and Human Services (HHS)
EXPIRED
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: Rapid Assessment Post-Impact of Disaster (R03)
Announcement Type
This is a reissue of PAR-02-133,
which was previously issued on July 24, 2002.
Update: The following update relating to this announcement has been issued:
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 (R&R) forms and Application Instruction Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and should be started at least four weeks in advance of the planned submission. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program
Announcement (PA) Number: PAR-06-252
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: March 17,
2006
Opening
Date: May 2, 2006 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): n/a
Application Submission Date(s): Applications
should be submitted within approximately six weeks of the identified disaster
event.
Peer
Review Date(s): RAPID applications will be handled on an expedited
external peer review and award basis to meet the goals of this program.
AIDS Application Submission Date(s): Not applicable.
Council Review Date(s): RAPID applications will be
handled on an expedited review basis. .
Earliest Anticipated Start
Date: RAPID applications will be handled on an expedited award
basis.
Additional Information
To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: March 18, 2009
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The purpose of this Funding Opportunity Announcement is to provide a rapid funding mechanism for research on the post-impact of disasters, in order to permit access to a disaster area in the immediate aftermath of the event.
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. Sending an Application 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
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
PURPOSE OF THIS FUNDING OPPORTUNITY
The purpose of this FOA is to provide a rapid funding mechanism for research on the post-impact of disasters, in order to permit access to a disaster area in the immediate aftermath of the event. The regular grant submission, review, and funding process is lengthy, such that it requires investigators who would conduct such studies to wait a minimum of nine months after the submission of the application to obtain the research funds, during which time important data may be lost. An emergency event of potential significance for mental health may occur with little or no warning (e.g., Hurricane Andrew, Los Angeles earthquake, the Oklahoma bombing, or the terrorist attacks of September 2001, including bioterrorism) and therefore modified procedures are required to expedite the funding of research applications on such events.
The Traumatic Stress Disorders Research Program of the NIMH recognizes that prompt assessment may be crucial to many kinds of mental health disaster studies, including those that focus on service seeking, on efficacy of outreach or prevention efforts, and on identifying high-risk victims on the basis of early response. Advances regarding post-traumatic psychopathology, which build on findings from basic research on cognitive processing, arousal, and memory, highlight the need for rapid data collection in the days and weeks following natural and human caused events. Rapidly supported pilot-type studies on the symptoms and course of traumatic stress reactions, the organization and delivery of mental health services, and approaches to intervention, can lay the foundation for larger studies on the neurobiological nature, cause, pathogenesis, treatment and prevention of these conditions.
This kind of research most often has a serious urgency with regard to availability of, or access to, data or facilities. The Rapid Assessment Post-Impact of Disaster (RAPID) grants described in this program announcement are designed to provide a limited sum of money for early assessment to investigators who intend to follow up with a full research application, using the preliminary data from this initial effort as a basis for their larger application.
RESEARCH OBJECTIVES
Although disasters are disconcertingly prevalent in modern culture, prospective systematic studies of them have been relatively few, in part because of the difficulties inherent in field research that are compounded by circumstances associated with disaster scenes. Additionally, the ability to generalize about psychological effects of disasters has been limited by vast differences in methodologies used including critical items such as time frames, identification of populations, sampling, and instruments.
Disasters and acts of mass violence are a terrible reality, with the potential to cause great public health and economic burdens. Unlike individual traumatic events, disasters tend to strike without preference to personal characteristics that increase the risk of exposure to other kinds of traumatic events. Individual characteristics predisposing to traumatic events are also associated with vulnerability to post-traumatic psychopathology, thus confounding the effects of the event with predisposing characteristics. Disasters and acts of mass violence provide for a unique scientific aperture, the need to learn more about the biological and behavioral consequences of traumatic stress can be uniquely addressed with careful and sensitive research involving disaster exposed populations.
The Traumatic Stress Disorders Research Program is the focal point in the NIMH for support of research projects on the mental health sequelae of emergencies resulting from events in the external environment, which include natural and human-made situations. Such events range from individual to community and to larger-than-community catastrophes, and they encompass natural disasters (e.g., flood, tornado, drought), human-made emergencies (e.g., toxic waste spill, fire, bridge collapse), and violence (e.g., riot, combat, school-based shootings, suicides, workplace violence, terrorism). The Program supports research on psychological, physiological, biological, and behavioral reactions to emergencies, risk factors for developing prolonged mental health sequelae (including post-traumatic stress disorder) resulting from exposure to such emergencies, service delivery and treatment of victims, and effectiveness of programs designed to prevent mental health problems.
In order to respond appropriately and in a timely manner to the psychological distress likely to occur in the context of any disaster, it is necessary to understand the nature of problems people experience, the types of help they seek, and the readiness of the health and human service delivery system to provide needed care and treatment. Collecting information following a disaster presents special challenges, foremost among them is the need for investigators to attach the highest priority to standards of privacy, dignity, and courtesy in their interactions with participants who were affected in any way by an event under study. Any information gathering activities in this context must acknowledge and adhere to the imperatives of doing no harm, placing the care and safety of victims and survivors above all else, and coordinating with assistance efforts. This may involve coordination with state and local response efforts as well as federally supported counseling and outreach activities such as those funded by the Federal Emergency Management Agency (FEMA) and administered by the Center for Mental Health Services (CMHS) in the Substance Abuse and Mental Health Services Administration (SAMHSA) http://www.mentalhealth.org/cmhs/EmergencyServices/default.asp.
The Traumatic Stress Disorders Research Program is concerned with research topics including but not limited to: psychological, physiological, biological, and behavioral reactions to trauma, risk factors for mental health sequelae (including post-traumatic stress disorder, depression and substance abuse), optimal provision of mental health services, prevention and treatment.
While each disaster or emergency event of potential significance for mental health is unique, NIMH emphasizes that new research applications should clearly demonstrate that:
a) the topic to be studied/questions to be asked and addressed represent significant scientific needs relevant to the NIMH mission (e.g., can highly predictive early indicators of distress, disorder, and functional sequelae be developed, are early interventions capable of preventing or reducing the severity of adjustment problems)
b) the disaster/event under study provides a unique scientific occasion to acquire needed information (e.g., the research questions cannot be efficiently addressed in another context and the nature of the event and/or impacted populations are well suited for the proposed study), and
c) the insight to be gained has the potential to advance the field by producing fundamental new insights as opposed to reinforcing established findings (e.g., identifying genetic and environmental interactions that cause posttraumatic disorders, developing highly predictive early diagnostics for PTSD, establishing the feasibility of cost-effective identification and treatment approaches for posttraumatic distress and psychopathology in mass causality contexts as opposed to assessing well established risk factors for adjustment problems.)
Applications for research support may include a substantive emphasis in any one or more but are not limited to of the following areas:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this FOA.
Section II. Award Information
1. Mechanism of Support
This Funding Opportunity Announcement (FOA) invites applications for small research projects (R03) that can be carried out in a short period of time with limited resources. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), 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).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Although the financial plans of the 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.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
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 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 is invited to work with their institution 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.
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 an Application Package and 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:
Project Directors/Principal Investigators PD/PIs should work with their institutions/organizations to make sure that institutional/organizational officials and PD/PIs are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electron application, as follows:.
1) Organization/Institutional Registration in Grants.gov/Get Started
2) Organization/Institutional Registration in the eRA Commons
3) Principal Investigator Registration in the eRA Commons: Refer to the eRA Commons User Guide
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 up to four weeks. Therefore, applicants should immediately check with their institutional/organizational official to determine whether their institution/organization 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) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application
Submission
Prepare all applications
using the SF424 (R&R) application forms and instructions at http://www.grants.gov/Apply. No paper
applications will be accepted.
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 Tips and Tools for Navigating Electronic Submission on the front page of 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) (An application cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Project/Performance Site
Locations
PHS398 Cover Page Supplement
PHS398 Modular Budget
PHS398
Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Note: While both budget components are
included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS
398 Modular Budget. (Do not use the detailed Research
& Related Budget.)
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide a unique research
opportunity not available in the U.S. and/or make a compelling case that the
foreign institution or investigator has unique skills, qualifications or
resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Application Submission Date(s): RAPID applications involve expedited peer review and funding consideration processes. To meet the goals of the RAPID program, applications should be submitted within approximately six weeks of the identified disaster event
Peer Review
Date(s): RAPID applications will be handled on an expedited external peer
review and award basis.
Council Review Date: Nor applicable.
Earliest Anticipated Start Date: RAPID applications
will be handled on an expedited award basis.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity. However, potential applicants are strongly encouraged to contact NIMH Program Staff before submitting a RAPID application to determine whether the proposed work meets the guidelines of this program, whether requested RAPID funding is likely to be available, and whether the idea should be considered for initial submission as a fully developed application. Inquiries not meeting the RAPID guidelines will be guided to other grant mechanisms and to program contacts to discuss alternatives.
3.B. Sending an Application 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.
In order to permit the expedited review, applicants must notify the NIMH Referral Office by email when the application has been submitted.
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd. Room 6154, MSC
9606
Bethesda, MD 20892-9609
Rockville, MD 20852 (for
express/courier service)
Telephone:
(301) 443-3367
FAX:
(301) 443-4720
Email: [email protected]
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
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.
Upon receipt,
applications will be transferred from Grants.gov to the NIH Electronic Research
Administration process for validation. Both the PD/PI and the SO for the
organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.
Upon receipt, applications
will be evaluated for completeness by the Center for Scientific Review (CSR),
NIH. Incomplete applications will not be reviewed.
The NIH will not
accept any application in response to this FOA that is essentially the same as
one currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such an application must include an Introduction addressing the previous
critique. Note that such an application is considered a
"resubmission" for the SF424 (R&R).
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.
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 (http://grants.nih.gov/grants/policy/policy.htm).
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 or competing
continuation 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
Renewal (formerly
competing continuation or Type 2 ) applications are not permitted.
Resubmissions may be considered if the scientific urgency/opportunity will not
be lost with a delay in onset of the work. It is recommended that applicants
consult with program staff before working on a resubmission. If an amended
(01A1) application is submitted, it is expected that a compelling case be made
that the scientific opportunity still remains despite the additional review and
funding consideration time required. A RAPID applicant is welcome to submit a
revised application under the regular, non-expedited submission process (in
response to the NIH-wide R03 announcement), if the RAPID application was not
funded. If mechanisms change in that submission (e.g. from R03 to R21) the
application must be submitted as new. It will not be considered as an amended (01A1)
application.
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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.
Plan for Sharing Research Data
A data sharing plan is not required; however, one may be proposed. The precise content of the data-sharing plan may 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. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. Peer reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing
Research Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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 this FOA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened by 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:
Also, noted above, while each disaster or emergency event of potential significance for mental health is unique, NIMH emphasizes that new research applications should clearly demonstrate that: a) the topic/questions to be studied/asked and addressed represent significant scientific needs relevant to the NIMH mission, b) the disaster/event under study provides a unique scientific occasion to acquire needed information, and c) the insight to be gained has the potential to advance the field by producing fundamental new insights as opposed to reinforcing established findings.
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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? How will the proposed
research yield answers to long-standing, relevant questions? What is the
fundamental new insight that can be gained? 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?
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 investigators
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 investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment 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? Is the feasibility
of working in the community or invitation to work in the community well
established (i.e., what is the nature of the collaborative relationships
established where participants will be recruited)?
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 item 6 of the 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 item 7 of the 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. Is the effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
2.C. Sharing
Research Data
Data Sharing Plan: 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.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee 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/part_ii_5.htm#availofrr and 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 will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and resource
sharing plans negotiated by both will become a condition of the award of the
grant. 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 or her Review Results and Summary
Statement (written critique) via the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 signing official shown on the
electronic application.
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 Also 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:
The NIH encourages inquiries concerning the FOA and welcomes the opportunity to
answer questions from potential applicants. Participating ICs and their
contacts are listed at http://grants.nih.gov/grants/funding/r03.htm.
Farris Tuma, Sc.D.
Division of Adult Translational Research and Treatment
Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111, MSC 9632
Bethesda, MD 20892-9632
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3648
FAX: (301) 443-4611
Email: [email protected]
Rajni Agarwal, MA
Division of Adult Translational Research and
Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7111A, MSC 9632
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3648
FAX: (301) 443-4611
Email: [email protected]
2. Peer Review
Contacts:
David Armstrong,
Ph.D.
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard,
Room 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: [email protected]
3. Financial or Grants Management Contacts:
Rebecca Claycamp
Division of Extramural Research
National Institute of Mental Health
6001 Executive Boulevard,
Room 6122 MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: [email protected]
Section VIII. Other
Information
Required
Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) 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).
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); 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 (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
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 DHHS 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. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
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 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 NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
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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