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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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