Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) ( www.nih.gov)
Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Center for Genomic and Phenomic Studies in Autism (U24)
Announcement Type
New
Request For Applications (RFA) Number: RFA-MH-07-080
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: November 29, 2006
Letters of Intent Receipt Date(s): December 27, 2006
Application Receipt Date(s): January 26, 2007
Peer Review Date(s): February/March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 1, 2007
Additional Information To Be Available Date (URL Activation Date):
Expiration Date: January 27, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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
A. Cooperative Agreement Terms and
Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
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
Autism is a neurodevelopmental disorder with early childhood onset and characterized by significant impairments in social, communicative, cognitive and behavioral functioning. Symptoms persist throughout life, disrupt families and lead to significant disability. It is known that genes play a greater role in the risk of autism than in any other common neurodevelopmental disorder, with a reported monozygotic-twin concordance:dyzygotic-twin concordance ratio of ~25 and heritability > 90%. However, while genes exert a strong influence in aggregate, it is clear that autism is genetically complex, i.e., multiple genes of relatively small effect must interact to produce risk in combination with nongenetic factors. In addition, a more comprehensive understanding of autism’s etiology ultimately will require advanced knowledge of brain structure and function at multiple levels of analysis.
Understanding the genetic etiology behind a complex, multi-gene disorder like autism remains an important challenge. Methodologic and technical advances in molecular, cellular and genomic neuroscience are setting the stage for a new era in autism research, and will greatly facilitate the translation of findings from basic to clinical research paradigms that aim to identify targets for new therapeutics. Highly accurate and comprehensive phenotypic assessment is critical to the success of these endeavors, and will permit resolution of underlying etiologic heterogeneity, delineation of discrete clinical subtypes and identification of specific components of the disorder that differentially respond to pharmacologic and other therapies.
Comprehensive phenotypic characterization will accelerate identification of intermediate phenotypes – so-called endophenotypes – that index physiological processes that lie between the level of the genotype and phenotype. Potential endophenotypes in autism may index underlying brain structure/function and neurodevelopmental abnormalities include assessments of facial dysmorphology, cognitive and intellectual deficits, language and communication abnormalities and social deficits. To the extent that such traits are under genetic control, it is expected that they will aggregate in families. The analysis of endophenotypes in clinically unaffected relatives of autistic probands thus offers a powerful study design to study these traits independent of the confounding effects of treatment and disease progressions. Ultimately, robust assessments of this endophenotypes are expected to serve as biomarkers (changes in gene or protein expression in relevant tissues , as determined from laboratory- and non-laboratory based approaches, e.g., brain imaging, biochemical assays) to resolve clinical heterogeneity and heterogeneity of therapeutic drug response. Such phenotypic assessments will play a potentially invaluable role in future clinical trials in autism, given their potential for identifying a new class of behavioral markers and clinical endpoints by which therapeutic efficacy may be assessed. Ultimately, the careful cataloging of clinical and endophenotypic features will be a prerequisite for the era of genomic medicine, in which detailed genetic information is utilized to develop individualized therapeutic regimens.
The key to the development of major translational paradigms in autism – by which underlying genetic and other biological information are indexed by endophenotypic or clinical measures – will be robust, rapid and comprehensive assessment of the autism phenotype. “Phenomics” is the name given to the science which attempts to integrate the information provided by all these areas of study into a holistic picture of the complete organism – its phenotype.
Environmental factors are clearly of importance in the etiology of autism. Ongoing work is focused on identifying specific components of environmental risk, and the methodologies that are most suitable for making such assessments. For example, several researchers are now beginning to explore the links between environmental chemicals that may alter brain function and regional brain growth. In the interim, it is expected that the Center will collect information that will inform future studies of the environment on brain development in autism and the effect of selected environmental agents, beginning with neuron formation and growth and proceeding to the overall behavior of the organism. Identification of environmental exposure and diagnostic biomarkers will allow researchers to measure exposure or susceptibility in children with autism more systematically. Examples of specific Center activities include the following: administration to parents or caregivers of a comprehensive environmental exposure assessment; collection of blood plasma, urine, and saliva; identification of signature profiles of metabolites and analytes; identification of metabolomic and proteomic signatures in subgroups of autistic patients; and the development of appropriate biomarker panels to measure proteins and metabolites
In order to develop a comprehensive catalog of the autism phenotype, the National Institute of Mental Health (NIMH) and its funding partners are soliciting applications that will establish a Center for Genomic and Phenomic Studies in Autism. The Center will accelerate identification and efficient measurement of a wide range of phenotypes across multiple behavioral, cognitive and social domains to advance interdisciplinary research on autism genomics and therapeutics. Facialdysmorphologies and cognitive, communication, behavioral and social abnormalities identified in autism offer quantitative phenotypes for genomic studies and clinical trials, and provide strong endophenotypic bridges to underlying neural systems models. The Center is expected to comprehensively collect in a high-throughput and highly reliable manner a set of phenotypic data from over 1500 autistic patients and their relatives from multiplex families collected nationwide for use in future studies. The data collected by the Center will be utilized to iteratively refine clinical phenotypes in interdisciplinary research and to provide translational validation of underlying physiological endophenotypes. A specific interest of this program is to collect an ethnically diverse sample of autistic probands and their relatives.The Center will require scientific expertise in the following areas:
The long-term goal of the Center is to foster trans-disciplinary research that will overcome bottlenecks in the discovery of treatments for autism that are caused by the use of traditional behavioral "symptom" phenotypes, which are heterogeneous and overlapping, and difficult to translate to basic research.
A specific goal of the Center will be to collect data and biomaterials for utilization in the next rounds of interdisciplinary genomic and basic and translational neuroscience research, including clinical trials. Autism phenotypes will be iteratively refined based on these data, in order to provide translational validation of physiological and other endophenotypes. The Center will initially leverage available resources such as provided by an NIH-funded hospital-based General Clinical Research Center (GCRC; http://www.gcrconline.org/) or a similar resource to provide bridging infrastructure and expertise in efficient clinical screening and systematic nationwide recruitment (especially in regard to ethnically diverse populations), database management, bioinformatics, high-throughput diagnostic assessments (of cognitive and intellectual functioning, language and communication skills, social functioning and adaptive functioning), quantitative dysmorphology utilizing state-of-the-art 3D morphometry and scanning of the craniofacial surface, cytogenetic analysis, clinical trials and regulatory issues, bioethics and human consent issues, and rapid data sharing. Specific functions and services to be performed by the Center include:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This RFA is
a one-time solicitation. This RFA will use the NIH Resource-Related Research
Projects – Cooperative Agreements award mechanism (U24). In the
cooperative agreement mechanism, the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH staff being substantially involved as a partner with
the Principal Investigator, as described under Section VI. 2. Administrative Requirements,
"Cooperative Agreement Terms and Conditions of Award".
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
NIMH intends to commit approximately $1,500,000 dollars in FY 2007 to fund one new cooperative agreement in response to this RFA. An applicant may request a project period of up to 5 years and a direct cost budget up to $1,250,000 in the first project year. Although the financial plans of the IC(s) and other sponsors provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficiently meritorious application.
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:
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
Cost sharing
is not required.
3. Other-Special Eligibility Criteria
Not applicable.
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) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-0088.
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.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated
Start Dates
Letter of Intent Receipt
Date: December 27, 2006
Application
Receipt Date(s): January 26, 2007
Peer Review Date: February/March
2007
Council Review
Date: May/June 2007
Earliest
Anticipated Start Date: July 1, 2007
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:
Thomas Lehner, Ph.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6100 Executive Blvd., Room 7190, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-1706
FAX: (301) 402-4740
Email: tlehner@mail.nih.gov
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 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).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov
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 NIMH. Incomplete and non-responsive
applications will not be reviewed. If the application is not responsive to the RFA, NIH
staff may contact the applicant to determine whether to return the application
to the applicant or submit it for review in competition with unsolicited
applications at the next appropriate NIH review cycle.
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 GPSC will meet twice a year at NIMH. Applications in response to this RFA should include a request for funds to cover the expense of attending these meetings in Rockville, MD.
Plan for Sharing Research
Data
The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All applications submitted in response to this RFA must include a plan
for sharing research data. The precise content of each data-sharing plan will
vary, depending on the data being collected and the expected schedule for data
sharing. References to data sharing may also be appropriate in other sections
of the application.
The reasonableness of the data sharing plan 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 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.
Data Sharing in the Center for Genomic and Phenomic Studies in Autism
The sharing in a timely manner of biomaterials and data has
been an essential element in the rapid progress that has been made in the
genetic analysis of human diseases. To address the joint interests of the
government in the availability of, and access to, the results of publicly
funded research and in the opportunity for economic development based on these
results, NIH requires applicants who respond to this RFA to develop and propose
detailed plans for data sharing. It is expected that data sharing plans
minimally include all phenotypic, endophenotypic and genotypic data. All data and biomaterials from subjects collected and studied by
the Center are required to be placed for distribution in common, public cell
repositories and databases that are widely accessible by investigators in the national
and international scientific community. Data and biomaterials (DNA, cell lines)
are required to be deposited in an NIMH-supported data management facility and
cell repository – the NIMH Center for Collaborative Genetic Studies on
Mental Disorders (http://nimhgenetics.org). Data
also are required to be deposited in NDAR (http://ndar.nih.gov/index.asp),
which currently is under development. Data from this database will be made
available to other researchers, under the guidelines to be established by this
entity, adhering to HIPAA and Human Subjects research codes.
It is expected that the investigator's data sharing plan will include the following elements: (1) comprehensive and verified databases that contain all clinical, diagnostic, and genotypic information; (2) high-quality cell lines, from which DNA will be extracted and stored; (3) mechanisms by which all databases and any biomaterials (DNA samples and cell lines, if applicable) are widely distributed to qualified investigators in the scientific community; (4) a protocol for wide dissemination of these data and applicable biomaterials; (5) a timetable for distribution; and (6) an assurance that data and applicable biomaterials are disseminated in a manner comparable to pre-existing protocols and procedures for distributing such data and biomaterials in the NIMH Human Genetics Initiative (see http://nimhgenetics.org).
The timeline for data sharing is evolving, and expectations for rapid data sharing are increasing. It is expected that all data will be released to the scientific community no later than one year after they are generated and validated. More rapid sharing, i.e., at quarterly intervals during the award period, is strongly encouraged.
NIMH, in consultation with NIH's Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, has developed a model consent form for use in human genetic research at http://zork.wustl.edu/nimh/NIMH_initiative/NIMH_initiative_link.html. This may then serve as a template that is subject to modification and/or approval by local institutional review boards. NIMH will review consent forms and IRB approvals for all projects prior to funding under this RFA. It is expected that the applicant's approved consent form address the following:
The adequacy of the data sharing plan 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
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 NIMH 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? Will the data to be shared by the
applicant accelerate gene discovery, translational research and the development
of new therapeutic compounds in autism?
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? Does the applicant utilize
state-of-the-art diagnostic and clinical assessments, including high-throughput
phenomics, quantitative dysmorphology and karyotyping? Does the applicant
utilize an approach to screening and recruitment that will lead to the
successful collection of an ethnically diverse sample of autistic probands and
their relatives?
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 high-throughput phenomics and other
Center activities?
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)? Does the investigative team have an
established relationship with nationwide family recruitment efforts in autism?
Does the investigative team have experience in diagnosis and high-throughput
phenomics in autism?
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? Does the
scientific environment include research infrastructure provided by an NIH-funded General Clinical Research Center (GCRC; http://www.gcrconline.org/)?
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).
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 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 expects that
grant award 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.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A.
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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement (U24 - Resource-Related Research Project), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above. Coordination of the Center's activities will be accomplished through close collaboration between the Center scientific staff, NIMH program staff, and a scientific steering committee (Genomic and Phenomic Steering Committee (GPSC)). A Genomic and Phenomic Advisory Panel (GPAP), composed of experts not affiliated with the Centers or GPSC, also will be formed to provide scientific oversight of the Center. GPSC, GPAP, PI, and NIH responsibilities are described below.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for coordinating project activities scientifically
and administratively at the awardee institution, and will have primary responsibility for performing all scientific and fee-for-service activities. The awardee institution will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current NIH policies. The Center PI must agree to participate with NIMH program staff and GPSC in coordinating the activities of the Center. Specifically, the PI will:
2.A.2. NIH
Responsibilities
An NIH (NIMH) “Project
Scientist” will have substantial programmatic involvement that is above
and beyond the normal stewardship role in awards, as described below. The NIMH Project Scientist will have
substantial scientific/ programmatic involvement during the conduct of this
activity through technical assistance, advice, and coordination. This
includes functioning as a peer with the PIs, facilitating the partnership
relationship between the NIMH and the Center, helping to maintain the overall
scientific balance in the program commensurate with new research and emerging
research opportunities, and ensuring that the activities of the Center are
consistent with the scientific mission of the NIMH Human Genetics Initiative (http://zork.wustl.edu/nimh/NIMH_initiative/NIMH%20Human%20Genetics%20Initiative%20Mission.htm).
The role of the NIMH will be to facilitate and not to direct activities. The NIMH
Project Scientist shall participate as a member of GPSC and will have one
vote. Specifically, the NIMH Project Scientist will:
Additionally, an agency program official (the NIMH project
officer) will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice. This will be a
different individual than the NIMH Project Scientist.
2.A.3. Collaborative Responsibilities
Genomic and Phenomic Steering Committee (GPSC)
All collaborative activities of the awardee and NIMH staff will occur through the activities of GPSC, which will serve as the governing board of the Center. The NIMH will formally interact and collaborate with the Center through GPSC, which will include the PI, the NIMH Project Scientist, and two researchers (advisors) with relevant scientific expertise who are not affiliated with the Center. The GPSC Chair will be responsible for developing meeting agendas and chairing meetings. GPSC will meet twice a year. Additional GPSC members may be added by action of NIH. NIH staff may attend GPSC meetings. The NIH Project Scientist, PI, and each advisor will have one vote each. In cases where members do not agree, any member may ask the chairperson to solicit a vote. In order for a decision or course of action to be finalized by GPSC, a majority of the possible votes must be cast in favor of the decision or course of action. GPSC will coordinate the activities of the Center. GPSC will discuss scientific progress, make recommendations regarding the enhancement of research resources and facilitation of free and open sharing. GPSC will address GPAP recommendations. The awardee will be required to accept and implement the common protocol and procedures approved by GPSC.
Genomic and Phenomic Advisory Panel (GPAP)
GPAP will meet at least once each year and will oversee Center activities to assure that the needs of the broader scientific community in conducting basic and translational research on autism using Center resources are being met. GPAP will provide scientific advice to GPSC and NIMH. GPAP members will provide scientific and operational recommendations concerning both long-term developments and activities at the Center. GPAP also will consult on the incorporation of emerging high-throughput phenomic methodologies and technologies into Center activities. GPAP will consist of about 10 scientists (panelists) who are not affiliated with the Center. GPAP panelists will be appointed by the NIMH project officer and will be selected for their broad expertise in relevant topics such as diagnosis, cognitive assessment, dysmorphology, cytogenetics, high-throughput phenomics, molecular genetics, genomics, pharmacogenomics, statistical genetics, bioinformatics and translational neuroscience. NIMH will select one panelist to be GPAP's chair. Additional GPAP members may be added by an action of GPAP. The NIH Project Scientist will attend GPAP meetings as a non-voting member and will act as a representative of GPSC. Other NIH staff and GPSC members may attend GPAP meetings. GPAP panelists will not vote on GPSC but may be invited to attend GPSC meetings. Periodically, at intervals determined by GPSC, a formal request for advice on specific subjects will be submitted to GPAP. GPAP will convene to consider and formulate opinions on the questions submitted to it. NIMH program staff will consider GPAP opinions with regard to overall Center functioning and when making determinations for renewal funding.
2.A.4. Arbitration Process
Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the GPSC chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant area
who is chosen by the other two; in the case of individual disagreement, the
first member may be chosen by the individual awardee. This special arbitration
procedure in no way affects the awardee's right to appeal an adverse action
that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50,
Subpart D and HHS regulations 45 CFR Part 16.
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.
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:
Thomas Lehner, Ph.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6100
Executive Blvd., Room
7190, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-1706
FAX: (301) 402-4740
Email: tlehner@mail.nih.gov
2. Peer Review Contacts:
Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov
3. Financial or Grants Management Contacts:
Dawn Walker
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115,
MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: walkerde2@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Human Subjects
Protection:
Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an application in response to this RFA 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 access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the 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.
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 PA 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
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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