PAR-03-046: DEVELOPMENTAL CENTERS FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (DCRC)

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DEVELOPMENTAL CENTERS FOR RESEARCH ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (DCRC) RELEASE DATE: December 19, 2002 PA NUMBER: PAR-03-046 (Second phase of this PAR available, see RFA-AT-06-001) (This PAR has been reissued, see PAR-06-108) (See NOT-AT-04-003) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/) LETTER OF INTENT RECEIPT DATE: March 15, 2003; January 17, 2004; January 15, 2005 APPLICATION RECEIPT DATE: April 15, 2003; February 17, 2004; February 15, 2005 THIS PROGRAM ANNOUNCEMENT WITH SET ASIDE FUNDS (PAS) CONTAINS THE FOLLOWING INFORMATION o Purpose of This PAR o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible To Become Principal Investigators o Special Requirements, including Cooperative Agreement Terms and Conditions of Award 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 PURPOSE OF THIS PAR The National Center for Complementary and Alternative Medicine (NCCAM) seeks applications for Developmental Centers for Research on Complementary and Alternative Medicine (DCRC) using the U19 cooperative agreement mechanism. The purpose of these awards is a) to increase the level and quality of complementary and alternative medicine (CAM) research by assisting extramural CAM researchers and practitioners to develop and participate in high-quality research, b) to promote CAM research expertise and infrastructure development, and c) to support enhanced communication and partnership- building between CAM and conventional institutions. Specifically, the DCRC will serve as a focal point to strengthen collaborations among CAM and conventional institutions and facilitate synergistic exploratory/developmental research projects. An essential characteristic of the DCRC is a requirement for committed partnerships between CAM and conventional institutions. NCCAM encourages a multidisciplinary approach to research, and it is expected that projects will reflect this priority. It is also expected that these awards will develop and sustain preliminary research studies that will lead to the submission of competitive R01 grant applications to conduct CAM research, to NCCAM and other NIH Institutes/Centers. RESEARCH OBJECTIVES Background CAM use in the U.S. is high, with yearly use prevalence between 30 and 42% of U.S. adults, and expenditures associated with CAM therapies exceeding non- reimbursed expenses incurred for all hospitalizations. Despite this broad use, there is insufficient scientific data on the safety and efficacy of CAM therapies. As outlined in its Strategic Plan, posted at http://nccam.nih.gov/about/plans/fiveyear/index.htm, NCCAM is dedicated to conducting rigorous scientific research on complementary and alternative healing practices; to training researchers; and to disseminating authoritative information. To this end, NCCAM employs a range of funding mechanisms, including centers, to support research, training, and career development. Centers have been a key component of NCCAM research portfolio because they offer an opportunity to develop a program of related research projects that result in "a whole greater than the sum of its parts" and can serve as a focal point for the development of additional research and training activity. The first generation of specialized research centers introduced in 1998 allowed (then newly created) NCCAM to cultivate research, scientific resources, and new investigators simultaneously within 16 programs. To assess the status of current CAM research centers and recommend future directions, in June 2002, NCCAM convened an Expert Panel on NCCAM Research Centers. Given that: 1) the areas of CAM research are broad, 2) the expertise of investigators available to pursue CAM research ranges from novice to highly skilled and accomplished, and 3) there is a need to facilitate the development of a sustained research culture within the CAM community, the Panel recommended a multifaceted approach to the next generation of NCCAM Centers. (The NCCAM Centers Expert Panel Report is available at http://nccam.nih.gov/training/centers/index.htm.) In response to the Panel's recommendation, NCCAM has established the Centers for Research on Complementary and Alternative Medicine (CRC) Program. Currently the Program consists of three individual activities, each designed to meet a different need. Additional individual programs may be developed and will be posted on the NCCAM website. The Centers of Excellence for Research on CAM (CERC), which uses the Program Project (P01) mechanism, is designed to provide a vehicle for highly skilled researchers to apply their expertise in addressing CAM research questions, with an emphasis on elucidating the mechanisms of action of CAM therapies and approaches. The International Centers for Research on Complementary and Alternative Medicine (ICRC) are designed to establish partnerships and cross-cultural exchange through which foreign and U.S. institutions and investigators can 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. The DCRC, described in this announcement, is intended to promote development of CAM research expertise and infrastructure, to support enhanced communication and partnership-building between CAM and conventional institutions/investigators and to support developmental research projects. CAM institutions represent a rich source of talent with the clinical and historical perspectives needed in CAM research. However, few CAM institutions have developed and sustained rigorous research programs. More specifically, there remains a serious shortage of experienced investigators who conduct independent, high-quality research at CAM institutions. Conversely, there is a cadre of classically trained, highly experienced scientists with an interest in CAM research at conventional institutions who may lack the unique clinical and cultural perspectives critical to CAM. One potential approach to addressing these issues is to create and sustain collaborations between scientists and faculty of CAM institutions and established investigators at conventional institutions in ways that integrate and take maximum advantage of their respective expertise and experience in mutually beneficial activities. Success in achieving support for research through the traditional NIH research project grant (R01) mechanism can be scientifically challenging. Often, CAM applications are unsuccessful in obtaining funding due to lack of preliminary data or poorly developed research methodology. The DCRC provides CAM and conventional investigators with an opportunity to explore the feasibility of and develop projects investigating CAM, and to generate preliminary data in areas where evidence is sparse or nonexistent via collaborative partnerships. It is expected that the preliminary work generated within the DCRC will lead to the submission of competitive research grant applications to NCCAM and other NIH Institutes/Centers. Objectives: The DCRC is designed to enhance the capacity of the CAM community to participate in CAM research and to provide conventional researchers with links to CAM practitioners who bring an important perspective necessary to conduct CAM research. To achieve this, the major goals of the DCRC are to: o conduct three year developmental/exploratory research projects to explore the feasibility of projects investigating CAM, and to generate preliminary data in areas where evidence is sparse or non- existent, o facilitate development of the capacity of CAM investigators and CAM institutions to participate in the CAM research enterprise, and o facilitate development of the capacity of conventional investigators and institutions to participate in the CAM research enterprise. Note that the project period for each individual DCRC project is three years. Single or multi-site projects that address CAM research are appropriate. Structure and Organization of the DCRC Leadership: Each DCRC will be directed by a Principal Investigator (P.I.), who may be from either a CAM or a conventional institution (see below for eligible institutions). The P.I. of the DCRC must also be a Project Co- Leader of one research project and is required to commit a minimum of 30% time to the DCRC (15% to the DCRC administrative core and 15% to one research project). The P.I. will identify and select key personnel and allocate and monitor funds. A DCRC External Advisory Committee (EAC) will provide guidance to the P.I. and feedback on DCRC progress to NCCAM staff. An Internal Steering Committee (ISC) will provide for frequent communication and sharing of information, and for regular adjustment of focus within the DCRC. The composition, duties, and reporting requirements of both committees, as well as further detail on responsibilities of the P.I. are described in the Special Requirements and/or Terms and Conditions section of this announcement. Research projects: Each DCRC will comprise three to four synergistic, exploratory/developmental research projects. Project Co-Leaders (15% effort each) are to be named from both CAM and conventional institutions for each project. Eligible areas of research: Each DCRC must be structured around a central scientific theme focused on at least two of the following: o A particular disease or class of diseases treated by CAM; o A specific group of CAM therapies or treatment approaches; or o Mechanisms of action of specific CAM therapies and/or approaches. Alternatively, the Center may be organized around a specific research theme such as wellness or the placebo effect. Projects of potential interest include: o Basic science studies (including in vitro studies or studies using animal models); o Studies of the pharmacognosy, pharmacology, pharmacokinetics, and drug interactions of natural CAM products; o Phase I studies, such as those to refine strategies for clinical trials (addressing, for example, feasibility, safety, optimization of protocol, validity of assessment methods, controls, target population), to determine effects on biomarkers and to perform imaging studies, etc.; o No more than one phase II study of modest size, provided it is adequately powered to detect a meaningful difference between groups or validates surrogate markers of disease or clinical endpoints; and o Health services research. This list should not be considered to be comprehensive, restrictive, or in priority order. Applicants proposing studies that include the use of botanicals or other complex natural products as a component should refer to the Policy of the NCCAM on Botanicals Research, posted on the NCCAM website at http://nccam.nih.gov/research/policies/index.htm. Applicants are encouraged to consult the NCCAM website (http://nccam.nih.gov/training/centers/index.htm) for relevant information regarding current NCCAM research priorities. Core(s): Each DCRC is required to have an administrative core, which must serve all projects within the DCRC. The administrative core is responsible for day-to-day administration, as well as program coordination and ongoing evaluation of the Center. If a clinical trial is proposed, a clinical core is suggested, to provide expertise and guidance in e.g., data management, biostatistics, or clinical trial design/coordination. Additional cores may be included, as appropriate, bearing in mind that each core must be utilized by at least two proposed projects. Applications must clearly demonstrate how each core will serve the needs of the research program, and how each project will use resources of additional cores. Two related considerations that should be detailed if applicable are: 1) the degree to which currently funded investigators, within or outside the DCRC, will use and benefit from core resources and; 2) the degree to which the resources will promote new and/or expanded CAM research efforts. MECHANISM OF SUPPORT This initiative will use the NIH U19 Cooperative Agreement, a mechanism for multiple project awards. In the NIH cooperative agreement award mechanism the P.I. retains the primary responsibility and dominant role for planning and directing the proposed project, with NIH staff being substantially involved as a partner with the P.I., as described in the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE This initiative is a three-year Program Announcement with set-aside funds (PAS). NCCAM intends to commit up to $1.8 million in direct costs in FY 2003 to fund up to three new non-renewable DCRC grant(s) for a period of up to three years in response to this initiative. Although the financial plans of the NCCAM provide support for this program, awards pursuant to this PAS are contingent upon the availability of funds and the receipt of a sufficient number of meritorious 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 or community-based organizations For the purposes of this Program Announcement, CAM and conventional institutions are defined in the following manner: o A CAM institution is a nationally or regionally accredited academic, health care or research institution with a primary goal of educating students to be CAM practitioners. Students who matriculate from the program must do so with either a degree or certificate in a designated CAM practice that is licensed or certified at the state level. Eligible institutions include but are not limited to colleges/schools of naturopathy, chiropractic, traditional Chinese medicine, acupuncture, and massage. o A conventional institution is an academic, health care and/or research institution with a tradition of rigorous research that does not have as a primary goal training of CAM practitioners. o For the purposes of this initiative, osteopathic medical institutions that teach manual manipulation as part of the core curriculum required for all students may collaborate with another conventional institution. 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 Each DCRC application must demonstrate that the following special requirements and provisions are met. Requirements are more fully explained under the heading "Supplemental Instructions" in the SUBMITTING AN APPLICATION Section, below. Institutional Infrastructure The awardee and collaborating institution(s) must demonstrate that it/they has/ve the requisite staff (e.g., administrative, and technical), clinical and/or laboratory facilities, patient populations, geographic distributions of space and personnel, etc.) to perform the proposed research, or indicate how they will be obtained. CAM institutions must document commitment to collaborative agreements by investigators at conventional research institutions that already have extramural funding from NIH or other comparable funding sources. Similarly, conventional institutions must document collaborative agreements with investigators at CAM institutions. Applicants must: o Attach letters of support from an appropriate, high-ranking official at the awardee institution and from each collaborating institution(s), documenting significant institutional commitment to the Center and to the collaboration, and clearly presenting expectations for interactions and performance by each partner; o Delineate how different components of the DCRC, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how the combined resources create capabilities that are more than the sum of the parts; o Describe the collaborative process and methods of communication, and identify areas of potential collaboration and areas of focused collaboration; o Describe scientific and/or programmatic synergy between projects, and between projects and proposed core (e.g., the degree of interaction between projects and with the core must result in a program where "the whole must be greater than the sum of its parts"). o Show that research projects proposed for the DCRC do not overlap in purpose or intent with existing NIH-funded grants, but will constitute new activities or a natural progression of current research; o Plan to participate, with collaborators, in an annual meeting with other NCCAM-funded Center P.I.s. Travel costs for this purpose should be included in the proposed budget for the application; o Describe the activities and the process through which the applicant institution will reach the goal of developing competitive projects and preliminary research results in support of applications for further grant support. The plan must include a chronological table listing specific first, second and third year objectives for each research project. For each objective, a brief statement should be made about the specific contributions of CAM and conventional scientists. o Enter into a Clinical Trial Agreement. Further information on NCCAM requirements for clinical trials are posted on the NCCAM website at http://nccam.nih.gov/research/policies/index.htm. Principal investigators are strongly encouraged to provide opportunities for postdoctoral clinical or bench research fellows (both CAM and conventional) and junior faculty to participate in individual projects as key personnel. Funds to support intensive, short-term research training experiences in either basic or clinical research as an exchange program between CAM and conventional institutions can be included in the administrative core. Such training may include instruction of students, fellows, interns, residents and other clinical and research personnel in CAM concepts and methodologies and in conventional research methodology (which may include analytical methods, molecular biological methods, clinical trial planning, statistical methods, ethical practices, or grant writing). Internal Steering Committee: The Principal Investigator is responsible for establishing an Internal Steering Committee (ISC), which will consist of the DCRC P.I., appropriate investigators from each of the collaborating institutions and the NCCAM Scientific Advisor in an ex officio capacity. The ISC will have responsibility for directing and monitoring the progress of the research projects. In addition, the ISC must develop opportunities for information exchange, and data sharing. Each ISC member (or their surrogate) will be expected to participate in all committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Outside ad hoc consultants can be added as desired. If plans call for inclusion of ad hoc consultants, their areas of expertise should be specified, but individuals should not be named. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following Terms and Conditions will be incorporated into the new award statements and will be provided to the Principal Investigator and to the appropriate institutional officials at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the U19 cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NCCAM programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement, the NCCAM supports and stimulates the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role. NCCAM will not assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole. 1. Awardee Rights and Responsibilities: The applicant (awardee) institution and the P.I. will be responsible for the collaborative research activities in the DCRC. The awardee institution will be legally and financially responsible and be accountable for the use and disposition of funds awarded to the awardee, and will attest to the availability of personnel and facilities capable of performing and supporting the administrative functions of the DCRC. The Awardee also has primary authority and responsibility to o Define DCRC objectives and approaches; o Plan, conduct, analyze, and publish results, interpretations, and conclusions of their research, and other activities; o Coordinate and maintain project activities within his or her institution, with collaborating scientists, and with the NCCAM Scientific Advisor (see below); and o Establish and Chair the Internal Steering Committee. The Awardee will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. 2. NCCAM Rights and Responsibilities As per the terms of the cooperative agreement arrangement, NCCAM will appoint a Scientific Advisor and a Program Official to participate in the conduct of the U19 cooperative agreement. The roles of Scientific Advisor and Program Official may be filled by one person. The NCCAM Scientific Advisor will: o Have substantial scientific and programmatic involvement with the awardees by providing technical assistance, advice and coordination above and beyond normal program stewardship of research grants; o Facilitate the coordination necessary to manage this complex project; o Participate as a non-voting member of the External Advisory Committee; o Participate in monitoring progress of ongoing studies; o Participate in planning and implementing efforts to disseminate information; o Participate in data interpretation and, when appropriate, in the preparation of publications and presentations. o Be subject to the same publication/authorship policies governing all participants in the study, as well as to the official NIH publication policy governing extramural employees. The NCCAM Program Official will: o Provide normal program stewardship and review the scientific progress of individual research project components, and the use of the core resource facilities among the research projects within each cooperative agreement; o Monitor compliance of the award with the operating policies of this program announcement; o May recommend withholding support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies outlined in this announcement or the Award Statement. o Is responsible for establishing and coordinating regular meetings of a DCRC External Advisory Committee (EAC), in consultation with the DCRC P.I. The EAC will be composed of the Program Official, who will serve ex officio, and up to five external advisors with appropriate expertise to provide advice relative to the objectives of the program. The EAC will serve as the primary advisory body of the DCRC, and the Program Official will rely on the EAC for objective evaluation of the Program. The EAC will: o Monitor progress of the research projects; o Monitor the effectiveness of communication and collaboration; o Monitor the use of core resources by DCRC participants and other investigators; o Evaluate the effectiveness of the DCRC P.I.; and o Identify problems and suggest possible solutions. The EAC's evaluations and recommendations, in the form of a written annual report, are to be submitted to the Program Official, the Scientific Advisor, and the DCRC P.I., and will be used by the Program Official and the DCRC P.I. to guide and direct the program. Subcommittees with additional ad hoc advisors may be established by the EAC as necessary in order to meet its planning, priority setting and evaluation responsibilities. Awardees generally will be expected to accept and implement the recommendations of the EAC; in those situations where the recommendations are not feasible to implement, the DCRC P.I. must provide a thorough explanation and rationale to NCCAM. The first EAC meeting will be convened by the Awardee nine months after the award date. The EAC will meet annually three months before the anniversary of the DCRC award date. 3. Arbitration Process Any disagreement that may arise on scientific or programmatic matters between U19 awardees and NCCAM may be brought to arbitration before an arbitration panel. The arbitration panel will be composed of three members. One member will be chosen by the awardee. A second member will be selected by NCCAM. The third member, having expertise in the relevant scientific area, will be chosen by the two selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Direct inquiries regarding scientific/programmatic issues 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 Blvd. Suite 401 Bethesda, MD 20892-5475 Office (301) 402-1030 Fax (301) 480-3621 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, Suite 401, MSC 5475 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov Direct inquiries 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 Blvd., Suite 401, MSC 5475 Bethesda, MD 20892-5475 Phone: 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, including project/core leaders; o Participating institutions; and o Number and title of this PAR. 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: Christine Goertz, D.C., Ph.D. Coordinator, Centers for Research on CAM Program National Center for Complementary and Alternative Medicine (NCCAM) National Institutes of Health 6707 Democracy Blvd. Suite 401 Bethesda, MD 20892-5475 Office (301) 402-1030 Fax (301) 480-3621 Goertzc@mail.nih.gov SUBMITTING AN APPLICATION Applications are to be submitted using the Form PHS 398 (rev. 5/01) using the SUPPLEMENTAL INSTRUCTIONS provided below. 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; FAX: (301) 480-0525; Email: grantsinfo@nih.gov. 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. Submit the complete signed application with the checklist, and three photocopies without the checklist to: Center for Scientific Review Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 (Bethesda, MD 20817 for express/courier service) At the time of submission, 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 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Telephone: (301) 594-2014 FAX: (301) 480-2419 Email: goldrosm@mail.nih.gov SUPPLEMENTAL INSTRUCTIONS This section supplements the instructions found in Form PHS 398 (Rev. 5/01) for preparing a grant application. Additional instructions are required because the Form PHS 398 has no specific instructions for multi-project applications consisting of research projects and core(s) interrelated by a common theme such as the DCRC. The following are specific instructions for sections of the PHS 398 (rev. 5/01) application form that are to be completed differently than usual. For all other items in the individual project application, follow the standard PHS 398 instructions. The instructions below are divided as follows: o DCRC application overview, which addresses the overall objectives and unifying theme(s) of this multi-project grant, the relationships among research projects and the administrative (including the administrative and organizational structure) and cores and how they will each contribute to the overall objectives and the overall budget. o Specific instructions for individual projects, describing modifications to PHS Form 398 instructions to address the collaborative/interactive nature of the project. o Specific instructions for the cores, each of which must provide services or resources to at least two research projects. Instructions describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the DCRC. DCRC application overview This multi-project grant application should be assembled and paginated as a single, complete document. Face page. Items 1 - 15: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively. Form page 2. Using page 2 of PHS 398, provide a succinct but accurate description (abstract) of the overall DCRC application addressing the major, common theme of the program. Do not exceed the space provided. Under "key personnel," list the P.I., followed by all other key personnel in alphabetical order. Form page 3 - Table of contents. Do not use Form page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application. Bearing in mind that the application will be scientifically reviewed project by project, including the cores, prepare a detailed table of contents that will enable reviewers to locate specific information pertinent to the overall application as well as each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g. project 1), title, and responsible Project Co-Leaders, and each core should be identified by number, title, and responsible core leader. Form page 4 - Detailed budget for initial budget period. Use Form page 4 of PHS Form 398 as a composite budget for the entire DCRC application. Indicate the page location of the composite budget in the "Table of Contents." Note: An additional Form page 4 must be used for each individual project and core within the DCRC application. Narrative justification for individual budget categories should be presented for each of the projects and cores. Form page 5 - Budget for entire proposed DCRC period. Complete the total direct cost line entries for all requested budget periods (years) and the total direct cost for entire period of support for each project and core. Biographical sketch form page. Biographical sketches of all professional personnel for all components should be placed at the end of the application with the P.I.s first, followed by those of other key personnel in alphabetical order. Resources form page. Do not complete for the overall application. Essential information is to be presented in the individual research project and core sections of the application. Checklist. Complete for the entire application and place at the end of the application package. If the facilities and administrative costs (F&A) rate agreement has been established, indicate the type of agreement and the date. Identify all exclusions used in the calculation of the F&A costs for the initial budget period and all future budget years. Other support page. Do not complete. Any required information will be requested from successful applicants prior to grant award. Program overview (research plan). Foreword: Include a one-page foreword in which you describe relevant previous collaborative arrangement(s), if any. Items a-d (see PHS 398 instructions) are limited to 25 pages. This narrative section summarizes the overall research plan for the multi-project application. The DCRC application should be viewed as a confederation of synergistic research projects, each capable of standing on its own scientific merit, but complementary to one another. This important section provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general aim of the overall research plan and by laying out a broad strategy for accomplishing the goals of the program. Indicate the contribution of each project and core to the overall concept. Include a chart showing the percentage of core activities required for support of each project throughout the requested funding period. Summarize the special features in the environment and/or resources that make this application strong or unique. Appendix. Follow the standard PHS 398 instructions, but provide six copies of a single appendix for the entire document. Order of materials in the appendix should follow that of the application, i.e., starting with materials relevant to the overall program, continuing with materials relevant to the individual projects, and concluding with any materials relevant to the core(s). Include letters (on institutional letterhead) from each proposed project Co- Leader and core leader confirming his/her role in the proposed DCRC, as well as from institutional officials confirming their commitment to the project. Specific instructions for individual projects A cover page is required for each research project and should include the number and title of the project. ) Use numbers (1,2,3, etc.) to designate individual research projects, give each a title; and provide the names and titles of the project leader and of participating investigators. All other items on the face page are to be completed following the standard PHS 398 instructions. Form page 2. For each proposed project, provide a description (abstract) of the proposed research according to the instructions for form page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute to attainment of the DCRC program objectives. Under "key personnel," follow the PHS 398 instructions, listing all key personnel participating in the project, beginning with the project leader. Distinguish co-investigators from other key personnel. Form page 3. Prepare a table of contents for each research project using form page 3 of the PHS 398. Since the biographical sketches of all participating investigators will be located at the end of the overall application and therefore should be referenced in the overall table of contents, it is not necessary to repeat these pages. Research plan (a-d). Do not exceed a total of 25 pages for Items a-d in the Research Plan for each individual project. Tables, charts, graphs, diagrams and figures must be included within the 25-page limit. Applications that exceed the 25-page limit or NIH requirements for type size and margins (refer to PHS 398 instructions for details) will be returned to the applicant without further consideration. The 25-page limit does not include Items e-i (Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators). Item A - Specific aims (typically one page): List in priority order the broad, long range objectives of the proposed project and describe concisely and realistically the more immediate goals. In addition, state the project's relationship to the DCRC program goals and how it relates to other research projects within the DCRC and to the cores. Item B - Background and significance: Use this section to describe how the proposed research will contribute to meeting the goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. In addition to the overall biological significance of the proposed research, this section should indicate the relevance of the project to the theme of the DCRC. Item C Preliminary studies: Inasmuch as these projects are exploratory/developmental, preliminary data as evidence of feasibility are not required. However, relevant pilot data should be cited when available. Item D - Research design and methods: Although preliminary data are not required, the conceptualization and planning of the project must be sufficient to allow for an assessment of the project's potential. The proposed research must be presented in sufficient detail to allow evaluation of the proposed methods. Appropriate expertise to conduct the proposed research must be included among the key personnel, e.g., for research involving human subjects, statistical and/or clinical trial design expertise (as appropriate) is essential during the design and conduct of research. . Appendix. A single appendix is to be provided for the entire DCRC application. Checklist. Submit a single checklist for the entire application. Specific instructions for cores The application must include an Administrative Core led by the P.I. of the DCRC. Other cores may be requested as appropriate. Funding for the overall administrative efforts, including secretarial and other administrative services, expenses for publications demonstrating collaborative efforts, all travel associated with the DCRC, communication expenses, etc., should be requested in the administrative core. A cover page is required for each core and should include the title of the core and provide the names and titles of the core leader and of participating investigators. All other items on the face page are to be completed using the standard PHS 398 instructions. Form page 2. Provide a Description (abstract) of the core activities and services according to the instructions on form page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute toward attainment of the DCRC program objectives. Form page 3. Prepare a Table of Contents for each core using page 3 of the PHS 398. Since the biographical sketches of all participating investigators will be located at the end of the overall application (and therefore should be referenced in the overall Table of Contents), it is not necessary to repeat these pages. Core Plan The research (core) plan (items a-d) for each core section is limited to 15 pages. Item A - Specific aims: State the core's relationship to the DCRC goals and how it relates to the research projects in the application. Item B - Background and significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. These resources should not duplicate resources already available to study investigators. In addition, this section should indicate the relevance of the core activities to the primary theme of the DCRC. Appendix. A single appendix for the entire DCRC application is to follow all projects and the core. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by NCCAM. Incomplete and non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PAS 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 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 may require site visits or that investigators come to NIH to meet with reviewers (reverse site visit); o receive a second level review by the National Advisory Council on Complementary and Alternative Medicine. REVIEW CRITERIA The following aspects of the DCRC will be evaluated: o Individual Research Projects o Cores o Principal Investigator o Environment o Program Synergy o Overall Program o Other Considerations A) INDIVIDUAL RESEARCH PROJECTS The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will be asked to comment on the following aspects of each proposed developmental research project in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move forward in a field. (1) Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation. Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigators. Are the investigators appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader(s) and other researchers (if any)? (5) Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, in accordance with NIH policy, all research components will also be reviewed with respect to the following: INCLUSION: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (Please see Inclusion Criteria included in the section on Federal Citations, below). 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. DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and duration in relation to the proposed research. Based on the evaluation described above, each project will receive a numerical score from 1.0 to 5.0. B) CORES Each core will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects: o Technical merit and justification of the proposed core; o Qualifications, experience, and commitment of the personnel involved in the core; o Adequacy of plans for the use of the core by the research projects and their integration with the core; and o Procedures for monitoring and evaluating the proposed research and for providing ongoing quality control and scientific review, including the proposed organization and activities of the Internal Steering Committee (Administrative Core only). C) PRINCIPAL INVESTIGATOR The P.I will be evaluated with respect to: o Leadership and scientific ability to develop a program of integrated research projects with a well-defined central research focus; and o Time commitment of a minimum of 30% effort (15% as Principal Investigator/administrative core leader and 15% as project leader of at one exploratory/developmental project). D) RESOURCES AND ENVIRONMENT Each application will receive a merit descriptor for Resources and Environment (outstanding, acceptable, unacceptable) that reflects the following: Institutional Commitment o The appropriateness of resources and policies for the administration of the DCRC; o The degree of incorporation of the DCRC within its institutional priorities; o As applicable, the degree to which the letters of support from senior faculty and/or institutional leaders address the need for mentoring of inexperienced Project Leaders to ensure the success of the collaboration; and o The extent of commitment to develop administrative capabilities that foster interdisciplinary collaborations. Collaborative Environment o The degree to which developmental research projects will enhance collaborations between CAM investigators and clinicians and conventionally trained scientists; o Strength of the evidence that the staff of the CAM and conventional institutions worked together closely to prepare the application; and o As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support and logistical services needed to make the collaboration successful. Resources Adequacy of facilities to support the proposed research, including clinical facilities, laboratory facilities and data management systems, when needed. F) PROGRAM SYNERGY Each application will receive a merit descriptor (highly integrated, integrated, not integrated) that reflects the degree of synergy of the proposed DCRC. In particular, program synergy will be evaluated on: o The potential for scientific impact of the proposed DCRC, which should be greater than that the sum of its component research projects and cores, i.e., the proposed components should interact synergistically to add value to the DCRC as a whole; o Demonstration of an effective relationship among collaborating institutions, including documentation of current relationships, as well as the functions, commitments and contributions that each collaborating member will bring to the proposed project; and o The nature, scope, and effectiveness of the plans for communication, coordination, and collaboration among research project investigators. G) OVERALL PROGRAM A single numerical priority score will be assigned to the DCRC application as a whole. In assigning the priority score for the application as a whole, although primary emphasis will be placed on scientific merit of the research projects, and past productivity (where applicable), significant consideration will also be given to the strength of core(s), leadership ability of the P.I., institutional commitment, collaborative environment and program synergy. The degree to which the proposed goals of the DCRC will likely lead to the submission of competitive R01 grant applications to conduct CAM research, to NCCAM and other NIH Institutes/Centers will also be considered. An application in which the reviewers consider no more than two component research projects to be of substantial and significant scientific merit will not satisfy the requirements for this U19 award, and therefore will not be recommended for further consideration (NRFC). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 15, 2003;January 17, 2004;January 15, 2005 Application Receipt Date: April 15, 2003; February 17, 2004; February 15, 2005 Peer Review: June/July 2003, 2004, 2005 Review by NCCAM Council: September 2003, 2004, 2005 Earliest Anticipated Award Date: September 15, 2003, 2004, 2005 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 INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy is based on the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted and supported by the NIH, unless there are clear and compelling 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the policy that was published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address 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 PAS 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. Reviewers are cautioned 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 PAS is related to the priority area of CAM Research. 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 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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