and Human Services (HHS)
EXPIRED
LARGE-SCALE COLLABORATIVE PROJECT AWARD RENEWALS
RELEASE DATE: December 17, 2003
RFA Number: RFA-GM-04-001
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of General Medical Sciences (NIGMS)
(http://www.nigms.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859
APPLICATION RECEIPT DATES: October 19, 2004 for FY 2005 Awards
October 19, 2005 for FY 2006 Awards
October 19, 2007 for FY 2008 Awards
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria for the Overall Project
o Review Criteria for Core Resources
o Review Criteria for Bridging and Pilot Projects
o Additional Review Criteria for All Components
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this solicitation is to invite the submission of renewal
applications and to describe application, review, and award procedures
for the renewal of large-scale collaborative project awards (commonly
called glue grants ,
http://www.nigms.nih.gov/funding/gluegrants.html). This announcement
applies to awards whose support from the National Institute of General
Medical Sciences (NIGMS) for the Phase II application began in FY 2000,
FY 2001, and FY 2003 (no awards were made in FY 2002). [New
applications for large-scale collaborative project awards are not
currently being accepted by NIGMS and are not part of this request for
applications (RFA). NIGMS may consider re-opening this program for new
awards at a future date.]
NIGMS issued the first RFA for large-scale collaborative project awards
in 1999, and the program was reannounced in each of the next three
years. One award was made in FY 2000, three awards were made in FY
2001, and one award was made in FY 2003. Each of these awards was made
for five years. Currently active large-scale collaborative project
awards are eligible to compete for one renewal period of up to five
additional years of support.
Critical elements of these renewal applications will include evidence
that a highly integrated and functioning team has been established;
that good progress is being made; that the progress makes feasible
accomplishment of the final goals in the next time period; that results
have been achieved that could not have been accomplished by individual
efforts alone; that plans for the next project period are compelling;
and that plans have been made to accommodate the termination of NIGMS
support at the end of that period. Overall, the applications should
describe the proposed and unanticipated challenges that were met, how
the project has evolved, where it stands currently, and how the final
phase will be achieved.
RESEARCH OBJECTIVES
The NIGMS held several meetings with members of the scientific
community in FY 1998 and 1999 to assess the needs and opportunities for
future research in areas supported by NIGMS. A common theme that
emerged from these meetings was the strongly felt need of the academic
community to have an award mechanism that facilitated the interaction
of independently funded scientists from the same and different
disciplines to work together as teams on common problems in biomedical
science.
It appeared that a new direction in the conduct of science was emerging
and the large-scale collaborative project awards were originated as a
new mechanism to meet this need. The suggestion was made to call these
new awards glue grants because they were meant to glue together
independently funded scientists. The general parameters for these
awards were as follows and remain applicable to the applications: the
solution of a major question in biomedical science where a synthesis of
information from participating laboratories is necessary; each of the
participating investigators has to hold competitive independent support
in the area of the glue grant; the funds are meant to support only
collaborative and integrative activities; and the biological question
has to fall within the mission of NIGMS (see
http://www.nigms.nih.gov/about/overview.html for scope of NIGMS
interests).
The goals of this program remain the same: to enable the solution of
major problems in biomedical research and to facilitate the next
evolutionary stage of integrative biomedical science. It is expected
that the research problem selected for the originally funded
application will remain the focus of the renewal application.
The renewal application should provide a detailed explanation of the
proposed project. It should explain how the project has evolved over
time and where it stands on the path to achieving its final goals. It
should also include specific intermediate goals (milestones) for the
next period of support and a timeline for their accomplishment.
Progress made on the overall goals of the collaborative projects and on
the individual elements will be a major factor in the assessment of the
renewal applications, and future plans should build on the progress to
date. Not only must adequate progress be demonstrated, but advances
that could not have been achieved with purely individual efforts must
be clearly articulated. The effective functioning of the collaborative
project team must be made clear. One assessment of the team’s
functioning will be the challenges met, the decisions made, and changes
in direction implemented.
A special feature of the renewal applications will be the plans for
these consortia beyond the renewal funding period. Large-scale
collaborative project awards have a maximum limit of ten years of
support (five years for the original award and five years for the
renewal period). The renewal application must describe plans for
bringing this activity to an orderly conclusion or for continuation
through other sources of support. In addition, these awards may have
generated research resources that need to be continued beyond the life
of the large-scale project. Plans for long-term maintenance and
management of such resources must be included. Thus, the plans beyond
year ten of these collaborative projects will receive close scrutiny by
the scientific review group, by the advisory council, and by institute
staff in reaching their recommendations.
MECHANISM OF SUPPORT
This RFA will use the NIH Specialized Center (U54, Cooperative
Agreements) award mechanism. As an applicant you will be responsible
for planning, directing, and executing the proposed project. This RFA
is a one-time solicitation. The anticipated award dates are September
2005, September 2006, and September 2008, as appropriate.
Amended renewal applications will not be accepted.
This RFA uses just-in-time concepts. Follow the instructions for non-
modular budget research grant applications. This program does not
require cost sharing as defined in the current NIH Grants Policy
Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
The NIH U54 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 "Cooperative Agreement Terms and Conditions of
Award." NIGMS does not plan to continue large-scale cooperative
project awards beyond one renewal period. However, the institute will
consider applications for our usual award mechanisms, such as R01
applications, to continue research resources generated by these
consortia beyond the lifetime of the large-scale award.
FUNDS AVAILABLE
NIGMS intends to commit the funds necessary for the competing
continuation of all ongoing large-scale collaborative project awards.
An applicant may request a project period of up to five years and a
budget for direct costs of up to $5M per year. Because the nature and
scope of the proposed research will vary from application to
application, the size and duration of each award may also vary.
Although the financial plans of the NIGMS provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of highly meritorious
applications.
ELIGIBLE INSTITUTIONS
You may submit a competing-continuation application in response to this
RFA if your institution was awarded a large-scale collaborative project
award from NIGMS in FY 2000, FY 2001, or FY 2003, or if, with the
approval of NIGMS, an awarded large-scale collaborative project award
was or will be transferred to your institution due to a change in
Principal Investigator or change in institution for the Principal
Investigator.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The major research activity of the Principal Investigator (PI) must be
in the research area of the collaborative project application, and the
PI is expected to commit an appropriate level of effort to directing
and managing the operation of the project; a substantial level of
effort will be necessary to manage projects of the largest magnitude.
Changes in PI or in lead institution for a large-scale collaborative
project award must be approved by the NIGMS program director for the
award in advance.
SPECIAL REQUIREMENTS
COLLABORATIVE PROJECT ORGANIZATION AND RESOURCES: The elements and
organization of a large-scale collaborative project remain the same.
The organizational structure of the collaborative project may have a
variety of forms depending on the needs of the research problem being
addressed.
Support to Individual Laboratories
Investigators are expected to bring their own support for their
individual laboratories to the collaborative project. The large-scale
collaborative project award mechanism is not meant to support R01-type
projects. It is recognized, however, that in some cases, there may be
a need for special efforts in the individual laboratories of the
participating investigators requiring additional funding to enhance the
efforts of the consortium or to integrate the individual work of a
participating investigator with the consortium. Two mechanisms,
bridging projects and pilot projects, have been designated for this
purpose.
Bridging Projects
Applications may propose new or continuations of existing bridging
projects to support work in the laboratories of the individual
participating investigators when that work is intended to provide
either a bridging function to more fully integrate the individual work
with the collaborative project or a service function to develop data or
resources or technology to benefit the overall glue project. Requests
for continuation of existing bridging projects must be justified in
terms of progress to date as well as future plans. Bridging projects
should add to or bridge the intellectual and technological approaches
of the collaborative project. They are not meant to be stand-alone
research efforts but are to be efforts that tie, or enhance the
contribution of, the independent work and expertise of the
participating investigator to the large-scale collaborative project. A
new bridging project should extend the participating investigator’s
independent work in a new direction(s). A new bridging project to do
more of what the investigator is already doing should be considered
only if there are extraordinary circumstances that make it essential
for the effective functioning of the large-scale project. If the
participating investigator’s work is already closely tied to the large-
scale project, a bridging project should not be needed. Stand-alone
new research projects should not be submitted for bridging projects.
If a bridging project could be submitted as a regular R01 application,
it should not be requested as a bridging project, even if it adds value
to the large-scale project. Judgment will be required on the part of
applicants and reviewers alike to distinguish between projects that are
appropriate for support by consortium resources and those that should
be submitted and reviewed as regular research grants (R01s).
Pilot Projects
New pilot projects may be requested in the renewal application, but
require strong justification keeping in mind that the award will be in
a final renewal period. Pilot projects are intended for investigators
who do not hold current independent support in the area of the
collaborative project in order to add elements where gaps exist, or to
add investigators with critical knowledge or expertise but who do not
have a research background in the area of the collaborative project.
These pilot projects must not exceed $75,000 in annual direct costs and
must be limited to no more than three pilot projects per year per
large-scale collaborative project. The pilot project should be of
sufficient scope to qualify as a stand-alone research effort. It is
primarily intended to allow the collaborative project to add
investigators outside the scientific mainstream of the project area in
a mode that will allow them to develop independent research in the area
of the collaborative project. Applicants must explain why the
expertise of the PI of the pilot project is needed for the large-scale
project and how the pilot project will contribute directly to
accomplishing the aims of the large-scale project. While funding for a
pilot project may run for five years, at the discretion of the steering
committee, it is expected that the PI of a pilot project will seek R01
funding during the period of the collaborative project, based on the
results obtained from the pilot project.
Cores
Core resources may be requested to speed progress on the scientific
goals of the project or to add additional capability to the
collaborative project by adding new or improved technology or by
standardizing data among different research teams. Requests for core
resources must be strongly justified in terms of value to achieve the
goals of the project, value to increase the synergy of the
collaborative project, and cost effectiveness. Requests for continuing
existing core resources must also be justified in terms of progress and
results achieved to date. It is expected that each large-scale
collaborative project will request core resources for continuing
information collection, coordination, and dissemination. A
bioinformatics core to include assembly and organization of data for
querying, developing tools for its querying, computation, and modeling
may be requested as a separate core or be combined with the information
dissemination core.
Administrative Management Plan
Each large-scale collaborative project award application must provide
an administrative management plan that includes: an overall description
of the organization of the large-scale project, the make up and
responsibilities of the steering committee (including how often and by
what means they will meet), and how information will flow within the
project and how it will be integrated into the solution of the
biological problem being addressed. It should outline the policies and
procedures whereby participating and non-participating investigators
can have access to the collaborative project resources. The
application should address the mechanism that will be followed to add
new participating investigators and delete members whose association
with the project has not been productive. The plan should include
proposed methods for information dissemination to the scientific
community, as well as to consortium members. Furthermore, each large-
scale collaborative project should discuss the mechanism whereby
concerns of the scientific community directly affected by the project
will be considered and responded to. A discussion of scientific
community views will be part of the agenda for annual meetings of the
steering committee with the advisory committee.
Project Management Plan
Each large-scale collaborative project award application must include a
project management plan, including an ongoing evaluation plan, to
ensure consistent forward progress of the project. Each collaborative
project will define, at a minimum, yearly milestones, developed by the
PI in consultation with the steering committee. Those receiving awards
will have the opportunity to modify these milestones at the time of
their awards, with the concurrence of NIGMS. It is expected that the
milestones will be adjusted annually at the award anniversary dates,
both to incorporate a team's scientific accomplishments and progress in
the field in general and to reflect the recommendations of the advisory
committee. The NIGMS program director responsible for the large-scale
collaborative project may include outside consultants in the annual
progress review and may recommend reducing or withholding funds, or
termination of the award, for failure to meet milestones. A report by
the NIGMS program director on the collaborative project's progress and
any recommendations to modify funding will be made annually to the
National Advisory General Medical Sciences Council.
Plan for Handling Intellectual Property and Sharing of Research
Resources:
The nature of large-scale collaborative projects is to move entire
fields forward. NIGMS intends that, to the extent possible, all
investigators within a field have equal access to research resources
generated by these collaborative projects. To address this interest in
assuring that research resources are accessible, NIGMS requires
applicants who respond to this RFA to (1) submit a plan for sharing the
research resources generated through the award and list the
collaborative project’s record to date on the timing of release of
shared research resources; and (2) address how they have exercised
intellectual property rights and describe plans for the future, should
any be generated through this award, while making such research
resources available to the broader scientific community. It is
expected that resources shared will include, among others, data and
information, materials such as cell lines and mutant animals, and novel
reagents and techniques.
The sharing of research resources plan and intellectual property plan
must make unique research resources readily available for research
purposes to qualified individuals within the scientific community in
accordance with the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final Notice,
December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also
define terms, parties, and responsibilities; prescribe the order of
disposition of rights; prescribe a chronology of reporting requirements;
and delineate the basis for and extent of government actions to retain
rights. Patent rights clauses may be found at 37 CFR Part 401.14 and
are accessible from the Interagency Edison web page,
http://www.iedison.gov.
As noted below (see Peer Review Process and Review Criteria), the
scientific review group will comment, as appropriate, on the adequacy
and feasibility of the sharing of research resources plan and the
intellectual property plan, as well as the consortium’s record to date.
Because dissemination is a critical aspect and fundamental purpose of
this RFA, evidence of the commitment of the large-scale project
leadership to the sharing of research resources and to effective
management of intellectual property issues will be part of the
scientific merit review. The adequacy and record to date of the
proposed sharing plans will be an important factor in the Institute’s
decision to make an award. Furthermore, the proposed sharing plans,
after negotiation with the applicant when necessary, will be made a
condition of the award. Evaluation of annual progress reports and of
subsequent renewal applications will include an assessment of the
effectiveness of the sharing of research resources.
Disclosures:
Members of the large-scale collaborative project must disclose in the
application their ties to profit-making organizations to aid the
administration of the collaborative project and to assist the NIH
review process in avoiding conflict-of-interest situations. Applicants
are also reminded that the grantee institution is required to disclose
each subject invention to the Federal Agency providing research funds
within two months after the inventor discloses it in writing to grantee
institution personnel responsible for patent matters.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD:
The following section represents Terms and Conditions that will be
incorporated into the award statement and will be provided to the PI,
as well as to the appropriate institutional official, at the time 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, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during performance of the
activities. Under the cooperative agreement mechanism, the NIH’s
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 primary responsibility resides with
the awardees for the project as a whole.
1. Principal Investigator Responsibilities: The PI is the scientist
who assembles the large-scale collaborative project and is responsible
for submitting the application in response to this RFA and for
performance of the project. The PI will coordinate project activities
scientifically and administratively originating from the awardee
institution. The PI will have the overall responsibility for the
scientific and technical direction and the administration and overall
operation of the large-scale collaborative project. The PI will chair
the steering committee. As for all participating investigators, the PI
must abide by the operating rules and guidelines developed by the
steering committee. The PI will agree to accept participation of NIGMS
staff in those aspects of management of the project described under
"NIGMS Program Director Responsibilities." He/she will also ensure the
timely dissemination of information generated by the large-scale
collaborative project to both the project members and the scientific
public.
Awardees will retain custody of and have primary rights to the research
resources developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies, and also
subject to the approved sharing of research resources plan and
intellectual property plan to make unique research resources readily
available for research purposes to qualified individuals within the
scientific community in accordance with the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final
Notice, December 1999
(http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf).
2. Participating Investigator Responsibilities: The participating
investigators are those scientists holding externally peer reviewed
grant support in the area of the project and who are involved with and
committed to the goals of the project. It is expected that the
majority will be funded through research grants supported by NIGMS,
other NIH institutes and centers, and other governmental and private
agencies. Exceptions to the rule of external funding may include
participating investigators from industry, foreign institutions or
allied fields not traditionally supported by the NIH (e.g., physics and
mathematics). Principal Investigators of pilot projects are also
included as participating investigators. Participating investigators
will work with the PI, the steering committee, and the other members of
the large-scale collaborative project to set goals and develop working
procedures; they must agree to support the goals of the project and to
abide by the operating guidelines and procedures established for the
project. They must provide a listing of organizational resources that
will be committed to the project. Participating investigators will be
actively involved in the project and interactive with the other members
of the project. During the period of the award, a participating
investigator whose independent research support terminates may continue
as a participating investigator at the discretion of the steering
committee and with the approval of the NIGMS program director.
However, funds from this award are not to be used to support the
independent research of such an investigator. It is expected that new
participating investigators will be added to the collaborative project
over the period of the award as deemed appropriate by the PI and
steering committee and with the approval of the NIGMS program director;
these additions will be reported in the annual progress report.
3. NIGMS Program Director Responsibilities: The NIGMS program director
will be responsible for the normal stewardship of the award. In
addition, s/he will serve as a voting member of the steering committee,
attending all meetings, and will have substantial programmatic
involvement. In addition to having all of the duties and
responsibilities of a steering committee member, the NIGMS program
director will facilitate interactions among the steering committee and
the advisory committee and NIGMS, and will provide advice and guidance
to assure that the large-scale-collaborative project adheres to the NIH
and NIGMS rules and regulations. The NIGMS program director will
facilitate communication with the scientific community directly
affected by the collaborative project and will assure that the steering
committee and the advisory committee address issues and concerns raised
by the community. Additional responsibilities may be negotiated at the
time of award depending on the individual characteristics of the awards
to be made.
4. Steering Committee Responsibilities: A steering committee will
continue to serve as the governing board of each large-scale
collaborative project and participate in setting direction, policies,
and operating procedures. Membership will include the PI, as well as
other scientists and administrators drawn from the staff and
participating investigators of the project, sufficient in breadth and
balance to be representative of the overall project. Current members
may continue and additional or replacement members will be selected by
the PI in consultation with the steering committee and with the
approval of the NIGMS program director. The steering committee will
work with the PI to establish the scientific and technical direction of
the project, develop common guidelines and procedures, establish rules
for access to resources of the project, deal with intellectual property
issues, and participate in the process of developing a cohesive group.
The steering committee will develop a policy regarding disclosure of
ties between scientists and for-profit organizations to aid the project
in avoiding conflict-of-interest situations. The steering committee
will monitor bridging projects, core resources, and pilot projects for
progress and efficiency, and recommend modification of support and
addition/deletion of these activities as needed to facilitate progress
on the goals of the large-scale collaborative project. An NIGMS
program director will serve as a voting member of the steering
committee and attend its meetings. The steering committee will meet
annually with the advisory committee, as described below.
5. Advisory Committee Responsibilities: The advisory committee will
continue in its role of advising the PI and steering committee. It
will be composed of a panel of a minimum of three scientists not
otherwise associated with the large-scale collaborative project. The
members will be appointed by the PI in consultation with the steering
committee, and with the approval of the NIGMS program director. The
NIGMS program director will attend the meetings of the advisory
committee as a member of the steering committee but will not actually
be a member of the advisory committee. The advisory committee will
meet at least once a year immediately prior to the submission of the
annual progress report to provide advice to the PI and steering
committee of the large-scale collaborative project about meeting its
goals and to comment on plans for future directions. The advisory
committee will raise issues for consideration by the PI and the
steering committee and will comment on the appropriateness of the level
of NIGMS support to achieve the goals of the project. The advisory
committee will also comment on the impact of the collaborative project
on the relevant scientific communities.
5. Milestones and Evaluations: It is expected that milestones will 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 the recommendations of the advisory
committee. In accordance with the procedure described above, the NIGMS
program director may recommend to the Director, NIGMS, augmenting any
subproject or core facility or reducing or withholding funds for any
subproject or core facility that substantially fails to meet its
milestones or to remain state of the art.
The Director, NIGMS, retains the right to call a meeting of advisors,
most likely members of the National Advisory General Medical Sciences
Council or their designee(s), at any time to provide advice on the
scientific progress of a large-scale collaborative project. It is
anticipated that such a group of advisors may want to attend a meeting
of the project advisory committee as part of its fact-finding mission.
6. Arbitration Process: Any disagreements that may arise in scientific
or programmatic matters (within the scope of the award) between award
recipients and the NIGMS may be brought to arbitration. An arbitration
panel will be convened by NIH. It will be composed of three members: a
designee of the steering committee without NIH staff voting, one NIGMS
designee, and a third designee with expertise in the relevant area who
is chosen by the other two. The decision of the arbitration panel, by
majority vote, will be binding. This special arbitration procedure in
no way affects the right of an awardee to appeal an adverse action in
accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS
regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
o Direct your questions about scientific/research issues to:
Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: [email protected]
Dr. James C. Cassatt
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
Email: [email protected]
Dr. Judith H. Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]
Direct your questions about peer review issues to:
Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Mr. Joseph Ellis
Chief, Grants Management Office
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5510
FAX: (301) 480-1969
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the most recent PHS 398 research
grant application instructions and forms (currently rev. 5/2001).
Applications must have a DUN and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the Universal Identifier when
applying for Federal grants or cooperative agreements. The DUNS number
can be obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/ . The DUNS number should be entered
on line 11 of the face page of the PHS 398 form. The PHS 398 document
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
SUPPLEMENTARY INSTRUCTIONS: Applications in response to this RFA
should consist of an application that, in addition to or in lieu of
part of the items requested in the PHS 398, includes:
Application face page. Complete all items. This is page 1; number
succeeding pages consecutively.
Abstract of Research Plan. On page 2, describe briefly the proposed
large-scale-collaborative research project. List all key personnel
involved in the collaborative project; use a continuation page as
needed.
Table of Contents. Prepare a detailed Table of Contents that includes
all elements of the application. Use numeric pagination only. The
major areas to be listed in the Table of Contents appear below in
capital letters. Units should be presented in the order in which they
appear in the application. Under Research Plan, identify each
component core with a capital letter (A, B, C), as well as title, and
provide the name of the core director.
BUDGET ESTIMATES: Specific examples of allowable costs that may be
requested include:
Salaries for the PI, members of the steering committee, participating
investigators, and technical and support personnel commensurate with
their level of effort in the large-scale collaborative project.
Although a substantial level of effort is expected for the PI, NIGMS
has not set minimum levels of effort; however, the appropriateness of
the level of effort of the PI will be a factor in the assessment of
scientific merit and in the Institute's funding selections. The level
of effort and commitment to the collaborative project of the members of
the steering committee will also factor into the assessment of
scientific merit as well as the Institute's funding decision.
Bridging projects to the laboratories of participating investigators.
Pilot projects to investigators without current independent research
support in the area. These subprojects must not exceed $75,000 in
annual direct costs and must be limited to no more than three such
projects per application.
Travel of personnel, which may include technicians, predoctoral
students, postdoctoral fellows, and investigators, to different
laboratories to gain specialized expertise.
Travel to and conduct of regular meetings of the steering committee and
regular meetings of the participating investigators.
Core facilities (examples: instrumentation, genomics, proteomics, model
organism, or high-throughput assay cores).
Electronic media cores to allow participation of off-site laboratories
and/or the means necessary to establish collaboratory capabilities and
to disseminate information.
Travel to and conduct of regular meetings of an advisory committee.
In addition to the overall budget, include a separate budget for each
bridging project and pilot project and each core resource.
Applications for large-scale collaborative project awards may not
request more than $5 million in annual direct costs (exclusive of
subcontract indirect costs requested as a direct cost by the applicant
organization, but including all equipment) for any year of the award.
Salaries for support personnel required for coordination and
maintenance of the project, such as secretaries, may also be included
as necessary in an administrative core.
Composite budget. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET
PERIOD," of Form PHS 398 to present the total budget for all requested
support for the first year. For each category such as "Personnel,"
Equipment," etc., give the amount requested for each core unit and each
component project, with subtotals. For consortium arrangements
involving other institutions or organizations, include total (direct
and facilities and administration) costs associated with such third-
party participation in the "Consortium/Contractual Costs" category.
Note: each participating consortium/contractual organization must
submit a separate composite budget for both the initial budget period
(using Form Page 4) and the entire proposed project period (using Form
page 5). Costs for purchased services should be itemized under "Other
Expenses."
Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form
PHS 398 to prepare a budget, by category, which provides totals for
each year of requested support. Requests for any increases in
succeeding years must be justified in the individual component
subprojects (bridging projects and pilot projects) and core unit
budgets.
Individual component core and research budgets. Place the budgets for
consortium components, cores, bridging projects, and pilot projects
immediately prior to the description of the relevant individual
component. For the 06 year budgets of each of the cores and projects,
use Form Page 4 of the PHS 398. Use Form Page 5 of the PHS 398 to
report the budgets of each of the projects and cores for entire project
period (years 06-10).
Budget justifications and explanations. Describe the specific
functions, including the level of effort, of all key personnel,
including consultants, collaborators, and technical staff. Provide
justifications for requested equipment. For years 07-10 of the
project, justify any significant increases or decreases in any category
over the 06 year budget.
BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches
must be included for all participating investigators along with one
page letters of commitment indicating their willingness to follow
guidelines and procedures established for the large-scale collaborative
project. For participating investigators who are continuing from the
original funding period, include a paragraph concisely stating the role
and interaction of the investigator with the large-scale project during
the original period. For all participating investigators, including
the PI, heads of core resources, and Principal Investigators of
bridging and pilot projects, provide a listing of all other support;
support for other investigators such as postdoctoral students should
not be listed. Highlight the relevant grant support that allows
participating investigators to be part of the large-scale collaborative
project. Provide the specific aims of the project and describe in
sufficient detail for evaluation of the relationship of the funded
grant to the goals of the proposed large-scale project.
RESEARCH ENVIRONMENT: Complete the "Resources" page of PHS 398 for the
overall large-scale collaborative project, including both the host
institution and any participating institutions. Briefly describe the
features of the institutional environment(s) that are relevant to the
effective implementation of the proposed program. As appropriate,
describe available resources, such as clinical and laboratory
facilities, participating and affiliated units, patient populations,
geographical distribution of space and personnel, and consultative
resources.
PARTICIPANT AFFILIATIONS: Applications should include a separate cover
sheet that lists 1) all participants, including consultants and private
sector alliances, 2) all the institutional affiliations for each
participant, 3) their roles on the project and whether new or
continuing, and 4) the percent effort listed separately for each role.
This added requirement will facilitate the review of applications.
RESEARCH PLAN: The NIGMS wishes to provide applicants with the
flexibility to organize large-scale collaborative projects in the
manner which best facilitates progress on the project being pursued.
Therefore, applicants may organize and present their large-scale
collaborative project applications strictly using the straightforward
format that follows, or may use alternate combined formats for some
parts of the application, as described below. Required components of
all applications are the program summary; progress report;
administrative and program management plans; a plan for data sharing
and intellectual property; Cores A (administrative) and B (information
dissemination and data coordinating); and responses to the
bioinformatics questions listed below (see Core Resource C
Bioinformatics Core) if the optional bioinformatics core is utilized.
If desired, Core B may be may be combined with an optional
bioinformatics core. The program summary and the progress report may
be combined. The Progress Report section must include the overall
progress report as well as summary progress reports for the individual
elements and discussion of how progress on the individual elements have
contributed to the success of the overall collaborative project.
The remainder of the Research Plan may be organized as deemed
appropriate, keeping in mind that the major purpose of a large-scale
collaborative project award is to provide resources to enable
collaboration rather than primary research support. For example, the
scientific cores and bridging projects may be presented in a combined
or more integrated fashion. When this, or a different alternate format
from that outlined below is used, applicants should explain, in the
program summary, why a different organizational structure is proposed.
Any combined unit may not exceed the sum of the page limits that would
have been allowed for the individual pieces of the unit. For example,
if two bridging projects were submitted as a combined unit, the page
limit for the combined unit would be twice that for one bridging
project. In all cases, the Research Plan, including the required
components, may not exceed 180 pages.
Program Summary (Required)
Describe the goals and operation of the large-scale project. Explain
what major biological problem is being solved and how the approach of
using a large-scale collaborative agreement is critical to its
solution. Explain how progress made and lessons learned have affected
your choices of approaches selected for the next and final period of
support. Discuss the range of scientific expertise to be used to
address the research problem. Explain the interactions that will occur
between investigators at the host site and at the participating sites.
Explain how each element of the large-scale collaborative project will
contribute to a cohesive overall program. Explain the programmatic
value of the core resources, bridging projects, and pilot projects.
Explain how the information coming from the collaborative project and
the laboratories of the participating investigators will be integrated
into a comprehensive whole. Discuss how and when information and other
research resources generated by the collaborative projects will be
disseminated to the scientific public. Explain why the ultimate goals
of this collaborative project could not be achieved simply by support
of individual investigators.
Progress Report (Required)
Present an overall summary of progress since the inception of the
collaborative project that has been made on the goals of the large-
scale collaborative project award and overall summaries of progress for
each of the individual elements, including original elements that are
not included for the renewal period. Describe both the accomplishments
of the large-scale project and the impact they have had within the
consortium and on the larger relevant scientific community. Explain
how progress made thus far has moved the field forward and has brought
the ultimate goal of the consortium within reach. Highlight progress
that could not have been achieved by individual investigator efforts
alone. Delineate new research resources produced by the consortium
that are now available to the research community. Provide measures of
the impact of those resources. For the individual element progress
reports, list the major accomplishments of each project element and
indicate its impact on the progress and cohesiveness of the overall
effort.
Include web hyperlinks to web sites and databases that are products of
research. These will be treated like publications. Reviewers may
access these sites to assess their quality and impact. Sufficient
description of these research resources and their content should be
included in the application text for a summary evaluation.
Administrative Management Plan (Required)
Describe the structure, organization, and operation of the project and
explain why and how this plan has evolved over the period of support.
Discuss changes that have been made during the course of the project,
including what elements have been dropped and what elements have been
added. Describe the organizational framework and provide an
organizational chart. Also describe how information will flow within
the collaborative project. Explain the role of the steering committee
in making administrative management decisions. Discuss arrangements
between the collaborating institutions that are important to effective
operation of the large-scale collaborative project. Detail the usage
of the core resources by the participating investigators. Include any
outreach efforts to provide access to the core resources to
investigators outside the collaborative project. Explain how decisions
will be made to add/delete participating investigators and to respond
to changes in short term goals necessitated by research findings.
Discuss how the views of the scientific community that are impacted by
the collaborative project will be considered.
Project Management Plan (Required)
Present a project management plan, including milestones, to keep the
collaborative project moving forward and on track. Define both yearly
milestones and what you expect to have been accomplished at the end of
the last period of support. Explain the past and planned role of the
steering committee in project management. Explain how progress in the
bridging projects and pilot projects and efficiency of the core
resources will be tracked. Include an evaluation plan to determine how
the collaborative project is progressing. Discuss the plan for
evolving milestones. Explain how the advisory committee will be used
in updating the project management plan. Any new members of the
advisory committee for the renewal period should not be contacted or
selected until an award has been made and the names of prospective new
members should not be included in the application.)
Plan for Termination after Final Period of Support (Required)
Describe how the NIGMS ten-year limit on funding for a large-scale
collaborative award will affect conduct of the award during the final
period of support. Present the plan for an orderly termination of the
project and how support will be sought if the project or some part of
it is intended for continuation. Delineate research resources
generated by the large-scale project that would be valuable to continue
beyond the life of the large-scale award and the plan for support of
these resources.
The program summary, progress report, administrative management plan,
project management plan, and the plan for termination sections have an
aggregate page limit of 50 pages. Page limits for other sections are
given within each section and a summary follows at the end.
Investigators should endeavor to be clear and concise.
Plan for Handling Intellectual Property and Sharing of Research
Resources (Required three-page limit)
List and comment on how the sharing of research resources and
intellectual property issues has been handled in the first period of
support, specifically indicating the resources that have been shared
and the timing of their release. For each element below, indicate if
this is a change from the initial period of support. The PI and
steering committee should (1) present their plan for providing access
to the research resources generated by the large-scale collaborative
project to the members of the project and the scientific public;
research resources include, among others, data and information,
materials such as cell lines and mutant animals, and novel reagents and
techniques; (2) address if or how intellectual property rights will be
exercised; (3) discuss guidelines for licensing of joint inventions;
(4) discuss procedures for settling of intellectual property disputes;
(5) discuss the existence of any pre-existing intellectual property
rights, including options to for-profit research sponsors; and (6)
propose a plan for disseminating the research resources developed under
this RFA.
Core Resource A: Administrative Core (Required five-page limit)
This core must be directed by the PI. Include the objectives of the
core, a description of its staffing, and services to be provided to
other core resources and to the participating investigators. Describe
any changes that were made during the first period of support and their
rationale. Communicating the objectives of the collaborative project
and fostering opportunities for collaboration are encouraged. Expenses
associated with the operation of the steering committee, meetings of
all or subgroups of the participating investigators, and meetings and
operation of the advisory committee would fall under the administrative
core.
Core Resource B: Information and Dissemination and Data Coordinating
Core (Required five-page limit)
Dissemination of information on techniques, scientific findings, and
methodologies is a vital component of each large-scale collaborative
project. Computer technology, print media, and telecommunications are
relevant. Describe the staffing (including a Core Director, as well as
any professional or technical personnel and their duties), facilities,
and resources that will be devoted to this goal. Describe any changes
that were made during the first period of support and their rationale.
Indicate plans to make results of research or other unique features of
the collaborative project available to as wide an audience as possible.
Describe how data generated by the core resources and the participating
investigators will be processed into the information to be
disseminated. Discuss plans and timing for dissemination of published
and unpublished data.
Core Resource C: Bioinformatics Core (optional and may be combined
with Core B)(15-page limit)
A bioinformatics core to include assembly and organization of data for
querying and developing tools for its querying, computation, and
modeling may be requested as a separate core or be combined with the
information dissemination core (combining the page limits of each for a
maximum of 20 pages).
The policies with respect to future dissemination of data and
computational tools should be explained in the proposal and it is
recommended, though not required for the renewal applications, that
they conform to the following principles:
It is recommended that: computational tools developed for analysis,
visualization, or modeling the data should be freely shared with the
scientific community as well as the annotated source code; others
should be free to modify the source code and share the modifications
with each other; and that the code should be made available to be
incorporated into commercial products.
The core description must include answers to the following queries,
whether a separate core or combined with the information dissemination
and data coordinating core. For each, describe any changes that were
made during the first period.
o What are the data release policies and what are the associated
intellectual property issues?
o How have the data been made available to the scientific community?
Is there browser access, formats for downloading complete data sets,
on-line computational aids, etc.? Will this change for the next phase
of the project?
o What is the nature and structure of the data? Describe the work to
date and the projected plans for ontologies, schema, or other data
models.
o What is the underlying structure of the database, e.g., relational,
object-oriented, etc.? Will this be continued?
o What is the mechanism to date and the projected mechanism for
communication (both computational and human) between the distributed
sites and the database managers? Are there data liaisons?
o What are the key interacting databases? How are the data be linked?
What are the plans for modifying or enhancing those linkages?
o How is progress made available to the public, e.g., are lists of the
systems being analyzed made available? Will the same arrangement
continue or be modified during the next phase of the project?
o What experience in bioinformatics is available in the group and what
resources can the consortium draw on? Compare the qualifications and
experience of the bioinformatics team you expect to have in the next
phase with the team that you started the project with.
o How has the bioinformatics plan changed and evolved over the initial
period of support?
Core D: Scientific Resource Core(s) (Optional - ten-page limit per
core)
Provide specific titles for any proposed scientific resource cores
(e.g., instrumentation, genomics, proteomics, model organism, or high-
throughput assay), along with a designated Core Director who possesses
expertise in the area of each core. Describe the professional and
technical staff to be involved in the core(s) and their duties.
Include plans to utilize the core(s), such as services that will be
provided and to whom and their bearing on productivity and quality of
the collaborative research effort. For continuing cores, discuss how
the direction, management and use of the core has changed and evolved
over the initial period of support.
Bridging Projects (Optional five-page limit for each)
Bridging projects will support work in the laboratories of the
participating investigators. Indicate whether this is a new or
continuing bridging project. For continuing projects, report progress
that has been made and discuss how the project has changed from and
builds on the initial period of support. For new and continuing
projects, describe the research proposed in the bridging project and
explain how this work more fully integrates the participating
investigator’s independently-supported work into the large-scale
collaborative project or provides a necessary service function or
technology to the collaborative project. For all proposed projects,
the underlying rationale and potential impact of the studies should be
specifically addressed. Projects must be described in sufficient
detail to permit evaluation through the competitive peer-review
process. For each bridging project undertaken as part of the
collaborative project, include a combined summary for the specific
aims, background and significance, preliminary studies/progress, and
research design and methods. Also include, as applicable, the
following sections, which do not count against the page limitations for
the section or the overall page limit: Abstract (one paragraph), Human
Subjects Research (also see special requirements in the Federal
citations below), Vertebrate Animals, and Literature Cited.
Pilot Projects (Optional ten-page limit for each)
Pilot projects will support the work of investigators not already
supported in the area of the collaborative project who have unique
skills or expertise to add to the collaborative project effort. For
all proposed projects, the underlying rationale and potential impact of
the studies should be specifically addressed. How the pilot project
will add new elements essential to achieving the goals of the
collaborative project must be described. It is necessary to justify
well the use of a pilot project taking into account that the
collaborative project is entering its final period of support.
Projects must be described in sufficient detail to permit evaluation
through the peer-review process. For each pilot project undertaken as
part of the collaborative project, include the following sections:
Abstract (one paragraph), Specific Aims, Background and Significance,
Preliminary Studies, and Research Design and Methods. As applicable,
include sections on Human Subjects Research (also see special
requirements in the Federal citations below), Vertebrate Animals, and
Literature Cited; these sections do not count against the page
limitations for the section or the overall page limit. There is a
maximum of three pilot projects allowed per large-scale collaborative
project.
Summary of Page Limits
o Combined length of the project summary, progress report,
administrative management plan, the project management plan, and plan
for termination of funding 50 pages
o Plan for handling intellectual property and sharing research
resources 3 pages
o Administrative core 5 pages
o Information dissemination and data coordinating core 5 pages
o Bioinformatics core (optional) 15 pages
o Scientific cores (optional) 10 pages each
o Bridging projects (optional) 5 pages each
o Pilot projects (optional) 10 pages each
o Combined units (optional) pages equal to combined total for
individual elements
o Overall limit for the Research Plan 180 pages
See also the SPECIAL REQUIREMENTS section above for additional
application guidance and instructions.
INSTITUTIONAL COMMITMENTS: Letters, signed by authorized business
officials of each of the participating investigators' institutions
committing support to the large-scale collaborative project, must be
included. Applicants that include consortium arrangements should refer
to the NIH Grants Policy Statement appendix on consortium arrangements
at
http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium.
APPENDICES: Appendices are allowed for the applications, but they
should follow the rules for appendices in the PHS 398 instructions.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) 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. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
Building 45, Room Number 3An.12, MSC 6200
Bethesda, MD 20892-6200
APPLICATION PROCESSING: Applications must be received on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIGMS. Incomplete or non-responsive
applications will not be reviewed.
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 the NIGMS in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Receive a written critique
o Receive a second level review by the National General Medical
Sciences Advisory Council
REVIEW CRITERIA FOR THE OVERALL PROJECT
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
SIGNIFICANCE: Does this large-scale collaborative project address a
complex biological problem of overarching significance to biomedical
science that would be difficult to address by separate grants? Has
progress been achieved that has moved its field of research forward?
If the aims of the renewal application are achieved, will the field of
biomedical science be advanced to a new level at the end of the next
period of support? Will these studies affect, in a meaningful and
important way, the concepts or methods that drive this field? Is there
a commitment to maximize the impact of the collaborative project
through the sharing of research resources generated by the large-scale
project?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the
scientific aims of the collaborative project? Do the plans for future
studies build logically on the progress made to date? Does the
applicant acknowledge potential problem areas and consider alternative
tactics? Is the project management plan adequate? Is the
administrative framework appropriate? Are the requested components,
such as core facilities, critical to achieving the scientific goals of
the collaborative project and are they cost effective? Do milestones
articulate key indicators set for appropriate times that will
demonstrate significant forward progress for the collaborative project?
Are the plans to monitor and evaluate progress of the collaborative
project adequate? Will the research resources generated by the large
scale project be shared with the larger community? Will the group take
the views of the scientific community impacted by the large-scale
collaborative project into consideration?
INNOVATION: Are the large-scale collaborative project's structure and
goals novel? Has the work to date been characterized by innovation?
Are the proposed aims original and innovative? Will the collaborative
project challenge existing paradigms or develop new methodologies or
technologies? Will the collaborative project attack a problem in a
significantly new way? Will there be value added over individual
grants?
INVESTIGATORS: Is the PI’s major research activity within the research
area of the collaborative project? Has the PI proven to be well suited
for the scientific and administrative leadership required to carry out
this work? Is the level of effort proposed for the PI and the members
of the steering committee appropriate? Is the work proposed
appropriate to the experience level of the collaborative project's
research and technical staff? Are the participating investigators well
chosen for their roles in the collaborative project? Are the research
grants of the participating investigators within the area of the
collaborative project? Have the investigators functioned effectively
as a team? Is the plan to add and delete participating investigators
to and from the collaborative project satisfactory?
ENVIRONMENT: Do the scientific environments in which the work will be
done contribute to the probability of success? Are support personnel
and resources in place to advance the work? Will the proposed
collaborative project take advantage of unique features of the
scientific environments of the component projects? Is the level of
institutional support adequate? Is access to the core facilities
appropriate?
ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the
above criteria, the following items will be considered in the
determination of scientific merit and the priority score:
o Demonstrated and planned commitment to the project by the PI and the
members of the steering committee.
o Commitment of the host and participating institutions to supporting
the large-scale collaborative project, e.g., this would be reflected in
efforts to work out ahead of time potential intellectual property
issues and to remove any institutional barriers to the establishment
and healthy maintenance of the collaborative project.
o Commitment and record of the leadership to the sharing of research
resources (including data and information, materials such as cell lines
and mutant animals, and novel reagents and techniques) generated by the
large-scale project with the broader scientific community.
O Adequacy of the plans to deal with the intellectual property issues
for the collaborative project.
o Quality and accessibility of websites and databases available to the
broader scientific community.
o Adequacy of plans for the termination of the large-scale
collaborative project award or continuation with other support at the
end of the final period of support.
REVIEW CRITERIA FOR THE CORE RESOURCES
Consideration of the technical merit of the core units will include:
(1) Facilities within the core compared to the state of the art. The
contributions of the cores to fulfilling the goals of collaborative
project.
(2) The extent to which core units promote greater collaboration and
cohesiveness among the participating investigators.
(3) Qualifications, experience, and commitment to the large-scale
collaborative project mission of the investigators responsible for the
core resources and their abilities to devote the required time and
effort to the program.
REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS
Reviewers will be asked to discuss the following aspects of each
bridging and pilot project.
SIGNIFICANCE: Does this study address an important problem? For
continuing bridging projects, has the progress to date added
significantly to the field and served to increase the cohesiveness of
the large-scale project? If the aims of the application are achieved,
how will scientific knowledge be advanced? Will the proposed studies
contribute to achieving the goals of the collaborative project?
Will/does the bridging project tie or enhance the independent work of
the participating investigator to the collaborative project, or
will/does the pilot project add an essential missing aspect to the
collaborative project?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? For continuing bridging projects, has the project evolved
in a logical and compelling fashion? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Is the
proposed work appropriate for support by the large-scale collaborative
project or would it be more appropriate for support by a regular
research grant?
INNOVATION: Does the project employ novel concepts, approaches, or
methods? For continuing bridging projects, have innovative results
been achieved to date? Are the aims original and innovative? Does the
project challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR(S): 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)? For continuing bridging projects, has the Principal
Investigator proved to be an effective contributor to the overall
project?
ENVIRONMENT: Does the scientific environment in which the work
will/has been 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?
ADDITIONAL REVIEW CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL
COMPONENTS
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 criteria
included in the section on Federal Citations, below.)
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. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below.)
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Application Receipt Date: October 19, 2004/October 19, 2005/
October 19, 2007
Peer Review Date: February/March 2005/2006/2008
Advisory Council Date: May 2005/2006/2008
Award Date: September 2005/2006/2008
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o adequacy of plans for handling of intellectual property and sharing
of research resources
o impact on the broader scientific community
o adequacy of plans for termination of NIGMS support
o program priorities
o program balance
o availability of funds
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). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (NIH Policy for Data and Safety Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy 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 is available at
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 proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, 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 (see
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.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA 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.
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).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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