INTEGRATION OF COMPLEMENTARY AND ALTERNATIVE MEDICINE: A HEALTH SERVICES RESEARCH PERSPECTIVE Release Date: October 25, 2000 RFA: AT-01-001 National Center for Complementary and Alternative Medicine Letter of Intent Receipt Date: December 8, 2000 Application Receipt Date: January 24, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA PURPOSE The National Center for Complementary and Alternative Medicine (NCCAM) invites research applications that investigate strategies to integrate CAM interventions with conventional medical/clinical practice and to evaluate the effects of this integration. For the purposes of this RFA, CAM is defined as healthcare practices that are not an integral part of conventional medicine. Integration is defined as the merging of CAM and conventional practice within a health care delivery system. The intent of the RFA is to 1) identify barriers and facilitators to the integration of CAM and conventional health care practices, 2) determine whether CAM research results obtained from studies conducted under ideal conditions (efficacy studies) can be translated to real-world settings (i.e., effectiveness) within an integrated model, and 3) support the evaluation of currently planned or recently initiated programs, goals of which are to improve the outcomes, quality, effectiveness, and/or cost-effectiveness of health care through the integration of CAM and conventional health care. Projects should focus on applied research with the objective of identifying and developing sustainable, reproducible strategies to integrate CAM research effectively into practice and/or evaluation of integration programs using appropriate concurrent comparison groups, documentation of costs and resources associated with the programs, identification of key model components and organizational conditions that have resulted in successful integration, and evaluation of transferability to other settings. It is important to note that this initiative is targeted toward investigating integration between CAM and conventional health care delivery systems. Efficacy studies and effectiveness studies that focus on specific treatment outcomes will not be considered responsive to this RFA. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Integration of Complementary and Alternative Medicine: A Health Services Research Perspective, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Questions about eligibility may be addressed to the programmatic contact listed in the INQUIRIES section. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and exploratory/developmental grant (R21) mechanisms. The Principal Investigator will be responsible for the planning, direction, and execution of the proposed research project. Awards will be administered according to the most recent NIH Grants Policy Statement. Applicants without extensive preliminary data or prior experience with the NIH grant application process are urged to submit applications using the exploratory/developmental mechanism (R21). Applicants for R21s may request up to two years of support and up to a maximum of $125,000 direct costs per year. R21 grants are non-renewable and may not be used to supplement an ongoing project. Applicants who anticipate submitting an R21 grant application should review the NCCAM Web site (Research Grants, Application Guidelines) at http://nccam.nih.gov/research/instructions/r21/index.htm for additional information on this mechanism. This RFA uses the "MODULAR GRANT" and "JUST-IN-TIME" application procedures. They will apply to all applications submitted. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm and in the NIH Guide to Grants and Contracts, December 15, 1998 (http://grants.nih.gov/grants/guide/notice-files/not98-178.html). FUNDS AVAILABLE The NCCAM intends to commit approximately $3.0 M in FY 2001 to fund five R21 and four R01 new grants in response to this RFA. An R21 applicant may request a project period of up to two years and a budget for Direct Costs of up to $125,000 per year. An R01 applicant may request a project period of up to four years and a budget for Direct Costs of up to $350,000 per year. Modular applications will apply to all applications. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NCCAM provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. RESEARCH OBJECTIVES BACKGROUND Alternative medicine is increasingly popular among consumers in the United States, (Eisenberg et al. 1998) with 42.1% of adults reporting use in 1997. This figure represents an estimated 47% increase in visits to alternative practitioners since 1993. Extrapolation to the population of the United States suggests that Americans spent a total of $21.2 billion, $12.2 billion out-of-pocket, for CAM therapies in 1997. Despite widespread use and a growing interest in integration, CAM remains largely outside the mainstream healthcare system. Nearly two- thirds of CAM consumers say they have not discussed CAM use with their medical doctor. Third party reimbursement for CAM therapies is the exception rather than the rule, with CAM consumers reporting no coverage nearly 60% of the time and complete coverage only 15% of the time (Eisenberg et al, 1998). Barriers and Facilitators to CAM Integration Several obstacles to integration of CAM with mainstream heath care have been acknowledged (Pellitier et al, 1999, Issues in Coverage for CAM Services, January 2000). The need for more research on the efficacy of CAM treatments has been identified. However, efficacy data does appear to translate readily into conventional practice. For example, although an NIH Technology Assessment Conference provided clear evidence that specific mind-body interventions relieved pain and insomnia, there appears to have been minimal incorporation of these interventions into routine practice. Similarly, an NIH Consensus Conference documenting the efficacy of acupuncture for management of certain types of acute pain, as well as for chemotherapy-related nausea and vomiting, does not appear to have impacted standard care as practiced by the conventional medical community Managed Care Organizations (MCO s) have identified the following obstacles to CAM integration: economics, ignorance about CAM, provider competition, medical establishment fear of change and the liability of making referrals to CAM practitioners, cultural bias and prejudice, and the lack of practice and license standards, CAM utilization data, consumer or employer demand, insurance reimbursement, and CAM provider networks (Pellitier et al, 1999). A multidisciplinary Clinician Workgroup on the Integration of CAM, initiated in the State of Washington by the Office of the Insurance Commissioner, similarly identified credentialing, care standards and professional liability as areas that require illumination (Issues in Coverage for CAM Services, January 2000). Other issues targeted by the Clinician Workgroup included the range of provider types that make up integrated practices and the juxtaposition of different health paradigms (condition versus whole person health care, and prevention). Consumers appear to be the most powerful facilitator of the integration of CAM with conventional healthcare. In fact, consumer demand is a primary reason MCOs offer CAM coverage (Pelletier, Astin and Haskell, Am J Health Promot, 1999, Landmark Report II on HMOs and Alternative Care, 1999). Other facilitators include the development of professional relationships between CAM providers, conventional providers and payers, mutual respect and understanding regarding differences in philosophies, training and professional experience between CAM and conventional clinicians, objective valuation of the evidence base for both CAM and conventional treatments, and an appreciation for the differences in CAM and conventional patient care paradigms (Issues in Coverage for CAM Services, January 2000). Strategies to Overcome Impediments and Facilitate Integration Research on how new conventional treatments are incorporated into standard medical care illustrates the difficulty in eliminating barriers to the integration of CAM therapies. For instance, the most common method to promote changes in practice patterns among conventional health professionals is the passive distribution of published or printed educational materials (eg: publication in the peer reviewed medical literature). Yet this method has been shown to produce little change in clinical practice and no change in health outcomes (Oxman et al., CMAJ, 1995, 153: 1423-1431, Chalmers, Clin Exp. Hypertens, 1999, 21: 647-657). Since the incorporation of innovative conventional medical practices is not accomplished through passive distribution, integration of CAM is not likely to be accomplished through this route. Most research investigating methods to promote changes in clinical care has been plagued by inadequate methodology and lack of generalizability (Bero et al., BMJ, 1998, 317:465-468). Moreover, several factors impact significantly on the effectiveness of an approach towards change: 1) the characteristics of the message (Grilli and Lomas, Med Care, 1994, 32: 202-213), 2) recognition of external barriers to change (Davis et al., JAMA, 1995, 274: 700-705), and 3) readiness of the clinician to change (Grol, Qual Health Care, 1992, 1: 184-191). As outlined above, preliminary work has begun to identify barriers to CAM integration and indicates that both CAM and conventional clinicians are willing to make changes that facilitate integration. For instance, approximately 40% of conventional medical doctors report referring patients to CAM providers (Astin et al. Arch Intern Med 1998) and most medical schools in the U.S. include at least an introduction to CAM in the curriculum. In the same vein, CAM practitioners have begun to recognize the usefulness of treatment guidelines (Issues in Coverage for CAM Services, January 2000). There is a need for studies focused on the outcomes and cost- effectiveness of evidence-based CAM treatment models that can be used in conjunction with conventional medical practice. Current Initiatives for Integration Sixty-seven percent of Health Maintenance Organizations (HMO s) offer at least partial coverage for at least one therapy defined as CAM. However, coverage is limited primarily to chiropractic (65%) and acupuncture (31%), with four percent or fewer of plans including homeopathy, Tai Chi, Yoga, and Naturopathy (Landmark Survey, 1999). The level of coverage varies among plans and ranges from discount networks (negotiated discounts for enrollees but no reimbursement) to full coverage for specific clinical conditions. Advocates of CAM have argued that coverage of CAM by payors will reduce overall health care costs. Data to date are insufficient to support this belief (Pellitier et al, 1999), and health plans appear to be skeptical about financial benefit assertions. Of those plans that offer CAM coverage, eight percent cited clinical effectiveness and twenty-one percent reported reduced total health care costs as the most important reasons for providing coverage (Landmark Survey, 1999). Data are also insufficient on CAM utilization, the potential for cost offsets and determination of medical necessity, making it difficult for health plans to make coverage decisions regarding CAM using standard actuarial methods. However, there are several types of existing or readily obtainable data that could be used in the conduct of research on the integration of CAM and conventional health care that may already be available. Examples include: 1) enrollment data (including basic demographic data), 2) administrative claims or encounter-level data (e.g., diagnosis and procedure codes, charges), 3) more detailed data on clinical (e.g., data on laboratory and diagnostic tests) and medication use, 4) survey data (e.g., satisfaction, health status etc.), and, 5) qualitative and quantitative data on characteristics of providers and organizations delivering care. The accuracy and completeness of these types of data and the extent to which they can be linked will influence their usefulness for research. There is increasing interest in the integration of CAM by hospitals and multi-disciplinary clinics (Pelletier et al, Am J Health Promot 1997, Weeks, Integrator May 2000). Although many programs are too new to provide data on cost effectiveness or clinical outcomes, they are widely used by patients and therefore, can provide sites for future evaluation. The issues delineated above will be relevant for studies that investigate the integration of CAM and conventional care. In addition, incentives and barriers to change among the conventional medical community, the legal stature of CAM and openness of policymakers within local areas will be important. OBJECTIVES This RFA addresses three main objectives: 1) identify barriers and facilitators to the integration of CAM and conventional health care practices, 2) determine whether CAM research results obtained from studies conducted under ideal conditions (efficacy studies) can be translated to real-world settings (i.e., effectiveness) within an integrated model, and 3) support the evaluation of currently planned or recently initiated programs, goals of which are to improve the outcomes, quality, effectiveness, and/or cost-effectiveness of health care through the integration of CAM and conventional health care. It is anticipated that each application will address one or more of the following research questions: a) The knowledge, attitudes, referral patterns and behaviors of both CAM and conventional practitioners, b) Impact of CAM integration on health care quality, c) Cost-effectiveness of CAM integration for specific health conditions, and d) Quantification of CAM cost offsets within care delivery systems or healthcare plans. It is anticipated that responses to this initiative will be multi- disciplinary, and may include collaborations between health services researchers, sociologists, medical anthropologists, clinical researchers, individual clinicians (CAM and conventional), and health care systems and organizations (e.g., purchaser groups, integrated health service delivery systems, academic health systems, managed-care programs including HMOs, practice networks, worksite clinics, etc.). These relationships will enable a rigorous evaluation of planned and ongoing integration efforts that may not otherwise occur. The presence of strong partnership arrangements is essential to determine the impact of CAM integration on clinical practice and patient outcomes in applied situations. Qualitative methods may be valuable for identifying promising areas of research. Discussion should be devoted to analytic features of the study including primary endpoints, power estimates, randomization procedures, and statistical methods, as applicable. Study methods must be adequately rigorous to address the research question, implementation of similar interventions, and issues of validity (internal and external) and reliability. It is expected that studies involving clinical interventions will include concurrent comparison groups rather than historical controls. Strategies for addressing selection bias among participants, including randomization at the patient level, practice or other organizational unit, pseudo-randomization or matching must be included. Studies that are not amenable to randomization should address challenges to internal validity in some other manner. Applicants are expected to demonstrate that they either routinely collect and maintain data necessary for the conduct of research as described in this initiative or have the capacity to collect such data within the time and budget limits of the proposed project. The specific data required for any project will be determined by the study purpose. Applicants must be able to identify the specific data that will be collected and used for the project, demonstrate that the data are available or can be collected, and describe how the data can be cleaned, linked, and developed into an analytic file capable of answering the study questions. Timely sharing of information, instruments, and technology will build the knowledge base by permitting researchers access to sufficiently large and well-characterized data resources as quickly as possible. This sharing of data is essential to rapid progress and will help to avoid unnecessary duplication of large data collections. To ensure timely sharing of information and materials, applications should describe in detail how, when, and in what manner data and technology will be made available to the scientific and practice-based communities. Applicants should consider taking advantage of other research projects (e.g., clinical trials about to be implemented) that could be expanded by adding a research component on integration. Such projects might provide access to subject populations or settings as well as reduce the costs of conducting research. A range of services (e.g., inpatient, acute, primary, or specialty care) delivered at a variety of sites (e.g. hospitals, outpatient clinics, worksite clinics, home health care, other community care sites) are all candidates for investigation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS In studies with a clinical component, it is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons to exclude them. (See NIH Guide to Grants and Contracts, March 6, 1998 or http://grants.nih.gov/grants/guide/notice-files/not98-024.html.) Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by December 8, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel (including research project collaborators and consultants) and participating institutions, and the number and title of this RFA. Although a letter of intent is not binding and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. The letter of intent should be sent to: Dr. Christine Goertz National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892-5475 Telephone: 301-402-1030 Fax: 301-402-4741 E-mail: goertzc@od.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) must be used in applying for these grants, with the modifications noted below. Applications kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E- mail: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. The MODULAR GRANT concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The JUST-IN-TIME concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. MODULAR GRANT applications request direct costs in $25,000 modules. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: (a) PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum request of $350,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, List all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Applicants are strongly encouraged to request the same number of modules for each year of funding. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at http://grants.nih.gov/grants/funding/modular/modular.htm. Complete the educational block at the top of the form page, List position(s) and any honors, Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. (b) Mailing Procedures The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title, and number, must be typed on Line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, original of the application, including the Checklist, and four (4) signed photocopies of the application in one package to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, send one (1) additional copy of the application to: Dr. Christine Goertz National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892-5475 It is important to send this copy at the same time that the original and four copies are sent to the Center for Scientific Review (CSR). Applications must be received by January 24, 2001. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NCCAM. Incomplete and nonresponsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCCAM in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the NCCAM Advisory Council. General Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? For Exploratory/Developmental (R21) Research Projects, what is the likelihood that the research will contribute to the development of interdisciplinary programs or more mature research endeavors? o Degree to which the research will improve our understanding of how we can narrow the gap between what is proven efficacious and what is practiced in the real world of healthcare regarding CAM, o Extent to which results will be transferable or reproducible in other healthcare systems, o Likelihood that the research findings can be implemented and sustained for a variety of conditions and in a range of settings, o Plans for dissemination and implementation of findings within and outside of the project’s organization. (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Appropriateness of methods to address research hypotheses and needs of those who may be interested in applying the results of the study in other words, how will scientific knowledge advance clinical practice. (3) INNOVATION: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATORS: Is each investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? o Incorporation of appropriate CAM expertise, including certified or licensed CAM practitioners, o The integration of appropriate CAM, conventional medical and health services research expertise. (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success of the project? Do the proposed studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? o Demonstration of substantial commitment by the health care organization/system to the CAM integration effort, including use of in- kind support and letters of support from clinical and administrative staff, o Extent to which the project builds-on or establishes meaningful linkages between CAM practitioners, researchers and health care systems/organizations. In addition to the criteria list below, the initial review group will examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research, and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Because the exploratory/developmental grant mechanism (R21) is designed to support innovative ideas, preliminary data as evidence of feasibility of the project are not required. However, the applicant does have the responsibility for developing a sound research plan approach, including appropriate statistical analyses and sample size calculations where appropriate. Innovation of the project and potential significance of the proposed research will be major considerations in the evaluation of this mechanism. AWARD CRITERIA The following will be considered in making funding decisions: o The scientific merit of the proposed project as determined by peer review, o Availability of funds, and o The research priorities of the NCCAM. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding specific PROGRAMMATIC ISSUES to: Dr. Christine Goertz National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892-5475 Telephone: 301-402-1030 Fax: 301-480-3621 E-mail: goertzc@od.nih.gov Direct inquiries regarding FISCAL MATTERS to: Ms. Victoria Putprush Grants Administration Branch National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892-5475 Telephone: 301-594-9102 Fax: 301-480-3621 E-mail: putprushv@od.nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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