TRADITIONAL, INDIGENOUS SYSTEMS OF MEDICINE Release Date: January 10, 2000 PA NUMBER: PA-00-041 National Center for Complementary and Alternative Medicine THIS PA 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 PA. PURPOSE The National Center for Complementary and Alternative Medicine (NCCAM) is committed to investigating the efficacy and safety of traditional, indigenous systems of medicine, including the support of well-designed, well-executed, definitive randomized clinical trials (RCT). The main objective of a full- scale, definitive RCT (Phase III trial) is to determine whether the intervention is more effective than that used in a control (or comparison) group. Before proceeding to a large RCT (Phase III trial), developmental studies are often required. The purpose of this Program Announcement (PA) is to support developmental studies to establish the methodological feasibility and strengthen the scientific rationale for proceeding to full-scale RCTs on the use of traditional, indigenous systems of medicine as practiced in the United States. These studies, which should emphasize the development of appropriate study designs to investigate safety and efficacy, have the potential to identify and address difficult methodological and design issues particular to complex medical interventions, as well as to allow for the development of contextually and culturally sensitive research more closely mirroring practice in the United States. These "proof of concept" trials could potentially, but not necessarily, lead to subsequent, large RCTs of the highest quality designed to test the efficacy and safety of traditional, indigenous systems of medicine. Such trials could expedite acceptance of these medical systems in the U.S. culture by the conventional biomedical community. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. "Healthy People 2000" does not specify a complementary and alternative medicine (CAM) objective, although this PA may be applied to several different priority areas within the Healthy People 2000" objectives. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, Federally- recognized Indian tribal governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Collaborations between domestic and foreign sites are encouraged as are collaborations between complementary and alternative medical institutions and conventional medical institutions. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) and exploratory/developmental grant (R21) award mechanisms. Applicants without extensive preliminary data or prior experience with the NIH grant application are urged to submit applications for this PA using the exploratory/developmental mechanism. On the other hand, applicants with preliminary findings obtained from R21 grants (or other sources) are urged to submit R01 applications. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. For all research project grant (R01) applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. 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, Applications Guidelines) at http://nccam.nih.gov/nccam/research/guidelines/r21grants.shtml for additional information on this mechanism. It is recommended that R21 applicants contact the Program Staff listed under INQUIRIES before submission. Relevant applications and amended applications are welcome throughout the duration of this PA (three years). Application receipt dates are the standard application receipt dates for investigator-initiated research as specified in the PHS 398 directions. The earliest possible award date is September 29, 2000. RESEARCH OBJECTIVES Background It has been estimated that two-thirds of the world’s population seek health care from sources other than conventional biomedicine (Huffard et al., 1992). While many of these individuals undoubtedly self-medicate (Eisenberg et al., 1998), most individuals seek care from learned practitioners of traditional, indigenous systems of medicine. Examples of these systems include Ayurveda, Kempo, Native American Medicine in all its variations, Traditional Chinese Medicine, Traditional Hawaiian Medicine, Unani, and Latin American folk systems. Despite diverse cultures, languages, geographic locations, world views, and health beliefs of the peoples from which these medical systems originated, they have common characteristics including: (1) the use of complex interventions often involving multiple botanical products, (2) individualized diagnosis and treatment of patients, (3) an emphasis on disease prevention versus disease treatment, (4) maximizing the body’s inherent healing ability, and (5) treatment of the whole patient (physical, mental, and spiritual) versus a single pathology. Despite the widespread use of traditional, indigenous systems of medicine, most research investigating these systems has stressed minimalist studies of one, or perhaps two, interventions taken out of context when used to treat a conventional medical diagnosis. For instance, there are hundreds of studies examining the efficacy of acupuncture needling, alone, for treating such diseases or conditions as asthma, pain, hypertension, and nausea, yet in real practice, acupuncture would be just one aspect of an arsenal employing, for instance, botanical potions, cupping, dietary changes, exercise, meditation, and moxibustion. The same can be said of using yoga alone, or a single herb, or chanting alone. It is readily acknowledged that inclusion of a complex intervention greatly complicates the design and implementation of a clinical trial, particularly the gold standard of clinical research, the double-blind, placebo-controlled, randomized trial (NIH Acupuncture Consensus Statement, 1997, Margolin et al., 1998). Given the intense competition for Federal research funding, investigators are loath to propose research that might be viewed as too ambitious or complicated. It is possible to design a well-controlled, blinded trial incorporating individualized care as demonstrated in a recent study looking at the use of Traditional Chinese Medicine to treat irritable bowel syndrome (Bensoussan et al., 1998). Although this three-arm study, which compared individualized Chinese herbal formulations, a standard Chinese herbal formulation, and a placebo, was less complex than a study of a healing system, it is illustrative of some of the methodological and design issues associated with individualized therapies. This dramatically increases the complexity and cost of the trial. As such, the preparation time required for these trials is greatly expanded and often requires extensive piloting of individual trial components (e.g., blinding, placebo, consist implementation of the intervention even if individualized, etc.) prior to initiation of the trial. The cultural context in which systems are practiced and studied needs to be considered. How systems are applied in the United States may be different from how they are applied in their place of origin. For example, curanderismo, a folk system used in Latin America, is used among many Hispanic-Americans, a rapidly growing population in the United States. While curanderismo may enjoy wide popularity, its application may be influenced and transformed by the dominant Western/American culture. Thus, arises the need for further demographic and effectiveness (e.g., outcomes research) studies, as well as for studies comparing the original system with the adapted system. Sensitivity to the culture of a system’s origin needs to be considered from two perspectives: (1) studying the system in cultural context of the system’s origin and (2) studying the system as adopted and adapted in other cultures. For example, many people in Native American communities have expressed the opinion that their healing systems are fragile and are easily disturbed by examination, discussion, and scientific inquiry. The knowledge of specific techniques of healing, sacred songs, and healing rituals is acquired by Native American healers directly from elder healers, from spirits encountered during vision quest, and as a result of initiation into secret societies. Many Native Americans believe that if this knowledge is shared indiscriminately, especially with non-Native Americans, the spiritual power of the medicine may be weakened, and use of the information outside the communities of its origin may be perceived as contributing to cultural exploitation. In addition, European-Americans interest in the adoption of Native American healing practices could lead to misrepresentation and dramatic transformations of Native American teachings (see previous paragraph). Nevertheless, there is a large literature on the healing practices of certain Native American groups, and many Native American healers are willing to share knowledge with health care professionals. This may stimulate important cross-cultural insights and prospects for collaboration between Native American communities and health researchers. While Native American cultures and healing systems were used to illustrate cultural sensitivity, similar issues can be found with most systems of traditional, indigenous medicine. Objectives The objective of this PA for Traditional, Indigenous Systems of Medicine is to increase the quality of clinical research evaluating the efficacy of traditional, indigenous systems of medicine for the treatment or prevention of disease and related risk factors and accompanying symptoms. To meet this objective, proposed studies must successfully incorporate creative and realistic solutions to difficult problems in clinical research for the particular disease or condition under study. The application should directly address how the grant may advance the design of a subsequent full-scale RCT. In preparing for the definitive RCT, these studies should address specific questions that are formulated to optimize the design of the eventual RCT rather than address the clinical question with lower power. The application should also address the intrinsic scientific merit of the study conducted under the pilot grant, regardless of whether a full-scale trial is eventually performed. The applicant should document that linkages exist between the complementary and alternative medical institutions and the conventional institutions, and that experienced practitioners of traditional systems collaborate in the design and implementation of the study. In addition, applicants should give their utmost attention to the cultural context in which the systems are practiced in the United States and in which they intend to study them. Applications in response to Traditional, Indigenous Systems of Medicine may include, but are not limited to: 1. Qualitative research, such as detailed case studies and patient and health care provider interviews, to describe diagnostic and treatment approaches, to explore patient and health care provider preferences, beliefs and attitudes, and to investigate the relevance of those approaches. 2. Studies of diagnoses including comparisons with those of other traditional, indigenous systems of medicine, as well as with conventional biomedicine, intra- and inter-practitioner reliability (diagnosis). 3. Studies to refine the intervention strategy including: (a) dosing, duration, and frequency of treatment, (b) type of treatment, comparisons of different systems of medicine to treat a particular disease/condition, (d) intra- and inter-practitioner reliability (intervention), (e) comparisons of complex versus simple interventions, (f) evaluation of compliance among different patient populations for interventions with varying levels of complexity. 4. Studies to refine the control strategy including comparisons of different types of controls (e.g., invasive control [sham] versus non-invasive control [placebo, standard therapy, wait list, etc.]), validation of randomization and blinding procedures. 5. Studies to define and refine the target population (e.g., inclusion/exclusion criteria) and develop adequate recruitment procedures. 6. Studies to determine the feasibility of the treatment strategy and develop realistic protocols. 7. Studies to establish the clinical usefulness (validity, reliability, responsiveness and utility) and appropriateness of commonly used assessment procedures, especially quality-of-life measures, as well as psychosocial, functional, and physiological measures, to construct and validate culturally sensitive data collection instruments, to design and pilot outcome measures consistent with the tenets of traditional, indigenous systems of medicine and comparisons of these outcome measures to those commonly used by conventional biomedicine. 8. Collection of preliminary data for establishing measures of efficacy (to establish the anticipated benefit of the treatment) and safety (to establish approximate rates of complications) for subsequent sample size calculations. (Note: Generally this will be the last in a progression of specific aims.) INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. The research plan should describe the composition of the proposed study population in terms of gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. 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 not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. Therefore, proposals for research involving human subjects must include a description of plans for including children. If children will be excluded from the research, the application must present an acceptable justification for the exclusion. 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. The PHS 398 application instructions and forms are available on the NIH grants Web site at http://grants.nih.gov/grants/forms.htm. Applicants are encouraged to access the application instructions and forms via the Internet. Application kits are available at most institutional offices of sponsored research and may be obtained 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, email: GrantsInfo@nih.gov. 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. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted in BUDGET INSTRUCTIONS below. Applicants wishing to submit R21 applications are encouraged to contact the Program Staff listed under INQUIRIES prior to submission. The NCCAM has guidelines for the preparation and submission of these applications as outlined in R21 APPLICATION GUIDELINES below. Applications for R21 grants that do not meet the requirements as outlined in these guidelines will not be accepted by the NCCAM. R21 APPLICATION GUIDELINES o For R21 applications, Direct Costs are limited to a maximum of $125,000 per year for a maximum of two years. Direct Costs requested for the proposed period may not exceed $250,000. Direct costs should be presented in increments of $25,000. Total Costs should equal the modular Direct costs plus Facilities and Administrative (F&A) costs. The award is nonrenewable and may not be used to supplement an ongoing project. o Do not exceed a total of fifteen pages for Items a-d in the Research Plan. Tables and figures are included in the page limitation. Applications that exceed the page limitation or NIH requirements for type size and margins (refer to PHS 398 application for details) will be returned to the applicant without further consideration. The fifteen-page limitation does not include Items e-I (Human Subjects, Vertebrate Animals, Literature Cited, Consortia, and Consultants). o Color illustrations or original photographs may be included in an Appendix. These are allowed only if there are copies of black and white figures appearing in the body of the application. No other appendix material is permitted. o Applications not following the above instructions will be returned to the applicant without review. BUDGET INSTRUCTIONS Modular Grant applications will request Direct Costs in $25,000 modules, up to a total Direct Cost request of $250,000 per year for R01s and $125,000 per year for R21s. Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions. 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: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) 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. o Under Personnel, List key 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. 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. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five 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) Applications will be accepted on the standard application receipt dates for investigator-initiated research as indicated in the PHS 398 directions. The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR staff. Incomplete applications will be returned to applicants without further consideration. Applications that are complete will be evaluated for scientific and technical merit in accordance with the standard NIH peer review procedures. R01 applications will be reviewed by a Special Emphasis Panel (SEP) convened by CSR, while R21 applications will be reviewed by an NCCAM SEP. As part of the initial merit review, all applications will receive a written critique and 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. 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. Because the exploratory 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. (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? (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? (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) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Marguerite Evans, M.S., R.D. National Center for Complementary and Alternative Medicine Building 31, Room 5B58 Bethesda, MD 20892 Telephone: (301) 402-5860 FAX: (301) 402-4741 Email: me16o@nih.gov Direct inquiries regarding fiscal matters to: Suzanne White* Grants Operations Branch National Heart, Lung, and Blood Institute National Institutes of Health Two Rockledge Center, Room 7150, MSC 7926 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: 301-435-0170 FAX: 301-480-3310 Email: WhiteSA@gwgate.nhlbi.nih.gov * Note: NHLBI is the Grants Management Service Center for the NCCAM. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.213. 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, and 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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