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/archive/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) 435-0714, 
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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