COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPY IN THE TREATMENT OF HIV/AIDS RELEASE DATE: August 26, 2002 RFA: AT-03-001 National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) LETTER OF INTENT RECEIPT DATE: November 11, 2002 APPLICATION RECEIPT DATE: December 10, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This initiative will support research to identify potential roles for the safe and effective use of CAM in the treatment of HIV/AIDS and its complications, or to ameliorate medication side effects. NCCAM and NINR are especially interested in supporting well-designed studies to characterize and investigate traditional medicine practices used in the treatment of HIV/AIDS. In this context, traditional medicine practices are derived from systems that have evolved their own coherent bodies of knowledge, and are differentiated from conventional or biomedical systems. RESEARCH OBJECTIVES Background Complementary and alternative medicine (CAM) practices are described as those not presently considered an integral part of conventional medicine. NCCAM has categorized the wide range of CAM modalities into five broad areas: 1) Alternative Medical Systems, 2) Mind-Body Interventions, 3) Biologically-based Therapies, 4) Manipulation and Body-based Methods, and 5) Energy Therapies. The medical literature includes reports of CAM use from each of the areas in patients with HIV-infection. 1) Alternative medical systems are built upon complete systems of theory and practice, and include Traditional Medicine systems that often have evolved apart from and earlier than the conventional medical approach used in the United States. Examples of traditional systems, many of which have developed in non-Western cultures, include traditional Chinese medicine, Ayurveda, and Unani, as well as traditional Native American (American Indian) and African/African- American systems. Examples of alternative medical systems that largely have developed in Western cultures include homeopathic medicine and naturopathic medicine. 2) Mind-Body interventions use a variety of techniques designed to enhance the mind"s capacity to affect bodily function and symptoms. Some techniques that were considered CAM in the past have become mainstream, for example, patient support groups and cognitive- behavioral therapy. Other mind-body techniques are still considered CAM, including meditation, prayer, mental healing, and therapies that use creative outlets such as art, music, or dance. 3) Biologically-based therapies in CAM use foods, diets, and dietary supplements such as vitamins, herbs, and other natural products. 4) Manipulation and body-based methods in CAM are based on manipulation and/or movement of one or more parts of the body. Examples include chiropractic or osteopathic manipulation, and massage therapy. 5) Energy therapies are of two types: 1) Biofield therapies (e.g., Qi gong, Reiki, and Therapeutic Touch), which are intended to affect energy fields that purportedly surround and penetrate the human body, and 2) Bioelectromagnetic-based therapies that involve the unconventional use of electromagnetic fields such as pulsed fields, magnetic fields, or alternating current or direct current fields. Estimates of CAM use by the general population vary, some surveys report prevalence as high as 40%. Although literature supporting the effectiveness of CAM for the treatment of HIV infection is limited, HIV-infected persons reportedly use CAM at higher rates than the general population, estimates range from 41% to 84%. HIV-infected persons reported substantial increases in CAM use after the diagnosis of HIV-infection. Generally, patients with HIV infection use CAM modalities in association with, rather than as a substitute for, conventional medical care. Although many patients perceive the use of CAM to be beneficial, the absence of controlled studies examining the outcomes of CAM use raise questions about the effectiveness of these interventions. The devastation of this epidemic increasingly focuses on racial and ethnic minority communities. Many HIV-infected people of color utilize CAM approaches, either in association with, or instead of conventional medical therapy. The scope of treatments is as varied as the cultures from which the people come. Studies on the range of CAM modalities may contribute to understanding the differences in health behaviors regarding HIV among minority populations and potentially identify effective integrative approaches to treating HIV in minority communities. Patients with HIV infection use CAM for many reasons: to reduce HIV- related symptoms or medication side effects such as nausea, fatigue, and weight loss, to strengthen the immune system, maintain health, and slow the progression of infection, to enhance energy, increase productivity, promote emotional well being, and reduce stress as well as depression, and to increase quality of life and perceived control over the disease process. In view of the potential effect of patient expectation on perceptions of benefit, well-designed studies are needed on the effectiveness of various CAM interventions used by patients with HIV/AIDS. While ineffective CAM therapies cannot be advocated in place of demonstrably effective pharmaceutical therapy, there are circumstances where the use of CAM therapies merits consideration. For example, recent changes in recommendations have resulted in later initiation of highly active antiretroviral therapy (HAART). Studies may investigate ethically the use of CAM to reduce viral load earlier in the course of infection and potentially delay progression of HIV infection prior to the time conventional treatment is recommended. Also, data indicate that the proportion of resistant virus is increasing. Although more new medications are being developed and introduced, individuals with resistant virus may be candidates for complementary non-pharmaceutical treatment. With the increased life expectancy afforded by HAART, individuals are on antiretroviral medications for longer periods of time, thereby increasing the risk of side effects. While the discovery of potent and effective CAM antiretroviral treatments may not be highly likely, some agents might be sufficiently active for use by individuals who cannot tolerate or do not accept conventional drugs. Moreover, they may be adequate to enhance antiviral responses when combined with conventional therapy, thereby decreasing required doses of pharmaceuticals, potentially lessening medication side effects and improving patient compliance. Finally, the identification of useful CAM antiretrovirals might serve to promote the further development of the active chemical entity(ies) by other NIH components or by private sector organizations. Additional research is needed on a wide range of CAM interventions, alone or in combination, to identify those CAM modalities that have potential roles in the treatment of HIV/AIDS. OBJECTIVES The objectives of this initiative are to: 1) Identify safe and effective CAM therapies that have potential roles in treating HIV/AIDS and its complications, or to ameliorate medication side effects, 2) Establish possible synergistic combinations of CAM and conventional treatments for HIV, and, 3) Understand mechanisms of action of CAM therapies that have the potential for contributing to the treatment of HIV/AIDS and its complications, or to ameliorate medication side effects. NCCAM and NINR are soliciting applications for research projects investigating the range of CAM modalities with the potential to contribute to the treatment of HIV/AIDS. They may range from basic through clinical studies, including in vitro, animal model, phase I human trials, and small phase II trials. Both preclinical and early clinical data, or at least substantive existing clinical study data, will be needed to justify phase II trials. Studies that investigate interactions between botanicals and drugs used to treat HIV infection or the clinical outcomes of treatment for HIV infection combining botanical substances with antiretroviral therapy will be considered responsive to this solicitation. In undertaking clinical studies, investigators may use surrogate markers (such as CD4 count or viral load) in order to remain within the budget and time limits of this solicitation. NCCAM and NINR are especially interested in supporting well-designed studies to characterize and investigate traditional medicine practices used in the treatment of HIV/AIDS. Following is a list of the types of studies that might be undertaken through this RFA, this list is exemplary, not exclusive. o In vitro studies examining antiretroviral properties of herbs or other supplements. o Studies investigating interactions between botanical substances and drugs used to treat HIV infection. o Projects that combine botanical substances with antiretroviral therapy to investigate clinical outcomes in treating HIV infection. o Studies of CAM interventions in treating HIV using animal models. o The use of CAM interventions to decrease symptoms of HIV infection or medication side effects. o Studies of the effects of herbs or other CAM interventions, alone or in combination with antiretroviral therapy, on progression of HIV infection or on patient adherence. o Projects to characterize and investigate the safety and efficacy of traditional medicine treatments in widespread use. o Clinical studies of herbs shown to have anti-HIV activity in vitro. o Studies of the potential benefits to persons with HIV infection of dietary supplements such as vitamins A, C, E, selenium, and natural substances. o Studies of the impact of massage therapy and other manual therapies on objective and subjective measures of symptoms and HIV infection. o The use of CAM interventions to improve the well being or enhance quality of life for patients with HIV infection. o Studies of the benefits of using homeopathic remedies in HIV- infected patients o Studies on the potential role for energy therapies including Therapeutic Touch, Qi gong, or magnets in treating symptoms or slowing the progression of HIV infection. o Studies to assess the impact, using objective or subjective measures, of using meditation and other mind-body interventions on patients with HIV infection. o Outcomes research investigating the use of a single CAM modality, a combination of CAM modalities, or traditional medicine approaches, alone or in association with conventional treatment for HIV/AIDS. o Studies to illuminate the differences in health behaviors regarding HIV among minority populations, and potentially identify effective integrative approaches to treating HIV in minority communities. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) R01 and NCCAM"s R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is June 2003. R01 Applications. R01 awards will vary in size and duration reflecting the nature and scope of the research proposed. Future unsolicited competing-continuation applications will compete with all investigator- initiated applications and be reviewed according to customary peer review. R21 Applications. The purpose of the R21 mechanism is to provide investigators, at all career levels, with a funding opportunity for exploring the feasibility, as well as the development, of projects investigating CAM and for generation of preliminary data. The R21 mechanism is specifically intended to support research where preliminary data as evidence of feasibility are sparse or do not exist. These grants are not intended for large-scale undertakings or to support or supplement ongoing research. Because the requirements for NCCAM R21 applications differ from those for the R01 applications, investigators intending to use the R21 mechanism are advised to consult the URL (http://nccam.nih.gov/research/instructions/r21/index.htm) for specific requirements, e.g. the 15 page limit for Items a-d in the Research Plan and restrictions on appendices, as well as additional information. This RFA 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 R01 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. FUNDS AVAILABLE The NCCAM intends to commit approximately $750,000 total funding in FY 2003 to fund two to four new and/or competitive continuation grants in response to this RFA. The NINR intends to commit up to $750,000 total funding in FY 2003 to fund two to four new or competitive continuation grants in response to this RFA, as well. For an R01 application, an applicant may request a project period of up to five years and a budget for direct costs of up to $375,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. For an R21 application, an applicant may request a project period of up to two years and a budget for direct costs of up to $125,000 per year. Although the financial plans of NCCAM and NINR 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The following special requirements apply to all applications concerning research with natural substances. Practitioners of 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 National Center for Complementary and Alternative Medicine (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 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. Investigators seeking funding from NCCAM for research that involves natural products must consider several issues when designing their studies and preparing their applications. Overall, the applicant is responsible for convincing the NCCAM and the NIH peer review committee that the natural products chosen are of sufficient quality to merit study as proposed. For these products, the levels of characterization, standardization, stability, purity, and optimization of the presumed active ingredient(s) will vary, and for some, the active ingredient(s) may be unknown. However, natural products should be chemically characterized as thoroughly as the state of the science allows, and the methods used must be described. When the active compound is unknown, "marker" compounds may be identified and measured. Natural products should be tested for contaminants such as microorganisms, pesticide residues, toxic elements, mycotoxins, and drugs. For in vitro studies of extracts or isolated chemical constituents of natural products that are normally ingested, the concentrations and chemical constituents should be physiologically and pharmacologically relevant. The experts who serve on the NIH peer review committee must be convinced that the natural products to be used in any study are described in sufficient detail that the results can be understood and independently reproduced. Studies that do not use a well- characterized, commercial product must provide evidence that the test material has been reliably identified. For botanical natural products, this evidence includes, but is not limited to, the correct plant name (Latin binomial with authority, cultivar where appropriate), geographic source of the material, time of harvest, plant part, and credentials of the person who collected and/or identified the material. A voucher specimen should be collected and placed into an identified repository. For some natural products, acceptable commercial sources may be available. When using commercial products, investigators must provide information from the product label. When possible, additional details available from the manufacturer should also be included in the application. Applicants also should consider having natural products, including those obtained from commercial sources, tested by an independent laboratory. Depending on the study design, independent verification of the samples before the start and at the end of the study may be necessary to ensure product stability. Testing of reserved product is especially important for large-scale clinical trials. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Morgan N. Jackson, M.D., M.P.H. National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: 301-402-1278 FAX: 301-480-3621 Email: mj145m@nih.gov Martha L. Hare, Ph.D., R.N. National Institute of Nursing Research 6701 Democracy Blvd., Suite 710 Bethesda, MD 20892-4870 Telephone: 301-451-3874 FAX: 301-480-8260 Email: harem@mail.nih.gov o Direct your questions about peer review issues to: Dr. Martin Goldrosen National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: 301-594-2014 FAX: 301-480-2419 Email: mg85x@nih.gov o Direct your questions about financial or grants management matters to: Mr. Brian Campbell Grants Management Branch National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: 301- 594-8738 Email: campbeb@mail.nih.gov Ms. Diane Drew Grants Management Branch National Institute of Nursing Research 6701 Democracy Blvd., Suite 710 Bethesda, MD 20892-4870 Telephone: 301-594-2807 Email: diane_drew@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCCAM staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Morgan N. Jackson, M.D., M.P.H. National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: 301-402-1278 FAX: 301-480-3621 Email: mj145m@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: R01 applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. R01 applications requesting in excess of $250,000 in direct costs must be submitted in a non-modular grant format. R21 applications must be submitted in the 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Martin Goldrosen National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: 301-594-2014 FAX: 301-480-2419 Email: mg85x@nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NCCAM. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NCCAM in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o May undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NCCAM National 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 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. (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: o 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. o 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) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 11, 2002 Application Receipt Date: December 10, 2002 Peer Review Date: February/March 2003 Council Review: May/June 2003 Earliest Anticipated Start Date: June 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic 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. 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 RFA 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 RFA 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 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.


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