and Human Services (HHS)
EXPIRED
DEVELOPMENTAL CENTERS FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE
(DCRC)
RELEASE DATE: December 19, 2002
PA NUMBER: PAR-03-046 (Second phase of this PAR available, see RFA-AT-06-001)
(This PAR has been reissued, see PAR-06-108)
(See NOT-AT-04-003)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov/)
LETTER OF INTENT RECEIPT DATE: March 15, 2003; January 17, 2004; January 15,
2005
APPLICATION RECEIPT DATE: April 15, 2003; February 17, 2004; February 15,
2005
THIS PROGRAM ANNOUNCEMENT WITH SET ASIDE FUNDS (PAS) CONTAINS THE FOLLOWING
INFORMATION
o Purpose of This PAR
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 PAR
The National Center for Complementary and Alternative Medicine (NCCAM) seeks
applications for Developmental Centers for Research on Complementary and
Alternative Medicine (DCRC) using the U19 cooperative agreement mechanism.
The purpose of these awards is a) to increase the level and quality of
complementary and alternative medicine (CAM) research by assisting extramural
CAM researchers and practitioners to develop and participate in high-quality
research, b) to promote CAM research expertise and infrastructure
development, and c) to support enhanced communication and partnership-
building between CAM and conventional institutions. Specifically, the DCRC
will serve as a focal point to strengthen collaborations among CAM and
conventional institutions and facilitate synergistic
exploratory/developmental research projects. An essential characteristic of
the DCRC is a requirement for committed partnerships between CAM and
conventional institutions. NCCAM encourages a multidisciplinary approach to
research, and it is expected that projects will reflect this priority. It is
also expected that these awards will develop and sustain preliminary research
studies that will lead to the submission of competitive R01 grant
applications to conduct CAM research, to NCCAM and other NIH
Institutes/Centers.
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.
As outlined in its Strategic Plan, posted at
http://nccam.nih.gov/about/plans/fiveyear/index.htm, NCCAM is dedicated to
conducting rigorous scientific research on complementary and alternative
healing practices; to training researchers; and to disseminating
authoritative information. 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 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 (then newly created) NCCAM 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 multifaceted approach to the next generation of NCCAM
Centers. (The NCCAM Centers Expert Panel Report is available at
http://nccam.nih.gov/training/centers/index.htm.)
In response to the Panel's recommendation, NCCAM has established the Centers
for Research on Complementary and Alternative Medicine (CRC) Program.
Currently the 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 Centers of Excellence for Research
on CAM (CERC), which uses the Program Project (P01) mechanism, is designed to
provide a vehicle for highly skilled researchers to apply their expertise in
addressing CAM research questions, with an emphasis on elucidating the
mechanisms of action of CAM therapies and approaches. 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.
The DCRC, described in this announcement, is intended to promote development
of CAM research expertise and infrastructure, to support enhanced
communication and partnership-building between CAM and conventional
institutions/investigators and to support developmental research projects.
CAM institutions represent a rich source of talent with the clinical and
historical perspectives needed in CAM research. However, few CAM institutions
have developed and sustained rigorous research programs. More specifically,
there remains a serious shortage of experienced investigators who conduct
independent, high-quality research at CAM institutions. Conversely, there is
a cadre of classically trained, highly experienced scientists with an
interest in CAM research at conventional institutions who may lack the unique
clinical and cultural perspectives critical to CAM. One potential approach to
addressing these issues is to create and sustain collaborations between
scientists and faculty of CAM institutions and established investigators at
conventional institutions in ways that integrate and take maximum advantage
of their respective expertise and experience in mutually beneficial
activities.
Success in achieving support for research through the traditional NIH
research project grant (R01) mechanism can be scientifically challenging.
Often, CAM applications are unsuccessful in obtaining funding due to lack of
preliminary data or poorly developed research methodology. The DCRC provides
CAM and conventional investigators with an opportunity to explore the
feasibility of and develop projects investigating CAM, and to generate
preliminary data in areas where evidence is sparse or nonexistent via
collaborative partnerships. It is expected that the preliminary work
generated within the DCRC will lead to the submission of competitive research
grant applications to NCCAM and other NIH Institutes/Centers.
Objectives:
The DCRC is designed to enhance the capacity of the CAM community to
participate in CAM research and to provide conventional researchers with
links to CAM practitioners who bring an important perspective necessary to
conduct CAM research. To achieve this, the major goals of the DCRC are to:
o conduct three year developmental/exploratory research projects to explore
the feasibility of projects investigating CAM, and to generate preliminary
data in areas where evidence is sparse or non- existent,
o facilitate development of the capacity of CAM investigators and CAM
institutions to participate in the CAM research enterprise, and
o facilitate development of the capacity of conventional investigators and
institutions to participate in the CAM research enterprise.
Note that the project period for each individual DCRC project is three years.
Single or multi-site projects that address CAM research are appropriate.
Structure and Organization of the DCRC
Leadership: Each DCRC will be directed by a Principal Investigator (P.I.),
who may be from either a CAM or a conventional institution (see below for
eligible institutions). The P.I. of the DCRC must also be a Project Co-
Leader of one research project and is required to commit a minimum of 30%
time to the DCRC (15% to the DCRC administrative core and 15% to one research
project). The P.I. will identify and select key personnel and allocate and
monitor funds. A DCRC External Advisory Committee (EAC) will provide
guidance to the P.I. and feedback on DCRC progress to NCCAM staff. An
Internal Steering Committee (ISC) will provide for frequent communication and
sharing of information, and for regular adjustment of focus within the DCRC.
The composition, duties, and reporting requirements of both committees, as
well as further detail on responsibilities of the P.I. are described in the
Special Requirements and/or Terms and Conditions section of this
announcement.
Research projects: Each DCRC will comprise three to four synergistic,
exploratory/developmental research projects. Project Co-Leaders (15% effort
each) are to be named from both CAM and conventional institutions for each
project.
Eligible areas of research: Each DCRC must be structured around a central
scientific theme focused on at least two of the following:
o A particular disease or class of diseases treated by CAM;
o A specific group of CAM therapies or treatment approaches; or
o Mechanisms of action of specific CAM therapies and/or approaches.
Alternatively, the Center may be organized around a specific research theme
such as wellness or the placebo effect.
Projects of potential interest include:
o Basic science studies (including in vitro studies or studies using animal
models);
o Studies of the pharmacognosy, pharmacology, pharmacokinetics, and drug
interactions of natural CAM products;
o Phase I studies, such as those to refine strategies for clinical trials
(addressing, for example, feasibility, safety, optimization of protocol,
validity of assessment methods, controls, target population), to determine
effects on biomarkers and to perform imaging studies, etc.;
o No more than 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; and
o Health services research.
This list should not be considered to be comprehensive, restrictive, or in
priority order. 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 Botanicals Research, posted on the NCCAM website
at http://nccam.nih.gov/research/policies/index.htm.
Applicants are encouraged to consult the NCCAM website
(http://nccam.nih.gov/training/centers/index.htm) for relevant information
regarding current NCCAM research priorities.
Core(s): Each DCRC is required to have an administrative core, which must
serve all projects within the DCRC. The administrative core is responsible
for day-to-day administration, as well as program coordination and ongoing
evaluation of the Center. If a clinical trial is proposed, a clinical core
is suggested, to provide expertise and guidance in e.g., data management,
biostatistics, or clinical trial design/coordination. Additional 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 resources of additional
cores. Two related considerations that should be detailed if applicable are:
1) the degree to which currently funded investigators, within or outside the
DCRC, 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 will use the NIH U19 Cooperative Agreement, a mechanism for
multiple project awards. In the NIH cooperative agreement award mechanism the
P.I. retains the primary responsibility and dominant role for planning and
directing the proposed project, with NIH staff being substantially involved
as a partner with the P.I., as described in the section "Cooperative
Agreement Terms and Conditions of Award."
FUNDS AVAILABLE
This initiative is a three-year Program Announcement with set-aside funds
(PAS). NCCAM intends to commit up to $1.8 million in direct costs in FY 2003
to fund up to three new non-renewable DCRC grant(s) for a period of up to
three years in response to this initiative. Although the financial plans of
the NCCAM 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.
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
For the purposes of this Program Announcement, CAM and conventional
institutions are defined in the following manner:
o A CAM institution is a nationally or regionally accredited academic, health
care or research institution with a primary goal of educating students to be
CAM practitioners. Students who matriculate from the program must do so with
either a degree or certificate in a designated CAM practice that is licensed
or certified at the state level. Eligible institutions include but are not
limited to colleges/schools of naturopathy, chiropractic, traditional Chinese
medicine, acupuncture, and massage.
o A conventional institution is an academic, health care and/or research
institution with a tradition of rigorous research that does not have as a
primary goal training of CAM practitioners.
o For the purposes of this initiative, osteopathic medical institutions that
teach manual manipulation as part of the core curriculum required for all
students may collaborate with another conventional institution.
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 DCRC application must demonstrate that the following special
requirements and provisions are met. Requirements are more fully explained
under the heading "Supplemental Instructions" in the SUBMITTING AN
APPLICATION Section, below.
Institutional Infrastructure
The awardee and collaborating institution(s) must demonstrate that it/they
has/ve the requisite staff (e.g., administrative, and technical), clinical
and/or laboratory facilities, patient populations, geographic distributions
of space and personnel, etc.) to perform the proposed research, or indicate
how they will be obtained.
CAM institutions must document commitment to collaborative agreements by
investigators at conventional research institutions that already have
extramural funding from NIH or other comparable funding sources. Similarly,
conventional institutions must document collaborative agreements with
investigators at CAM institutions.
Applicants must:
o Attach letters of support from an appropriate, high-ranking official at the
awardee institution and from each collaborating institution(s),
documenting significant institutional commitment to the Center and to the
collaboration, and clearly presenting expectations for interactions and
performance by each partner;
o Delineate how different components of the DCRC, 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 core (e.g., the degree of interaction
between projects and with the core must result in a program where "the
whole must be greater than the sum of its parts").
o Show that research projects proposed for the DCRC 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 the activities and the process through which the applicant
institution will reach the goal of developing competitive projects and
preliminary research results in support of applications for further grant
support. The plan must include a chronological table listing specific
first, second and third year objectives for each research project. For
each objective, a brief statement should be made about the specific
contributions of CAM and conventional scientists.
o Enter into a Clinical Trial Agreement. Further information on NCCAM
requirements for clinical trials are posted on the NCCAM website at
http://nccam.nih.gov/research/policies/index.htm.
Principal investigators are strongly encouraged to provide opportunities for
postdoctoral clinical or bench research fellows (both CAM and conventional)
and junior faculty to participate in individual projects as key personnel.
Funds to support intensive, short-term research training experiences in
either basic or clinical research as an exchange program between CAM and
conventional institutions can be included in the administrative core. Such
training may include instruction of students, fellows, interns, residents and
other clinical and research personnel in CAM concepts and methodologies and
in conventional research methodology (which may include analytical methods,
molecular biological methods, clinical trial planning, statistical methods,
ethical practices, or grant writing).
Internal Steering Committee:
The Principal Investigator is responsible for establishing an Internal
Steering Committee (ISC), which will consist of the DCRC P.I., appropriate
investigators from each of the collaborating institutions and the NCCAM
Scientific Advisor in an ex officio capacity. The ISC will have
responsibility for directing and monitoring the progress of the research
projects. In addition, the ISC must develop opportunities for information
exchange, and data sharing. Each ISC member (or their surrogate) will be
expected to participate in all committee activities, e.g., conference calls,
special subcommittees as may be necessary, etc. Outside ad hoc consultants
can be added as desired. If plans call for inclusion of ad hoc consultants,
their areas of expertise should be specified, but individuals should not be
named.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following Terms and Conditions will be incorporated into the new award
statements and will be provided to the Principal Investigator and to the
appropriate institutional officials 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
U19 cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NCCAM programmatic involvement
with the awardees is anticipated during performance of the activities. Under
the cooperative agreement, the NCCAM supports and stimulates the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role. NCCAM will not assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole.
1. Awardee Rights and Responsibilities:
The applicant (awardee) institution and the P.I. will be responsible for the
collaborative research activities in the DCRC. The awardee institution will
be legally and financially responsible and be accountable for the use and
disposition of funds awarded to the awardee, and will attest to the
availability of personnel and facilities capable of performing and supporting
the administrative functions of the DCRC.
The Awardee also has primary authority and responsibility to
o Define DCRC objectives and approaches;
o Plan, conduct, analyze, and publish results, interpretations, and
conclusions of their research, and other activities;
o Coordinate and maintain project activities within his or her institution,
with collaborating scientists, and with the NCCAM Scientific Advisor (see
below); and
o Establish and Chair the Internal Steering Committee.
The Awardee will retain custody of and have primary rights to the data
developed under these awards, subject to government rights of access
consistent with current HHS, PHS, and NIH policies.
2. NCCAM Rights and Responsibilities
As per the terms of the cooperative agreement arrangement, NCCAM will appoint
a Scientific Advisor and a Program Official to participate in the conduct of
the U19 cooperative agreement. The roles of Scientific Advisor and Program
Official may be filled by one person.
The NCCAM Scientific Advisor will:
o Have substantial scientific and programmatic involvement with the awardees
by providing technical assistance, advice and coordination above and
beyond normal program stewardship of research grants;
o Facilitate the coordination necessary to manage this complex project;
o Participate as a non-voting member of the External Advisory Committee;
o Participate in monitoring progress of ongoing studies;
o Participate in planning and implementing efforts to disseminate
information;
o Participate in data interpretation and, when appropriate, in the
preparation of publications and presentations.
o Be subject to the same publication/authorship policies governing all
participants in the study, as well as to the official NIH publication
policy governing extramural employees.
The NCCAM Program Official will:
o Provide normal program stewardship and review the scientific progress of
individual research project components, and the use of the core resource
facilities among the research projects within each cooperative agreement;
o Monitor compliance of the award with the operating policies of this program
announcement;
o May recommend withholding support, suspension, or termination of an award
for lack of scientific progress or failure to adhere to policies outlined
in this announcement or the Award Statement.
o Is responsible for establishing and coordinating regular meetings of a DCRC
External Advisory Committee (EAC), in consultation with the DCRC P.I. The
EAC will be composed of the Program Official, who will serve ex officio,
and up to five external advisors with appropriate expertise to provide
advice relative to the objectives of the program. The EAC will serve as
the primary advisory body of the DCRC, and the Program Official will rely
on the EAC for objective evaluation of the Program.
The EAC will:
o Monitor progress of the research projects;
o Monitor the effectiveness of communication and collaboration;
o Monitor the use of core resources by DCRC participants and other
investigators;
o Evaluate the effectiveness of the DCRC P.I.; and
o Identify problems and suggest possible solutions.
The EAC's evaluations and recommendations, in the form of a written annual
report, are to be submitted to the Program Official, the Scientific Advisor,
and the DCRC P.I., and will be used by the Program Official and the DCRC P.I.
to guide and direct the program. Subcommittees with additional ad hoc
advisors may be established by the EAC as necessary in order to meet its
planning, priority setting and evaluation responsibilities. Awardees
generally will be expected to accept and implement the recommendations of the
EAC; in those situations where the recommendations are not feasible to
implement, the DCRC P.I. must provide a thorough explanation and rationale to
NCCAM. The first EAC meeting will be convened by the Awardee nine months
after the award date. The EAC will meet annually three months before the
anniversary of the DCRC award date.
3. Arbitration Process
Any disagreement that may arise on scientific or programmatic matters between
U19 awardees and NCCAM may be brought to arbitration before an arbitration
panel. The arbitration panel will be composed of three members. One member
will be chosen by the awardee. A second member will be selected by NCCAM. The
third member, having expertise in the relevant scientific area, will be
chosen by the two selected members. This special arbitration procedure in no
way affects the awardee's right to appeal an adverse action that is otherwise
appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart
D and HHS regulation at 45 CFR Part 16.
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
Goertzc@mail.nih.gov
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: goldrosm@mail.nih.gov
Direct inquiries about financial 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: vp8g@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, including project/core leaders;
o Participating institutions; and
o Number and title of this PAR.
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 (NCCAM)
National Institutes of Health
6707 Democracy Blvd. Suite 401
Bethesda, MD 20892-5475
Office (301) 402-1030
Fax (301) 480-3621
Goertzc@mail.nih.gov
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) 710-0267;
FAX: (301) 480-0525; Email: grantsinfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Submit the complete signed application with the checklist, and three
photocopies without the checklist to:
Center for Scientific Review
Division of Research Grants
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
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: goldrosm@mail.nih.gov
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 DCRC. 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:
o DCRC application overview, which addresses the overall objectives and
unifying theme(s) of this multi-project grant, the relationships among
research projects and the administrative (including the administrative and
organizational structure) and cores and how they will each contribute to the
overall objectives and the overall budget.
o Specific instructions for individual projects, describing modifications to
PHS Form 398 instructions to address the collaborative/interactive nature of
the project.
o 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 DCRC.
DCRC 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 DCRC 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 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 each component research project and core. 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 DCRC
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 DCRC application. Narrative
justification for individual budget categories should be presented for each
of the projects and cores.
Form page 5 - Budget for entire proposed DCRC 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 in which you describe 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 DCRC 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 aim of the overall
research plan and by laying out a broad strategy for accomplishing the goals
of the program. Indicate the contribution of each project and core to the
overall concept. 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).
Include letters (on institutional letterhead) from each proposed project Co-
Leader and core leader confirming his/her role in the proposed DCRC, 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, give each a title; and provide the names and
titles of the project leader and of participating investigators.
All other items on the face page are to be completed following the standard
PHS 398 instructions.
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 DCRC 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 DCRC program goals and how it relates to other research
projects within the DCRC 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 DCRC.
Item C Preliminary studies: Inasmuch as these projects are
exploratory/developmental, preliminary data as evidence of feasibility are
not required. However, relevant pilot data should be cited when available.
Item D - Research design and methods: Although preliminary data are not
required, 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. A single appendix is to be provided for the entire DCRC
application.
Checklist. Submit a single checklist for the entire application.
Specific instructions for cores
The application must include an Administrative Core led by the P.I. of the
DCRC. Other cores may be requested as appropriate. Funding for the overall
administrative efforts, including secretarial and other administrative
services, expenses for publications demonstrating collaborative efforts, all
travel associated with the DCRC, communication expenses, etc., should be
requested in the administrative core.
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.
All other items on the face page are to be completed using the standard PHS
398 instructions.
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 toward attainment of the DCRC 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 15
pages.
Item A - Specific aims: State the core's relationship to the DCRC 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 DCRC.
Appendix. A single appendix for the entire DCRC application is to follow all
projects and the core.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the Center
for Scientific Review 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:
o receive a written critique,
o undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score,
o may require site visits or that investigators come to NIH to meet with
reviewers (reverse site visit);
o receive a second level review by the National Advisory Council on
Complementary and Alternative Medicine.
REVIEW CRITERIA
The following aspects of the DCRC will be evaluated:
o Individual Research Projects
o Cores
o Principal Investigator
o Environment
o Program Synergy
o Overall Program
o Other Considerations
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 the use of the core by the research projects and
their integration with the core; and
o Procedures for monitoring and evaluating the proposed research and for
providing ongoing quality control and scientific review, including the
proposed organization and activities of the Internal Steering Committee
(Administrative Core only).
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 30% effort (15% as Principal
Investigator/administrative core leader and 15% as project leader of at
one exploratory/developmental project).
D) RESOURCES AND ENVIRONMENT
Each application will receive a merit descriptor for Resources and
Environment (outstanding, acceptable, unacceptable) that reflects the
following:
Institutional Commitment
o The appropriateness of resources and policies for the administration of the
DCRC;
o The degree of incorporation of the DCRC within its institutional
priorities;
o As applicable, the degree to which the letters of support from senior
faculty and/or institutional leaders address the need for mentoring of
inexperienced Project Leaders to ensure the success of the collaboration;
and
o The extent of commitment to develop administrative capabilities that foster
interdisciplinary collaborations.
Collaborative Environment
o The degree to which developmental research projects will enhance
collaborations between CAM investigators and clinicians and conventionally
trained scientists;
o Strength of the evidence that the staff of the CAM and conventional
institutions worked together closely to prepare the application; and
o As applicable, the adequacy of provisions made for day-to-day oversight,
coordination, support and logistical services needed to make the
collaboration successful.
Resources
Adequacy of facilities to support the proposed research, including clinical
facilities, laboratory facilities and data management systems, when needed.
F) PROGRAM SYNERGY
Each application will receive a merit descriptor (highly integrated,
integrated, not integrated) that reflects the degree of synergy of the
proposed DCRC. In particular, program synergy will be evaluated on:
o The potential for scientific impact of the proposed DCRC, 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 DCRC as a whole;
o Demonstration of an effective relationship among collaborating
institutions, including documentation of current relationships, as well as
the functions, commitments and contributions that each collaborating
member will bring to the proposed project; and
o The nature, scope, and effectiveness of the plans for communication,
coordination, and collaboration among research project investigators.
G) OVERALL PROGRAM
A single numerical priority score will be assigned to the DCRC 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, collaborative environment and program
synergy. The degree to which the proposed goals of the DCRC will likely lead
to the submission of competitive R01 grant applications to conduct CAM
research, to NCCAM and other NIH Institutes/Centers will also be considered.
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 U19 award, and therefore will not be
recommended for further consideration (NRFC).
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 15, 2003;January 17, 2004;January 15, 2005
Application Receipt Date: April 15, 2003; February 17, 2004; February 15, 2005
Peer Review: June/July 2003, 2004, 2005
Review by NCCAM Council: September 2003, 2004, 2005
Earliest Anticipated Award Date: September 15, 2003, 2004, 2005
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
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as participants in
Research Involving Human Subjects "that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
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.
http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.
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