This Program Announcement expires on October 22, 2003, unless reissued.

DEVELOPMENTAL /PILOT PROJECTS IN CANCER COMPLEMENTARY AND ALTERNATIVE 
MEDICINE (CAM)
 
Release Date:  December 17, 2001

PA NUMBER:  PAR-02-040
 
National Cancer Institute
 (http://cancer.gov/)
National Center for Complementary and Alternative Medicine
 (http://nccam.nih.gov/)

Letter of Intent Dates:     January 16, 2002, May 17, 2002, September 16, 2002, 
                            January 16, 2003, May 23, 2003, September 16, 2003
Application Receipt Dates:  February 20, 2002, June 21, 2002, October 21, 2002, 
                            February 20, 2003, June 20, 2003, October 21, 2003

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS 
THAN $250,000 PER YEAR IN ALL YEARS.  MODULAR BUDGET INSTRUCTIONS ARE 
PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The Office of Cancer Complementary and Alternative Medicine of the National 
Cancer Institute (NCI), and the National Center for Complementary and 
Alternative Medicine (NCCAM) invite research grant applications from 
interested investigators to conduct innovative developmental pilot research 
investigating Complementary and Alternative Medicine (CAM) in cancer. The 
intent of this initiative is to encourage and support the development of 
basic and clinical CAM cancer research and to provide the basis for more 
extended research projects by establishing the methodological feasibility and 
strengthening the scientific rationale for these projects. This announcement 
is also intended to stimulate and facilitate the entry of promising 
investigators into cancer CAM research through a program of exploratory 
investigator-initiated R21 grants.

The exploratory/developmental (R21) grant mechanism is used for pilot 
projects or feasibility studies to support the exploration of feasibility, as 
well as the development, of projects investigating CAM in cancer and for the 
generation of preliminary data.  The R21 mechanism is specifically intended 
to support innovative ideas where preliminary data are sparse or do not 
exist.  The R21 supported projects are intended to serve as a foundation for 
planning and developing future research projects (R01s).  The objective of 
this Program Announcement (PA) is to encourage applications from individuals 
who are interested in testing novel or conceptually creative ideas that may 
produce innovative advances in the understanding and use of CAM in cancer.
 
RESEARCH OBJECTIVES

The widespread use of a variety of nutritional, psychological and natural 
medical approaches, collectively termed complementary and alternative 
medicine (CAM), has been well documented.  Recent surveys demonstrate that 
between 9 and 91% of U.S. cancer patients use CAM therapies at some time 
after their diagnosis. Despite the broad use of CAM treatment for cancer, 
there is a lack of data available to indicate whether these CAM practices are 
efficacious and safe.  Various NIH advisory groups have cited the need for 
increased research on CAM approaches for the treatment of cancer and have 
encouraged the NIH to support the evaluation of CAM therapies.

There is a paucity of R01 funded research grants in the field of cancer CAM. 
Therefore, to increase the number and quality of investigator-initiated R01 
research grants on cancer CAM, the NCI"s Office of Cancer Complementary and 
Alternative Medicine and NCCAM developed this PA for Developmental/Pilot 
Projects in Cancer CAM.  Applications will undergo competitive review 
organized by the NCCAM in collaboration with the NCI.

The intent of this initiative is to encourage and support the development of 
basic, and clinical (prevention, therapeutic and palliative) CAM cancer 
research.  Another goal of this initiative is to facilitate communication and 
collaboration between the CAM practitioner and the conventional cancer 
research communities.  

For the purpose of this PA, applicants must include modalities from the 
following broad program areas in CAM:

Alternative Medical Systems (e.g., oriental medicine, Ayurvedic, homeopathy, 
naturopathy),

Manipulative and Body-based Systems (e.g., chiropractic, osteopathic, massage 
therapy or unconventional applications of integrated conventional and 
physical therapies),

Energy Therapies. These approaches focus either on energy fields purported to 
originate within or be conducted through the body (e.g., external qi gong, 
therapeutic touch, Reiki, intentional effects on living systems), or those 
from other sources [e.g., therapeutic application of electromagnetic (EM) 
fields including pulsed EM fields, magnetic fields, Direct Current (DC) 
fields].

Pharmacological or Biologically based Therapies (e.g., metabolic therapies 
and immunoaugmentative therapies as used by CAM practitioners or the public 
such as Coley"s toxin, Enzyme therapies, the Livingston-Wheeler system, the 
Revici system, or 714-X )

Herbal Medicine (Note: This category includes studies of whole plant products 
or extracts and does not include the study or isolation of active ingredients 
from herbal preparations except where identification and standardization of 
optimal whole product are the specific aim -- e.g. optimal ratio of 
glycosides and terpenoids in Ginkgo biloba -- or comparisons are being made 
to the whole product),

Orthomolecular Medicine - This category includes the use of nutritional and 
food supplements, Co-enzyme Q10, carnitine, melatonin, vitamins) for 
therapeutic or preventive purposes. These products are usually used in 
combinations and at very high doses (5-10 fold) well above the Recommended 
Daily Allowance (RDA) when such RDAs have been defined.

Mind-Body Medicine: Concept proposals in this category will be considered 
only if they are limited to those mind-body approaches that are used by the 
public or practitioners outside of a conventional medicine setting (e.g., 
transcendental meditation, imagery, hypnosis, biofeedback, music therapy, 
yoga, relaxation, spirituality, biological effects of consciousness).  Mind-
body approaches that are relatively integrated into conventional medicine 
(e.g., patient education, psychotherapy, cognitive-behavioral approaches, 
etc.) will NOT be considered unless physiologic endpoints (e.g., immune 
parameters) or disease parameters (response rate to conventional therapy, 
disease-free survival, overall survival) are the primary outcome measures,

Applications may also focus on interactions between these modalities and non-
CAM cancer treatment and therapies (e.g. Drug Interactions: studies to 
evaluate the potential interaction of antioxidant compounds and conventional 
chemotherapy and/or radiation therapy.)

Most commercially available CAM products lack data on product 
characterization, purity, standardization or stability.  Therefore, 
applicants are encouraged to discuss quality control of the source material 
for the proposed research.  Authentication and characterization of the 
material will assure reproducibility for future trials. 

Dosing of most CAM interventions is rarely standardized, in fact a basic 
tenant of CAM is individualized diagnosis and treatment of patients.  Thus, 
the applicant must carefully consider dosing.  If the dosage is not 
established but based on traditional use, a citation(s) from a well-
recognized, accessible source to support the proposed dosage should be 
referenced.  If the dosage deviates from traditional use, this decision 
should be justified.  

It is the sole responsibility of the applicant to obtain all necessary 
clearances from the Food and Drug Administration (FDA) as required.  It is 
expected that applicants will have contacted the FDA about necessity of an 
Investigation New Drug (IND) request well before submission of the current 
application.  In addition, applicants are strongly encouraged to consult 
their local Institutional Review Boards (IRBs) concerning IND status and the 
IRB approval process.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) 
exploratory/developmental (R21) grant mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely 
that of the applicant.  The total project period for an application submitted 
in response to this PA may not exceed TWO years.  Though the size of award 
may vary with the scope of research proposed, it is expected that 
applications will stay within the budgetary guidelines for an 
exploratory/developmental project, direct costs are limited to $150,000 (six 
budget modules).  These grants are non-renewable and continuation of projects 
developed under this PA will be through the traditional unsolicited 
investigator initiated grant program.  The earliest anticipated award date is 
September 2002.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH. Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and not-
for-profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators. 

INQUIRIES
 
Inquiries are strongly encouraged.  The opportunity to clarify any issues or 
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Wendy B. Smith, Ph.D.
Office of Cancer Complementary and Alternative Medicine
National Cancer Institute
Executive Plaza North
6130 Executive Blvd
Suite #102, MSC 7302
Bethesda, MD  20892-7302
Telephone:  (301) 435-7980
FAX:  (301) 480-0075
Email:  smithwe@mail.nih.gov

Mary Ann Richardson, DrPH
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd, Suite 102 
Bethesda, MD  20892-5475
Telephone:  (301) 402-1272
FAX:  (301) 480-3621
Email:  marich@mail.nih.gov

Direct inquiries regarding fiscal matters to:
 
Ms. Eileen Natoli
Grants Administration Branch
National Cancer Institute
EPS-Room 243
Bethesda, Maryland  20892
Telephone:  (301) 496-8791
FAX:  (301) 496-8601
Email:  natolie@gab.nci.nih.gov

Direct inquiries regarding review matters to:

NCI Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-3428
Fax:  (301) 402-0275
Email:  ncidearefof-r@mail.nih.gov

Dr. Martin Goldrosen
Office of Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 106
MSC 5475
Bethesda, Maryland  20892-5475
Telephone:  (301) 496-4792
Fax:  (301) 480-2419
Email:  goldrosm@mail.nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit a Letter of Intent by the dates 
listed on the front page of this PA that includes a descriptive title of the 
proposed research, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of the PA in response to which the 
application may be submitted.  Although a Letter of Intent is not required, 
is not binding, and does not enter into the review of a subsequent 
application, the information that it contains allows IC staff to estimate the 
potential review workload and plan the review
 
The Letter of Intent is to be sent to Dr. Wendy B. Smith at the address 
listed under INQUIRIES.

APPLICATION PROCEDURES.

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable format.

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  

All clinical trials supported or performed by NIH require some form of 
monitoring.  The method and degree of monitoring should be commensurate with 
the degree of risk involved in participation and the size and complexity of 
the clinical trial.  Monitoring exists on a continuum from monitoring by the 
principal investigator/project manager or NIH program staff to a Data and 
Safety Monitoring Board (DSMB).  These monitoring activities are distinct 
from the requirement for study review and approval by an Institutional Review 
Board (IRB).  For details about the Policy of the NCI for Data Safety 
Monitoring of Clinical Trials see 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For NCCAM"s Policy 
and guidelines on safety monitoring see 
http://nccam.nih.gov/research/policies/datasafety/index.htm For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety-monitoring plan as part of the research application.  See NIH 
Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I 
and II Trials" for additional information:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available to 
http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided 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)

To expedite the review process, at the time of submission, send two 
additional copies of the application to:  

NCI Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD  20892-8109
Rockville, MD  20852 (for overnight/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275

Applications must be received by the receipt dates listed at the beginning of 
this program announcement.  

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the Center for Scientific 
Review.  Incomplete applications will be returned to the applicant without 
further consideration.  Applications that are complete will be evaluated for 
scientific and technical merit by an appropriate scientific review group 
convened by the National Center for Complementary and Alternative Medicine 
and National Cancer Institute in accordance with the standard NIH peer review 
procedures.  As part of the initial merit review, all applications will 
receive a written critique, and may undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the top 
half of applications under review, will be discussed, assigned a priority 
score, and receive a second level review by the appropriate national council 
or advisory board of participating ICs.

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
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 comment on the following aspects of the application in their 
written critiques 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 be judged 
likely 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 a field 
forward.
 
Because the exploratory/developmental grant mechanism (R21) is designed to 
support innovative ideas, preliminary data as evidence of feasibility of the 
project are not required.  However, the applicant does have the 
responsibility for developing a sound research plan approach, including 
appropriate statistical analyses and sample size calculations where 
appropriate.  Innovation of the project and potential significance of the 
proposed research will be major considerations in the evaluation of this 
mechanism.

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 
method?  Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies?
 
4.  Investigator.  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the principal investigator 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?

The initial review group will also examine: 

o  the appropriateness of proposed project budget and duration, 
o  the adequacy of plans to include both genders, minorities (and their 
subgroups), and children as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects, 
o  the provisions for the protection of human and animal subjects, 
o  the safety of the research environment,
o  the adequacy of the proposed plan to share data

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.

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 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.

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 or 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.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is 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.  
A continuing education program in the protection of human participants in 
research is now available online at http://cme.nci.nih.gov/.

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.  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 PA, 
Developmental/Pilot Projects in Cancer Complementary and Alternative 
Medicine, is related to priority area of cancer and seeks to increase life 
expectancy and quality of life.  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. 
93.395 (NCI) and 93.213 (NCCAM).  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 and Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-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.



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