PLANNING GRANT FOR INTERNATIONAL CENTERS FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (PICRC) RELEASE DATE: December 2, 2002 RFA: AT-03-002 National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) Fogarty International Center (FIC) (http://www.nih.gov/fic) LETTER OF INTENT RECEIPT DATE: February 28, 2003 APPLICATION RECEIPT DATE: March 28, 2003 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of This RFA o Research Objectives o Mechanism 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 Supplemental Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o Summary of the Phase II Initiative PURPOSE OF THIS RFA NCCAM wishes to enhance the understanding of complementary and alternative (CAM)/traditional medical (TM) systems. Many CAM/TM practices originate or are traditional in other countries. An international scope is therefore critical for all areas of NCCAM's strategic plan (available at http://nccam.nih.gov/about/plans/fiveyear/index.htm). NCCAM is thus committed to the study of CAM both in its native setting, with the cooperation and collaboration of indigenous peoples and practitioners, and among minority populations in the U.S, some of which have brought these healing traditions to the U.S. where, over time, the practices may have been modified. It is NCCAM's belief that the optimal means of conducting such studies at this time is through collaborations between experienced investigators in U.S. institutions and scientists and practitioners in foreign countries. This RFA outlines a mechanism to facilitate such collaborative efforts. Alternative medical systems are complete systems of theory and practice that have evolved independently of, and often prior to, current conventional biomedical approaches. Examples of alternative medical systems include, but are not limited to, Ayurveda, traditional Chinese medicine, homeopathy, and the traditional medical systems that have been developed by African, European, Middle-Eastern, Asian, and Central and South American cultures. Components that might be studied include, but are not limited to, diet, meditation and/or the medical use of herbal preparations. Global studies of alternative medical systems and practices can serve a dual purpose: 1) They can establish which CAM/TM interventions, as practiced in their countries of origin or as assimilated in the U.S. as a result of immigration or globalization, can benefit health and well being; and 2) They can facilitate the integration of these practices into conventional health care, especially into programs designed to address the health needs of minority populations. NCCAM intends to address the above issues by establishing partnerships and cross-cultural exchange through which foreign and U.S. institutions and investigators collaborate to design and implement research on CAM/traditional indigenous medical systems or components thereof in the cultures and/or environments in which they originated by supporting International Centers for Research on Complementary and Alternative Medicine (ICRC). The ICRC will provide conventional investigators (both U.S. and foreign) with a unique opportunity to study traditional medical systems and practices on their native grounds in collaboration with indigenous practitioners. The conventional researchers would then be uniquely positioned to examine how CAM/TM practices may be changed when they are imported to the U.S. The ICRC should benefit scientists in the foreign country(ies) by enhancing their skills in the design and implementation of cutting-edge research through collaboration with U.S. scientists. Both U.S. and foreign CAM/TM researchers should also benefit from the development of institutional and regional research infrastructure in the foreign country(ies), and from enhanced opportunities for career training and development. It is the hope that infrastructure and other enhancements resulting from the initial ICRC funding will make the participating institutions centers of excellence in rigorous CAM/traditional medicine research in their geographical areas, and that the resulting research will benefit health in all participating countries. Because the applications for the ICRC will require documentation of the structure and infrastructure of a complex, international, multidisciplinary, multi-site center comprising three synergistic, exploratory/developmental research projects and at least one core, including formulation of details of research plans, subcontracts, etc., the overall initiative will use a two-phase approach. This RFA solicits applications for the prerequisite Phase I of the future ICRC initiative. The Phase I ICRC (PICRC) initiative provides support for organization, planning, preparation and assembly of a full-fledged Phase II ICRC application. The two-year planning grants funded within the PICRC initiative, like the more extensive grants to be awarded in Phase II, should be focused on studies of CAM/TM, or components thereof, in their areas and populations of origin. NCCAM intends to issue an RFA for the Phase II ICRC initiative in 2004. NCCAM does not currently expect to fund more than one Phase II ICRC. RESEARCH OBJECTIVES Background: The NCCAM Centers Program Despite the widespread use of CAM/TM therapies, there are, in general, insufficient scientific data on the efficacy and safety of CAM/TM therapies. NCCAM intends to support rigorous research on CAM/TM and to disseminate information to the public and professionals on the efficacy and safety of CAM/TM therapies. Among the means NCCAM has adopted to achieve these goals is the creation of a centers program to bring together the resources necessary for the multidisciplinary scientific investigation of CAM/TM. The specialized research centers introduced in 1998 allowed NCCAM to cultivate research, scientific resources, and new investigators simultaneously. With more than a dozen NCCAM- funded CAM Research Centers approaching the end of their initial project periods, NCCAM convened an Expert Panel on NCCAM Research Centers in June 2002 to assess the status of current CAM Centers and make recommendations regarding future directions for the NCCAM Centers Program. Several new NCCAM initiatives are based upon recommendations provided by the expert panel as outlined their report, "The NCCAM Centers Expert Panel Report" available at http://nccam.nih.gov/about/plans/centers/index.htm. The NCCAM Centers Initiatives are described on the NCCAM Centers website: http://nccam.nih.gov/training/centers/index.htm. The objective of this RFA is to support the development/enhancement of the collaborations and resources necessary to assemble applications that will compete successfully as an ICRC in Phase II of this initiative, which is expected to be released, and applications processed, in time to provide for seamless funding for the successful awardees. An outline of the ICRC (Phase II) follows at the end of this document. Awardees of this planning grant who do not receive ICRC funding may apply for subsequent funding through mechanisms for individual (non-center) grant awards (e.g., R21, R01). The PICRC application must include at least two investigators, one from the U.S., and one from a foreign country. The applicants should propose specific milestones and a timeline to meet their collaborative, resource development and scientific goals. The Phase I award will provide support for the applicant to: o Further define the research to be proposed in the subsequent ICRC (or other) application; o Develop and solidify collaborative relationships and understandings between the partners in the participating countries; o Assess current resources and needs, e.g., the need for an Institutional Review Board for studies involving human subjects; o Develop and initiate a plan to address these needs, so that the research to be proposed in Phase II can be successfully and ethically conducted; o Identify appropriate training and other capacity-building activities to be incorporated into the research application; o Initiate cross-disciplinary training of the collaborators where necessary for the research to be proposed; and o Initiate pilot studies that could form the basis for fuller investigations that would be supported through the ICRC or other grant mechanisms. Applicants should describe their plan to consolidate partnerships, obtain necessary permits, and establish contract elements in preparation for an application for an ICRC award. Applicants must also clearly explain how the two-year developmental award will enhance the successful implementation of the envisioned research program. The emphasis of this initiative is on establishing a partnership between U.S. and foreign researchers and practitioners rather than on the development of foreign infrastructure, although the latter is encouraged where it is required for the research to be proposed. The ability to utilize existing NIH-funded programs and resources in the participating foreign country(ies) will greatly enhance the likelihood that this planning process will be successful. Some potential collaborating countries may require compliance with additional, country-specific requirements. Applicants should check http://www.nih.gov/fic/regional/CountryInstructions.html for such special considerations. Relevant host country governmental, non-governmental and community organizations should be consulted during the planning stage to ensure that research and development plans are compatible with national and local objectives, and to identify potential barriers to implementation early on. Public meetings or workshops in the foreign country(ies) are recommended early in the development of the program, to gain early feedback on working plans and broad-based support for the research program. Such consultations should be well-documented, and may involve, as appropriate: o individuals from local communities, including community leaders, o individuals from the local research and clinical communities, o respected local non-governmental organizations, and o the relevant national and regional governments. Seeking the advice or participation of social scientists and development organizations with local expertise is advisable during this process. Eligible areas of research for the ICRC Research related to alternative/traditional medical systems or component practices that are endemic to the region of the foreign institution(s) are eligible for consideration. Traditional medical systems from Asia, Europe, Africa, the Middle East and South or Central America are examples of such systems. Some additional eligible topics are described in the NCCAM Strategic Plan, http://nccam.nih.gov/about/plans/fiveyear/fiveyear.pdf, Appendix I, pages 27 through 29. These lists should not be considered to be comprehensive, restrictive, nor in priority order. Eligible projects may span the continuum from basic, through translational, to clinical (including Phase I and Phase II, but NOT Phase III clinical trials) and behavioral research. Applicants planning to propose research involving human subjects should refer to the NCCAM Terms of Award for Clinical Trials, available on the web at http://nccam.nih.gov/research/policies/terms-of-awards.htm. Additionally, special attention should be paid to establishing locally relevant but internationally respected standards and procedures for verifying informed consent. Applicants planning to propose research on botanicals or other complex natural products should refer to the Policy of NCCAM on Botanicals Research, posted on the NCCAM website at http://www.nccam.nih.gov/research/policies/naturalproducts.htm. MECHANISM OF SUPPORT This RFA (the PICRC) will use the NIH R21 award mechanism. As an awardee 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. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE The participating Institutes and Centers intend to commit approximately $900,000 in FY 2003 to fund up to six new grants in response to this RFA. An applicant may request a project period of up to two years and direct costs of up to $150,000 for any single year. The total cost (direct and indirect costs) for the two-year project period however, cannot exceed $275,000. Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the participating IC's 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 for the Phase I planning grants will be reissued. 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 o Offers, or is affiliated with, accredited institutions that offer, Ph.D., M.D., D.O., D.C., N.D. and/or equivalent doctoral degrees. o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The P.I. must have the skills, knowledge, and resources necessary to carry out the proposed research. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS This application must include at least one investigator from a foreign country. The application must clearly delineate the contributions of each investigator to the pilot projects, planning, training and other activities proposed. Applicants must outline the research program envisioned for the Phase II ICRC (which is summarized at the end of this document), and clearly explain how the two-year developmental award will enhance the successful implementation of the research program envisioned for Phase II. The emphasis of this initiative is on establishing partnerships between foreign and U.S. researchers and practitioners, and between conventional and CAM/TM researchers and practitioners. Applicants must delineate which personnel will be responsible for which aspects of the pilot projects and planning activities, and indicate expected responsibilities of the proposed PICRC personnel and of prospective additional personnel in the Phase II activities. Applicants must also detail specific timelines for meeting the goals of the application, including goals for each activity (research, training, planning, infrastructure development, etc.) during each year of the award. Pilot projects may include Phase 1 clinical studies to test feasibility, dosing, outcome instruments, etc., for studies to be proposed for a subsequent award. Phase 2 and 3 clinical studies will not be funded through this RFA. More than 50% of the direct costs requested must be used at foreign institutions for planning, developmental or capacity-building activities expected to be critical to the success of the Phase II proposal. Applicants should provide a detailed assessment of the capacity-building and training needs in the foreign country(ies) that must be addressed to support the proposed research, and a detailed plan for addressing these needs. If enhancement of scientific infrastructure is proposed, the applicant must specifically consult with the relevant participating developing country officials to assure that the enhanced research capabilities can be sustained by the host country after completion of the award. WHERE TO SEND INQUIRIES Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. We strongly encourage inquiries concerning this RFA and strongly advise potential applicants to contact the coordinator of the NCCAM Centers for Research on CAM Program during the planning phase of the application. Direct inquiries about scientific/research issues to: Christine Goertz, D.C., Ph.D. Coordinator, Centers for Research on CAM Program Division of Extramural Research and Training National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd., Ste. 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 402-1030 FAX: (301) 480-3621 Email: goertzc@mail.nih.gov Direct inquiries about peer review issues to: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Ste. 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov Direct questions about financial or grants management matters to: Victoria Carper, MPA Grants Management Officer National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Ste. 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-9102 FAX: (301) 480-1552 Email: vp8g@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 staff of the participating IC's 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: Christine Goertz, D.C., Ph.D. Coordinator, Centers for Research on CAM Program National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Ste. 401, MSC 5475 Bethesda, MD 20892-5475 FAX: (301) 480-3621 Email: goertzc@mail.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 https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, telephone (301) 710-0267, FAX (301) 480-0525, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS Applications responding to this RFA must present a description of the anticipated longer-term goals of the collaboration, and the specific roles to be played by each investigator and site in achieving those goals. They should provide a clear plan for conducting pilot projects, as well as for capacity building, development/enhancement of collaborations and development of the full- fledged ICRC application. This plan should include a detailed assessment of the specific research issues and capacity-building/training needs in the foreign country that the proposed activities will address. The plan should include a timeline specifying goals for each year of the award. Capacity-building activities may include training of investigators, technicians, practitioners and/or administrative personnel, informal meetings, workshops or small conferences, use of appropriate consultants, and analyses of extant data sets using new methodologies or approaches. Travel among sites for these purposes may be proposed. This RFA will not allow applications that are exclusively for meetings/travel and that do not have as their main goal the development of collaborations and the resources needed to support them, and the development of the collaborative research proposal to be submitted for Phase II. Pilot projects may include Phase 1 clinical studies to test feasibility, dosing, outcome instruments, etc., in preparation for studies to be proposed for a subsequent award. Phase 2 and 3 clinical studies will not be funded through this RFA. A maximum of 15 pages are allowed for items a-d of the research plan. 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: https://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 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: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Boulevard, Suite. 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.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 the participating IC's. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCCAM in accordance with the review criteria stated below. As part of the initial merit review, all applications: o receive a written critique, o 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 National Advisory Council for Complementary and Alternative Medicine. REVIEW CRITERIA Reviewers of the PICRC applications will be required to judge the likelihood that the proposed activities will support the submission of subsequent competitive research proposal(s) to the NIH. Because this R21 application for Phase I of the ICRC initiative is designed to support the development of innovative, multidisciplinary, international collaborative research, preliminary data as evidence of feasibility of the research are not required. It is useful, however, to include or cite pilot data where relevant and available. The applicant is, in any case, responsible for presenting the relevant background literature, and for developing a rigorous plan. The following aspects of the PICRC will be evaluated: A) Pilot Projects B) Collaboration and Institutional Environments C) Planning D) Training A) PILOT PROJECTS 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 pilot study(ies) proposed in the current application will facilitate the pursuit of these goals: o Significance o Approach o Innovation o Investigators o Environment Note that the project 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: Do(es) your study(ies) address (an) important problem(s)? 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(s)? Do you acknowledge potential problem areas and consider alternative tactics? Is the plan to build capacity for rigorous CAM/TM research adequate and appropriate to local and international scientific needs beyond the specific targets of the proposed work? (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 and the other participating investigators 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? Do you and the other investigators have appropriate administrative experience and competence in the development, implementation and management of comprehensive domestic and international research programs? (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 for, and commitment to, the proposed activities? Is the extent and level of non-U.S. participation and support appropriate and sufficient? Is there sufficient evidence of the availability and competence of the institutions involved to carry out all required legal, fiscal and policy responsibilities? B) COLLABORATION AND INSTITUTIONAL ENVIRONMENTS The following will be evaluated: o Strength of the evidence that the U.S. and foreign researchers and faculty worked closely together in the preparation of the application; o Likelihood that this planning activity will result in ongoing collaborative relationships between the partners in the participating countries; o As applicable, the degree to which the letters of support from senior faculty and/or institutional/center leaders address the need for mentoring of inexperienced Principal Investigators or for specific institutional/center commitments to ensure the success of the collaboration; o As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful; o The degree to which the foreign institutions are likely to improve their capacity and ability to address important issues in CAM/TM research, develop independently supported research and capacity development programs and obtain financial support nationally and internationally, and the ways in which this will occur. C) PLANNING The following will be evaluated: o The adequacy of the different planning methods proposed to ensure highly interactive and integrated efforts between individual U.S. and foreign researchers and practitioners, and between conventional researchers and CAM/TM researchers and practitioners; o The appropriateness and adequacy of the specific researchers and practitioners identified from the U.S. and foreign institutions to contribute effectively to each aspect of this planning effort; o The relevance of the plans to develop resources/infrastructure to research to be proposed subsequently; o Likelihood that a successful planning effort will result in the submission of subsequent competitive, collaborative CAM/TM research applications; o As appropriate, the extent to which the local community will be involved in the planning process. D) TRAINING In the context of the PICRC, training may include instruction of students, fellows, interns, residents and other clinical and research personnel in CAM/TM concepts and methodologies and in conventional research methodology (which may include analytical methods, molecular biological methods, clinical trial planning, statistical methods, ethical practices, grant writing and understanding of the U.S. research funding system). Training and career development activities may also include development of mechanisms to allow for regular professional networking of investigators with their international peers. The training and career development program should also include appropriate training of administrative personnel. The following will be evaluated: o Feasibility of training programs to augment existing curriculum or aid in the development of new curricula at the U.S. and foreign institutions; o Likelihood that the proposed training will increase the pool of researchers conducting rigorous scientific research on CAM/TM in all participating countries; o The appropriateness of training and other capacity-building activities to the personnel involved and to the research to be proposed subsequently. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 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 planning process. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 28, 2002 Application Receipt Date: March 28, 2003 Peer Review Date: June/July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 15, 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; o Geographic balance. 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: https://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 (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.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 https://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 https://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 https://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 https://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. SUMMARY OF THE ANTICIPATED PHASE II ICRC INITIATIVE The currently envisioned research objectives, structure of, and review criteria for the Phase II ICRC are summarized on the NCCAM website at http://nccam.nih.gov/training/centers/planned/.

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