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 of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse
(NIDA), (http://www.nida.nih.gov)
Title: Developmental Psychopharmacology (R01)
Announcement Type
This is a reissue of PA-03-113, which was previously issued on April 21, 2003.
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program
Announcement (PA) Number: PA-06-379
Catalog of Federal Domestic Assistance Number(s)
93.242 , 93.865
, 93.279.
Key Dates Due Dates for E.O. 12372 Table of Contents Part I Overview Information Section I. Funding Opportunity
Description 1. Research
Objectives The National Institute of Mental Health (NIMH), the National Institute of Child Health and Human Development (NICHD), and the National Institute on Drug Abuse (NIDA) request research grant applications to examine the impact of psychotherapeutic medications upon the immature brain, with particular emphasis upon mapping the precise developmental profile of physiological response to psychotropic agents used in the treatment of mental disorders in children. This program announcement addresses an identified gap in basic and clinical research on stage-specific developmental outcomes of pediatric psychotropic pharmacotherapy: understanding the neurobiological effect of relevant drug classes during critical windows of brain development, spanning the postnatal periods through adolescence. This initiative therefore encourages new neuroscience research to examine the effect of exposure to psychotropic medications at different stages of development on the molecular and cellular mechanisms relevant to the neural circuitry underlying mood, cognition and emotion, and the possible implications for altering the trajectory of mental illness. The complementary purpose of studies in pediatric clinical populations is to examine the safety and efficacy of psychotherapeutic drugs. The overarching goal is to understand the neurobiological implications, including possible corrective influences upon aberrant circuits, of pediatric psychopharmacotherapy for psychiatric and behavioral disorders that are emergent during childhood and adolescence. The ultimate intention is to advance basic neuroscience and clinical research that will inform as to the safety and effectiveness of pharmacotherapy for children and adolescents. This program announcement represents the re-issue of PA-03-113, which generated a significant amount of basic neuroscience research aimed at examining the long-term impact of developmental exposure to therapeutic levels of psychotherapeutic drugs on adult neurobiological and behavioral endpoints. Therefore, this updated announcement now requests research applications focusing upon molecular and cellular mechanisms whereby therapeutic doses of drugs affect brain physiology and behavior during the course of development through adolescence. This focus includes developmental processes that contribute to variations in drug action as well as those that are altered by psychotherapeutic medications across development. Clinical studies in patients aimed at examining the long-term consequences of psychotherapeutic drug administration across development and into adulthood remain appropriate in response to this announcement. Background Psychotropic medications, including stimulants, antidepressants, anxiolytics, mood stabilizers and antipsychotics, are prescribed to pediatric patients at progressively younger ages and often for extended periods of time. These drugs act upon neurobiological substrates that undergo profound changes during the first two decades of life, yet the immediate molecular, structural, and functional effects of psychotherapeutic drugs on the developing nervous system are relatively unknown. As psychopharmacological treatments become more accepted in clinical pediatric practice, there is increasing concern that exposure of children and adolescents to psychoactive agents might result in subtle but significant effects upon the functional connectivity of neural circuits underlying emotion and cognition. Current treatments are based largely upon extremely limited evidence in juveniles or upon accepted adult treatment paradigms. The postnatal maturation and refinement of several neural systems suggests that treatment-responsive circuitry may have inherent windows of sensitivity to drug exposure. Early exposure to these compounds may alter the trajectory of brain development by influencing a range of neural processes, including proliferation, migration, synaptogenesis, myelination and plasticity, that contribute to ultimate patterns of connectivity in the mature brain. Moreover, a given drug may exert unique and differing effects on distinct neural populations and circuits at different points along the developmental spectrum. Neuroscience research studies complement clinical findings to suggest that developing and mature brains respond differently to drug treatment. Basic research also suggests that early treatment with certain psychoactive agents may have persistent, long-term impact upon adult behavior, even after cessation of drug treatment. However, it is not clear whether these behavioral changes are the result of functional alterations originating within critical periods of brain maturation, and few behavioral models are currently available to assess emotional and cognitive function in developing animals. In order to address the current paucity of knowledge regarding the consequences of psychotherapeutic drug treatment on brain development and behavior, this initiative encourages basic and clinical studies that will ascertain the impact of these drugs on the trajectory of brain development that may in turn result in lasting changes in brain function and behavior. Identification of neurobiological mechanisms that maximize therapeutic potential and minimize adverse effects of these drugs will inform optimization of psychotherapeutic medication usage for pediatric psychiatric and behavioral disorders. Research Objectives The overarching goal of this research initiative is to determine the neurobiological consequences of acute or chronic psychotherapeutic drug administration during juvenile development, from childhood through adolescence. Focused study of drug effects across developmental periods of therapeutic exposure will provide clues to the relevant neural circuits contributing to the disorders as well as sites mediating therapeutic and/or adverse CNS effects. Related research using model systems may also address the biological basis of adverse or paradoxical responses to specific drug classes. Responsive research proposals may include basic or clinical approaches to examine neurobiological and functional endpoints within defined brain circuitry at critical developmental windows. Investigations in model organisms may examine molecular, genetic, neurochemical, physiological, and behavioral effects of early drug administration in both juvenile and adolescent animals. In vivo systems should emulate drug concentrations, doses and routes of administration used in children; age of exposure and duration of drug administration should also be considered. Model systems may assess species, sex, and age differences in the kinetics and metabolism of drugs over the range of therapeutic doses. Integrative studies in non-human primates and preliminary studies in other species are encouraged, including rodent, zebrafish, fly and nematode, to identify gene-environment interactions and relevant signaling mechanisms modulated by developmental drug exposure. Research approaches to address these questions could include, but are not limited to, the following: Molecular mechanisms and neurobiological outcomes of psychotherapeutic drug treatment: in vitro and in vivo studies in model organisms are required to characterize the neurobiological and behavioral responses to acute and chronic exposure to psychotropic drugs and to identify corresponding cellular and molecular substrates at specific points along the developmental continuum. Examples of relevant medications include antidepressants, antipsychotics, anxiolytics, mood stabilizers and therapeutic doses of stimulants, as well as drugs used in the treatment of developmental disorders including autism and Fragile X syndrome. Responsive applications may also consider the context of spatiotemporal and sex-specific drug responses. Examples of relevant research goals include, but are not limited to: Age-appropriate behavioral paradigms: Develop and refine behavioral paradigms to assess effects of psychotherapeutic drug administration on cognitive and emotional measures in model organisms during juvenile and adolescent development. Behavioral models should be amenable to studies of the neural pathways, transmitters, and signaling molecules responsible for therapeutic and adverse effects of drugs. Examples of relevant research goals include, but are not limited to: Clinical studies: develop and expand clinical studies to examine possible effects of psychotherapeutic administration on juvenile and adolescent development as assessed by behavioral and brain measures obtained during childhood. Examples of relevant research goals include, but are not limited to: NICHD Statement of Interest: NICHD is interested in the possible impact of psychopharmacological treatment on developmentally relevant clinical parameters including cognitive development, physical growth and sexual maturation. Responsive studies may also address developmental changes in the pharmacokinetics, metabolism, disposition and pharmacodynamics of psychotropic medications commonly used in children and adolescents, including examination of gender and ethnic differences in these measures. Mechanisms of adverse drug reactions to psychotropic medications is another area appropriate for this announcement. NIDA Statement
of Interest: NIDA is interested the possible impact of psychotherapeutic
pharmacologies on the emergence of addictive diseases later in life as function
of treatment within critical periods of development. As such treatments may
confer vulnerability or resilience to addictive processes, they should be
coupled with the study of neuroadaptations that occur as a consequence of
exposure to abused substances during development, including structural and
functional changes in the brain, neurotoxicity, neuroprotection, tolerance and
sensitization, and comorbidity with other disease states. Studies of sex
differences in response to psychotherapeutic treatment will also be considered
appropriate for this FOA. See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement. 1.
Mechanism of Support This funding opportunity uses just-in-time
concepts. It also uses the modular as well as the non-modular budget formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular budget format described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications. 2. Funds Available Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of
meritorious applications. Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Section III. Eligibility Information
1. Eligible
Applicants 1.B. Eligible Individuals Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support. 2. Cost Sharing or Matching Not applicable. Section IV. Application and
Submission Information 1. Address to Request Application
Information Telecommunications
for the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application
Submission 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. 3. Submission Dates and Times 3.A.
Submission, Review and Anticipated Start Dates 3.A.1. Letter of Intent A letter of intent is not
required for the funding opportunity. 3.B. Sending an Application to the NIH Applications must be submitted on or before the
application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for
completeness by CSR. Incomplete applications will not be reviewed. 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. This does not preclude the submission of a substantial revision of an
application already reviewed, but such application must include an Introduction
addressing the previous critique. Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/. 4. Intergovernmental Review All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm). Applications requesting up to $250,000 per year in
direct costs must be submitted in a modular budget format. The modular budget
format simplifies the preparation of the budget in these applications by
limiting the level of budgetary detail. Applicants request direct costs in
$25,000 modules. Section C of the research grant application instructions for
the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year. Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps: 2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and, This policy applies to all investigator-initiated new
(type 1), competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional information on
this policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. The precise content of the data-sharing plan will vary, depending on the
data being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by
mailing a disk or posting data on their institutional or personal website,
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the
application. Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (http://grants.nih.gov/grants/policy/data_sharing). Sharing
Research Resources The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting. Section V. Application Review Information
1. Criteria 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. Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed. 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 2.C. Sharing
Research Data Section VI. Award
Administration Information
1. Award
Notices If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm). 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: Beth-Anne Sieber, Ph.D. Questions regarding scientific/research issues about
research focused on clinical outcomes may be directed to: Benedetto Vitiello, M.D. Questions regarding scientific/research issues about translational pediatric research may be directed to: Regina Smith James, M.D. Questions regarding psychotropic medication
interactions with child growth and mechanisms of drug adverse reactions may be
directed to: George P. Giacoia, M.D. Questions regarding applications relevant to drug
abuse may be directed to: Nancy S. Pilotte, Ph.D. 2. Peer
Review Contacts: 3. Financial or Grants Management Contacts: John Chris Robey Gary Fleming, J.D. Section VIII. Other
Information
Required
Federal Citations 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: NIH Public Access Policy:
Release/Posted Date: May 1, 2006
Application
Submission Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
Peer Review Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review
Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest
Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional
Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Not Applicable
Additional Overview
Content
Executive Summary
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible
Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
This FOA will use
the NIH Research Project Grant (R01) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project. The total project period for an R01 application submitted in response
to this FOA may not exceed 5 years.
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
See Section IV.3.A for details.
Application
Submission Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review
Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council
Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest
Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:
Center for Scientific
Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
Pre-Award Costs are allowable. A grantee may, at
his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
Plan for Sharing Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
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 Research Plan, Section E on Human Subjects in the PHS Form
398).
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 Research Plan, Section E on Human Subjects in the PHS Form
398).
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The presence of a data
sharing plan will be part of the terms and conditions of the award. The funding
organization will be responsible for monitoring the data sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
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 eRA Commons.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the signing official shown on the
electronic application.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency
Contacts
1. Scientific/Research Contacts:
Questions
regarding scientific/research issues about basic or clinical neuroscience
research including sites and mechanisms of drug action may be directed to:
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: [email protected]
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7147, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: [email protected]
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6181, MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-9263
FAX: (301) 480-4415
Email: [email protected]
Center for Research in Mothers and Children
National Institute of Child Health and Human
Development
6100 Executive Boulevard, Room 4B11B
Bethesda, MD 20982-5288
Telephone: (301) 496-5589
FAX: (301) 480-9791
Email: [email protected]
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1317
FAX: (301) 594-6043
Email: [email protected]
Not applicable.
Dawn
Walker
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC
9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: [email protected]
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17K,
MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6996
FAX: (301) 480-4782
Email: [email protected]
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 270, MSC
9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Use of Animals in Research:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
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.
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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