and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Center for Genomic Studies on Mental Disorders (U24)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-MH-08-100
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: October 23, 2007
Letters of Intent Receipt Date: December 11, 2007
Application Receipt Date: January 11, 2008
Peer Review Date: April 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available Date (URL Activation Date):
Expiration Date: January 12, 2008
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
Background
The identification of genetic and environmental contributions to disease and response to treatment is a major public health challenge. Several recent developments and technological advances in genetic sciences suggest that progress may be quite rapid. These include the sequence of the human genome, identification of large numbers of single nucleotide polymorphisms (SNPs), exploration of human genetic variation, affordable high-throughput multiplexed microarray systems and other approaches to genome-wide SNP genotyping that are applicable to large pre-treatment population samples, maps of human haplotype structure, DNA pooling that permits measurement of allele frequencies in large groups of individuals using far fewer PCR reactions and genotyping assays, and emerging methods to measure environmental exposures.
Realization of the full potential of these tools and technologies for accelerating discoveries in human genetics will require the free and open sharing of genetic material, phenotypic data and genetic analysis tools among researchers. For mental disorders and other genetically complex diseases in which gene effects are modest, sharing is often absolutely necessary to achieve sample sizes that have adequate statistical power for gene mapping and mutation detection. Other specific scientific advantages of sharing research resources include facilitating the rapid replication of new findings, stimulating multidisciplinary translational research programs that include clinical and basic scientists, providing needed resources to promising young investigators, avoiding duplicative data collection efforts and laboratory work, and facilitating the rapid application of state-of-the-art genomic technologies and analytic methods to human genetic data sets. These advantages are expected to facilitate our understanding of pathophysiology, and accelerate the development of new therapeutic compounds and diagnostic tests.
In the late 1980's, NIMH launched a Human Genetics Initiative (http://www.nimhgenetics.org) to characterize the genetic basis of vulnerability to schizophrenia, Alzheimer disease, and bipolar disorder. The main goal of this effort was to accelerate gene discovery through the sharing of electronic databases of clinical information, DNA samples, and cell lines as a national resource for the scientific community. In 1997 a workgroup of the National Advisory Mental Health Council reviewed the NIMH genetics research portfolio and recommended that NIMH continue to fund large-scale data collection efforts and to maintain a repository of DNA and clinical data for sharing with the scientific community (see the report summary at http://www.nimh.nih.gov/research/genetics.htm). The Workgroup also discussed future expansion of these efforts to include other mental disorders. At a joint meeting in September 2000, the National Advisory Councils of both NIMH and the National Institute of Neurological Disorders and Stroke recommended that data sharing for the genetic analysis of complex diseases supported by these Institutes continue to be strongly encouraged.
In order to continue to enhance and enrich research resources in the NIMH Human Genetics Initiative for free and open sharing with the scientific community, NIMH plans to fund one Center under this FOA. The long-term objective of data sharing and research resource enrichment under this FOA is to accelerate gene discovery in mental disorders that include Alzheimer disease, attention-deficit hyperactivity disorder, autism/related spectrum disorders, bipolar disorder/other related mood disorders, recurrent early-onset depression, eating disorders, obsessive-compulsive disorder/other anxiety disorders, panic disorder and schizophrenia/other psychotic disorders.
As this resource matures, high-throughput biological data sources hold the promise of revolutionizing molecular biology by providing critical information from genomic sequence, gene expression experiments and in silico comparative genomic studies directly relevant to mental disorders. Complexities arise, given that genomic information is scattered across hundreds of heterogeneous and autonomous information systems - each with their own interfaces and control languages - that represent information using inconsistent data models and formats. Computing grids and more sophisticated ontology-based tools to integrate, analyze and visualize genomic data will be critical for in silico gene discovery and elucidation of regulatory networks. A genomic cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources by the scientific community will be essential to improve research productivity and enable scientific breakthroughs not otherwise possible.
Program Objectives
The intent of this FOA is to seek applications for and support one Center for Genomic Studies on Mental Disorders to serve as a national and international resource to the scientific community. The Center funded under this FOA will be directed by a Principal Investigator (PI), and will receive guidance from NIMH program staff to assist with identification and implementation of appropriate strategies and priorities. It is expected that the Center will be comprised of an integrated team of investigators (within a single institution or across institutions) with expertise in molecular biology, computer science and information technology, statistical genetics and psychiatric genetics. It is expected that this effort will involve activities at multiple institutions that are strategically and functionally coordinated such that the Center will function as a single, national resource.
Given that genome mapping and sequencing projects push the frontiers of molecular biology, genetics and genomics toward information science, a new critical feature of the Center will be the establishment of a genomic cyberinfrastructure that represents the coordinated aggregate of software, hardware and other technologies, as well as human expertise, required to support current and future discoveries in the genetics of mental disorders. This cyberinfrastructure will integrate relevant and often disparate genetic and genomic resources to provide a useful, usable, and enabling framework for human genetic research and gene discovery in mental disorders that will be characterized by broad access and end-to-end coordination.
It is expected that the principal investigator and the proposed collaborative team have direct experience in providing to the scientific community research resources and services for genetic studies, as well as experience in establishing cyberinfrastructure for a mature scientific discipline. Specific areas of scientific expertise required by the Center include the following:
Research Topics
Specific functions and services to be performed by the Center for the scientific community will include:
These services and research resources will be provided to the scientific community by the Center on a fee-for-service basis. Fees charged will recover costs and service delivery costs. Applications in response to this FOA should include detailed plans for the advisory, research and development, and other fee-for-service functions of the Center.
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
Resource-Related Research Projects Cooperative Agreements award mechanism
(U24). As an applicant, you will be solely responsible for planning, directing,
and executing the proposed project. The NIH U24 is a cooperative agreement award mechanism. 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 the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award". NIMH intends to continue this cooperative agreement
beyond the initially awarded period of performance.
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 $7,000,000 in FY 2008 to fund one new cooperative agreement in response to
this FOA. An applicant may request a project period of
up to 5 years. The anticipated start date is September 30, 2008.
Although the financial plans of the IC(s) provide
support for this program, awards pursuant to this funding opportunity are contingent
upon the availability of funds and the receipt of 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:
Foreign institutions are not eligible to apply in response to this FOA.
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. 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
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) 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.
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
Letters of Intent Receipt Date: December 11, 2008
Application Receipt Date: January 11, 2008
Peer Review Date: April 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 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:
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: [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 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: [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 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 Genetics Steering Committee will meet quarterly at NIMH in Rockville, MD. Applications submitted in response to this RFA should include a request for
funds to cover the expenses of attending these meetings.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI "Award Administration Information".
Plan for Sharing
Research Data
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
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 FOA to develop and propose detailed plans for
data sharing. It is expected that data sharing plans minimally include all
phenotypic and genotypic data. All data and
biomaterials managed and produced by the Center are required to be widely
distributed to the national and international scientific community.
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 the end of the award period, even if a competing renewal application is submitted. 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 FOA. It is expected that the applicant's approved consent form address the following:
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 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.
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 Center funded under this FOA will facilitate and accelerate free and open sharing among researchers in the scientific community by providing DNA, cell lines, electronic datafiles and cyberinfrastructure for the genetic analysis of mental disorders.
Section V. Application Review Information
2.
Review and Selection Process
The following will be considered in making funding
decisions:
Adequacy of plans to establish genomic infrastructure for
the broader scientific community to efficiently access data and biomaterials
generated by the Center
Applications that are complete and responsive to the
FOA 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? 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?
What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? If the aims of the application are achieved and research resources for genetics studies are freely shared with the scientific community and a genomic cyberinfrastructure established to integrate relevant and often disparate resources to provide a useful, usable, and enabling framework for genetic research and gene discovery, how will knowledge on the genetic basis of mental disorders be advanced? What will be the effect of these research resources on other scientific activities 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?
Will the genomic cyberinfrastructure developed by the Center succeed in accelerating the discovery of genes producing vulnerability to mental disorders? Does the applicant utilize state-of-the-art methods to create an efficient cyberinfrastructure? Does the investigator utilize appropriate molecular biological techniques to assure a high rate of success (98% or greater) in establishing cell lines from both domestic and foreign sites?
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?
Does the project employ novel concepts, approaches, or methods for the production and sharing of research resources and for the development of genomic cyberinfrastructure?
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 principal investigator have demonstrated experience in providing high-quality research resources and services for genetic studies on mental disorders to the scientific community? Is the principal investigator highly committed to the principals of free and open sharing of research resources for genetic studies of mental disorders?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional
Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of Human
Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed (see the Research
Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women,
Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).
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 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
below.
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 Steering Committee:
(GSC). A Genomic Advisory Panel (GAP), composed of experts not affiliated
with the Centers or GSC, also will be formed to provide scientific oversight of
the Center. GSC, GAP, PI and NIH responsibilities are described below.
2.A.1. Principal Investigator
Rights and Responsibilities
The awardee, as Center PI, will coordinate project
activities scientifically and administratively at the awardee institution, and
will have primary responsibility for performing all scientific and
fee-for-service activities. The Center PI must agree to participate with
GSC in coordinating the activities of the Center, with the result that all
investigators included in the application function as a single functioning
Center. The PI agrees to accept the close coordination, cooperation, and
participation of GSC and GAP in those aspects of scientific and technical
management of the project as described below. Specifically, the PI will have the primary responsibility for:
Awardees 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 HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An NIH Project Scientist will have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards, as described below. The NIH 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. The role of the NIMH will be to
facilitate and not to direct activities. The NIH Project Scientist shall
participate as a member of GSC and will have one vote. Specifically, the
NIH 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 NIH Project Scientist.
2.A.3.
Collaborative Responsibilities
Genomic Steering Committee (GSC)
All collaborative activities of the awardee and NIMH staff will occur through the activities of GSC, which will serve as the governing board of the Center. The NIMH will formally interact and collaborate with the Center through GSC, 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 GSC Chair will be responsible for developing meeting agendas and chairing meetings. GSC will meet quarterly. Additional GSC members may be added by action of NIH. NIH staff may attend GSC 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 GSC, a majority of the possible votes must be cast in favor of the decision or course of action. GSC will coordinate the activities of the Center. GSC will discuss scientific progress, make recommendations regarding the enhancement of research resources and facilitation of free and open sharing. GSC will address GAP recommendations. Awardee will be required to accept and implement policies approved by GSC.
Genomic Advisory Panel (GAP)
GAP will meet at least once each year and will oversee Center activities to assure that the needs of the broader scientific community using Center resources are being met. GAP will provide scientific advice to GSC and NIMH. GAP members will provide scientific and operational recommendations concerning both long-term developments and activities at the Center. GAP also will consult on the incorporation of emerging high-throughput phenomic methodologies and technologies into Center activities. GAP will consist of about 10 scientists (panelists) who are not affiliated with the Center. GAP panelists will be appointed by the NIMH project officer and will be selected for their broad expertise in relevant topics such as molecular genetics, cell banking and transformation, bioinformatics and data integration. NIMH will select one panelist to be GAP's chair. Additional GAP members may be added by an action of GAP. The NIH Project Scientist will attend GAP meetings as a non-voting member and will act as a representative of GSC. Other NIH staff and GSC members may attend GAP meetings. GAP panelists will not vote on GSC but may be invited to attend GSC meetings. Periodically, at intervals determined by GSC, a formal request for advice on specific subjects will be submitted to GAP. GAP will convene to consider and formulate opinions on the questions submitted to it. NIMH program staff will consider GAP 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
GSC 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.
2.A.5. Milestones and Evaluations
Applicants should define yearly milestones in their applications, and the selected awardee will have the opportunity to modify these milestones at the time of award. The awardee's milestones will be reviewed by GSC and GAP. It is expected that the milestones should be adjusted annually at the award anniversary dates, both to incorporate a group's scientific accomplishments and progress in the field in general, as well as to reflect GSC and GAP recommendations. Following the evaluation of milestones, the NIMH Project Officer may recommend augmenting any activity or reducing or withholding funds for an activity that substantially fails to meet its milestones or to remain state-of-the-art. Augmentation of funds must be in the scope of work of the Center's activities and subject to approval by the NIMH and the National Advisory Mental Health Council.
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: [email protected]
2. Peer Review Contacts:
David
Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd., Rm. 6138, MSC 9606
Bethesda, MD 20892-9606
Telephone: (301) 443-3534
FAX: (301)443-4720
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Victoria Carper
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda , MD 20892
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (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 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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