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 Child
Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
Title: Mental Retardation and Developmental Disabilities Research Centers 2008
(P30)
Announcement Type
This is a
reissue of RFA-HD-05-030 which was previously released on September 29, 2005.
Update: The following update relating to this announcement has been issued:
Due Dates for E.O. 12372
Not
Applicable
Additional Overview
Content
Executive Summary
The National Institute
of Child Health and Human Development (NICHD) invites applications for Center
Core Grants designed to advance the diagnosis, prevention, treatment, and
amelioration of mental retardation and developmental disabilities (MRDD). This
Request for Applications (RFA) seeks applications from institutions that meet
the qualifications for a program of MRDD research as specified at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm.
The grants fund core resources to support interdisciplinary research and
research training. Funds for the research projects using these core facilities
come from independent sources including Federal, State, and private
organizations.
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(s) 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. Address to Request Application Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
1. Developmental and neurobiological studies to define the molecular and cellular bases of MRDD and to facilitate development of specific hypotheses about basic abnormalities that underlie these conditions.
2. Studies of cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation.
3. Applied clinical and experimental studies of inborn errors of metabolism relevant to MRDD that involve pathophysiology of cellular and subcellular organelles.
4. Development of novel and innovative technologies for pre- and post-natal diagnosis of common and rare causes of MRDD; investigation and therapy of conditions associated with MRDD.
5. Studies of the genetic and epigenetic basis of MRDD by molecular genetic, genomic, and proteomic approaches.
6. Studies of the pathways by which genotype affects the development, function, and dysfunction of the nervous system, particularly with respect to cognition and behavior.
7. Creation and characterization of animals that, through genetic alteration, model specific important aspects of MRDD by clear neurodevelopmental, pathophysiological, genetic, and/or functional homology, and their use to test existing and to develop new medications that are safe and effective for individuals with MRDD.
8. Prenatal therapy of genetic and structural defects using nutritional, pharmacological, surgical, and other techniques.
9. Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to the MR syndromes, such as Down, Fragile X and Rett.
10. Studies of physical environmental factors in the etiology, treatment, and prevention of MRDD, such as heavy metals (e.g., lead and mercury) and toxic wastes (e.g., hydrocarbons and polycarbonates or PCBs) and their effects on morphogenesis and function that contribute to MRDD. Areas of interest include developmental and behavioral teratology, neuroimmunological toxicology, and conditions such as fetal alcohol syndrome.
11. Studies of the effects of malnutrition (protein, caloric, micronutrient) on intellectual, behavioral, social, and physical development; intergenerational effects of malnutrition.
12. Studies of psychopharmacology, including medication use and development; cellular and molecular mechanisms, pharmacokinetics, behavioral effects; rational drug development (e.g., combinatorial chemistry, pharmacogenomics); medication use and treatment efficacy in different subpopulations of MRDD; dual diagnoses.
13. Clinical trials for the treatment, amelioration, and/or prevention of MRDD. NICHD encourages the Centers to apply for clinical trials grants (R34, R01, and U01).
14. Studies of infectious diseases in the etiology, treatment, and prevention of MRDD; neuropathological, neurological, behavioral, and intellectual consequences of AIDS in children.
15. Studies that develop and test novel methods and measures for screening and diagnosis, and/or identify children and infants at risk; validation of emerging technologies (e.g., microarrays, proteomics, microanalysis of analyates, biomolecule sensing, mass spectrometry, functional imaging) for screening and diagnosis.
16. Studies that develop methods to better define clinical phenotypes, including sources of variability, in MRDD, with particular focus on characteristic components of behavior and cognition; measurement tools to assess cognitive and behavioral development; tests that highlight abilities and disabilities, including tests for specific subpopulations (e.g., specific inborn errors of metabolism and syndromes such as Down, Fragile X, Prader-Willi, and Williams).
17. Studies involving early interventions (biological, behavioral, educational, environmental) for infants born at risk for MRDD; research into the strategies for early intervention; follow-up of high-risk infants and children whose risk is due to biomedical conditions such as low birth weight and/or conditions of environmental deprivation; studies of intergenerational effects and outcomes for children whose parents have conditions associated with MRDD; effects of teen pregnancy on at-risk infant outcome.
18. Predictive and developmental studies of perinatal problems associated with MRDD; developmental studies of low birth weight, including infants who are small for gestational age, preterm, medically fragile, and neonatally sick (such as those who experience hypoxic or ischemic insults).
19. Neurodevelopmental and longitudinal studies that characterize the neuropathogenesis and inherent variability in MRDD to develop specific hypotheses about the initial (primary) abnormality, and to address the degree to which phenotypic variation impacts upon postnatal brain development.
20. Studies to follow the developmental trajectories of different brain functions and their influence on developing cognitive and motor skills; such studies might use techniques of imaging, electrophysiology, pharmacology, molecular biology, and behavioral science.
21. Studies of psychological processes in MRDD, including attention, cognition, information processing, perception, motor development, neuropsychology, and affective, social, motivational, and personality factors.
22. Studies of autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental course, using medical, biological, and pharmacological approaches; behavioral and pharmacological interventions.
23. Studies involving manipulations of interaction between behavior and environment of individuals with MRDD throughout the life-span to reduce behavior problems or to facilitate vocational training, social and self-help skills, and learning; use of social support networks; parent-child, sibling, peers, and family interactions over the life-span.
24. Studies that examine and evaluate residential, educational, and vocational settings of individuals with MRDD throughout the life span.
25. Studies of learning disabilities, dyslexia, and attention deficit hyperactivity disorder.
26. Studies of language and communication in MRDD populations.
27. Studies of socio-ecological processes: individuals with MRDD from various cultural and ethnic groups in multiple settings (naturalistic observation); ethnographic research, life history reporting, and systematic observation of specific activities.
28. Studies of hyperaggressive, destructive, and self-injurious behavior in humans and animal models, including pharmacological and behavioral treatments; stereotypic behaviors; lack of adherence associated with MRDD in family and educational settings.
29. Studies of the epidemiology of MRDD: analytic and case-control studies of etiology; incidence and prevalence; follow-up over the life span for outcomes.
30. Studies that examine and evaluate behavior, life styles, health needs, and health disparities of affected individuals that could affect mortality and morbidity throughout the life span.
31. Studies that develop and utilize assistive devices (e.g., computer software, hand-held devices, and touch screen computers) to help individuals with MRDD to learn and communicate.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the NIH Center Core Grant (P30) award mechanism(s).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
Applicants
must prepare the application in a manner consistent with the guidelines
presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).
This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
NICHD intends to commit
approximately 4.5 million dollars in FY 2008 to fund up to three new and/or renewal (competing
continuation) applications in response to this RFA. An applicant for a new
grant may
request a project period of up to five years and a budget for direct costs up to 750,000 dollars
per year. An applicant for a renewal (competing continuation) grant may request
a project period of up to five years and a budget for initial year direct costs
of 750,000 dollars or the amount representing an increase of up to 3 percent
above the direct costs awarded in the final noncompeting (Type 5) year,
whichever is greater. Budget increments for subsequent years will have a three
percent limit. Budgets for new and renewal applications will undergo stringent
review within these guidelines. Applications with budgets that
exceed these guidelines will be deemed by NICHD to be non-responsive to this
FOA and will be returned without review. The cost of a proposed Center will be
a material consideration in the selection of applications for funding.
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 NICHD provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number 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.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
For the purpose of this RFA, the NICHD will support no more than one MRDDRC grant (P30) per institution. To be eligible for an award, the proposed Center must provide core support for a minimum of 10 projects funded from non-university sources. Additional eligibility criteria for the P30 are listed in the NICHD P30 CENTER CORE GRANT GUIDELINES at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm.
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.
The MRDDRC Director should be a
scientist or science administrator who can provide effective scientific and
administrative leadership. The Director will be responsible for the
organization and operation of the MRDDRC and for communication with the NICHD
on scientific and operational matters. She/he should be able to integrate and
synthesize the proposed research and, thereby, serve as an example to other
investigators.
2. Cost Sharing or Matching
Cost
sharing is not required.
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
Applications
for P30 MRDDRC grants must propose a program consisting of cores to be accessed
by grants that propose research addressing at least five topics relevant to the
research mission of MRDD. A list of examples is outlined above (in Section I.1.
Research Objectives ). This list of topics is not comprehensive,
nor are the examples exhaustive.
The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality and provide a multidisciplinary approach to the problem(s) under investigation. Each project is to be summarized in accordance with the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). Projects funded under initiatives unrelated to this RFA (such as Fragile X Research Centers, Autism Centers of Excellence, Rare Disease Cooperative Research Centers, and traditional P01s) may be counted in the 10 externally funded research projects.
An MRDDRC must contain an Administrative Core and a minimum of two additional core units. A minimum of three federally funded research projects must utilize each core unit. These projects must relate to MRDD and at least one must be funded by NICHD, exclusive of research contracts, training grants, interagency agreements, and supplemental projects funded by other agencies.
When determining core support, subprojects within a Program
Project (P01) will be considered as individual projects comparable to an R01.
Projects located at institutions that do not already have an MRDDRC must
receive NICHD prior approval to access core facilities.
Section
IV. Application and Submission Information
1. Address to Request Application
Information
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].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
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.
Instructions
for application preparation can be found in the NICHD P30 CENTER CORE GRANT
GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times not applicable.
3.A.
Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt
Date: November 21,
2007
Application
Receipt Date: December 21,
2007
Peer Review Date: March/April, 2008
Council Review
Date: May 2008
Earliest
Anticipated Start Date: July 1, 2008
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
at the beginning of this document.
The letter of intent
should be sent to:
Ljubisa
Vitkovic, Ph.D.
Mental Retardation and
Developmental Disabilities Branch
National Institute of
Child Health and Human Development
6100 Executive Boulevard
Room 4B09E, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for
express/courier/non-USPS service )
Telephone: (301) 402-1822
FAX: (301) 496-3791
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three 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/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).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Robert
Stretch, Ph.D
Director, Division of Scientific
Review
National Institute of
Child Health and Human Development
6100 Executive Boulevard
Room 5B01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier/non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NICHD. Incomplete and
non-responsive applications will not be reviewed.
Upon receipt in NICHD, an administrative review of the application is performed by NICHD staff for conformance to NIH policy and NICHD guidelines, responsiveness to the RFA, as well as for its relevance to NICHD program interests. If the application fails to comply with NIH policy and guidelines or is determined to be non-responsive to the RFA, it will be returned to the applicant without review.
Budgets for new and renewal applications will undergo stringent review within the guidelines described in Section II.2 (above). Applications with budget requests exceeding these guidelines will be considered non-responsive to this FOA and will be returned to the applicants without review.
Research projects proposed for core use that are of questionable relevance or are not thematically related may be also be considered non-responsive.
The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to a funding
opportunity, it is to be prepared as a NEW application. That is, the
application for the funding opportunity must not include an Introduction
describing the changes and improvements made, and the text must not be marked
to indicate the changes from the previous unfunded version of the application.
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
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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 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
The
applicant must provide a detailed description of each Core unit proposed as
part of the Center, with detailed budget and budget justification.
Budgetary items allowable for Administrative Core Units include salaries and support for a limited number of administrative and clerical personnel; administrative support services, when not covered by institutional Facilities and Administrative (F & A) charges; travel to one Center Directors' meeting to discuss scientific advancements of the Centers annually; and travel to one Center Directors' and administrators' meeting annually to confer with other NICHD Center Directors.
Budgetary items allowable for other Cores include salaries and support for core staff; supplies (including animals); scientific equipment; computer facilities and services; travel for technical or administrative staff for technical training or to maintain operation of the core unit; and consultant services .
The applicant must name a scientist to be responsible for each Core unit proposed. The description of each Core unit proposed should include a rationale, indicating how the Core will support the research effort in an efficient and cost-effective manner. Cores should integrate with or buy in to existing institutional resources rather than duplicate them. Core support to individual investigators should not overlap with support already available to them from other sources.
The applicant institution and pertinent departments must show a strong commitment to the Center's support. Dedicated space and/or equipment, staff recruitment, investigators' salaries or other financial support for the proposed Center exemplify such commitment. The facilities should require no more than modest alteration and/or renovation. NICHD provides no funds for new construction.
Scientific personnel and institutional resources must be available to provide a strong research base in the specified fields.
As a major goal, the MRDDRC Program promotes 1) interdisciplinary collaboration among Centers investigators, 2) data/information sharing and integration, 3) synthesis of knowledge about MRDD, and 4) translational research that will lead to amelioration and prevention. Each Center application should present a specific plan for achieving this major goal.
Another goal of the MRDDRC Program is to attract scientists to MRDD research. Where appropriate, the applicant may request up to five years' support for "New Program Development" for direct research support of one or more projects. This support should not exceed a total of $100,000 direct costs per year, or 10 percent of total direct costs, whichever is less. Applicants may use such funds to attract new investigators to the Center, to develop a new area or program of research, to facilitate the development of new research programs of newly trained investigators or investigators new to MRDD research, or to facilitate use of a Core at one Center by investigators affiliated with another Center that lacks that kind of Core. Description of New Program Development projects should compare to R01 research grant applications in detail and development. Each New Program Development project may provide support for no more than two years to any one investigator.
A major
goal of the NICHD is to promote active collaboration among MRDDRCs. To
accomplish this goal, successful applicants will participate in the
collaborative efforts of established Centers' programs. In planning the
program, applicants should consider potential collaborative studies and
projects that they may propose for the MRDDRCs network. The Administrative Core
should budget for the maintenance of the MRDDRC Network Web-Portal and for the
development of common protocols, databases, and communications and informatics
technologies.
Plan for Sharing Research
Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
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).
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.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Keeping
with the goals of the MRDDRC Program enunciated in the Guidelines and in Other
Submission Requirements, above, the applicants should highlight potentially
unique core resources and how they plan to share them with other MRDDRCs.
Section
V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NICHD in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
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?
In their considerations, the reviewers will also be guided by the following criteria:
NICHD will evaluate all applications responding to this RFA according to the review criteria for Core units, New Program Development projects, and the overall center as outlined in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).
Review of competing continuation (renewal) applications (type 2) will evaluate the progress made by a Center in the previous funding period in addition to the review criteria applied to new applications. The reviewers will evaluate productivity of investigators affiliated with a Center by the number, impact and relevance to MRDD of the publications that acknowledge support by the Center grant.
A site visit is not a prerequisite for consideration of any
application by an NICHD review committee. Site visits will not be conducted for
applications responding to this RFA. The applicant should not rely on a site
visit to supplement or improve an incompletely written application.
A
five-year total project period is required.
Core units may be recommended for a minimum of three years. This would not preclude requests for support of core units for less than three years. However, a minimum of three core units is required in each of the five years of the Center grant.
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).
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
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.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 reviewers will be asked to
assess the adequacy of the plan.
3. Anticipated Announcement and Award Dates
Not applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
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 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.
The Non-Competing Grant Progress Reports must explicitly describe the progress in achieving the goals of the MRDDRC Program that are articulated in this document and should follow the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).
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:
Ljubisa
Vitkovic, Ph.D.
Mental Retardation and
Developmental Disabilities Branch
National Institute of
Child Health and Human Development
6100 Executive Boulevard
Room 4B09E, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for
express/courier service)
Telephone: (301) 402-1822
Email: [email protected]
2. Peer Review Contacts:
Robert
Stretch, Ph.D
Director, Division of
Scientific Review
National Institute of
Child Health and Human Development
6100 Executive Boulevard
Room 5B01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for
express/courier service)
Telephone: (301) 496-1485
Email: [email protected]
3. Financial or Grants Management Contacts:
Bryan S. Clark, M.B.A
Chief Grants Management Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8A01, MSC 7510
Bethesda, MD 20892
Rockville, MD 20852 (for
express/courier service)
Phone: (301) 435-6975
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
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide public 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.
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 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 new PHS Form 398; 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. Applications that do not provide this
information will be returned without review.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central
(PMC) an electronic version of the author's final manuscript upon acceptance
for publication, resulting from research supported in whole or in part with
direct costs from NIH. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications from
the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy
of Individually Identifiable Health Information:
The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for 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 RFA 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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