and Human Services (HHS)
EXPIRED
BASIC AND PRECLINICAL RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) RELEASE DATE: July 2, 2002 PA NUMBER: PA-02-124 (This PA has been reissued, see PA-05-141) EXPIRATION DATE: July 15, 2005 National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov) National Cancer Institute (NCI) (http://nci.nih.gov) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) 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 Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Center for Complementary and Alternative Medicine (NCCAM) invites research grant applications to help stimulate the amount and elevate the quality of basic, mechanistic, and preclinical research in all domains of CAM in order to provide a stronger foundation for ongoing and planned clinical studies. The NCCAM desires to encourage the most rigorous CAM and conventional researchers to focus on the opportunities in CAM research, and to employ the most current and emerging technologies to strengthen the biomedical research knowledge bases needed to elevate clinical practice. The National Cancer Institute (NCI), the National Institute of General Medical Sciences (NIGMS), and the National Institute of Mental Health (NIMH) share programmatic interests in some areas of CAM research with the NCCAM. The NCCAM, NCI, NIGMS, and NIMH areas of interest are described under INQUIRIES. RESEARCH OBJECTIVES The NCCAM is dedicated to exploring complementary and alternative healing practices in the context of exacting science. The NCCAM desires to encourage the most rigorous CAM and conventional researchers to focus on the opportunities in CAM research, and to employ the most current and emerging technologies. Chemists, physicists, psychologists, neuroscientists, endocrinologists, immunologists, geneticists, pharmacologists, and others in relevant fields of inquiry who are interested in applying their expertise and powerful contemporary technologies to help advance the science of CAM are encouraged to apply. In order to strengthen the biomedical research knowledge bases needed to inform CAM clinical practice, more basic, mechanistic, and preclinical research is needed across the broad spectrum of biomedical science underlying CAM practices. These practices may be grouped in five major domains: alternative medical systems, mind-body interventions, biologically based treatments, manipulative and body-based methods, and energy therapies, with some overlap across categories (NCCAM"s Five-Year Strategic Plan can be accessed at http://nccam.nih.gov/about/plans/healthdisparities/appendices.htm ,see especially Appendix I). The individual systems and treatments within each category of CAM are numerous, so the following examples are presented to demonstrate the broad range of research contemplated by this initiative, and are not meant to be exclusive: ---Immunomodulatory mechanisms underlying CAM therapeutics, such as basic and animal model studies aimed at determining whether and what changes are induced in immune response pathways by CAM therapeutics, and whether any such changes might be relevant to resolving a disorder or preventing one ---Neurophysiological, neuroendocrinological, and biochemical pathways in massage therapy, including studies utilizing animal models, and instrumentation-based approaches including imaging ---Mechanistic studies of biologically-based treatments, herbs, nutritional supplements, or natural products for enhancing cognitive function in brain disorders ---Chemical and physical reactions during the dilution process and the principles of biophysics associated with homeopathy, for example, studies using detailed and sensitive physical measurements of water to determine whether it is altered in any measurable and reproducible way by the process of ultrahigh dilution employed in the preparation of some homeopathic remedies ---Mechanisms underlying the biochemical and/or neurophysiological causes of spinal dysfunction, and investigations of the therapeutic pathways being impacted by manual therapies such as spinal manipulation and mobilization as performed in chiropractic or osteopathic practices ---Studies on the rationales for the use of complex products from a single plant species and studies to evaluate the mechanisms of action and to help establish the biomedical bases for the belief in the therapeutic efficacy of using multiple plant species simultaneously ---Basic biological mechanisms and processes underlying acupuncture, including investigations using animal models, and studies employing imaging ---Identification and properties of the energies underlying therapies such as Qi gong, Reiki, distant healing, acupuncture, and other therapeutic modalities involving bioenergies, especially new biophysical approaches involving instrumentation ---Mechanisms of action of Saw Palmetto, PC-SPES, Pygeum africanum and other complex botanicals on the male reproductive tract, and of black cohosh, red clover, and other complex botanicals on the female tract: The studies are expected to focus on the cellular, molecular, endocrinological and metabolic changes induced in vitro, in animal models, and inhuman subjects treated with these botanicals ---Interactions between CAM and conventional therapeutic modalities, including but not limited to those of complex botanicals with pharmaceutical drugs Summary This initiative is designed to focus the attention and efforts of CAM and conventional researchers towards more basic, mechanistic, and preclinical research on CAM. MECHANISMS OF SUPPORT This PA will use the NIH R01, R21 and R15 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PA may not exceed 5 years for R01, 2 years for R21, or 3 years for R15 grants. The guidelines for R21 applications may differ between NIH Institutes and Centers. The URLs listed below provide guidance for the participating Institutes" R21 programs. NCCAM: http://nccam.nih.gov/research/instructions/r21/index.htm NCI: http://deainfo.nci.nih.gov/extra/pa/mechanism/r21.htm NIGMS: http://www.nigms.nih.gov/funding/grntmech.html#explor NIMH: http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html Potential applicants should contact the programmatic representatives listed under INQUIRIES for additional guidance on all award mechanisms. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. 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 organizations The NIH has published Program Guidelines for Academic Research Enhancement Awards (AREA, R15 grants) which include a list of schools/components that are inelegible for this Program, see http://grants.nih.gov/grants/funding/area.htm for details. 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 PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE (NCCAM) The NCCAM areas of interest are broad, and include five major domains of CAM research: alternative medical systems, mind-body interventions, biologically based treatments, manipulative and body-based methods, and energy therapies The NCCAM"s programs in natural products research have arisen from a unique perspective. Practitioners of Complementary and Alternative Medicine (CAM) believe that the polypharmacy of complex natural products has advantages over single-ingredient drugs by providing greater therapeutic benefit and less overall toxicity. In pursuit of its mission, the NCCAM supports research to determine safety, efficacy, and mechanisms of action of complex natural products. NCCAM will support research characterizing single constituents extracted from complex natural products if the purpose is to identify and standardize whole products, compare the actions of single constituents with the complex product, or identify the mechanisms of action for the whole product. NCCAM will not accept applications to isolate the active constituents of complex natural products for the express purpose of developing these constituents as discrete drugs. Funding support for applications to develop active constituents as drugs may be available from other Institutes and Centers at NIH. Shan Wong, Ph.D. Program Officer National Center for Complementary and Alternative Medicine Two Democracy Plaza, Suite 401 6707 Democracy Boulevard Bethesda, MD 20892-5475 Phone: 301-496-7498 Fax: 301-480-3621 E-mail: [email protected] NATIONAL CANCER INSTITUTE (NCI) The National Cancer Institute is interested in basic, mechanistic, and preclinical research as it relates to the prevention, diagnosis and treatment of cancer as well as management of cancer symptoms and side effects due to conventional cancer treatment. Areas of interest include interactions between conventional cancer treatment and CAM modalities. Wendy B. Smith, Ph.D. Program Director Office of Cancer Complementary and Alternative Medicine National Cancer Institute 6130 Executive Blvd, EPN Suite #102, MSC 7302 Bethesda, Maryland 20892-7302 Telephone: 301-435-7980 FAX: 301-480-0075 Email: [email protected] NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) NIGMS areas of interest include structure identification and chemistry of natural products in herbals, mechanisms underlying interactive biological/pharmacological effects of multiple components within a single herbal or a mixture of herbals, metabolism of herbal and natural products by drug metabolizing enzymes, herbal-drug interactions resulting from effects on drug metabolizing enzymes and transporters, biological mechanisms underlying anesthetic effects of herbals, natural products, or acupuncture, and biological mechanisms underlying the placebo effect. Michael E. Rogers, Ph.D. Director, Pharmacology, Physiology, and Biological Chemistry Division National Institute of General Medical Sciences Rm. 2As.49c, Natcher Building Bethesda, MD 20892-6200 Telephone: 301-594-3827 FAX: 301-480-2802 Email: [email protected] NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) The NIMH is interested in research on the identification and testing of promising biologically-based interventions, herbs, nutritional supplements, and natural products for the treatment of mental disorders and the enhancement of cognitive function in depression and schizophrenia. Linda Brady, Ph.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7185 Bethesda, MD 20892 Telephone: (301) 443-5288 FAX: (301) 402-4740 Email: [email protected] o Direct your questions about NCCAM financial or grants management matters to: Marc Pitts, M.B.A. Grants Management Specialist National Center for Complementary and Alternative Medicine Two Democracy Plaza, Suite 401 6707 Democracy Boulevard Bethesda, MD 20892-5475 Telephone: (301) 594-9095 Fax: (301) 480-3621 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 at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened 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 appropriate national advisory council or board 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 your 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 your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. 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 AMENDMENT "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 are 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 PA 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. 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 No. 93.213 and 93.242, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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. http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.
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