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: Biobehavioral Research Awards for Innovative New Scientists (BRAINS) (R01)
Announcement Type
This is a reissue of RFA-MH-09-100.
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-MH-10-060
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 (4) weeks prior to the grant submission date. See Section IV.
Catalog
of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release/Posted Date: October 2, 2009
Opening Date: November 9, 2009 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): November 9, 2009
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 Due Date(s): December 9, 2009
Peer Review Date(s): February 2010
Council Review Date(s): May
2010
Earliest Anticipated Start
Date(s): July 1, 2010
Additional Information To Be Available Date (Activation
Date): Not Applicable
Expiration Date: December 10, 2009
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. Receipt, 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. Resource Sharing Plan(s)
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 Contacts
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
The mission of the National Institute of Mental Health
(NIMH) is to transform the understanding and treatment of mental illnesses
through basic and clinical research, paving the way for recovery, prevention,
and cure. An essential element of this mission is the support and career
promotion of the future generation of exceptionally talented and creative new
scientists who will transform the understanding and treatment of mental illnesses
and enable NIMH to fulfill its vision of a world in which mental illnesses are
prevented and cured. The NIMH supports a number of training and fellowship
programs for pre and postdoctoral training, as well as mentored career
development awards for faculty in the early stages of their career. However,
even with these career development mechanisms in place, to fulfill its mission
of assuring a cadre of productive, innovative mental health investigators for
the future, NIMH needs to support additional programs to identify and inspire
the best new investigators and facilitate their establishing vibrant,
independent research programs in areas relevant to the mission of the NIMH.
Research Scope and Goals
To support its mission, NIMH has formulated a strategic plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) with the following four overarching objectives:
1. Promote discovery in the brain and behavioral sciences to fuel research on the causes of mental disorders
2. Chart mental illness trajectories to determine when, where, and how to intervene
3. Develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses
4. Strengthen the public health impact of NIMH-supported research
These four Strategic Objectives can be viewed as a cumulative progression that begins with promoting discovery in the brain and behavioral sciences in order to better understand the workings of the brain that can be translated to the study of mental disorders. In effect, our efforts to understand how changes in the brain can lead to mental illness will inform (and be informed by) fundamental research to understand the trajectories of mental illnesses across the lifespan and across diverse populations. By learning more about the trajectories by which mental illnesses develop, we hope to stimulate innovative psychosocial and biomedical approaches that can preempt or change these trajectories before mental illness occurs. Finally, we will retain a strong focus on public health impact and create better methods for ensuring that our research reaches all whose lives are affected by mental illness, as well as those who are dedicated to their care.
In order to identify outstanding basic, translational and clinical investigators at the formative stages of their careers and assist them in launching innovative research programs with the potential to transform our understanding of the underlying mechanisms of mental illness and develop innovative treatments and prevention strategies, the NIMH has established this program of R01 research grants intended for early career researchers who have not received their first R01 research grant and are Early Stage Investigators according to NIH policy (NOT-OD-09-013). This program is expected to be highly competitive, and only a limited number of grants will be awarded per year.
Research programs supported by this funding opportunity seek to support the most highly creative and promising new scientists who are committed to enabling NIMH to fulfill its mission and can bring innovative, ground-breaking, and potentially risky research initiatives and thinking to transform the understanding and treatment of mental illnesses. Special emphasis will be placed on multi-disciplinary research approaches, utilizing humans and/or model organisms that directly address the four objectives of the NIMH Strategic Plan. Examples of research topics that address priorities, gaps and opportunities consistent with the four NIMH Strategic Objectives include but are not limited to:
The R01 applications in this program are distinguished from most other R01 research grants in that the applications: 1) incorporate a statement of the PI’s research goals relevant to the mission of the NIMH, 2) include active participation of an external advisory committee, and 3) require demonstration of the commitment by the institution to actively support the research program development of the Principal Investigator. In this year, research projects proposed in response to this Funding Opportunity Announcement (FOA) will be expected to directly address the objectives and sub-objectives of the NIMH strategic plan and to have a defined impact on our understanding the pathophysiology, trajectories, effective treatment and/or prevention of psychiatric diseases.
It is anticipated that the BRAINS program would be evaluated on a continuing basis by NIMH program staff to assess the impact of the program on the portfolio of the NIMH, as well as on the progress of the awardees. Metrics to be used include, but are not limited to: publications (both numbers and impact factors); academic promotion of Principal Investigators; awards; invited talks at national/international symposia; students and postdoctoral fellows trained in the Principal Investigator's laboratory; honors received by Principal Investigators; committee service of Principal Investigators; and subsequent grant support awarded. Principal Investigators of awarded BRAINS grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to ten years after the award.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
This FOA will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
Applicants requesting more than $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
The NIMH intends to commit $5,000,000 in totals costs to fund 7-10 new grants
in FY 2010. An applicant may request a project period of up to five
years and budget for direct costs up to $1.625 million dollars with no more
than $400,000 in direct costs for any single year.
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 IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs
requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
Foreign institutions are not eligible to apply.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI and who qualifies as an Early Stage Investigator as defined in NOT-OD-09-013, 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.
To be eligible for this award, applicants must have a Ph.D., M.D., or equivalent graduate degree.
This Funding Opportunity Announcement will not utilize the multiple PI/PD option.
More than one PD/PI (i.e. multiple PDs/PIs) may be designated on the application. However, given that the intent of this announcement is to support Early Stage Investigators (ESI) in obtaining their first R01, NIMH encourages single PI applications. If a multi-PI application is submitted, all PIs must be ESIs.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs 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 the multiple PD/PI option, 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 PDs/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
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA. Previously unfunded applications submitted in response to RFA-MH-09-100 may not be revised and resubmitted. Applicants who previously applied to RFA-MH-09-100 and are still eligible as an NIH-defined Early Stage Investigator may submit a new application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Applicants must be designated Early Stage Investigators (ESI) by NIH as defined in NOT-OD-09-013. In addition, applicants must have faculty appointments that are tenure track or equivalent, generally at the level of Assistant Professor or equivalent, and have a research or health professional level degree (e.g., Ph.D., M.D., or equivalent) at the time of application. If the applicant is at an institution/organization that does not have a tenure track, he or she should hold an equivalent appointment and must have demonstrated support from the institution. Individuals must show that they have established research independence from a mentor, and have dedicated independent laboratory and research resources available to conduct the research proposed in the grant application.
Ineligible individuals include federal employees and current and former Principal Investigators on substantial competing NIH research projects (e.g. R01s). Applicants may hold other early career awards, such as those from the McKnight Foundation, Pew Charitable Trust, or The Searle Foundation, however, they will be expected to devote at least 50% time and effort to the BRAINS award and have a long-term commitment to mental health research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Applicants must have a research career and a long-term commitment to a career in research on the causes, diagnosis, treatment and prevention of mental illnesses consistent with the core mission areas of the NIMH. The NIMH will decline applications not considered central to either the mission or the research priorities of the NIMH as part of the initial evaluation for responsiveness. Applicants are encouraged to discuss their research plans with an NIMH Program Officer prior to submission to ensure eligibility.
Applicants may not simultaneously submit identical/essentially identical applications under both this FOA and another PHS funding opportunity announcement. Investigators who have another scientifically distinct R01 application pending at the time of the BRAINS receipt deadline, i.e., submitted October or November 5, 2009 for review at May 2010 Council, are eligible to submit a BRAINS application for a different project. However, since the BRAINS award is designed for Early Stage Investigators who do not have R01 support, individuals who receive a fundable score and accept funding for the regular R01 prior to the award of the BRAINS grant are not eligible to receive the BRAINS award.
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, use the Apply for Grant Electronically button in this FOA or 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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the 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 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. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
More than one PD/PI (i.e. multiple PDs/PIs) may be designated on the application. However, given that the intent of this announcement is to support Early Stage Investigators (ESI) in obtaining their first R01, NIMH encourages single PI applications. If a multi-PI application is submitted, all PIs must be ESIs.
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 plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the Research Strategy, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Strategy 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, and should include 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 (NoA).
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: November 9, 2009 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt
Date(s): November 9, 2009
Application Due Date(s): December 9,, 2009
Peer Review
Date(s): February 2010
Council Review
Date(s): May 2010
Earliest Anticipated Start
Date(s): July 1, 2010
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:
Kathleen C. Anderson, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email: [email protected]
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/applicants/apply_for_grants.jsp
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 ([email protected]) 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. 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 the 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. The NIH will not accept any application for this FOA that is essentially the same as one already reviewed. Applicants who previously applied to RFA-MH-09-100, are still eligible as an NIH-defined Early Stage Investigator, and wish to apply to the RFA, must submit a new application to this FOA.
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 its
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 or renewal award if such costs: 1) are necessary to conduct the
project, and 2) 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 renewal
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(s)/PI(s) 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.
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
The Research Plan is limited to 12 pages and should include Specific Aims, Background and Significance, Research Design and Methods. The Preliminary Studies section should not be included. Preliminary data are allowed but not required. If included, preliminary data should be part of the Research Design and Methods section.
Although 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 additional requirements:
The Research Plan should follow SF424(R&R) Application Guide for font size, type density and margins. In the Research Design and Methods Section of the Research Plan, applicants must address the following topics as they pertain to the research project proposed (while understanding that the Investigator qualifications and Environment will also be supported by the Biosketch in the Senior/Key Person Profile Component and the Facilities & Other Resources Section of the Other Project Information Component):
Advisory Committee
The Principal Investigator is expected to form an external advisory committee. Names of Advisory Committee members should not be listed in the application. This FOA uses the just-in-time concept for the External Advisory Committee members. The application should indicate the areas of scientific expertise and anticipated input, and any critical considerations in the selection of members, at the time of submission. The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research; to discuss future research goals, aims, and ideas; and to provide research career guidance to the awardee during the five years of the grant.
NIMH suggests an Advisory Committee structure such as the following: At least three scientists, two of whom are external to the Department, (one external to the University or Institution). One member should have research expertise similar to that of the Principal Investigator, and one should be an individual who is expert in human or clinical studies and who can provide input into the translation of the research. A copy of the minutes of meetings of the Advisory Committee should be provided to the NIMH as part of the annual progress report of the grant.
Discussion of the Advisory Committee should be included as part of the Field 5, Research and Design and Methods Attachment of the Research Plan.
Institutional Support
The Chair of the Department where the Principal Investigator holds the primary academic appointment should provide a letter (attached as a letter of support in the PHS398 Research Plan Component of the SF424 application, Item 16) describing any tangible research support that has been committed to the Principal Investigator. This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities that will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant. The department is encouraged to provide release time so that the applicant will be able to devote 9 calendar months (75%) of his/her professional effort to research (See Section III.3. Other Special Eligibility Criteria). The strength of the institutional commitment will be considered a factor in the review of the application.
If a previous postdoctoral or research mentor remains in the same Institution as the Principal Investigator, a letter (attached as a letter of support, in the PHS398 Research Plan Component of the SF424 application, Item 16) should be included in the application and outline the respective roles of the Principal Investigator and the research mentor in the design and conduct of the proposed research. The research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory
Future Goals and Career Objectives
A one-page narrative presentation section entitled Future Goals and Objectives should be included in the application as an attachment (item 11, under Other Project Information Component). The Future Goals and Career Objectives section (one page maximum) should briefly describe the career track and long-term research interests/objectives of the Principal Investigator with emphasis on how these interests/objectives relate to the mission of NIMH.
Bibliography & References Cited
Limited to two pages and should be attached to the Other Project Information Component (item 8). Note that the 12 page limit for the Research Plan does not include the References Cited section.
Budget
Applicants may request up to five years and up to $1.625 million in total direct costs to be allocated according the research needs of the Principal Investigator but not to exceed $400,000 in direct costs in any single year. These funds will be for research-related expenses. The Principal Investigator is encouraged to budget sufficient travel costs to present the results of the research at a variety of high-caliber technical meetings, at least one of which is devoted directly to mental health research and is widely attended by other NIMH grantees. A portion of the budget could include travel for external members of the advisory committee to meet yearly, in (See Grants Policy Statement). In addition, the Principal Investigator should budget for travel to the NIH campus in Bethesda, MD each year in years 3-5 to present a seminar or participate in a research symposium.
Applicants are expected to devote at least 6 calendar months (50%) effort to the grant. However, after three full years of funding for this grant, should the PI be successful in obtaining funding through another R01 or similar award, the effort on the BRAINS award may be negotiated with the NIMH program staff down to no less than 3.6 calendar months, (30%), if adequate progress has been made on the aims of the BRAINS award. In addition, the awardees' departments are encouraged to provide an additional 3-3.6 calendar months (25-30%) release time commencing clinical, teaching, and administrative duties in order to allow the awardee to devote a larger amount of time to research efforts.
Project Effort for mentored K-awardees
Mentored K awardees are encouraged to seek R01 or equivalent funding to support their research programs. Therefore, NIMH expects that such awardees may be particularly interested in seeking support through the BRAINS R01 program. Such PIs are encouraged to consult with their mentored K program officer prior to submission to ensure that the large effort commitments of both awards are feasible for their individual circumstance. However, since the BRAINS program requires minimum 50% effort, K-Awardees should not apply unless they will be past the first 3 years of the K-Award at the time of a BRAINS award, in light of NIH policies limiting reduction in minimum required percent effort for K recipients (see NIH Guide NOT-OD-09-036).
Appendix Materials
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 comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/).
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 this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIMH and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does 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? Is the potential impact of the proposed research exceptional, in terms of the magnitude of the impact and the size of the community affected? If the applicant is attempting to verify a novel hypothesis, is it critical, for the field, that the hypothesis be verified or disproved? Is the work paradigm shifting or if no paradigm exists will this project create one? If the proposed work is successful does it have the potential to transform our understanding of the origins of mental illness, prevent their onset, improve diagnostic accuracy, and/or create cures?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Do the past achievements of the PI suggest that the investigator is exceptionally innovative and likely to make paradigm-shifting, high-impact discoveries relevant to mental illness? If the PI does not have a history of doing exceptionally innovative, high-impact research, does the logic of the experimental plan suggest that there is some likelihood of success? Is there potential for the investigator to profoundly transform our understanding of the underlying mechanisms of mental illness or translate into the development of effective interventions, preventions or cures for mental disorders?
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? Is the hypothesis and/or the proposed methodology unconventional and exceptionally innovative?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the information in the timeline inspire confidence that the PI will be able to document progress in each year of the award and either complete the project or demonstrate that it is not feasible, despite good-faith efforts, during the term of the award? If the approach involves a high degree of risk, has the applicant adequately explained what he/she will do if the approach is unsuccessful?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the strength of the Institutional support to the career advancement of Principal Investigator evident?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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 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.
As part of the just-in-time information
request, the applicant will be asked to name the Advisory Committee members,
and ask each potential member to provide a letter
outlining his/her expected role and the expertise to be provided to the
Principal Investigator’s research and career experiences. However, the names
of the committee members should not be included in the application.
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
Awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A copy of the meeting report from the designated Chair of the Advisory Committee, provided to the NIMH as part of the annual progress report of the grant, will be used by the NIMH in assessing progress on the individual grants, as well as in evaluating the program as a whole.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Kathleen C.
Anderson, Ph.D.
Division of
Developmental Translational Research
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6189, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone:
(301) 443-5944
FAX: (301)
480-4415
Email: [email protected]
2. Peer Review Contact(s):
David Armstrong,
Ph.D.
Division of
Extramural Activities
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/Grants Management Contact(s):
Rebecca Claycamp, CRA
Division of
Extramural Activities
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
Use
of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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
institutional review board (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.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC
lines that are registered in the NIH Human Embryonic Stem Cell Registry will be
eligible for Federal funding (http://escr.nih.gov/).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The NIH
Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
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.
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/.
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