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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
Title: Novel Interventions for Neurodevelopmental Disorders (R21/R33)
Announcement
Type
New
Request For Applications (RFA) Number: RFA-MH-09-161
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Catalog
of Federal Domestic Assistance Number(s)
93.242, 93.273
Key Dates
Release/Posted Date: March 6, 2009
Opening Date: April 12, 2009 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 12, 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 Submission/Receipt Date(s): May 12, 2009
Peer Review Date(s): July
2009
Council Review Date(s): August
2009
Earliest Anticipated Start Date(s): September
30, 2009
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration Date: May
13, 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. Submission, Review, and
Anticipated Start Dates
1.
Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
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 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
The purpose of this Funding Opportunity Announcement (FOA) is to provide support for the development of novel and innovative interventions for autism spectrum disorders (ASD) and other neurodevelopmental disorders, including fetal alcohol spectrum disorders (FASD), with the aim of improving functioning in various domains that are impaired across disorders and are altering developmental trajectories. This FOA provides support for a two-phase approach in which the first phase (R21) supports initial technical development and proof-of-principle for innovative and cutting-edge interventions and the second phase (R33) calls for further development, application, and evaluation of the clinical utility of the intervention(s). It is intended that the results will support the development of larger efficacy studies of the proposed novel intervention. The overarching goal of this FOA is to spur the development of new treatment approaches that are novel and innovative in both conceptual and operational framework. Also of interest are innovative and theoretically sound intervention approaches that are currently in clinical use but which have not been adequately evaluated for safety and efficacy. Although it is expected that treatment development will occur within a particular diagnostic category, the intent is to support the development of novel approaches that target particular domains of functioning and will therefore offer potential for application across disorders. Research to be supported under this FOA may include technical development, proof of principle projects, pilot studies, and exploratory studies, to provide preliminary data, new methods, new treatment targets, and/or a foundation with which to pursue larger trials supported by subsequent grant application mechanisms such as the R01.
Background
For the purposes of this FOA, "neurodevelopmental disorders" are mental disorders that have their onset during the developmental period. These include, but are not limited to, autism spectrum disorders, childhood-onset schizophrenia, pediatric bipolar disorder, attention-deficit hyperactivity disorder, Tourette syndrome, child- and adolescent-onset obsessive-compulsive disorder, and neurodevelopmental disorders with a known etiologic basis that have been associated with psychiatric symptomatology, such as Fragile X and velocardiofacial syndrome (22q deletion syndrome). In addition, neurodevelopmental disorders caused by infection or exposure to HIV-1 will also be considered responsive to this FOA.
NIAAA is particularly interested in supporting applications focused on fetal alcohol syndrome (FAS) and fetal alcohol spectrum disorders (FASD), but also would consider contributing to broader applications in which FAS and/or FASD are among the neurodevelopmental disorders to be studied.
In contrast to adult-onset disorders, neurodevelopmental disorders interfere with early skill acquisition and hold potential for eliciting a cascade of events with dire consequences for brain and behavioral development. Early deficits that impact social cognition, attention, learning, emotion regulation and other domains of functioning as well as additional symptoms characterizing the disorders, such as anxiety, obsessions, repetitive behaviors, or psychotic symptoms, are not only impairing in themselves, but may preclude normal environmental experiences. This may in turn further perturb experience-dependent brain organization. This FOA encourages applications that utilize a developmental framework to structure interventions and treatments that are dynamic and address the variability of symptomatology and severity across development.
Neurodevelopmental disorders are characterized by phenotypic heterogeneity, high comorbidity and shared deficits/impairments. Not all children with a particular diagnosis manifest the same profile of symptoms and impairments, and these symptoms and impairments may well be shared across disorders. Examples include the frequent presence of social impairment, attention deficits, hyperactivity, impulsivity, anxiety, and repetitive or obsessive-compulsive symptoms across disorders. Given a symptom-focused approach to treatments, this FOA seeks out novel interventions that address symptom overlap and high comorbidity of disorders; and which propose interventions or treatments that can be applied to more than one disorder. When feasible within the constraints of the R21/R33 mechanism, there is interest in studies that address the impact of interventions at different levels, including both the level of clinical symptoms and, in parallel, the effects on underlying neurobiological aspects.
In general, pharmacologic and psychotherapeutic treatments have garnered the most visible support in terms of empirical testing and evaluation. Medications most frequently are tested first in adults, then tried in children in order to decrease risks of adverse effects. However this may also minimize opportunities for considering developmental neurobiology in pediatric drug development. Psychosocial approaches may include family therapy, behavioral management, cognitive-behavior therapy of various forms (e.g., exposure and response prevention) and multi-system interventions. In contrast, nonpharmacologic physiological treatment approaches, cognitive training, nontraditional cognitive- and cognitive-behavioral treatment approaches, and approaches that use new technology to allow the rapid assessment of behaviors and adaptation of therapeutic modules to match an individual's needs, have received less empirical scrutiny and evaluation.
A primary, guiding rationale for this FOA is that in order to make great strides in developing effective treatments for neurodevelopmental disorders, investigators must have opportunities to apply novel and sometimes unconventional thinking to significant problems. Thus a key feature of this FOA, which will be emphasized to applicants and peer reviewers, is on the novelty and innovativeness of an intervention or treatment and its potential impact on improved functioning. It is understood that, as if often the case in research, a high level of innovation may entail higher risks of failing to find useful applications. Nevertheless, in order to stimulate innovation, reviewers will be instructed to emphasize novelty and significance in their evaluations and that these will be the primary criteria for funding decisions. A sound conceptual and theoretical rationale for the intervention approach is necessary, but the initial R21 phase can appropriately be used to demonstrate proof-of-principle and feasibility. Previous demonstration of feasibility would not be required when the R21 phase will be used for that purpose. Applicants should comment on the risks associated with the proposed work and how the potential gains outweigh the risks.
Research Scope
This funding opportunity is intended to stimulate the development of novel efficacious therapies targeted at one or more domains of functioning and impairment in neurodevelopmental disorders. These include, but are not limited to: social perception and cognition; social interest and motivation; executive functions such as attention, cognitive control, working memory, organizational skills and planning; mood and emotion regulation; and positive symptoms such as anxiety, obsessions, repetitive behaviors, and psychosis.
Investigators should target one or more domains of functioning in a particular diagnostic group and address in their applications the rationale and potential for generalization of the novel treatment approach (with or without modification) to other disorders. Safety, compliance, or feasibility issues will, in some cases, favor the initial study of older subjects, e.g., adolescents, adults. Given the chronicity of these disorders, these age groups are, in themselves, appropriate candidates for study and new therapies. In some cases, (e.g., autism spectrum disorders), interventions for adults are particularly lacking. In other cases, (e.g., Tourette syndrome), symptoms persisting into adulthood may be particularly intractable and therefore warrant different strategies However, applications involving older subjects should discuss/touch on the implications of targeting their particular age group for broader applicability and/or eventually extending the treatment research downward in age.
This FOA is intended to support research in the earliest stages of treatment development including new, exploratory and developmental efforts. Applicants should explicate a clear conceptual link between relevant psychological or behavioral factors, the intervention components being proposed (including a description of the mechanism of action by which these components are hypothesized to have an effect), and their relationship to the outcomes that are being targeted. The first (R21) phase supports initial technical development and proof-of-principle projects which may include, but are not limited to; focus groups; testing of safety, tolerability and feasibility in case series; protocol and manual development. The second (R33 phase) supports further development, application, and evaluation of clinical utility to lay the foundation with which to pursue a larger efficacy trial. Initiation of the second (R33) phase of support is contingent upon successful accomplishment of the objectives and milestones investigators set out in the first (R21) phase of their research. Research aims may include, but are not limited to, determination of dosing levels and duration; side effects and safety monitoring; demonstration that outcome measures have appropriate sensitivity to change in the target population; demonstration of feasibility (implementing the intervention and study procedures, evaluating attrition); and working out details of the experimental protocol (e.g., the assessment, experimental intervention and comparison intervention protocols; and randomization procedures, if appropriate). It should be noted that although estimation of effect sizes is a logical step in evaluating the efficacy of an intervention or treatment, studies conducted under this mechanism are likely to have small sample sizes resulting in potentially unstable and unreliable effect size estimates that would have limited utility in power calculations for a larger clinical trial. Therefore, attempting to obtain an estimate of effect size is not an expected outcome.
The application should provide clear aims and measurable objectives for each phase of the proposed research, with explicit discussion of how the results of the R21 phase will inform the R33 phase. The applicant should also describe how the results from the combined project will accomplish the prerequisites for conducting a larger (e.g., R01) study that more definitively test the efficacy of the intervention.
Examples of types of applications that would fit the goals of this FOA include, but are not limited to:
Investigators interested in applying for support for pre-clinical early phase drug discovery including early proof of concept and toxicology studies for neurodevelopmental disorders are directed to alternate funding announcements, National Cooperative Drug Discovery and Development Groups (NCDDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U01/U19) http://grants.nih.gov/grants/guide/pa-files/PAR-08-238.html or Drug Discovery for Nervous System Disorders http://grants.nih.gov/grants/guide/pa-files/PAR-07-048.html and http://grants1.nih.gov/grants/guide/pa-files/PAR-07-049.html.
Alternative and complementary treatment approaches will likely be better suited for submission to the National Center for Complementary and Alternative Medicine (NCCAM) and thus would not be considered responsive to this FOA. These approaches include mind-body techniques (e.g., meditation, mental healing, art therapy), vitamins and other dietary supplements, and manipulative and body-based practices (e.g., chiropractic manipulation, massage).
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This funding opportunity will use the NIH Exploratory/Developmental Phased Innovation Grant
(R21/R33) award mechanisms. Applicants
must apply for the combined R21 and R33 award. Applicants using only the R21
mechanism or only the R33 mechanism will not be considered. 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 non-modular budget format. All applicants, including foreign applications, must complete and submit budget request using the Research and Related (R&R) Budget component. Modular budgets are not permitted for this FOA.
2.
Funds Available
The NIMH intends to commit approximately $1,500,000 and the NIAAA intends to commit $1,000,000 in total
costs for FY09 to support four to eight grants in response to this FOA and the companion R34 FOA. The combined R21/R33 award is limited to five years in duration. The R21 phase may not exceed 2
years. The R33 phase may not exceed 3 years. For the R21 phase of the
application, direct costs are limited to a maximum of $275,000, with a ceiling
on direct costs of $150,000 for any single year. For the R33 phase of the
application, direct costs must be limited to $450,000, with no more than $225,000
in any single year. The award of R33 funds will
be based on program priorities, on the availability of funds, and on successful
completion of negotiated scientific milestones as determined by NIH staff in
the context of peer review recommendations.
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 provides 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.
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
You may submit an application(s) if your
institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (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. Applications originally submitted in response to RFA-MH-09-020 and RFA-MH-09-021 may be resubmitted. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, 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. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
This FOA uses ONLY the detailed Research & Related Budget. (Do not use the PHS398 Modular Budget.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
3.
Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: April 12, 2009 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent
Receipt Date(s): April 12, 2009
Application Submission/Receipt Date(s): May 12, 2009
Peer Review Date(s): July
2009
Council Review Date(s): August
2009
Earliest Anticipated Start Date(s): September
30, 2009
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:
Ann Wagner, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
6001 Executive
Boulevard, Room 6184, 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/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the NIMH Referral Office by email ([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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsive by the NIMH. Incomplete
and non-responsive applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review..
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: are necessary to conduct the
project, and would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
new or renewal 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 and Information
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
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. 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:
Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application
Prior to funding an application, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. For funded applications, the Project Director/Principal Investigator (PD/PI) will submit a progress report to the Program Officer upon completion of the R21 milestones. Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.
The R21 and R33 cannot be funded in the same fiscal year.
1. In the Research & Related Other Project Information Component (item 6 Project Summary/Abstract )
As part of the Summary/Abstract attachment, identify concisely the therapeutic intervention to be developed, its innovative nature, its relationship to presently available interventions, and its expected impact on clinical research and treatment.
2. In the Research & Related Budget Component Section K ( Budget Justification )
For the R21 phase of the application, direct costs are limited to a maximum of $275,000, with no more than $150,000 in direct costs for any single year and a maximum of two years. For the R33 phase of the application, direct costs are limited to $450,000 per year, with no more than $275,000 in direct costs in any single year and a maximum of three years. Budgets can only exceed these caps to accommodate Facilities and Administrative (F&A) costs of subcontracts to the project. The combined R21/R33 application is limited to five years in duration.
The application should provide a detailed budget for each Budget Period of the R21 phase and the R33 phase. All budgets should include a written justification Section K, Budget Justification. In Section K of each Budget Period, the application should indicate whether it is the R21 or the R33 phase. The modular budget format is not permitted for this funding opportunity.
3. In the "PHS398 Research Plan Component" - Research Plan Attachments:
Item 1: Specific Aims.
A specific section labeled Milestones should appear at the beginning of the Specific Aims attachment. Milestones should be well described, quantifiable, and scientifically justified. Applicants should write the milestones assuming that scientifically literate program officers who may not be active researchers in the specific specialty being evaluated will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims or a timeline. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical.
The milestones should demonstrate the feasibility of the R33 phase and permit a straightforward decision as to whether or not the applicant is ready to initiate the R33 phase of the project. For example, milestones might include the development and standardization of study protocols demonstration of safety, tolerability and feasibility in a case series or pilot study; development of treatment manuals; determination of dosing levels and treatment duration; demonstration that outcome measures have appropriate sensitivity to the expected "signal" emanating from the response to treatment. This list is illustrative, rather than exhaustive or compulsory.
Applications lacking this information, as determined by the NIH staff, will be returned to the applicant without review.
Include headers titled R21 Phase Specific Aims and R33 Phase Specific Aims. Under each header, state the specific objectives of the research and development effort, including the technical questions you will try to answer to determine the feasibility of the proposed approach. Since the goal of the R21 phase of this FOA is the development of novel interventions for neurodevelopmental disorders, hypothesis testing, per se, may not be the driving force in developing such a proposal, and therefore, may not be applicable in the R21 phase.
Item 2: Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify how the fundamental approach to be developed will result in a significant improvement over existing approaches. Clearly identify how the project, if successful, will result in new capabilities for clinical interventions, the immediacy of the opportunity, and how the proposed treatment approaches will impact clinical research and treatment.
Item 3: Preliminary Studies
The R21 component will be considered exploratory, so that extensive preliminary data from the applicant's own laboratory are not required. However, the project must be based on a strong rationale, and the applicant should provide evidence that the initial exploratory work is promising. This section should provide current thinking or evidence in the field that substantiates the feasibility of the R21 phase. Although not required, preliminary data should be included where available.
Item 4: Research Design and Methods
Follow the instructions in the SF424 Application Guide. Include headers titled R21 Phase Research Design and Methods and R33 Phase Research Design and Methods, and address the research design and methods for the R21 and R33 phases in the appropriate sub-section.
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.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
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/.)
Foreign Applications (Non-domestic (non-U.S.) Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
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 NIMH in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge or clinical practice be advanced?
What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field? Does the intervention
strategy fill an important need or gap in our armamentarium of interventions
for neurodevelopmental disorders? Does the therapeutic approach hold promise for altering developmental
trajectories? Does the proposed therapy hold promise for application or
extension to multiple disorders (either with or without adaptation)? Does the
approach offer potential for having a high clinical impact, e.g., by stimulating new, even groundbreaking, treatment
approaches or dramatically improving patient functioning? Is there a clear conceptual
link between relevant psychological or behavioral factors, the intervention
components being proposed (including a description of
the mechanism of action by which these components are hypothesized to have an
effect), and their relationship to the outcomes that are being targeted?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? If the application involves older subjects does the applicant discuss/touch on the implications of targeting their particular age group for broader applicability and/or eventually extending the treatment research downward in age? Are the two phases clearly described and integrated? Does the work proposed for the R21 phase provide a solid foundation for the R33 phase? Are the milestones well described, quantifiable, and scientifically justified? Do the aims for the R33 phase provide the foundation for conducting a larger (e.g., R01) efficacy study of the intervention? Reviewer should bear in mind that the R21 component is to be considered exploratory, so that extensive preliminary data from the applicant's own laboratory are not required. However, applicants should be judged on whether the project is based on a strong rationale, and whether evidence is provided that the initial exploratory work is promising. This section should provide current thinking or evidence in the field that substantiates the feasibility of the R21 phase. Although not required, preliminary data should be included where available.
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? Although the emphasis of this FOA is on innovation and pursuing projects that hold promise for developing new approaches, it is understood that, as is often the case in research, a high level of innovation may entail higher risks of failing to find useful applications. Does the applicant adequately acknowledge possible risks and do the potential benefits from the study outweigh these risks. Does the applicant elaborate on the innovative nature of the proposed research and clarify how the fundamental approach to be developed will result in a significant improvement over existing approaches? Does the applicant clearly identify how the project, if successful, will result in new capabilities for clinical interventions, the immediacy of the opportunity, and how the proposed treatment approaches will impact clinical research and treatment?
Investigators: Are the PD/PI(s) and other key personnel
appropriately trained
and well suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers? Does the
PD/PI(s) and investigative team bring complementary and integrated expertise to
the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will
be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See the Human Subjects Sections of
the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See the Human Subjects Sections of the PHS398
Research Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award Dates
Not
Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of
award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
The following terms and conditions will be
incorporated into the NoA and will be provided to the PD/PI and the appropriate
institutional official at the time of award.
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:
Ann Wagner, Ph.D.
Division of Developmental Translational Research
National Institute of Mental Health
600 1 Executive Boulevard, Room 6184, MSC 9617
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email: awagner@mail.nih.gov
For inquiries regarding HIV-1 related research:
Pim Brouwers, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard,
Room 6216, MSC 9619
Bethesda, MD 20892-9619
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-4526
FAX: (301) 443-6000
Email: [email protected]
For inquiries regarding alcohol-related research:
Dale Hereld, M.D, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2027, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-0912
FAX: (301) 594-0673
Email: [email protected]
John A. Matochik, Ph.D.
Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2048, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 451-7319
FAX: (301) 443-1650
Email: [email protected]
2. Peer Review Contacts:
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 or Grants Management Contacts:
Joy Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9659
Bethesda, MD 20892-9659
Telephone: 301-443-8811
FAX: 301-480-1956
Email: [email protected]
Judy S. Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-1705
Telephone: (301) 443-4705
FAX: (301) 443-3891
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-02-005.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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NIH Funding Opportunities and Notices
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