BASIC AND PRECLINICAL RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) 

RELEASE DATE:  July 2, 2002

PA NUMBER: PA-02-124 (This PA has been reissued, see PA-05-141)

EXPIRATION DATE:  July 15, 2005

National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov)
National Cancer Institute (NCI)
 (http://nci.nih.gov)
National Institute of General Medical Sciences  (NIGMS)
 (http://www.nigms.nih.gov/)
National Institute of Mental Health  (NIMH)
 (http://www.nimh.nih.gov/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

The National Center for Complementary and Alternative Medicine (NCCAM) 
invites research grant applications to help stimulate the amount and elevate 
the quality of basic, mechanistic, and preclinical research in all domains of 
CAM in order to provide a stronger foundation for ongoing and planned 
clinical studies.  The NCCAM desires to encourage the most rigorous CAM and 
conventional researchers to focus on the opportunities in CAM research, and 
to employ the most current and emerging technologies to strengthen the 
biomedical research knowledge bases needed to elevate clinical practice.  The 
National Cancer Institute (NCI), the National Institute of General Medical 
Sciences (NIGMS), and the National Institute of Mental Health (NIMH) share 
programmatic interests in some areas of CAM research with the NCCAM.  The 
NCCAM, NCI, NIGMS, and NIMH areas of interest are described under INQUIRIES.

RESEARCH OBJECTIVES

The NCCAM is dedicated to exploring complementary and alternative healing 
practices in the context of exacting science.  The NCCAM desires to encourage 
the most rigorous CAM and conventional researchers to focus on the 
opportunities in CAM research, and to employ the most current and emerging 
technologies.  Chemists, physicists, psychologists, neuroscientists, 
endocrinologists, immunologists, geneticists, pharmacologists, and others in 
relevant fields of inquiry who are interested in applying their expertise and 
powerful contemporary technologies to help advance the science of CAM are 
encouraged to apply.

In order to strengthen the biomedical research knowledge bases needed to 
inform CAM clinical practice, more basic, mechanistic, and preclinical 
research is needed across the broad spectrum of biomedical science underlying 
CAM practices. These practices may be grouped in five major domains: 
alternative medical systems, mind-body interventions, biologically based 
treatments, manipulative and body-based methods, and energy therapies, with 
some overlap across categories (NCCAM"s Five-Year Strategic Plan can be 
accessed at http://nccam.nih.gov/about/plans/healthdisparities/appendices.htm 
,see especially Appendix I).  The individual systems and treatments within each 
category of CAM are numerous, so the following examples are presented to 
demonstrate the broad range of research contemplated by this initiative, and are 
not meant to be exclusive:

---Immunomodulatory mechanisms underlying CAM therapeutics, such as basic and 
animal model studies aimed at determining whether and what changes are 
induced in immune response pathways by CAM therapeutics, and whether any such 
changes might be relevant to resolving a disorder or preventing one

---Neurophysiological, neuroendocrinological, and biochemical pathways in 
massage therapy, including studies utilizing animal models, and 
instrumentation-based approaches including imaging

---Mechanistic studies of biologically-based treatments, herbs, nutritional 
supplements, or natural products for enhancing cognitive function in brain 
disorders

---Chemical and physical reactions during the dilution process and the 
principles of biophysics associated with homeopathy, for example, studies 
using detailed and sensitive physical measurements of water to determine 
whether it is altered in any measurable and reproducible way by the process 
of ultrahigh dilution employed in the preparation of some homeopathic 
remedies 

---Mechanisms underlying the biochemical and/or neurophysiological causes of 
spinal dysfunction, and investigations of the therapeutic pathways being 
impacted by manual therapies such as spinal manipulation and mobilization as 
performed in chiropractic or osteopathic practices 

---Studies on the rationales for the use of complex products from a single 
plant species and studies to evaluate the mechanisms of action and to help 
establish the biomedical bases for the belief in the therapeutic efficacy of 
using multiple plant species simultaneously

---Basic biological mechanisms and processes underlying acupuncture, 
including investigations using animal models, and studies employing imaging 

---Identification and properties of the energies underlying therapies such as 
Qi gong, Reiki, distant healing, acupuncture, and other therapeutic 
modalities involving bioenergies, especially new biophysical approaches 
involving instrumentation

---Mechanisms of action of Saw Palmetto, PC-SPES, Pygeum africanum and other 
complex botanicals on the male reproductive tract, and of black cohosh, red 
clover, and other complex botanicals on the female tract: The studies are 
expected to focus on the cellular, molecular, endocrinological and metabolic 
changes induced in vitro, in animal models, and inhuman subjects treated with 
these botanicals

---Interactions between CAM and conventional therapeutic modalities, 
including but not limited to those of complex botanicals with pharmaceutical 
drugs

Summary

This initiative is designed to focus the attention and efforts of CAM and 
conventional researchers towards more basic, mechanistic, and preclinical 
research on CAM. 

MECHANISMS OF SUPPORT 

This PA will use the NIH R01, R21 and R15 award mechanisms.  As an applicant, 
you will be solely responsible for planning, directing, and executing the 
proposed project.  The total project period for an application submitted in 
response to this PA may not exceed 5 years for R01, 2 years for R21, or 3 
years for R15 grants.  The guidelines for R21 applications may differ between 
NIH Institutes and Centers.  The URLs listed below provide guidance for the  
participating Institutes" R21 programs. 

NCCAM:  http://nccam.nih.gov/research/instructions/r21/index.htm

NCI:  http://deainfo.nci.nih.gov/extra/pa/mechanism/r21.htm

NIGMS:  http://www.nigms.nih.gov/funding/grntmech.html#explor

NIMH:  http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html

Potential applicants should contact the programmatic representatives listed 
under INQUIRIES for additional guidance on all award mechanisms.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant 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 organizations

The NIH has published Program Guidelines for Academic Research Enhancement 
Awards (AREA, R15 grants) which include a list of schools/components that are 
inelegible for this Program, see 
http://grants.nih.gov/grants/funding/area.htm for details. 

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.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE (NCCAM)

The NCCAM areas of interest are broad, and include five major domains of CAM 
research: alternative medical systems, mind-body interventions, biologically 
based treatments, manipulative and body-based methods, and energy therapies 

The NCCAM"s programs in natural products research have arisen from a unique 
perspective.  Practitioners of Complementary and Alternative Medicine (CAM) 
believe that the polypharmacy of complex natural products has advantages over 
single-ingredient drugs by providing greater therapeutic benefit and less 
overall toxicity.  In pursuit of its mission, the NCCAM supports research to 
determine safety, efficacy, and mechanisms of action of complex natural 
products.  NCCAM will support research characterizing single constituents 
extracted from complex natural products if the purpose is to identify and 
standardize whole products, compare the actions of single constituents with 
the complex product, or identify the mechanisms of action for the whole 
product.  NCCAM will not accept applications to isolate the active 
constituents of complex natural products for the express purpose of 
developing these constituents as discrete drugs.  Funding support for 
applications to develop active constituents as drugs may be available from 
other Institutes and Centers at NIH. 

Shan Wong, Ph.D.
Program Officer
National Center for Complementary and Alternative Medicine
Two Democracy Plaza, Suite 401
6707 Democracy Boulevard
Bethesda, MD  20892-5475
Phone: 301-496-7498
Fax: 301-480-3621
E-mail:  shanw@mail.nih.gov

NATIONAL CANCER INSTITUTE (NCI)

The National Cancer Institute is interested in basic, mechanistic, and 
preclinical research as it relates to the prevention, diagnosis and treatment 
of cancer as well as management of cancer symptoms and side effects due to 
conventional cancer treatment.  Areas of interest include interactions 
between conventional cancer treatment and CAM modalities.

Wendy B. Smith, Ph.D.
Program Director
Office of Cancer Complementary and Alternative Medicine
National Cancer Institute
6130 Executive Blvd, EPN
Suite #102, MSC 7302
Bethesda, Maryland 20892-7302
Telephone:  301-435-7980
FAX:  301-480-0075 
Email:  smithwe@mail.nih.gov

NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS)

NIGMS areas of interest include structure identification and chemistry of 
natural products in herbals, mechanisms underlying interactive 
biological/pharmacological effects of multiple components within a single 
herbal or a mixture of herbals, metabolism of herbal and natural products by 
drug metabolizing enzymes, herbal-drug interactions resulting from effects on 
drug metabolizing enzymes and transporters, biological mechanisms underlying 
anesthetic effects of herbals, natural products, or acupuncture, and  
biological mechanisms underlying the placebo effect.

Michael E. Rogers, Ph.D.
Director, Pharmacology, Physiology, and Biological
     Chemistry Division
National Institute of General Medical Sciences
Rm. 2As.49c, Natcher Building
Bethesda, MD 20892-6200
Telephone: 301-594-3827
FAX: 301-480-2802
Email:  RogersM@nigms.nih.gov

NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) 
 
The NIMH is interested in research on the identification and testing of 
promising biologically-based interventions, herbs, nutritional supplements, 
and natural products for the treatment of mental disorders and the 
enhancement of cognitive function in depression and schizophrenia.

Linda Brady, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7185
Bethesda, MD 20892
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email:  lb@helix.nih.gov

o Direct your questions about NCCAM financial or grants management matters 
to:

Marc Pitts, M.B.A. 
Grants Management Specialist 
National Center for Complementary and Alternative Medicine 
Two Democracy Plaza, Suite 401
6707 Democracy Boulevard 
Bethesda, MD 20892-5475 
Telephone: (301) 594-9095 
Fax: (301) 480-3621 
Email: pittsm@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete
copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.213 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 under 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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