SECONDARY ANALYSIS OF DATA ON CAM USE IN MINORITY POPULATIONS
RELEASE DATE: April 11, 2003
PA NUMBER: PAR-03-102 (see NOT-AT-04-005)
EXPIRATION DATE: August 17, 2005, unless reissued
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: No. 93.213
APPLICATION RECEIPT DATE: August 15, 2003; August 16, 2004; August 16, 2005
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PAR
The National Center for Complementary and Alternative Medicine (NCCAM)
invites applications for research grants to support secondary analyses of
existing data sets regarding complementary and alternative medicine (CAM) use
in racial and ethnic minority populations. Complementary and alternative
medicine practices are best described as those not presently considered an
integral part of conventional medicine. As used in this solicitation, CAM
also includes traditional medicine systems -- e.g., Chinese Medicine, Native
American Medicine, Hawaiian Medicine and Latin American folk systems -- those
systems of care that have evolved apart from the conventional medical
approach used in the United States. Data used in secondary analyses may be
obtained from current or past investigator-initiated research activities or
from other archival data sets and from public or private sources.
RESEARCH OBJECTIVES
NCCAM seeks to promote the analysis of previously collected data to increase
knowledge regarding CAM use in racial and ethnic minority populations where
appropriate data sets exist. The objectives of this solicitation are to
enhance the understanding of CAM use by racial and ethnic minority
populations as well as to inform and further the associated research agenda.
The specific objectives of this announcement are to provide support for (a)
analyzing previously collected data that would advance scientific knowledge
on the use, effectiveness, and outcomes of CAM in minority populations; (b)
studying patterns of CAM use and the types of problems for which CAM is used
in minority populations and specific sub-populations; (c) characterizing
differences in CAM use among racial/ethnic groups; (d) evaluating, where
possible, the cost and cost-effectiveness of CAM use ; (e) preliminary
projects using secondary analyses that could lead to subsequent applications
for individual research awards; and (f) the archiving of datasets to be made
available for public use to conduct research related to CAM. Grants under
this announcement are not intended to support ongoing data analysis nor for
the maintenance and distribution of data sets.
BACKGROUND
The NCCAM is dedicated to exploring complementary and alternative healing
practices in the context of rigorous science; training CAM researchers; and
disseminating authoritative information. Although studies increasingly
provide information on patterns of and results from CAM use in the general
population, a shortage of information on CAM use and outcomes of such use in
racial and ethnic minority populations continues. Studies are especially
needed to understand the extent of CAM use, the conditions for which CAM is
used, and the results of CAM use by different racial and ethnic minority
populations and sub-populations. Several types of data may contribute to a
better understanding of patterns and results of CAM use - enrollment data,
administrative claims or encounter data, provider data, and survey data, such
as data from the National Health Interview Survey (NHIS). While some of
these data sets may not have been intended initially for use within a
research context, they are potentially rich sources of information that can
illuminate a wide range of research questions and policy-relevant topics.
The NHIS, which over-samples African-American and Hispanic-American
households, included a supplemental questionnaire on CAM in 2002. Data from
this supplement are scheduled to be available as public use data sets in
January 2004. Information collected through this supplement will improve the
understanding of CAM use in minority populations. The current solicitation
invites applications for research projects that will analyze available data
sets, including the NHIS when released, to illuminate patterns of use of CAM
by minority populations.
Information obtained through this PAR will help NCCAM meet its goals as part
of the overall National Institutes of Health (NIH) Strategic Plan to Reduce
and Ultimately Eliminate Health Disparities and the Department of Health and
Human Services (DHHS) Initiative to Eliminate Racial and Ethnic Disparities
in Health. The potential role of CAM in contributing to the elimination of
health disparities also remains to be defined. Results from this initiative
may generate information on the use of CAM relative to conventional medical
services by minority populations, and lead to more focused studies in them,
that aim to determine if CAM might improve the outcomes, quality,
effectiveness, and/or cost-effectiveness of health care in comparison to
conventional health care services. Studies evaluating practices used as
complements to conventional therapies, as opposed to as alternatives to them
are also warranted.
Areas of Research Interest
Because of the lack of information regarding CAM utilization and outcomes in
minority populations, NCCAM encourages analyses of previously collected data
sets as an efficient way of increasing the knowledge base and informing the
research agenda on these issues. The characteristics of the data sets will
determine which questions can be answered and it may not be possible to
address each of the issues below. The following areas are intended to be
exemplary and not exhaustive.
Epidemiology Although studies have been conducted in the United States to
measure utilization of CAM therapies in the general population, small sample
sizes have limited generalization of findings to racial and ethnic minority
populations. Additional analyses are needed on available datasets to inform
future research regarding the types of CAM used and patterns of use within
and among minority populations and sub-populations (number, frequency, and
types of interventions), the duration of use, the conditions for which CAM is
used, and the differences between populations in CAM utilization.
Investigations of similarities and differences between minority populations
and the general population also are of interest.
Health Services Research Health services research studies the organization,
financing and delivery of health care services with attention to issues such
as the quality of care as well as costs and outcomes of care. Potential
questions related to racial and ethnic minority populations could address
issues regarding access to CAM, the impact of insurance availability and
costs of CAM on CAM use, demographic as well as geographic variations in CAM
use, and the impact of managed care on CAM use. Questions of interest
include: Is CAM used in minority communities as a complement to or an
alternative to conventional care to degrees and in ways different from in the
more general community?
Outcomes Research Outcomes research is a type of health services research
that specifically examines the results of treatments on conditions. It
measures non-clinical patient-oriented variables as well as clinical
variables in assessing results and includes measures of the patient's health-
related quality of life: e.g., the patient/provider relationship, patient
satisfaction, personal preferences, and functional abilities. For example,
as related to racial and ethnic minority populations: How does CAM use
affect the results of treatment? For what conditions does CAM use appear to
influence outcomes either positively or unfavorably? Are there conditions
for which CAM use appears more effective? If so, what are those conditions?
Does the use of CAM affect patient satisfaction or make a difference in the
functional result of care? Can use of CAM interventions be linked causally
to specific outcomes? Regarding health status measures, does the use of CAM
affect favorably or adversely biological or physiological factors, symptoms,
functioning, general health perceptions, or quality of life?
MECHANISMS OF SUPPORT
This PAR will use the NIH R21 and R03 award mechanisms. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project.
This PAR uses just-in-time concepts. It also uses the modular budgeting
format. (See http://grants.nih.gov/grants/funding/modular/modular.htm). All
applications submitted in response to this announcement must use the modular
budget format. This program does not require cost sharing as defined in the
current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
R21 Applications. The purpose of the R21 mechanism is to provide
investigators, at all career levels, with a funding opportunity for exploring
the feasibility, as well as the development, of projects investigating CAM
and for generation of preliminary data. The R21 mechanism is specifically
intended to support research where preliminary data as evidence of
feasibility are sparse or do not exist. These grants are not intended for
large-scale undertakings or to support or supplement ongoing research. You
may request a project period of up to two years with a combined budget for
direct costs of up $275,000 for the two-year period. The request should be
tailored to the needs of your project. Normally, no more than $200,000 may
be requested in any single year. Because the requirements for NCCAM R21
applications differ from those for the R01 applications, investigators
intending to use the R21 mechanism are advised to consult the URL
(http://nccam.nih.gov/research/instructions/r21/index.htm) for specific
requirements, e.g., the 15-page limit for Items a-d in the Research Plan, and
restrictions on appendices, as well as additional information.
R03 Applications. The purpose of the R03 mechanism is to provide
investigators, at all career levels, with opportunities to conduct targeted
research relating to CAM and collect limited preliminary data. The R03, or
Small Grant mechanism, has the following features: There is a 10-page limit
for Items a-d in the Research Plan and no appendices are permitted. Direct
costs may not exceed $50,000 per year; the modular budget format therefore
limits the budget to two modules. The project period is limited to one year.
No preliminary data are required. One revision is permitted. A grant award
may not be renewed.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Morgan N. Jackson, M.D., M.P.H.
Director, Office of Special Populations
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: 301-402-1278
FAX: 301-480-3621
Email: mj145m@nih.gov
o Direct your questions about peer review issues to:
Dr. Martin Goldrosen
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: mg85x@nih.gov
o Direct your questions about financial or grants management matters to:
Mr. Brian Campbell
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-8738
FAX: (301) 480-1552
Email: campbeb@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted on August 15, 2003; August 16, 2004; and August
16, 2005.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
Also send two copies of the application to:
Dr. Martin Goldrosen
Director, Office of Scientific Review
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD 20892-5475
(Bethesda, MD 20817 for express/courier service)
Telephone: (301) 594-2014
FAX: (301) 480-2419
Email: mg85x@nih.gov
APPLICATION PROCESSING: This PAR has specified receipt dates. Applications
must be received by August 15, 2003; August 16, 2004; and August 16, 2005.
The CSR will not accept any application in response to this PAR that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PAR will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened by NCCAM in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on
Complementary and Alternative Medicine.
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:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. 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.
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? Will the research increase our understanding of the use of CAM
and outcomes of CAM use in minority populations.
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? Are the methods used to address research hypotheses
appropriate?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
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)? Does the
project team include appropriate CAM and health services research expertise?
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?
For the exploratory/developmental grant mechanism (R21), 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.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Application Receipt Date: August 15, 2003 (August 16, 2004; August 16, 2005)
Peer Review Date: November 2003 (November 2004; November 2005)
Council Review: January 2004 (January 2005; January 2006)
Earliest Anticipated Start Date: February March 2004 (February - March
2005; February March 2006)
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the "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 is available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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 PAR 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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