and Human Services (HHS)
EXPIRED
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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected]. 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: [email protected] 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||