MICROARRAY CENTERS FOR RESEARCH ON THE NERVOUS SYSTEM
Release Date: February 13, 2001
RFA: RFA-NS-02-001
National Institute of Neurological Disorders and Stroke
National Institute of Mental Health
Letter of Intent Receipt Date: May 15, 2001
Application Receipt Date: July 13, 2001
PURPOSE
The National Institute of Neurological Disorders and Stroke (NINDS) and the
National Institute of Mental Health (NIMH) invite applications for support of
Microarray Centers. These Centers will support gene expression profiling in the
nervous system through the application of microarray technologies. The
Microarray Centers, which will function as a consortium, will provide reagents,
services, and training to the neuroscience community, on a fee-for-service
basis. The term consortium is used here to refer to the Centers that are
funded through this RFA, and not to refer to non-grantee, participating
organizations.
RESEARCH OBJECTIVES
Background:
Oligonucleotide and cDNA microarrays are used to make quantitative or relative
measurements of gene expression. The microarrays contain nucleotide sequences
corresponding to known genes or expressed sequence tags. A single array can
contain thousands of genes, which may represent a significant subset of the
genes, or even the entire genome, of an organism. A comparison of cells or
tissues from experimental and control preparations provides data on differences
in expression levels between the two conditions. Changes in gene expression of
ubiquitously expressed genes might reveal clues to underlying, widespread
alterations of cellular physiology. Changes in expression patterns of genes
that are regulated temporally or spatially within the organism might provide
information on developmental or disease processes. Changes in one or a few
genes might lead to the discovery of individual molecular targets for drug
therapy.
Drawbacks to the application of microarray technologies to research problems
include the expense of performing the experiments, and, in some cases,
significant technical barriers to success. It is the goal of this RFA to
establish up to three Microarray Centers that will work together in a consortium
arrangement to provide microarray reagents, services, and training to the
neuroscience community.
Objective and Scope:
NINDS and NIMH will use the U24 Resource-Related Research Projects Cooperative
Agreements funding mechanism to establish up to three Microarray Centers. The
Centers will serve as regional and national resources to the neuroscience
community. Each Center will be directed by a Principal Investigator (PI), and
will receive guidance from NINDS and NIMH program staff to assist with
identification and implementation of appropriate strategies and priorities.
Although the Centers may specialize with regard to equipment, expertise, and
proprietary reagents, they will work closely together in a consortium
arrangement. The efforts of the Centers will be coordinated, strategically and
functionally, with the result that the Centers will function as a single,
national resource.
Coordination of the Centers will be accomplished through close collaboration
between the Center PIs, leadership and direction from NINDS and NIMH program
staff, and oversight by a Steering Committee. A Consortium Advisory Panel
(CAP), composed of experts not affiliated with the Centers, will be formed. The
CAP will advise Center PIs and NINDS and NIMH program staff on the organization
and operation of the microarray consortium. The CAP will address long-term
strategic issues and policies, and will also assist with the development of
general guidelines for daily operations, including the acceptance/rejection of
projects and prioritization of workload.
The Microarray Centers will provide services to NINDS-funded and NIMH-funded
investigators to support microarray analyses on the nervous system. These
services will include a broad spectrum of activities. The Centers will produce
arrays for use by the neuroscience community. These arrays may be standard,
nervous system-specific arrays designed by the Centers for general use, or they
may be custom arrays suited to the needs of smaller groups of investigators.
The Centers will run array experiments, including hybridization reactions, array
reading, and data analyses. The Centers will also advise and train the
neuroscience community. They may assist with experimental design, and advise on
how best to obtain experimental results. The Centers will train neuroscientists
on the effective use of microarray experimental techniques, in an effort to
disseminate expertise throughout the neuroscience community. The services
provided by the Centers will be on a fee-for-service basis. Fees charged will
recover product costs and service delivery costs. Research and development
costs for array production and development of best practices will not be
recovered, except in specific cases where custom arrays are developed for
limited uses. A significant portion of the first-year funding may be requested
for equipment. Applications in response to this RFA should include detailed
plans for the advisory, training, research and development, and fee-for-service
functions of the Centers. Research projects associated with the Centers,
including those of the PIs, are expected to have independent funding.
SPECIAL REQUIREMENTS
Program Income:
Fees charged by the Centers will constitute Program Income. Program Income is
gross income earned by the awardee that is directly generated by a supported
activity or earned as a result of the award (see 45 CFR 74.2 and 74.24 for
additional information). An estimate of the amount and source of Program Income
that will be generated as a result of the award must be included on the
Checklist Page of all competing and non-competing continuation applications.
Net program income earned during a budget period must be reported on the annual
Financial Status Report (FSR) (except for Program Income earned as a result of
inventions, to which special rules apply). Costs incident to the generation of
Program Income may be deducted from gross income to determine Program Income to
be reported on the FSR, provided that these costs have not been charged to the
award.
Program Income earned during the project period shall be retained by the award
recipient and used in the following way:
The first $25,000 earned during a budget period is added to funds committed to
the project or program, and used to further eligible project or program
objectives,
Any amount over $25,000 earned during a budget period is to be deducted from the
total project or program allowable costs in determining the net allowable costs
on which the federal share of costs is based. The NINDS and NIMH may offset a
future award by this amount or reauthorize it for expenditure on a future award.
Pre-application Meeting:
The NINDS and NIMH strongly encourage all potential applicants to attend a pre-
application meeting at the National Institutes of Health (NIH) in June 2001.
This meeting will provide NINDS and NIMH program staff with the opportunity to
clarify any requirements of the RFA and, thereby, enable applicants to present
the strongest possible case for support. After the date, time, and place of the
pre-application meeting have been set, the details will be announced in the NIH
Guide for Grants and Contracts. For potential applicants who are unable to
attend, a summary will be made available within two weeks of the meeting.
Biannual Meetings:
Center PIs and scientists, along with NINDS and NIMH program staff, will make up
a Steering Committee that will meet twice annually at the NIH. Applications in
response to this RFA should include a request for funds to cover the expense of
attending the biannual Steering Committee meetings in Bethesda, Maryland.
Data Sharing:
Genomic data from microarray analyses are useful for many purposes. It is very
important that the data generated from experiments supported by the Centers are
shared with the broader scientific community. The consortium of Centers will
require data sharing by users of the Centers products and services. The
Centers will collect these data and share them. The Centers are encouraged to
share data on the National Center for Biotechnology Information Gene Expression
Omnibus (http://www.ncbi.nlm.nih.gov/geo/), and to submit data to other public
gene expression databases specified by the Steering Committee. Applications in
response to this RFA should include a detailed plan for data sharing, which will
be considered during review of the proposals.
Terms and Conditions of Award:
These 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, and other HHS, PHS, and NIH Grant Administration
policy statements.
The administrative and funding instrument used for this program is a cooperative
agreement (U24). As described previously, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the project as a
whole, although specific tasks and activities in carrying out the project will
be shared among the awardees, NINDS and NIMH program staff, and the CAP.
1. Awardee Rights and Responsibilities
Awardees, as Center PIs, have primary responsibilities to define objectives and
approaches, and to plan and conduct the activities of the Centers that they
manage. Awardees will collaborate with other Center PIs, and coordinate Center
developmental and fee-for-service activities with those of the other Centers.
Each Center PI must agree to participate with NINDS and NIMH program staff and
the CAP in coordinating the activities of the Centers, with the result that the
Centers will function as a single consortium. Although each Center will be
independently funded and managed, the planning and implementation of Center
activities will be done in a way to maximize the overall effectiveness of the
consortium of Centers.
Each Center will maintain a log of Center usage by NINDS and NIMH grantees that
records the products and services provided to the grantees, the fees charged for
the products and services, and the institute (NINDS or NIMH) from which the
grantee receives support.
Prior to each non-competing renewal of these awards, each Center will submit to
the NIH a progress report that describes the activities and accomplishments of
the Center for the preceding award period, and the goals to be accomplished
during the renewal period. The progress report will include the log of Center
usage. The contents of the progress report will be used by NINDS and NIMH
program staff, along with other information, to determine the amount of funding
the Center will receive for the renewal period.
Center PIs will attend, and participate in, biannual Steering Committee meetings
at the NIH. Awardees will be voting members of the Steering Committee, and will
accept any modification, deletion, or addition of Center activities that is
approved by the Steering Committee.
2. NINDS and NIMH Program Staff Responsibilities
NINDS and NIMH program staff, as Project Scientists, will have substantial
scientific-programmatic involvement during conduct of this activity, through
technical assistance, advice, and coordination above and beyond normal program
stewardship for grants.
The NIH Project Scientists will have a single, combined vote on the Steering
Committee, and will participate with the other members of the committee in
planning the overall structure and strategy of the consortium of Centers.
Microarray technologies are evolving rapidly, and program staff will play an
active role in assuring that Centers remain on the cutting edge of the research
technologies. This role will be carried out by assisting the Center PIs and the
CAP with assessing the current state of the technologies and methodologies for
gene expression profiling.
The Project Scientists will select and recruit the members of the CAP, who will
each serve a three-year term. The Project Scientists will also have the
responsibility of replacing CAP members that choose to leave the CAP. Project
Scientists may, but are not required to, consult with Center PIs, CAP members,
or other outside advisors when recruiting members of the CAP.
NINDS and NIMH program staff will determine the amount of support that will be
awarded to each Center as a non-competing renewal. The progress report received
from each Center, along with other information, will be used to make this
determination. The criteria used for this decision will include, but not be
limited to, Center production, customer satisfaction, and successful performance
of the Center as a member of the consortium.
NINDS and NIMH program staff will assist with and facilitate the coordination
and research efforts of the Centers, but will not direct these activities.
3. Collaborative Responsibilities
Consortium Advisory Panel
The CAP will be composed of between four and six experts not associated with the
Centers. This panel will provide oversight to the consortium, and advice to the
Steering Committee and NIH. CAP members will provide technical and operational
advice concerning both long-term developments and day-to-day operations at the
Centers.
The CAP members will choose a chairperson, who will coordinate communication
among the members, and between the CAP, the Centers, and the Project Scientists.
The CAP members will not vote on the Steering Committee, but may be invited to
attend Steering Committee meetings, if attendance would significantly facilitate
Steering Committee business.
Periodically, at intervals determined by the Steering Committee, a formal
request for advice on specific subjects will be submitted to the CAP. The CAP
will convene to consider and formulate opinions on the questions submitted to
it. NINDS and NIMH program staff will consider the opinions of the CAP with
regard to overall consortium functioning, and the performance of individual
Centers, when making determinations for renewal funding.
Steering Committee
A Steering Committee composed of the Center PIs, one additional manager or
scientist from each Center, two NINDS Project Scientists, and one NIMH Project
Scientist, will convene at the NIH twice annually. Each year the Steering
Committee will select a chairperson who will serve a one-year term. The
chairperson of the Steering Committee may not be a NINDS or NIMH Project
Scientist. Each Center will have one Steering Committee vote, and the NIH will
have one Steering Committee vote. 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 the Steering Committee, a majority of the
possible votes must be cast in favor of the decision or course of action.
The Steering Committee will be the main governing board of the consortium of
Microarray Centers. The committee may take actions, deemed appropriate by vote
of the members when necessary, to facilitate the functioning of the consortium.
Such actions might include, but are not limited to, formation of sub-committees,
consultations with outside persons, and specialization of the Centers.
Awardees will be required to accept and implement the common protocol and
procedures approved by the Steering Committee.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NINDS or the NIMH may be
brought to arbitration. An arbitration panel will be composed of three members
one chosen by the Steering Committee (with NIH not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by the NINDS and NIMH, and the third member selected by the two prior
selected members. This special arbitration procedure in no way affects the
awardee’s right to appeal an adverse action that is otherwise appealable in
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS
regulation at 45 CFR Part 16.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this program will be
the NIH Resource-Related Research Projects Cooperative Agreements award
mechanism (U24), an assistance mechanism in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated during
performance of the activity. Under the cooperative agreement, the NIH purpose
is to support and/or stimulate the recipient’s activity by involvement in and
otherwise working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility, or a dominant role in the
activity.
The total project period for an application submitted in response to this RFA
may not exceed three (3) years. At this time, NINDS and NIMH have not
determined whether or how this solicitation will be continued beyond the present
RFA. The earliest anticipated award date is April 1, 2002.
FUNDS AVAILABLE
NINDS and NIMH intend to commit up to $3.5 million in total costs to fund up to
three successful applications in FY 2002 in response to this RFA. Applicants
may request up to three years of support. Although the financial plans of NINDS
and NIMH provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a sufficient number
of meritorious applications.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of state and local governments, and eligible agencies of the
federal government. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding scientific and other application-related issues, and
inquiries specific to NINDS to:
Thomas Miller, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2139
Bethesda, MD 20892
Tel: 301-496-1779
Fax: 301-402-1501
Email: tm208y@nih.gov
Direct inquiries specific to NIMH to:
Hemin R. Chin, Ph.D.
Genetics Research Branch
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Blvd., Room 7190
Bethesda, MD 20892
Tel: 301-443-1706
Fax: 301-443-9890
Email: hc7v@nih.gov
Direct inquiries regarding review issues to:
Lillian Pubols, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 3208
Bethesda, MD 20892
Tel: 301-496-9223
Fax: 301-402-0182
Email: lp28e@nih.gov
Direct inquiries regarding fiscal matters to:
King P. Bond, Jr.
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 3258
Bethesda, MD 20892
Tel: 301-496-9231
Fax: 301-402-0219
Email: kb33s@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit, by May 15, 2001, a Letter of Intent
that includes a descriptive title, the name, address, telephone number, and
email address of the PI, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to which the
application may be submitted. 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 institute staff to estimate the potential
review workload and avoid conflict of interest in the review.
The Letter of Intent is to be sent to:
Thomas Miller, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2139
Bethesda, MD 20892
Tel: 301-496-1779
Fax: 301-402-1501
Email: tm208y@nih.gov
SCHEDULE SUMMARY
Letter of Intent Receipt Date: May 15, 2001
Application Receipt Date: July 13, 2001
Peer Review Date: November 2001
Council Review: February 2002
Early Anticipated Start Date: April 1, 2002
APPLICATION PROCEDURES
The Research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research, and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, Room
MSC 7910, Bethesda, MD 20892, telephone 301-710-0267, email:
GrantsInfo@nih.gov.
The RFA label available in the PHS 398 (rev. 4/98) application form 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.
There is a sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Note that this is in
pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three (3) 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
BETHESDA, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be
sent to:
Lillian Pubols, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 3208
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it will be
returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The CSR
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NINDS. Incomplete applications will be returned to the
applicant without further consideration.
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
NINDS in accordance with the review criteria stated below. As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed, assigned a priority score, and receive a second level review by
the NINDS and NIMH National Advisory Councils.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments reviewers will be asked to discuss the following aspects of the
application 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 the 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.
(1) Significance: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive this
field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches, or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator 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 (if any)?
(5) Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
In addition to the above criteria all applications will also be reviewed with
respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals, or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
o The adequacy of the proposed plan to provide advice and training to the
neuroscience community.
o The adequacy of the proposed fee-for-service plan, including administration
and funds management
o The adequacy of the proposed plan to share data.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities, and program balance
o geographic balance
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
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 that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the Internet sites.
Reviewers are cautioned 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, "Microarray Centers for Research
on the Nervous System" 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 No.
93.853 (NINDS), and 93.242 (NIMH). Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and
284) and administered under NIH grants policies and Federal Regulations 42 CFR
52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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.
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