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) 435-0714; 
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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