INTEGRATION OF COMPLEMENTARY AND ALTERNATIVE MEDICINE:  A HEALTH SERVICES 
RESEARCH PERSPECTIVE

Release Date:  October 25, 2000

RFA:  AT-01-001

National Center for Complementary and Alternative Medicine

Letter of Intent Receipt Date:  December 8, 2000
Application Receipt Date:       January 24, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA

PURPOSE

The National Center for Complementary and Alternative Medicine (NCCAM) 
invites research applications that investigate strategies to integrate 
CAM interventions with conventional medical/clinical practice and to 
evaluate the effects of this integration. For the purposes of this RFA, 
CAM is defined as healthcare practices that are not an integral part of 
conventional medicine. Integration is defined as the merging of CAM and 
conventional practice within a health care delivery system. The intent 
of the RFA is to 1) identify barriers and facilitators to the 
integration of CAM and conventional health care practices, 2) determine 
whether CAM research results obtained from studies conducted under 
ideal conditions (efficacy studies) can be translated to real-world 
settings (i.e., effectiveness) within an integrated model, and 3) 
support the evaluation of currently planned or recently initiated 
programs, goals of which are to improve the outcomes, quality, 
effectiveness, and/or cost-effectiveness of health care through the 
integration of CAM and conventional health care. 

Projects should focus on applied research with the objective of 
identifying and developing sustainable, reproducible strategies to 
integrate CAM research effectively into practice and/or evaluation of 
integration programs using appropriate concurrent comparison groups, 
documentation of costs and resources associated with the programs, 
identification of key model components and organizational conditions 
that have resulted in successful integration, and evaluation of 
transferability to other settings. It is important to note that this 
initiative is targeted toward investigating integration between CAM and 
conventional health care delivery systems. Efficacy studies and 
effectiveness studies that focus on specific treatment outcomes will 
not be considered responsive to this RFA.

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 RFA, 
Integration of Complementary and Alternative Medicine: A Health 
Services Research Perspective, 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by for-profit and non-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. Questions about eligibility may be 
addressed to the programmatic contact listed in the INQUIRIES section.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research 
project grant (R01) and exploratory/developmental grant (R21) 
mechanisms. The Principal Investigator will be responsible for the 
planning, direction, and execution of the proposed research project. 
Awards will be administered according to the most recent NIH Grants 
Policy Statement.

Applicants without extensive preliminary data or prior experience with 
the NIH grant application process are urged to submit applications 
using the exploratory/developmental mechanism (R21). Applicants for 
R21s may request up to two years of support and up to a maximum of 
$125,000 direct costs per year. R21 grants are non-renewable and may 
not be used to supplement an ongoing project. Applicants who anticipate 
submitting an R21 grant application should review the NCCAM Web site 
(Research Grants, Application Guidelines) at 
http://nccam.nih.gov/research/instructions/r21/index.htm for 
additional information on this mechanism.

This RFA uses the "MODULAR GRANT" and "JUST-IN-TIME" application 
procedures.  They will apply to all applications submitted. Complete 
and detailed instructions and information on Modular Grant applications 
can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm and in the NIH 
Guide to Grants and Contracts, December 15, 1998 
(http://grants.nih.gov/grants/guide/notice-files/not98-178.html).  

FUNDS AVAILABLE

The NCCAM intends to commit approximately $3.0 M in FY 2001 to fund 
five R21 and four R01 new grants in response to this RFA. An R21 
applicant may request a project period of up to two years and a budget 
for Direct Costs of up to $125,000 per year. An R01 applicant may 
request a project period of up to four years and a budget for Direct 
Costs of up to $350,000 per year.  Modular applications will apply to 
all applications.  Because the nature and scope of the research 
proposed may vary, it is anticipated that the size of each award will 
also vary. Although the financial plans of the NCCAM provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications. At this time, it is not known if this RFA 
will be reissued. 

RESEARCH OBJECTIVES

BACKGROUND

Alternative medicine is increasingly popular among consumers in the 
United States, (Eisenberg et al. 1998) with 42.1% of adults reporting 
use in 1997. This figure represents an estimated 47% increase in visits 
to alternative practitioners since 1993. Extrapolation to the 
population of the United States suggests that Americans spent a total 
of $21.2 billion, $12.2 billion out-of-pocket, for CAM therapies in 
1997. Despite widespread use and a growing interest in integration, CAM 
remains largely outside the mainstream healthcare system. Nearly two-
thirds of CAM consumers say they have not discussed CAM use with their 
medical doctor. Third party reimbursement for CAM therapies is the 
exception rather than the rule, with CAM consumers reporting no 
coverage nearly 60% of the time and complete coverage only 15% of the 
time (Eisenberg et al, 1998). 

Barriers and Facilitators to CAM Integration
Several obstacles to integration of CAM with mainstream heath care have 
been acknowledged (Pellitier et al, 1999, Issues in Coverage for CAM 
Services, January 2000). The need for more research on the efficacy of 
CAM treatments has been identified. However, efficacy data does appear 
to translate readily into conventional practice. For example, although 
an NIH Technology Assessment Conference provided clear evidence that 
specific mind-body interventions relieved pain and insomnia, there 
appears to have been minimal incorporation of these interventions into 
routine practice. Similarly, an NIH Consensus Conference documenting 
the efficacy of acupuncture for management of certain types of acute 
pain, as well as for chemotherapy-related nausea and vomiting, does not 
appear to have impacted standard care as practiced by the conventional 
medical community

Managed Care Organizations (MCO s) have identified the following 
obstacles to CAM integration: economics, ignorance about CAM, provider 
competition, medical establishment fear of change and the liability of 
making referrals to CAM practitioners, cultural bias and prejudice, and 
the lack of practice and license standards, CAM utilization data, 
consumer or employer demand, insurance reimbursement, and CAM provider 
networks (Pellitier et al, 1999). A multidisciplinary Clinician 
Workgroup on the Integration of CAM, initiated in the State of 
Washington by the Office of the Insurance Commissioner, similarly 
identified credentialing, care standards and professional liability as 
areas that require illumination (Issues in Coverage for CAM Services, 
January 2000). Other issues targeted by the Clinician Workgroup 
included the range of provider types that make up  integrated  
practices and the juxtaposition of different health paradigms 
(condition versus whole person health care, and prevention). 

Consumers appear to be the most powerful facilitator of the integration 
of CAM with conventional healthcare. In fact, consumer demand is a 
primary reason MCOs offer CAM coverage (Pelletier, Astin and Haskell, 
Am J Health Promot, 1999, Landmark Report II on HMOs and Alternative 
Care, 1999). Other facilitators include the development of professional 
relationships between CAM providers, conventional providers and payers,  
mutual respect and understanding regarding differences in philosophies, 
training and professional experience between CAM and conventional 
clinicians, objective valuation of the evidence base for both CAM and 
conventional treatments, and an appreciation for the differences in CAM 
and conventional patient care paradigms (Issues in Coverage for CAM 
Services, January 2000).

Strategies to Overcome Impediments and Facilitate Integration
Research on how new conventional treatments are incorporated into 
standard medical care illustrates the difficulty in eliminating 
barriers to the integration of CAM therapies. For instance, the most 
common method to promote changes in practice patterns among 
conventional health professionals is the passive distribution of 
published or printed educational materials (eg: publication in the peer 
reviewed medical literature). Yet this method has been shown to produce 
little change in clinical practice and no change in health outcomes 
(Oxman et al., CMAJ, 1995, 153: 1423-1431, Chalmers, Clin Exp. 
Hypertens, 1999, 21: 647-657). Since the incorporation of innovative 
conventional medical practices is not accomplished through passive 
distribution, integration of CAM is not likely to be accomplished 
through this route. 

Most research investigating methods to promote changes in clinical care 
has been plagued by inadequate methodology and lack of generalizability 
(Bero et al., BMJ, 1998, 317:465-468). Moreover, several factors impact 
significantly on the effectiveness of an approach towards change: 1) 
the characteristics of the message (Grilli and Lomas, Med Care, 1994, 
32: 202-213), 2) recognition of external barriers to change (Davis et 
al., JAMA, 1995, 274: 700-705), and 3) readiness of the clinician to 
change (Grol, Qual Health Care, 1992, 1: 184-191). As outlined above, 
preliminary work has begun to identify barriers to CAM integration and 
indicates that both CAM and conventional clinicians are willing to make 
changes that facilitate integration. For instance, approximately 40% of 
conventional medical doctors report referring patients to CAM providers 
(Astin et al. Arch Intern Med 1998) and most medical schools in the 
U.S. include at least an introduction to CAM in the curriculum. In the 
same vein, CAM practitioners have begun to recognize the usefulness of 
treatment guidelines (Issues in Coverage for CAM Services, January 
2000). There is a need for studies focused on the outcomes and cost-
effectiveness of evidence-based CAM treatment models that can be used 
in conjunction with conventional medical practice.

Current Initiatives for Integration
Sixty-seven percent of Health Maintenance Organizations (HMO s) offer 
at least partial coverage for at least one therapy defined as CAM. 
However, coverage is limited primarily to chiropractic (65%) and 
acupuncture (31%), with four percent or fewer of plans including 
homeopathy, Tai Chi, Yoga, and Naturopathy (Landmark Survey, 1999). The 
level of coverage varies among plans and ranges from discount networks 
(negotiated discounts for enrollees but no reimbursement) to full 
coverage for specific clinical conditions. Advocates of CAM have argued 
that coverage of CAM by payors will reduce overall health care costs. 
Data to date are insufficient to support this belief (Pellitier et al, 
1999), and health plans appear to be skeptical about financial benefit 
assertions. Of those plans that offer CAM coverage, eight percent cited 
clinical effectiveness and twenty-one percent reported reduced total 
health care costs as the most important reasons for providing coverage 
(Landmark Survey, 1999).

Data are also insufficient on CAM utilization, the potential for cost 
offsets and determination of medical necessity, making it difficult for 
health plans to make coverage decisions regarding CAM using standard 
actuarial methods. However, there are several types of existing or 
readily obtainable data that could be used in the conduct of research 
on the integration of CAM and conventional health care that may already 
be available. Examples include: 1) enrollment data (including basic 
demographic data), 2) administrative claims or encounter-level data 
(e.g., diagnosis and procedure codes, charges), 3) more detailed data 
on clinical (e.g., data on laboratory and diagnostic tests) and 
medication use, 4) survey data (e.g., satisfaction, health status 
etc.), and, 5) qualitative and quantitative data on characteristics of 
providers and organizations delivering care. The accuracy and 
completeness of these types of data and the extent to which they can be 
linked will influence their usefulness for research. 

There is increasing interest in the integration of CAM by hospitals and 
multi-disciplinary clinics (Pelletier et al, Am J Health Promot 1997, 
Weeks, Integrator May 2000). Although many programs are too new to 
provide data on cost effectiveness or clinical outcomes, they are 
widely used by patients and therefore, can provide sites for future 
evaluation. 

The issues delineated above will be relevant for studies that 
investigate the integration of CAM and conventional care. In addition, 
incentives and barriers to change among the conventional medical 
community, the legal stature of CAM and openness of policymakers within 
local areas will be important.

OBJECTIVES

This RFA addresses three main objectives: 1) identify barriers and 
facilitators to the integration of CAM and conventional health care 
practices, 2) determine whether CAM research results obtained from 
studies conducted under ideal conditions (efficacy studies) can be 
translated to real-world settings (i.e., effectiveness) within an 
integrated model, and 3) support the evaluation of currently planned or 
recently initiated programs, goals of which are to improve the 
outcomes, quality, effectiveness, and/or cost-effectiveness of health 
care through the integration of CAM and conventional health care. It is 
anticipated that each application will address one or more of the 
following research questions:  

a) The knowledge, attitudes, referral patterns and behaviors of both 
CAM and conventional practitioners,
b) Impact of CAM integration on health care quality,
c) Cost-effectiveness of CAM integration for specific health 
conditions, and 
d) Quantification of CAM cost offsets within care delivery systems or 
healthcare plans. 

It is anticipated that responses to this initiative will be multi-
disciplinary, and may include collaborations between health services 
researchers, sociologists, medical anthropologists, clinical 
researchers, individual clinicians (CAM and conventional), and health 
care systems and organizations (e.g., purchaser groups, integrated 
health service delivery systems, academic health systems, managed-care 
programs including HMOs, practice networks, worksite clinics, etc.). 
These relationships will enable a rigorous evaluation of planned and 
ongoing integration efforts that may not otherwise occur. The presence 
of strong partnership arrangements is essential to determine the impact 
of CAM integration on clinical practice and patient outcomes in applied 
situations.

Qualitative methods may be valuable for identifying promising areas of 
research. Discussion should be devoted to analytic features of the 
study including primary endpoints, power estimates, randomization 
procedures, and statistical methods, as applicable. Study methods must 
be adequately rigorous to address the research question, implementation 
of similar interventions, and issues of validity (internal and 
external) and reliability. It is expected that studies involving 
clinical interventions will include concurrent comparison groups rather 
than historical controls. Strategies for addressing selection bias 
among participants, including randomization at the patient level, 
practice or other organizational unit, pseudo-randomization or matching 
must be included. Studies that are not amenable to randomization should 
address challenges to internal validity in some other manner. 

Applicants are expected to demonstrate that they either routinely 
collect and maintain data necessary for the conduct of research as 
described in this initiative or have the capacity to collect such data 
within the time and budget limits of the proposed project. The specific 
data required for any project will be determined by the study purpose. 
Applicants must be able to identify the specific data that will be 
collected and used for the project, demonstrate that the data are 
available or can be collected, and describe how the data can be 
cleaned, linked, and developed into an analytic file capable of 
answering the study questions.

Timely sharing of information, instruments, and technology will build 
the knowledge base by permitting researchers access to sufficiently 
large and well-characterized data resources as quickly as possible. 
This sharing of data is essential to rapid progress and will help to 
avoid unnecessary duplication of large data collections. To ensure 
timely sharing of information and materials, applications should 
describe in detail how, when, and in what manner data and technology 
will be made available to the scientific and practice-based 
communities.

Applicants should consider taking advantage of other research projects 
(e.g., clinical trials about to be implemented) that could be expanded 
by adding a research component on integration. Such projects might 
provide access to subject populations or settings as well as reduce the 
costs of conducting research. A range of services (e.g., inpatient, 
acute, primary, or specialty care) delivered at a variety of sites 
(e.g. hospitals, outpatient clinics, worksite clinics, home health 
care, other community care sites) are all candidates for investigation.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 
In studies with a clinical component, 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 are 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 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 are 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.

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.

NIH POLICY AND GUIDELINES ON THE 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 scientific and ethical reasons 
to exclude them. (See NIH Guide to Grants and Contracts, March 6, 1998 
or http://grants.nih.gov/grants/guide/notice-files/not98-024.html.) 

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

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 8, 2000, a 
letter of intent 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 (including research 
project collaborators and consultants) and participating institutions, 
and the number and title of this RFA. Although a letter of intent is 
not binding and does not enter into the review of a subsequent 
application, the information that it contains allows NIH staff to 
estimate the potential review workload and plan the review.

The letter of intent should be sent to:

Dr. Christine Goertz
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 106
Bethesda, MD 20892-5475
Telephone: 301-402-1030
Fax: 301-402-4741
E-mail: goertzc@od.nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) must be used in 
applying for these grants, with the modifications noted below. 
Applications kits are available at most institutional offices of 
sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-
mail: GrantsInfo@nih.gov. Applications are also available on the World 
Wide Web at http://grants.nih.gov/grants/forms.htm.

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 Institute staff. 

MODULAR GRANT applications request direct costs in $25,000 modules. The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below: (a) PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum request of $350,000) 
and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) costs] for the initial budget period Items 8a 
and 8b should be completed indicating the Direct and Total Costs for 
the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete 
Form Page 4 of the PHS 398. It is not required and will not be 
accepted with the application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398. It is 
not required and will not be accepted with the application. 

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs 
requested for each year. This is not a Form page.

Under Personnel, List all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use 
the NIH appropriation language salary cap and the NIH policy for 
graduate student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000. List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of key personnel, and the role on the project. Indicate whether  
the collaborating institution is foreign or domestic. The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount. Include the Letter of Intent to 
establish a consortium.

Applicants are strongly encouraged to request the same number of 
modules for each year of funding. Provide an additional narrative 
budget justification for any variation in the number of modules 
requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual"s 
qualifications for a specific role in the proposed project, as well 
as to evaluate the overall qualifications of the research team. A 
biographical sketch is required for all key personnel, following the 
instructions below. No more than three pages may be used for each 
person. A sample biographical sketch may be viewed at 
http://grants.nih.gov/grants/funding/modular/modular.htm. 

Complete the educational block at the top of the form page,
List position(s) and any honors,
Provide information, including overall goals and 
responsibilities, 
on research projects ongoing or completed during the last three 
years.
List selected peer-reviewed publications, with full citations,

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, 
indicate the type of agreement and the date. All appropriate 
exclusions must be applied in the calculation of the F&A costs for 
the initial budget period and all future budget years.

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review. 

(b) Mailing Procedures

The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application. 
Failure to use this label could result in delayed processing of the 
application such that it may not reach the review committee in time for 
review. In addition, the RFA title, and number, must be typed on Line 2 
of the face page of the application form and the YES box must be 
marked. The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change. Please note this is in pdf format.

Submit a signed, original of the application, including the Checklist, 
and four (4) signed photocopies of the application in one package to: 

CENTER FOR SCIENTIFIC REVIEW (formerly 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, send one (1) additional copy of the 
application to:

Dr. Christine Goertz
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 106
Bethesda, MD 20892-5475

It is important to send this copy at the same time that the original 
and four copies are sent to the Center for Scientific Review (CSR).

Applications must be received by January 24, 2001. If an application is 
received after that date, it will be returned to the applicant without 
review. The Center for Scientific Review (CSR) will not accept any 
application in response to this RFA 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. 

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NCCAM. Incomplete and nonresponsive applications 
will be returned to the applicant without further consideration. 
Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NCCAM in accordance with the review 
criteria stated below. 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 NCCAM Advisory Council.

General 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 the application 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 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 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. 

(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? For Exploratory/Developmental (R21) 
Research Projects, what is the likelihood that the research will 
contribute to the development of interdisciplinary programs or more 
mature research endeavors?

o Degree to which the research will improve our understanding of how we 
can narrow the gap between what is proven efficacious and what is 
practiced in the real world of healthcare regarding CAM,

o Extent to which results will be transferable or reproducible in other 
healthcare systems,

o Likelihood that the research findings can be implemented and 
sustained for a variety of conditions and in a range of settings,

o Plans for dissemination and implementation of findings within and 
outside of the project’s organization.

(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? 

o Appropriateness of methods to address research hypotheses and needs 
of those who may be interested in applying the results of the study   
in other words, how will scientific knowledge advance clinical 
practice.

(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) INVESTIGATORS: Is each 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)? 

o Incorporation of appropriate CAM expertise, including certified or 
licensed CAM practitioners,

o The integration of appropriate CAM, conventional medical and health 
services research expertise.

(5) ENVIRONMENT: Does the scientific environment in which the work will 
be done contribute to the probability of success of the project? Do the 
proposed studies take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?

o Demonstration of substantial commitment by the health care 
organization/system to the CAM integration effort, including use of in-
kind support and letters of support from clinical and administrative 
staff,

o Extent to which the project builds-on or establishes meaningful 
linkages between CAM practitioners, researchers and health care 
systems/organizations.

In addition to the criteria list below, the initial review group will 
examine: the appropriateness of proposed project budget and duration, 
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, the 
provisions for the protection of human and animal subjects, and the 
safety of the research environment.

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.

AWARD CRITERIA

The following will be considered in making funding decisions:

o The scientific merit of the proposed project as determined by peer 
review,

o Availability of funds, and

o The research priorities of the NCCAM.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to 
clarify any issues or questions from potential applicants is welcome. 

Direct inquiries regarding specific PROGRAMMATIC ISSUES to: 

Dr. Christine Goertz
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 106
Bethesda, MD 20892-5475
Telephone: 301-402-1030
Fax: 301-480-3621
E-mail: goertzc@od.nih.gov

Direct inquiries regarding FISCAL MATTERS to: 

Ms. Victoria Putprush
Grants Administration Branch
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 106
Bethesda, MD 20892-5475
Telephone: 301-594-9102
Fax: 301-480-3621
E-mail: putprushv@od.nih.gov

AUTHORITY AND REGULATIONS

Awards are made under authorization of the Public Health Service Act, 
Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 
42 USC 241 and 285) and administered under PHS grants policies and 
Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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 and contract 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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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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