CENTERS OF BIOMEDICAL RESEARCH EXCELLENCE (COBRE)
RELEASE DATE: September 24, 2002
RFA: RR-02-007
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov)
LETTER OF INTENT RECEIPT DATE: December 18, 2002
APPLICATION RECEIPT DATE: January 22, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
The purpose of the Institutional Development Award (IDeA) Program is to
foster health-related research and increase the competitiveness of
investigators at institutions located in states with historically low
aggregate success rates for grant awards from the National Institutes of
Health (NIH). To provide flexible support to build research capacity, the
National Center for Research Resources (NCRR) of the National Institutes of
Health invites applications for Centers of Biomedical Research Excellence
(COBRE) from investigators at independent biomedical research institutions or
biomedical research institutions that award doctoral degrees in the health
sciences or sciences related to health within IDeA eligible states.
Collaboration with other non-doctoral degree granting and research performing
institutes or institutions is encouraged.
The purpose of this Request for Applications (RFA) is to augment and
strengthen the institutional biomedical research capacity through flexible
support to expand and develop biomedical faculty research capability and
enhance research infrastructure through support of a multi-disciplinary
center, led by a peer-reviewed, funded investigator with expertise central to
the research theme of the proposal. The application must have a thematic
scientific focus in a specific research area, such as neuroscience, cancer,
structural biology, immunology, or bioengineering, and may use basic,
clinical or both research approaches to attain the goals of the proposed
center. The scientific leadership provided by one or more established
biomedical research faculty is critical to the success of this initiative,
especially for the mentoring of promising junior investigators. The center is
intended to support investigators from several complementary disciplines. It
will enable the institution to develop a critical mass of investigators and
enhance their competitiveness in a specific research area that accelerates
the rate at which those investigators compete for other complementary NIH
research grant support. It is also anticipated that, in some instances, the
support through this initiative will facilitate the development of new
disease specific research centers or augment the capability of existing
centers.
RESEARCH OBJECTIVES
This program seeks to promote the initiation and development or expansion of
unique, innovative state-of-the-art biomedical and behavioral research at
institutions in IDeA-eligible states. The research focus of this program
encompasses the full spectrum of the basic and clinical sciences and also
includes cellular and molecular biology, biophysics and biotechnology,
genetics and developmental biology, pharmacology and others. The NIH
recognizes that the contributions from the institutions in IDeA-eligible
states are important and essential in fulfilling the promise of the NIH
research agenda. The intent of this RFA is to assist these institutions to
implement and use the technologies and other resources needed to conduct
state-of-the-art biomedical research.
The objectives of this program are (1) to enhance the ability of
investigators to compete independently for complementary NIH individual
research grant or other external peer-reviewed support and (2) to strengthen
an institution"s biomedical research infrastructure through the establishment
of a multi-disciplinary center. This goal is accomplished through the
direction provided by a Principal Investigator (PI), who provides leadership
to junior investigators (defined below) and has the primary responsibility
for administering the program and for overseeing the development of the
center and its associated core facilities. The PI of the COBRE application
must be an established biomedical or behavioral research scientist who will
ensure that high quality research be performed and who has the experience to
effectively administer and integrate all components of the program. The PI
must have an active biomedical or behavioral research program that receives
NIH, NSF or other peer-reviewed support in the scientific area of the center
and have the requisite administrative experience to direct the program. A
minimum time commitment of 25 percent is required for this individual,
however, up to 50 percent effort will be supported for mentoring and
administrative oversight of the COBRE. If the PI is not in place at the
institution at the time of review or award, a plan to recruit such an
individual must be included in the application. An award pursuant to this RFA
will not be made until and unless the institution has appointed a permanent
COBRE PI.
Each COBRE program should include three to five research projects that stand
alone, but share a common thematic scientific focus. Each research project
should be supervised by a single junior investigator who is responsible for
insuring that the specific aims of that project are met. For the purpose of
eligibility a junior investigator is defined either as (1) an individual who
does not have or has not previously had an external, peer-reviewed Research
Project Grant from either a Federal or non-Federal source that names that
investigator as the PI or (2) an established investigator who is making a
significant change to his/her career.
With respect to the item (1), grants that name an individual as a co-
investigator, collaborator or consultant do not disqualify that investigator.
Starter grants (such as NIH"s FIRST award mechanism, R29), Academic Research
Enhancement Award grants (AREA, R15), or exploratory/pilot project grants
(such as NIH R03 or R21 awards) also do not disqualify the investigator. The
investigator must hold either a tenure track or non-tenure track faculty
appointment of any rank at the time that the award is made. Furthermore, a
clear commitment to support this faculty appointment must be demonstrated
from the institution by a letter(s) from the appropriate senior institutional
official(s). Postdoctoral fellows or other positions that do not carry
independent faculty status will disqualify that individual and his/her
research project from further consideration.
With respect to the item (2), support may be provided to an individual who is
making a significant change to his/her career goals by initiating a new line
of research that is distinctly and significantly different from his/her
current investigative program. In this case a current or previous history of
independent peer-reviewed research support in a different investigative area
from that proposed in this application does not disqualify the investigator.
Moreover, this individual can be of any faculty rank.
This initiative is not intended to replace support for ongoing investigator-
initiated research programs of established investigators, nor are established
investigators eligible for support. Instead, established investigators should
serve as mentors to advance the junior investigators" careers.
RESEARCH PLAN: Each application should describe an overall research plan to
justify support of a multi-disciplinary COBRE program for five years. It is
recommended that the research plan contain the descriptions of at least three
and up to five research projects. In addition, the establishment of core
facilities necessary to carry out the objectives of a multi-disciplinary,
collaborative program may be proposed.
Each individual research project should describe the Specific Aims in the
selected area of research and the goals for the first year and for the long
term. The design principles supporting the research or the hypotheses to be
tested should be delineated. Preliminary studies are not required for COBRE
applications, but applicants with preliminary results should describe them.
In the absence of preliminary results, applicants should describe the
rationale and scientific basis for the proposed research. Furthermore, each
research project should describe the area of multi-disciplinary research that
is the focus of the COBRE and critically assess the existing knowledge and
approaches that have been or are being directed in the area with an emphasis
on specifically how the multi-disciplinary COBRE approach will advance the
field. Moreover, the importance and health relevance of the proposed research
to the Specific Aims should be concisely stated.
With respect to the overall COBRE program the PI should describe the unique
research opportunities that will be provided to the junior investigators and
to the institution. If the proposed COBRE research is closely related to
ongoing research or an existing center, an explanation how the research
activities of the COBRE will complement but not overlap with existing
research should be described. In addition, the PI should describe how the
efforts of each junior investigator will assist in the establishment of a
multi-disciplinary research center.
The qualifications of the COBRE PI selected for this effort should be clearly
described. If that individual is not a member of the faculty at the time of
review of the application, include a detailed plan that will result in having
that individual on the full-time faculty within one year from the date of
peer-review of the institution"s application.
Although no non-federal matching funds are required for these applications,
clear evidence of institutional commitment should be included with the
application. The level of institutional commitment will differ among
applicant institutions because of the variability of resources available
among institutions. At a minimum, a letter of support from a senior
institutional official (e.g., President or Dean) should outline the
commitment of resources and facilities to sustain and support the COBRE
throughout the period of funding.
The institutional environment and resources that are available to
investigators must be briefly described. Available resources (e.g.,
laboratory facilities, patient populations, geographic distributions of space
and personnel) and collaborative resources should be described. If core
facilities are included for support, the relationship of each component
research project to the core(s) should be described.
A clear plan for the development and graduation of investigators who are
provided research support from the COBRE program should be included. This
plan should detail the long-term goals as to how the institution intends to
make the transition from the research support of multi-disciplinary COBRE
projects to competitive grant support through applications submitted by its
faculty members to relevant NIH institutes and centers or to other
appropriate Federal or non-Federal agencies or organizations. This must
include both formative and summative evaluation strategies with specific
milestones. Faculty development should include a mentoring plan that involves
oversight by established senior faculty members assigned as mentors,
constructive evaluations by members of the External Advisory Committee (EAC)
(see below under Special Requirements), and coordinated management of all of
these individuals by the PI of the COBRE program. Additional oversight may be
augmented through the use of an internal advisory committee, but this
committee should not act as substitute for the EAC.
Each junior investigator should be assigned to at least one mentor. The
mentor is an established faculty member who has demonstrated the ability to
advise others through the acquisition of external support and the maintenance
of an independent research laboratory. In some instances a suitable mentor
may not be available within the applicant"s institution and it is therefore
acceptable to enlist appropriate mentors from outside institutions. Mentors
may request between 10 and 15 percent effort and should be listed in the
Administrative Core"s budget section of the application and not in the
individual projects" budget sections. The junior investigators should clearly
designate in the text the identity of their mentors and describe the
qualifications, both scientific and advisory, that make them appropriate to
assist in the oversight of the project.
The award of a Research Project Grant (RPG) to a junior investigator should
be viewed as a milestone and a basis for graduation of that investigator from
the COBRE program. In addition, a junior investigator may be graduated from
the COBRE program if the PI and/or the EAC deem that the investigator has
achieved independent status.
The receipt of an award that overlaps or is significantly similar to that
described in the COBRE program is sufficient justification to graduate a
junior investigator from the program. However, if the specific aims of the
junior investigator"s RPG are significantly different from the project
described in the COBRE, then the junior investigator has an obligation to
remain in the program to complete his/her COBRE project.
Following the graduation of a junior investigator from the COBRE program, the
PI can appoint another investigator to assume the vacated slot. The
appointment of a replacement investigator should involve review and
recommendation of that investigator"s project by the EAC. The PI should
communicate the EAC"s recommendations to NCRR Program staff to review and
approve the appointment of new investigators (and possibly new mentors) to
the program.
BIOGRAPHICAL SKETCHES: The Principal Investigator, co-investigator(s), junior
investigators, and mentors must provide a biographical sketch as initiated in
the PHS 398 instructions. This section must not exceed four pages per person.
RESOURCES: The application must describe the equipment and facilities
available to the proposed COBRE.
ALTERATION AND RENOVATION: Alteration and Renovation (A&R) costs to improve
existing research laboratories or animal facilities are allowed. This RFA
will provide up to $500,000 in direct costs in year one only of the award as
a one-time cost expenditure. Alteration and renovation projects must be
relevant to the scope of the proposed research and at the institution.
Sufficient detail must be provided to estimate the cost and suitability of
the project. Failure to adequately justify A&R requests will likely result in
its deletion from the requested budget. Proposed renovations in successful
applications will subsequently require the submission of design documents for
review and approval before the renovation project may commence. This RFA will
not provide support for new construction, including the completion of shell
space, or for movable research equipment/instrumentation or for equipment
intended for teaching or other non-research related purposes. Please note
that alteration and renovation costs will only be approved for facilities
improvements at the applicant"s organization. Proposed improvements at
consortia sites is disallowed.
For any proposed A&R, a narrative summary (as outlined below), line drawings,
and cost estimates must be provided. The following sample format is
suggested:
o NARRATIVE SUMMARY
(1) Relate the proposed renovations to the research projects that will use
the facility. If renovations to animal facilities are proposed, relate the
proposed renovations to the projected animal populations (by species). If
renovations to animal facilities are proposed, please include the lines of
authority and responsibility for administering the institution"s animal care
and use program. The role and composition of the Institutional Animal Care
and Use Committee (IACUC) and how compliance with relevant laws, policies,
and guidelines is achieved should also be included.
(2) List the functional components, including the size (dimensions) and
square footage of each component (room, alcove, cubicle) that will be
directly affected by the renovation project.
(3) List engineering criteria applicable to each component (mechanical,
electrical, and utilities). Include information such as the number of air
changes per hour, electrical power, light levels, hot and cold water, steam.
(4) List appropriate architectural criteria (such as width of corridors and
doors, surface finishes).
(5) List and justify all fixed equipment items requested for the renovated
area.
o LINE DRAWINGS
(1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT
BLUEPRINTS) These drawings will not be counted against the 25-page limit. All
floor plans must be legible, with the scale clearly indicated.
(2) The line drawings of the proposed renovation must be at a scale adequate
to explain the project. The drawings should indicate size (dimensions),
function, and net and gross square feet of space for each room. The total net
and gross square feet of space to be renovated should also be given.
(3) The plan should indicate the location of the proposed renovation area in
the building.
(4) Include the as-built drawings of the proposed renovation area and
indicate any areas which will be demolished.
(5) Changes or additions to existing mechanical and electrical systems should
be clearly described in notes made directly on the plan or attached to the
plan.
(6) Indicate the type(s) of new finishes to be applied to room surfaces.
o COST ESTIMATES
Detailed cost estimates must be included. Provide vendor quotes when
available.
Those individuals interested in seeking additional funds for facilities
improvements are referred to the NCRR Research Facilities Improvement
Program, that accepts applications for construction and for extensive
renovation. Please refer to the NCRR Website: http://www.ncrr.nih.gov/.
MECHANISM OF SUPPORT
This RFA will use the NIH exploratory grant award mechanism (P20). The
applicant will be solely responsible for planning, directing, and executing
the proposed project. This RFA is a one-time solicitation. The anticipated
award date is September 2003.
All budget requests should be submitted in non-modular format. Individual
project and core facility budgets should be grouped together with
justifications and prefaced by a summary budget for the entire program.
FUNDS AVAILABLE
The NCRR intends to commit approximately $35 million in FY03 to fund 15 to 20
new grants in response to this RFA. An applicant must request a project
period of 5 years and may request a budget for direct costs of up to and no
more than $1.5 million per year, excluding facilities and administrative
(F&A) costs on consortium arrangements. The applicant may also request
additional direct costs in year one only of up to $500,000 as a one-time
expenditure for alteration and renovation of laboratory or animal facilities.
If alteration and renovation costs are requested, then the total budget
request for year one must not exceed $2 million in direct costs, excluding
F&A costs on consortium arrangements. Regardless whether alteration and
renovation costs are requested, budget requests for years two through five
cannot exceed $1.5 million per year, excluding F&A costs on consortium
arrangements.
Funds may be used to develop Offices of Sponsored Programs and for faculty
expansion (i.e., recruitment of additional faculty who complement the scope
of the proposed program) up to $100,000 per year for each position. These
funds may be used for salary, supplies and equipment costs.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size of each award
will also vary. Although the financial plans of the NCRR 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. At this time, it is not known if this RFA will be reissued.
CONSORTIUM ARRANGEMENTS: When a grant application includes research
activities that involve institutions other than the grantee institution, it
is considered a consortium effort. Such activities may be included in the
COBRE grant application, but it is imperative that a consortium application
be prepared so that the programmatic, fiscal, and administrative
considerations are explained fully. In addition, the COBRE"s thematic
scientific focus must be evident in applications that include consortia
arrangements. Applicants for COBRE grants should exercise great diligence in
preserving the interactions of the participants and the integration of the
consortium project(s) with those of the parent institution, because synergism
and cohesiveness can be diminished when projects are located outside of the
group at the parent institution.
For the purposes of this RFA, F&A costs for the consortium organization(s)
are excluded from the limit on the amount of direct costs that can be
requested for the entire application. Applicants are encouraged to review the
NIH policy and procedures applicable to consortium agreements, which are
published as part of the NIH Grants Policy Statement, Part III, available on
the NIH homepage at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/index.htm.
Questions may be directed to the fiscal contact identified below under Inquiries.
ELIGIBLE INSTITUTIONS
o CRITERIA FOR ELIGIBILITY OF AN IDeA STATE
In making its assessment for eligibility, NCRR included all
states/commonwealths with a success rate for obtaining NIH grant awards
(number of applications awarded vs. number of applications approved) of less
than 20 percent over the period of 1997-2001. Also included are those states
that had higher success rates, but received less than $75 million average NIH
funding over the five-year period. Under these criteria, the following
states/commonwealth are eligible IDeA states:
Alaska Arkansas Delaware Hawaii
Idaho Kansas Kentucky Louisiana
Maine Mississippi Montana Nebraska
Nevada New Hampshire New Mexico North Dakota
Oklahoma Puerto Rico Rhode Island South Carolina
South Dakota Vermont West Virginia Wyoming
o CRITERIA FOR INSTITUTIONAL ELIGIBILITY
An eligible institution must be within an IDeA state. An eligible institution
must either be (1) a domestic, public or private, or non-profit research
institution that awards doctoral degrees in health sciences or sciences
related to health, or (2) an independent biomedical research institute.
Applications will be accepted from institutions that do not currently hold a
COBRE award. Applications will also be accepted from institutions that hold
one active COBRE award. However, applications will NOT be accepted from
institutions that hold two or more active COBRE awards. These institutions
are disqualified from this competition and cannot submit applications.
Applications are encouraged from veterinary and dental schools in IDeA
states. Applications will be accepted from veterinary and dental schools
regardless of the number of active COBRE awards held by that institution.
Applications are also encouraged from eligible institutions in IDeA states
that propose research that relates to the scope and mission of the National
Institute on Deafness and Other Communication Disorders (NIDCD).
o RESTRICTIONS FOR SUBMITTING AN APPLICATION
No eligible institution, including veterinary and dental schools, can submit
more than one application in response to this RFA. Multiple applications
received from these institutions or applications received from disqualified
institutions (those that hold two or more active COBRE awards) will be
returned without further consideration. If an institution is writing more
than one application, it is the responsibility of that institution to appoint
a steering or selection committee to decide which single application to
submit in response to this RFA.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs. The PI of the COBRE application must be
an established biomedical or behavioral research scientist who has
demonstrated the administrative abilities to effectively carry out the
objectives of the COBRE program and meet its goals. The qualifications of the
PI have been previously described.
SPECIAL REQUIREMENTS
The COBRE PI should budget for an annual two-day meeting in Bethesda,
Maryland with NCRR staff.
Each COBRE application must include an External Advisory Committee (EAC),
comprised of at least three to five scientists, with national scientific
reputations in their field, their expertise must be directly relevant to the
scientific theme of the COBRE. The EAC critiques scientific progress of the
COBRE and also offers advice on scientific matters to the COBRE PI. The EAC
activities include concept development, program planning, encouraging and
assisting with faculty development and mentoring, identifying resources, and
evaluating progress toward stated goals. The PI will share the advice and
critiques provided by the EAC with other investigators at the center. The EAC
will also review and approve candidates for replacement/substitute projects
and investigators as required, before such requests are forwarded to NCRR for
confirmation and approval. The EAC must meet at least twice per year on
average. Minutes are to be recorded and made available for review by NCRR
program staff responsible for the COBRE. A summary of the issues discussed at
each EAC meeting, recommendations made, and actions taken must be included in
the yearly progress reports submitted to the NCRR.
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. Lawrence N. Yager
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Suite 6030
Bethesda, MD 20892-7965
Telephone: (301) 435-0760
FAX: (301) 480-3770
E-mail: lawrencey@ncrr.nih.gov
o Direct your questions about peer review issues to:
Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD 20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Irene Grissom
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6086
Bethesda, MD 20892
Telephone: (301) 435-0844
FAX: (301) 480-3777
E-mail: grissomi@ncrr.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD 20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS: An application for a COBRE award must include the
following:
o A clear definition of the nature and extent of research collaboration,
including a full explanation of the necessary administrative, fiscal, and
scientific aspects of the proposed COBRE.
o A research plan for five years that includes the proposed organization and
component functions of the COBRE. The plan should demonstrate the applicant"s
knowledge, ingenuity, practicality, and commitment to developing a
significant, productive, research program.
o A description of and justification for the proposed individual research
projects (a ten-page limitation for the Research Plan Section for each
project) and core service facilities that collectively will contribute to the
center. Applicants are required to propose at least three and up to five
meritorious research projects and must describe the nature and scope of any
scientific research collaborations.
o A description of the research and research training or career development
goals and capabilities of the proposed COBRE. The PI must establish a time
line for supported applicant investigators to prepare and submit proposals
for traditional research grant review during the performance period of the
COBRE award.
o A description of the infrastructure for conducting studies aimed at
developing a nationally-competitive biomedical research program.
o A narrative summary, line drawings and cost estimates must be provided for
any proposed alteration and renovation project. An itemized budget and
justification of the impact that this alteration and renovation would have on
the COBRE activities must also be provided.
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:
https://grants.nih.gov/grants/funding/phs398/label-bk.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 five
copies of any appendices must be sent to:
Dr. Sheryl K. Brining
Office of Review
National Center for Research Resources
National Institutes of Health
6705 Rockledge Drive, Room 6018
Bethesda, MD 20892
Telephone: (301) 435-0809
FAX: (301) 480-3660
E-mail: sb44k@nih.gov
APPLICATION PROCESSING: 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.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NCRR. Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration. Applications
that exceed the maximum allowable first year direct cost limit of $1.5
million (or $2 million, if requesting first year alteration and renovation
costs), excluding F&A costs for consortium budgets, 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 the Office of Review, NCRR in accordance with the review criteria
stated below.
As part of the initial merit review, all applications will:
o receive a written critique,
o undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score,
o receive a second level review by the National Advisory Research Resources
Council.
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 are asked to discuss the following aspects of
an application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The review of the COBRE application is additionally based not only on these
traditional review criteria, but also on the qualification and stature of the
Principal Investigator to provide both scientific and administrative
leadership and on the feasibility and potential for investigators to become
competitive for independent funding. Senior, funded investigators must not be
proposed as subproject leaders.
The following criteria will be used to evaluate the 1) administrative
leadership and overall potential for enriching the intellectual milieu for
doing research, 2) scientific merit of the individual biomedical research
projects, and 3) effectiveness in training and promoting junior
investigators:
ADMINISTRATIVE LEADERSHIP AND OVERALL POTENTIAL FOR ENRICHING THE
INTELLECTUAL MILIEU FOR DOING RESEARCH: Reviewers will be asked to consider
the following:
o The qualifications of the Principal Investigator to provide scientific and
administrative leadership in developing and directing the COBRE, and
establishing thematic collaborative research efforts. The Principal
Investigator must be an established biomedical or behavioral research
scientist. He/she should be supervising an active research laboratory that is
supported by relevant, peer-reviewed, research grants (NIH, NSF or other
peer-reviewed research awards).
o The significance, approach, and innovation of the proposed research
projects and of the COBRE as a whole.
o The nature, scope, and effectiveness of the plans for coordination and
cooperation among research project investigators.
o The strengths of the applicant investigators and the collaborating
researchers, if involved, particularly their academic qualifications,
biomedical expertise and research productivity.
o The level of institutional commitment with regard to assuring that the
resources and facilities to sustain the COBRE program are present, including,
but not restricted to, existing relevant equipment, animal, and/or computer
resources, and departmental or interdepartmental cooperation.
o The need for the proposed core facilities and the effectiveness of these
facilities to enhance the research effort.
o The ability to augment and strengthen the institutional biomedical research
capability.
o The ability to provide support for the development of a multidisciplinary
center.
o The means by which basic or clinical research is encouraged.
o The establishment and maintenance of a scientific thematic focus.
o The suitability of the External Advisory Committee.
o The appropriateness and suitability of evaluation strategies and specific
milestones necessary to measure progress toward attaining long-range goals.
SCIENTIFIC MERIT OF THE INDIVIDUAL BIOMEDICAL RESEARCH PROJECTS: The
scientific review group will address and consider each of the below criteria
in assigning the project"s overall merit and weighting them as appropriate
for each project. The project does not need to be strong in all categories to
be judged likely to have major scientific impact. For example, important work
may be proposed that by its nature is not innovative but is essential to move
a field forward.
o SIGNIFICANCE: Does the study address an important problem? If the aims of
the application are achieved, how do they advance scientific knowledge? What
will be the effect of these studies on the concepts or methods that drive
this field?
o APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Are potential problem areas acknowledged and alternative tactics
considered?
o INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
o 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 investigator and to that of other researchers (if any)?
o 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?
EFFECTIVENESS IN TRAINING AND PROMOTING JUNIOR INVESTIGATORS: The reviewers
will be asked to use the following criteria in evaluating this criterion:
o The quality of the research training, career development and mentoring plan
for junior investigators of the center.
o The plan for development and graduation of junior investigators.
o The suitability of the plan for recruiting new faculty.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
application will also be reviewed with respect to the following:
o PROTECTIONS: 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 INCLUSION: 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 included in the
section on Federal Citations, below.)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 18, 2002
Application Receipt Date: January 22, 2003
Peer Review Date: June 16, 2003 (subject to change)
Council Review: September 11, 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Funding decisions will be based on scientific and technical merit as
determined by the Initial Review Group, the National Advisory Research
Resources Council, geographic distribution, program balance, the enhancement
of the research competitiveness of the institution, and the availability of
funds.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://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 AMENDMENT "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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html),
a complete copy of the updated Guidelines are available at
https://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
https://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
https://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 https://grants.nih.gov/grants/stem_cells.htm and at
https://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 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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA 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.
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 No. 93.389. Awards are made under authorization
of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92
and are not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards made under these
authorizations are administered under NIH grants policies described at
https://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.