and Human Services (HHS)
EXPIRED
CENTERS OF EXCELLENCE FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE
MEDICINE (CERC)
RELEASE DATE: December 4, 2002 (This PA has been reissued, see PAR-06-047)
(Clarification of program requirements, see NOT-AT-05-002)
(see NOT-AT-04-002)
PA NUMBER: PAS-03-038
LETTER OF INTENT RECEIPT DATE: March 29, 2003
APPLICATION RECEIPT DATE: April 29, 2003
EXPIRATION DATE: April 30, 2003
National Center for Complementary and Alternative Medicine (NCCAM)
(http://www.nccam.nih.gov/)
THIS PROGRAM ANNOUNCEMENT WITH SET-ASIDE FUNDS (PAS) CONTAINS THE
FOLLOWING INFORMATION
o Purpose of This PAS
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible To Become Principal Investigators
o Special Requirements, Including Cooperative Agreement Terms and
Conditions of Award
o Where To Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplemental Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAS
The National Center for Complementary and Alternative Medicine (NCCAM)
seeks applications for Centers of Excellence for Research on
Complementary and Alternative Medicine (CERC), using the NIH Program
Project (P01) mechanism, as one component of a multi-faceted Centers
for Research on Complementary and Alternative Medicine Program. The
purpose of the CERC is to provide a vehicle for accomplished
researchers to apply their expertise to address complementary and
alternative medicine (CAM) research questions, with an emphasis on
applying cutting-edge scientific approaches to elucidating the
mechanisms of action of CAM therapies and modalities. Applications must
comprise three to four research projects structured around a central
scientific theme that is clearly relevant to CAM. Applicants should
consult the NCCAM website
(http://nccam.nih.gov/training/centers/index.htm) for relevant
information regarding current specific NCCAM research priorities.
RESEARCH OBJECTIVES
Background
CAM use in the U.S. is high, with yearly use prevalence between 30 and
42% of U.S. adults, and expenditures associated with CAM therapies
exceeding non-reimbursed expenses incurred for all hospitalizations.
Despite this broad use, there is insufficient scientific data on the
safety and efficacy of CAM therapies.
NCCAM is dedicated to conducting rigorous scientific research on complementary
and alternative healing practices; to training researchers; and to
disseminating authoritative information, as outlined in its Strategic
Plan, posted at http://nccam.nih.gov/about/plans/fiveyear/index.htm.
To this end, NCCAM employs a range of funding mechanisms, including
centers, to support research, training, and career development. Centers
have been a key component of the NCCAM research portfolio because they
offer an opportunity to develop a program of related research projects
that result in "a whole greater than the sum of its parts" and can
serve as a focal point for the development of additional research and
training activity. The first generation of specialized research
centers introduced in 1998 allowed the NCCAM (then newly created) to
cultivate research, scientific resources, and new investigators
simultaneously within 16 programs. To assess the status of current CAM
research centers and recommend future directions, in June 2002, NCCAM
convened an Expert Panel on NCCAM Research Centers.
Given that 1) the areas of CAM research are broad, 2) the expertise of
investigators available to pursue CAM research ranges from novice to
highly skilled and accomplished, and 3) there is a need to facilitate
the development of a sustained research culture within the CAM
community, the Panel recommended a multi faceted approach to the next
generation of NCCAM Centers. (The NCCAM Centers Expert Panel Report is
available at http://nccam.nih.gov/about/plans/centers/index.htm.)
In response to the Panel's recommendation, the NCCAM has established the Centers
for Research on Complementary and Alternative Medicine (CRC) Program.
Currently the Centers Program consists of three individual activities,
each designed to meet a different need. Additional individual programs
may be developed and will be posted on the NCCAM website. The
Developmental Centers for Research on Complementary and Alternative
Medicine (DCRC) is intended to promote development of CAM research
expertise and infrastructure, support enhanced communication and
partnership-building between CAM and conventional
institutions/investigators and to support developmental research
projects. The International Centers for Research on Complementary and
Alternative Medicine (ICRC) are designed to establish partnerships and
cross-cultural exchange through which foreign and U.S. institutions and
investigators can collaborate to design and implement research on
CAM/traditional indigenous medical systems or components thereof in the
cultures and/or environments in which they originated.
Objectives
The Centers of Excellence for Research on CAM (CERC), described in this
announcement, are designed to provide a vehicle for highly skilled and
accomplished researchers to apply their expertise in addressing CAM
research questions, with an emphasis on elucidating the mechanisms of
action of CAM therapies and approaches.
STRUCTURE AND ORGANIZATION OF THE CERC
Leadership
Each CERC will be directed by a Principal Investigator (P.I.), who is
required to commit a minimum of 25% time to the CERC. The P.I. will
identify and select key personnel and allocate and monitor funds. A
CERC External Advisory Committee (EAC) will provide guidance to the
P.I. Further detail on responsibilities of the P.I. and the EAC are
described in the Special Requirements of this announcement.
Research Projects/Eligible Areas of Research
Each CERC will comprise three to four synergistic research projects
that must be structured around a central scientific theme focused on
either a particular disease or class of diseases treated by CAM, a
specific group of CAM therapies or treatment approaches, or a specific
research theme such as wellness or the placebo effect. The emphasis of
the research is to be on elucidating mechanisms of action. However, the
program may include one Phase I clinical trial or one Phase II study of
modest size, provided it is adequately powered to detect a meaningful
difference between groups or validates surrogate markers of disease or
clinical endpoints.
Some examples of disciplinary approaches of potential interest include:
o Molecular biology
o Cellular biology
o Psychoneuroimmunology
o Pharmacology
o Neurobiology
This list should not be considered to be comprehensive, restrictive, or
in priority order.
Specific NCCAM research priorities are listed on the NCCAM website
(http://nccam.nih.gov/training/centers/index.htm). Applicants proposing
studies that include the use of botanicals or other complex natural
products as a component should refer to the Policy of the NCCAM on
Natural Products Research, posted on the NCCAM website at
http://www.nccam.nih.gov/research/policies/naturalproducts.htm.
Core(s)
Each CERC is required to have an administrative core, which must serve
all projects within the CERC. The administrative core is responsible
for day-to-day administration, as well as program coordination and
ongoing evaluation of the Center. Additional scientific cores may be
included, as appropriate, bearing in mind that each core must be
utilized by at least two proposed projects.
Applications must clearly demonstrate how each core will serve the
needs of the research program, and how each project will use core
resources. Two related considerations that should be detailed if
applicable are: (1) the degree to which investigators within the CERC will
use and benefit from core resources and; (2) the degree to which the
resources will promote new and/or expanded CAM research efforts.
MECHANISM OF SUPPORT
This initiative is a three-year Program Announcement with set-aside
funds (PAS) that will use the NIH program project (P01) award
mechanism. A P01 Center grant application (CERC) may request up to
five years of support.
Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and
duration of each award will also vary. The length of award will be
determined through the peer review and Council advisory process.
Applicants are solely responsible for planning, directing, and
executing the proposed CERC. This type of award supports broadly based
multidisciplinary research programs that have a well-defined central
research focus or objective. An important feature is that the
interrelationships among the individual scientifically meritorious
projects will result in a greater contribution to the overall program
goals than if each project were pursued individually.
FUNDS AVAILABLE
In FY 2003, NCCAM will commit up to $3.6 million to fund as many as
three new CERC applications in response to this initiative.
Applications exceeding 1.2 million total cost in any year will be
considered unresponsive and returned without further consideration.
The requested direct cost budget for the CERC will include direct and
facilities and administrative costs for all subcontracts. Applications
will be accepted in response to this initiative on April 29, 2003, on
February 17, 2004, and on February 15, 2005. NCCAM's research
priorities are posted at the NCCAM website
(http://nccam.nih.gov/training/centers/index.htm) and will be updated
on or before October 1 of each year beginning in 2003. Although
NCCAM's financial plans provide support for this program, awards
pursuant to this PAS 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 PAS will be reissued.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
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.
SPECIAL REQUIREMENTS
Each CERC application must demonstrate that the following Special
Requirements and Provisions are met. Further requirements are
explained under the heading "Supplemental Instructions" in the
SUBMITTING AN APPLICATION Section, below.
Applicants must:
o Attach letters of support from an appropriate, high-ranking official
at the applicant institution and from each collaborating
institution(s), documenting significant institutional commitment to the
Center and to the collaboration;
o Delineate how different components of the CERC, including key
personnel, will interact, why they are essential to accomplishing the
overall goal of the research, and how the combined resources create
capabilities that are more than the sum of the parts;
o Describe the collaborative process and methods of communication, and
identify areas of potential collaboration and areas of focused
collaboration;
o Describe scientific and/or programmatic synergy between projects, and
between projects and proposed cores (e.g., the degree of interaction
between projects and with the cores must result in a program where "the
whole is be greater than the sum of its parts").
o Show that research projects proposed for the CERC do not overlap in
purpose or intent with existing NIH-funded grants, but will constitute
new activities or a natural progression of current research;
o Plan to participate, with collaborators, in an annual meeting with
other NCCAM-funded center P.I.s. Travel costs for this purpose should
be included in the proposed budget for the application;
o Describe plans for an External Advisory Committee (EAC). Specific
expertise required of EAC members should be specified but the names of
individuals should not be provided.
o Address how the effects of separation will be managed, if any
component of a proposed Center is physically separated from the others
(i.e., in a different department or institution)
o Enter into a Clinical Trial Agreement, if applicable. Further
information on NCCAM requirements for clinical trials are posted on the
NCCAM website at http://nccam.nih.gov/research/policies/index.htm.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA 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:
Direct inquiries regarding scientific/programmatic issues to:
Christine Goertz, D.C., Ph.D.
Coordinator, Centers for Research on CAM Program
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd. Suite 401
Bethesda, MD 20892-5475
Office (301) 402-1030
Fax (301) 480-3621
[email protected]
Direct inquiries about peer review issues to:
Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: [email protected]
Direct inquiries about fiscal or grants management matters to:
Victoria Carper, MPA
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-9102
Fax: 301-480-1552
Email: [email protected]
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, name, address, and
telephone number of the Principal Investigator;
o Names of other key personnel, participating institutions;
o Number and title of this PAS.
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 NCCAM 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:
Christine Goertz, D.C., Ph.D.
Coordinator, Centers for Research on CAM Program
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd. Suite 401, MSC 5475
Bethesda, MD 20892-5475
Office (301) 402-1030
Fax (301) 480-3621
[email protected]
SUBMITTING AN APPLICATION
Applications are to be submitted using the Form PHS 398 (rev. 5/01)
using the SUPPLEMENTAL INSTRUCTIONS provided below. The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
telephone (301) 435-0714; FAX: (301) 480-0525; email:
[email protected].
Submit the complete signed application with the checklist, and three
photocopies without the checklist to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040
MSC 7710
Bethesda, MD 20892-7710
(Bethesda, MD 20817 for express/courier service)
At the time of submission, two additional copies of the application
must be sent to:
Martin Goldrosen, Ph.D.
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: [email protected]
SUPPLEMENTAL INSTRUCTIONS
This section supplements the instructions found in Form PHS 398 (Rev.
5/01) for preparing a grant application. Additional instructions are
required because the Form PHS 398 has no specific instructions for
multi-project applications consisting of research projects and core(s)
interrelated by a common theme such as the CERC. The following are
specific instructions for sections of the PHS 398 (rev. 5/01)
application form that are to be completed differently than usual. For
all other items in the individual project application, follow the
standard PHS 398 instructions.
The instructions below are divided as follows:
CERC application overview, which addresses the overall objectives and
unifying theme(s) of this multi-project grant, the relationships among
research projects and the cores (including the administrative and
organizational structure) and how they will each contribute to the
overall objectives and the overall budget.
Specific instructions for individual projects, describing modifications
to PHS Form 398 instructions to address the collaborative/interactive
nature of the project.
Specific instructions for the cores, each of which must provide
services or resources to at least two research projects. Instructions
describe modifications to PHS Form 398 instructions on selected items
to address the collaborative or interactive role of the CERC.
CERC application overview
This multi-project grant application should be assembled and paginated
as a single, complete document.
Face page
Items 1 - 15: complete these items as instructed. This should be the
first page of the entire application and all succeeding pages should be
numbered consecutively.
Form page 2
Using page 2 of PHS 398, provide a succinct but accurate description
(abstract) of the overall CERC application addressing the major, common
theme of the program. Do not exceed the space provided.
Under "key personnel", list the P.I., followed by all other key
personnel (project leader, core leaders, consultants) in alphabetical
order.
Form page 3 - Table of contents
Do not use Form page 3 of the PHS 398; a more comprehensive table of
contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed
project by project, including the cores, prepare a detailed table of
contents that will enable reviewers to locate specific information
pertinent to the overall application as well as to each component
research project and core. Describe scientific and/or programmatic
synergy between projects, and between projects and proposed cores
(e.g., the degree of interaction between projects and with the cores
must result in a program where "the whole is be greater than the sum of
its parts"). Delineate how different components of the CERC, including
key personnel, will interact, why they are essential to accomplishing
the overall goal of the research, and how the combined resources create
capabilities that are more than the sum of the parts. Describe the
collaborative process and methods of communication, including areas of
potential collaboration and areas of focused collaboration. Also show
that the research projects proposed for the CERC do not overlap in
purpose or intent with existing NIH-funded grants, but will constitute
new activities or a natural progression of current research. A page
reference should be included for the budget for each project and each
core. Further, each research project should be identified by number
(e.g. project 1), title, and responsible Project Co-Leaders, and each
core should be identified by number, title, and responsible Core
Leader.
Form page 4 - Detailed budget for initial budget period
Use Form page 4 of PHS Form 398 as a composite budget for the entire
CERC application. Indicate the page location of the composite budget
in the "Table of Contents." Note: An additional Form page 4 must be
used for each individual project and core within the CERC application.
Narrative justification for individual budget categories should be
presented for each of the projects and cores.
Form page 5 - Budget for entire proposed CERC period
Complete the total direct cost line entries for all requested budget
periods (years) and the total direct cost for entire period of support
for each project and core.
Biographical sketch form page
Biographical sketches of all professional personnel for all components
should be placed at the end of the application with the P.I.'s first,
followed by those of other key personnel in alphabetical order.
Resources form page
Do not complete for the overall application. Essential information is
to be presented in the individual research project and core sections of
the application.
Checklist
Complete for the entire application and place at the end of the
application package.
If the facilities and administrative costs (F&A) rate agreement has
been established, indicate the type of agreement and the date.
Identify all exclusions used in the calculation of the F&A costs for
the initial budget period and all future budget years.
Other support page
Do not complete. Any required information will be requested from
successful applicants prior to grant award.
Program overview (research plan)
Foreword:
Include a one-page foreword that describes relevant previous
collaborative arrangement(s), if any.
Items a-d (see PHS 398 instructions) are limited to 25 pages. This
narrative section summarizes the overall research plan for the multi-
project application. The CERC application should be viewed as a
confederation of synergistic research projects, each capable of
standing on its own scientific merit, but complementary to one another.
This important section provides the group of investigators an
opportunity to give conceptual wholeness to the overall program by
giving a statement of the general problem area and by laying out a
broad strategy for attacking the problems. Indicate the contribution
of each project and core to the overall scheme. Include a chart
showing the percentage of core activities required for support of each
project throughout the requested funding period. Summarize the special
features in the environment and/or resources that make this application
strong or unique.
Appendix
Follow the standard PHS 398 instructions, but provide six copies of a
single appendix for the entire document. Order of materials in the
appendix should follow that of the application, i.e., starting with
materials relevant to the overall Program, continuing with materials
relevant to the individual projects, and concluding with any materials
relevant to the core(s). Every appendix item pertaining to a specific
project or core must be clearly labeled as such.
Include letters (on institutional letter head) from each proposed
project Co-Leader and Core Leader confirming his/her role in the
proposed Center, as well as from institutional officials confirming
their commitment to the project.
Specific instructions for individual projects
A cover page is required for each research project and should include
the number and title of the project. ) Use numbers (1,2,3, etc.) to
designate individual research projects and give each a title; and
provide the names and titles of the project leader and of participating
investigators.
Form page 2
For each proposed project, provide a description (abstract) of the
proposed research according to the instructions for form page 2 of the
PHS 398. In addition, the abstract should contain a brief description
of how the research project will contribute to attainment of the CERC
program objectives.
Under "key personnel", follow the PHS 398 instructions, listing all key
personnel participating in the project, beginning with the project
leader. Distinguish co-investigators from other key personnel.
Form page 3
Prepare a table of contents for each research project using form page 3
of the PHS 398. Since the biographical sketches of all participating
investigators will be located at the end of the overall application and
therefore should be referenced in the overall table of contents, it is
not necessary to repeat these pages.
Research plan (a-d)
Do not exceed a total of 25 pages for Items a-d in the Research Plan
for each individual project. Tables, charts, graphs, diagrams and
figures must be included within the 25-page limit. Applications that
exceed the 25-page limit or NIH requirements for type size and margins
(refer to PHS 398 instructions for details) will be returned to the
applicant without further consideration. The 25-page limit does not
include Items e-i (Human Subjects, Vertebrate Animals, Literature
Cited, Consortia and Consultants/Collaborators).
Item A - Specific aims (typically one page): List in priority order the
broad, long range objectives of the proposed project and describe
concisely and realistically the more immediate goals. In addition,
state the project's relationship to the CERC program goals and how it
relates to other research projects within the CERC and to the cores.
Item B - Background and significance: Use this section to describe how
the proposed research will contribute to meeting the goals and
objectives and explain the rationale for the selection of the general
methods and approaches proposed to accomplish the specific aims. In
addition to the overall biological significance of the proposed
research, this section should indicate the relevance of the project to
the theme of the CERC.
Item C Preliminary studies: Relevant preliminary studies and pilot
data should be cited for each project.
Item D - Research design and methods: The conceptualization and
planning of the project must be sufficient to allow for an assessment
of the project's potential. The proposed research must be presented in
sufficient detail to allow evaluation of the proposed methods.
Appropriate expertise to conduct the proposed research must be included
among the key personnel, e.g., for research involving human subjects,
statistical and/or clinical trial design expertise (as appropriate) is
essential during the design and conduct of research. .
Appendix. No appendix need be provided for individual projects, as a
single appendix is to be provided for the entire CERC application.
Checklist. Not required for individual projects. Submit a single
checklist for the entire application.
Specific instructions for cores
The CERC application must include an administrative core and may
include other scientific cores.
Administrative core. The applicant (awardee) institution and the
Principal Investigator will be responsible for the application and for
collaborative research activities in the CERC program. The awardee
institution will be legally and financially responsible and be
accountable for the use and disposition of funds awarded to the
application, and will attest to the availability of personnel and
facilities capable of performing and supporting the administrative
functions of the CERC program.
Funding for the overall administrative efforts including secretarial,
and other administrative services, travel to the annual NCCAM Center
Director's meeting, expenses for publications demonstrating
collaborative efforts, communication expenses, etc., should be
requested here.
Scientific core(s). A scientific core is a resource to the CERC grant
as a whole. The application must indicate the specific projects it will
serve. This section should present a clear picture of the facilities,
techniques, and skills that the core will provide. The role of the core
leader and each of the key participants should be described. The
apportionment of dollars, or percentage of dollars, that will be
required to support each component research project, which will utilize
each scientific core should be presented.
A cover page is required for each core and should include the title of
the core and provide the names and titles of the core leader and of
participating investigators.
Form page 2
Provide a description (abstract) of the core activities and services
according to the instructions on form page 2 of the PHS 398. In
addition, the abstract should contain a brief description of how the
core services will contribute towards attainment of the CERC program
objectives.
Form page 3
Prepare a table of contents for each core using page 3 of the PHS 398.
Since the biographical sketches of all participating investigators will
be located at the end of the overall application (and therefore should
be referenced in the overall Table of Contents), it is not necessary to
repeat these pages.
Core plan
The research (core) plan (items a-d) for each core section is limited
to 25 pages.
Item A - Specific aims: State the core's relationship to the CERC goals
and how it relates to the research projects in the application.
Item B - Background and significance: Use this section to describe how
the proposed core activities will contribute to meeting the goals and
objectives and explain the rationale for the selection of the general
methods and approaches proposed to accomplish the specific aims. These
resources should not duplicate resources already available to study
investigators. In addition, this section should indicate the relevance
of the core activities to the primary theme of the CERC.
Appendix.
No appendix is to be presented in the section for the administrative
core; a single appendix for the entire CERC application is to follow
all projects and the core.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NCCAM. Incomplete and non-responsive applications
will be returned to the applicant without further consideration.
Applications that are complete and responsive to the PAS will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NCCAM in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review
group convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
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 Council on
Complementary and Alternative Medicine.
REVIEW CRITERIA
The following aspects of the CERC will be evaluated:
A) Individual Research Projects
B) Cores
C) Principal Investigator
D) Resources and Environment
E) Program Synergy
F) Overall Program
A) INDIVIDUAL RESEARCH PROJECTS
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
The reviewers will be asked to comment on the following aspects of each
proposed developmental research project in order to judge the
likelihood that the proposed research will have a substantial impact on
the pursuit of these goals. Each of these criteria will be addressed
and considered by the reviewers in assigning the overall score,
weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to have a
major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move forward in a
field.
(1) Significance. Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
(2) Approach. Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
(3) Innovation. Does the project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) Investigators. Are the investigators appropriately trained and
well-suited to carry out this work? Is the work proposed appropriate
to the experience level of the Project Leader(s) and other researchers
(if any)?
(5) Environment. Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Additional review criteria: In addition to the above criteria, in
accordance with NIH policy, all research components will also be
reviewed with respect to the following:
Inclusion: The adequacy of plans to include both genders, minorities
and their subgroups, and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (Please see Inclusion Criteria
included in the section on Federal Citations, below).
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.
Data Sharing: The adequacy of the proposed plan to share data.
Budget: The reasonableness of the proposed budget and duration in
relation to the proposed research.
Based on the evaluation described above, each project will receive a
numerical score from 1.0 to 5.0.
B) CORES
Each core will receive a merit descriptor (outstanding, acceptable,
unacceptable) that reflects:
o Technical merit and justification of the proposed core;
o Qualifications, experience, and commitment of the personnel involved
in the core;
o Adequacy of plans for use of the core by the research projects and
the benefit to the projects from core resources; and
o Adequacy of day-to-day administration, as well as program
coordination and ongoing evaluation of the center (administrative core)
C) PRINCIPAL INVESTIGATOR
The P.I will be evaluated with respect to:
o Leadership and scientific ability to develop a program of integrated
research projects with a well-defined central research focus; and
o Time commitment of a minimum of 25% effort.
D) RESOURCES AND ENVIRONMENT
Each application will receive a merit descriptor for Resources and
Environment (outstanding, acceptable, unacceptable) that reflects the
following:
o Institutional commitment to the program;
o The extent to which CAM investigators and clinicians are involved in
the research, if appropriate;
o The intellectual and physical resources available to the program
project participants; and
o Adequacy of facilities to support the proposed research, including
clinical facilities, laboratory facilities and data management systems,
when needed.
E) PROGRAM SYNERGY
Each application will receive a merit descriptor (highly integrated,
integrated, not integrated) that reflects the degree of synergy of the
proposed CERC. In particular, program synergy will be evaluated on:
o The potential for scientific impact of the proposed CERC, which
should be greater than that the sum of its component research projects
and cores, i.e., the proposed components should interact
synergistically to add value to the CERC as a whole.
o Demonstration of an effective relationship among collaborating
departments and institutions, including documentation of current
relationships, as well as the functions, commitments and contributions
that each collaborating member will bring to the proposed project.
o The nature, scope, and effectiveness of the plans for communication,
coordination, and collaboration among research project investigators.
F) OVERALL PROGRAM
A single numerical priority score will be assigned to the CERC
application as a whole.
In assigning the priority score for the application as a whole,
although primary emphasis will be placed on scientific merit of the
research projects, and past productivity (where applicable),
significant consideration will also be given to the strength of
core(s), leadership ability of the P.I., institutional commitment,
resources and environment, and program synergy.
An application in which the reviewers consider no more than two
component research projects to be of substantial and significant
scientific merit will not satisfy the requirements for this P01 award,
and therefore will be recommended for "no further consideration."
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 29, 2003
Application Receipt Date: April 29, 2003
Peer Review: July 2003
Review by NCCAM Council: September 2003
Earliest Anticipated Award Date: September 15, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review);
o Availability of funds;
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups
and their sub- populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy is based
on the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-
43).
All investigators proposing research involving human subjects should
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities
as Subjects in Clinical Research," published in the NIH Guide for
Grants and Contracts on August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a
complete copy of the updated Guidelines is available at
ttp://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:
The revisions relate to NIH defined Phase III clinical trials and
require: a) all applications or proposals and/or protocols to provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) all investigators to report accrual,
and to conduct and report analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS.
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted and
supported by the NIH, unless there are clear and compelling scientific
and ethical reasons not to include them. This policy applies to all
initial (Type I) applications submitted for receipt dates after October
1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
participants in Research Involving Human Subjects "that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should
read the policy that was published in the NIH Guide for Grants and
Contracts, June 5, 2000 (Revised August 25, 2000), available at the
following URL address
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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 PAS 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. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS-led national activity for setting priority areas. This PAS is
related to the priority area of CAM Research. 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. 93.213 and 93.242, and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and administered under NIH grants policies described
at http://grants.nih.gov/grants/policy/policy.htm and Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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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