
2. Peer Review Contacts:
David Armstrong,
Ph.D.
Division of
Extramural Activities
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301)
443-3534
Email: armstrda@mail.nih.gov
3. Financial or
Grants Management Contacts:
Rita
Sisco
Division of
Extramural Activities
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301)
443-2805
FAX: (301) 443-6885
Email: siscor@mail.nih.gov
Section VIII. Other Information
Required
Federal Citations
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access to Research Data
through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP recipient
with the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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