COMPREHENSIVE CENTERS ON HEALTH DISPARITIES (CCHD) AT RCMI-ELIGIBLE INSTITUTIONS RELEASE DATE: February 3, 2003 RFA: RR-03-004 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) LETTER OF INTENT RECEIPT DATE: March 17, 2003 APPLICATION RECEIPT DATE: April 16, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Center for Research Resources (NCRR) and the National Institute of Mental Health (NIMH) invite applications for the establishment of Comprehensive Centers on Health Disparities (CCHD) at NCRR-supported Research Centers in Minority Institutions (RCMI) with affiliated medical schools. The purpose of this Request for Applications (RFA) is to augment and strengthen the institutional clinical research capabilities that are needed to address the cause(s) of health disparities in the racial and ethnic minority populations served by these institutions. Equally important will be the development of sustainable, replicable and culturally appropriate prevention and/or intervention research programs targeted to minority populations, designed to decrease the burden of disease in these populations. This is consistent with the health disparities agenda set forth by the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS). These CCHD will provide support to augment and strengthen the research capabilities of faculties at the grantee institutions to encourage innovative and effective research strategies to reduce the burden of diseases that disproportionately affect minority populations. Support will be provided to recruit established clinical researchers with an active research laboratory and independent research support. They will serve as mentors to junior researchers in basic or clinical research. These new faculty will receive support to establish their research laboratories, acquire specialized equipment, and hire postdoctoral fellows and technical assistants. It is anticipated that they will serve as magnet investigators for the recruitment of other research faculty who will complement the thematic focus of the application. Support will also be provided to facilitate collaboration with other NIH-supported disease-specific centers and community health centers. Therefore, the research focus of the application must be one or more of the diseases that disproportionately affect the indigenous populations served by the RCMI institution. In the long range, it is anticipated that this program will facilitate the development of the institution's clinical research capacity. It is also anticipated that the CCHD will complement existing support provided to the applicant institution via the NCRR RCMI Program and other Public Health Service (PHS) funding. RESEARCH OBJECTIVES This program seeks to foster improved health status and reduce the health disparity experienced by racial and ethnic minority Americans. The NIH recognizes that minority institutions are important and essential in fulfilling the promise of the NIH biomedical research agenda. Therefore, the NCRR and NIMH are offering programmatic assistance for the development of the technology and resources that are necessary to conduct state-of-the-art biomedical and behavioral research at these institutions. Over the long range, it is anticipated that this will facilitate the participation of these institutions in preparing the next generation of biomedical investigators, especially from those populations that are under-represented in the biomedical sciences. This RFA is one way that the NIH identifies and supports biomedical and clinical researchers at eligible institutions to conduct and report the meritorious research that will foster successful competition for traditional research project grants (e.g., R-series and P-series). The long-range objectives of this initiative are to:(1) assist the participating institutions to conduct clinical research that will improve the health of the nation's citizens, especially racial and ethnic minorities; (2) enhance the clinical research capacity of the eligible institutions; and (3) position the grantee institutions to compete successfully for PHS-supported research. The primary goals of CCHD are to: (1) develop sustainable, replicable and culturally appropriate prevention and/or intervention research programs targeted to minority populations designed to decrease the incidence and prevalence of disease; (2) strengthen clinical and translational research capacity at minority medical schools committed to addressing health disparities; (3) enhance opportunities for multi- disciplinary research collaborations between minority institutions and institutions with more established research programs in the identified areas; and (4) increase the role of research in maintaining a vigorous and stimulating academic environment that will inspire students and fellows to pursue careers that focus on health disparities. RESEARCH AREAS: In FY 1985, the legislation that authorized the RCMI Program called attention to the disparity in the health status of minorities as compared to Caucasian Americans. Research areas for the CCHD initiative include such disparities, as have now been identified for a variety of cancers (breast, prostate and colon/rectal), diabetes, infant mortality, cerebrovascular and cardiovascular disease, and Acquired Immunodeficiency Syndrome (AIDS). NIMH support will be limited to Centers focusing on HIV/AIDS research, funded through the Center for Mental Health Research on AIDS (CMHRA). RESEARCH PLAN: The research plan of a CCHD application should have a single-disease focus, and must contain a description of three to five multi-disciplinary, collaborative, developmental research projects that will be mutually beneficial to participating investigators through coordinated, cooperative interactions. The research excellence of these projects will be enhanced by effectively using the scientific and technical strengths of collaborating investigators. These projects must add to the body of knowledge that will address the disproportionate effect of various diseases in minority populations. The proposed application must be presented in two phases. Phase I may last for up to two years. During Phase I, a PI and/or other essential scientific personnel will be hired and collaborative research links and partnerships will be developed. Phase II, lasting up to four years, will be a research development phase whereby CCHD research faculty and their collaborators will conduct exploratory studies. For a detailed description of the structure of the CCHD application, refer to the Supplemental Instructions in this RFA. Program Characteristics: The Principal Investigator (PI) of the CCHD application must be an established clinical investigator with relevant expertise and a documented record of research accomplishments and administrative skills to direct a prevention-intervention research program and train junior faculty. The PI must have an active research program receiving NIH or other peer-reviewed support in the scientific area of the center and have the requisite administrative experience to direct the program. A minimum time commitment of 25 percent is required for this individual; however, up to 50 percent effort will be supported for mentoring and administrative oversight of the CCHD. If the PI is not in place at the institution at the time of review or award, a plan to recruit such an individual must be included in the application. An award pursuant to this RFA will not be made until and unless the institution has appointed a permanent CCHD PI. A Program Advisory Committee (PAC) that advises the PI must be established. For a detailed description of the PAC, refer to the Terms and Conditions of Award in this RFA. MECHANISM OF SUPPORT The NIH U54 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with the NIH Program Official being substantially involved as a partner with the Principal Investigator, as described in the section "Cooperative Agreement Terms and Conditions of Award". FUNDS AVAILABLE The NCRR intends to commit up to $1,500,000 in FY03 to fund one to two new grants in response to this RFA. NIMH intends to commit up to $350,000 in FY03. NIMH support will be limited to Centers focusing on HIV/AIDS research. In Phase I, an applicant may request up to $500,000 direct costs per year for two years. In Phase II, the applicant may request up to $2,000,000 direct costs per year for up to four years. Phase II funds will not be released until Phase I objectives have been successfully achieved, a qualified Principal Investigator has been hired, and Phase II exploratory prevention-intervention research studies have been reviewed by the PAC and approved by the participating funding components of the NIH. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. At least 75% of the direct costs in any given year should be used to support CCHD activities at the applicant institution. Costs are expected to decrease in the final years of Phase II, which should be devoted to data analysis and the reporting of results. Although the financial plans of the NCRR and the NIMH 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. ELIGIBLE INSTITUTIONS Applications will be accepted only from RCMI-supported institutions with affiliated medical schools that have not previously received NCRR support for the establishment of a CCHD. Each applicant institution must identify one or more collaborating disease-specific centers supported by the NIH and a network of community health centers. All collaborating institutions must be domestic Federal or non-Federal, public or private, non-profit organizations. Ideally, participating applicant investigators who are already resident at the applicant institution must have completed two or more years of postdoctoral clinical research and must be full-time employees of the applicant institution. All collaborating investigators must be NIH grantees currently supported by R-series, P-series, and/or U-series grants. INDIVIDUALS ELIGIBLE TO BECOME THE PRINCIPAL INVESTIGATOR 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. The PI of the CCHD application must be an established clinical investigator who has demonstrated the administrative abilities to effectively carry out the objectives of the CCHD program and meet its goals. The qualifications of the PI have been previously described. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD: The following Terms of Award are in addition to, and not instead of, otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other DHHS, PHS, and NIH grant administration policies. Cooperative Agreements are subject to the administrative requirements outlined in pertinent OMB, DHHS, PHS, and NIH guidelines, with particular emphasis on DHHS regulations at 42 CFR Part 52 and 45 CFR Part 74. F&A costs are calculated and awarded for cooperative agreement awards the same as for grants. The administrative and funding instrument used for this program is a cooperative agreement (U54), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the grantee is anticipated during performance of the activity. Under the cooperative agreement, the NIH supports and/or stimulates the recipient's activity by being involved in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCRR and NIMH Program Coordinators. These are summarized below: 1. Awardee Rights and Responsibilities a. Awardees will work to establish research priorities within the approved research scope of each CCHD award through discussions with the Division of Research Infrastructure (DRI), NCRR. The Center for Mental Health Research on AIDS (CMHRA), NIMH will provide advice as needed. The NCRR and NIMH reserve the right to include outside consultants/experts in these discussions. Awardees will have primary responsibility for the project as a whole, including research design and conduct, data collection, data quality control, data analysis and interpretation, and preparation of publications, and collaborations with other awardees. Awardees will retain primary rights to the data developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and NIH policies. However, awardees must be committed to making available to the research community the research tools and research materials they develop. b. Awardees agree to follow the advice and recommendations of the Program Advisory Committee, whenever possible, in meeting the intent of this initiative. c. Awardees and each partner in the CCHD should plan regular meetings (no less frequently than monthly) to discuss the progress and directions of its activities and to ensure that the necessary interactions are taking place via teleconferencing, videoconferencing or web conferencing, as well as face-to-face meetings (semi-annually or quarterly). d. The Co-Investigators and other designated investigators from partnering institutions will attend the annual meetings of the CCHD- funded investigators. e. Awardees will submit annual progress reports on behalf of all collaborating entities (including the PAC annual meeting evaluation and recommendations) to the appropriate NCRR Program Official. The progress report describes activities and accomplishments during the previous funding period as part of the non-competing continuation application. The awardee and the NCRR will interact in a cooperative manner throughout the duration of the award to facilitate progress and resolve any problems that may arise. The NIMH will provide advice as needed. Other NIH program staff may participate in establishing research priorities throughout the performance period of the CCHD award. f. Intellectual Property. All Awardees must adhere to the policy for distribution of unique research resources produced with PHS funding, published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 25, No. 23, July 12, 1996). The Guide can be accessed electronically at: http://grants.nih.gov/grants/guide/index.html. All awardees must also adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090). The Principles and Guidelines can be accessed electronically at: http://www.nih.gov/od/ott/RTguide_final.html. "Institution agrees to grant to commercial collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Institution Inventions for research purposes only; and (ii) a time- limited first option to negotiate an exclusive, world-wide royalty- bearing license for all commercial purposes, including the right to sub-license, to all Institution Inventions on terms to be negotiated in good faith by the collaborator and Institution. The collaborator shall notify Institution, in writing, of its interest in obtaining such an exclusive license to any Institution Invention within six (6) months of the collaborator's receipt of notice of such Institution Invention(s). In the event that a collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then the collaborator's option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such Institution Invention in accordance with Institution's policies. If Institution and collaborator fail to reach agreement within ninety (90) days, (or such additional period as collaborator and Institution may agree) on the terms for an exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the Institution Invention to any third party on materially better terms than those last offered to collaborator without first offering such terms to collaborator, in which case collaborator shall have a period of thirty (30) days in which to accept or reject the offer." "Institution agrees that notwithstanding anything contained herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject Inventions as defined in 35 USC 201(e), arising out of any unauthorized use of the collaborator's agent and/or any modifications to the agent, shall be the property of the collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the collaborator in writing of any such Collaborator Inventions and, at collaborator's request and expense, Institution will cause to be assigned to collaborator all right, title and interest in and to any such collaborator inventions and provide collaborator with assignment or other documents. Institution may also be conducting other research using the agent under the authority of a separate Material transfer Agreement (MTA) with the collaborator. Inventions arising there under shall be subject to the terms of the MTA, and not to this clause." g. Protection of Proprietary Data. The ability to publish new results in a timely and intellectually unconstrained manner is fundamental to the academic enterprise. This need must be balanced with the legitimate requirements of commercial collaborators to protect the proprietary or confidential information that they provide concerning their proprietary agents. Commercial collaborators also may require exclusive access to the raw and primary data generated in studies of their agents. Therefore, The NCRR urges that the following statement also be incorporated in Partner applications: "Raw and primary data may be provided exclusively to the NCRR, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators' right to disseminate their research findings through publications or presentations." 2. NCRR Staff Responsibilities The NCRR Program Official will be responsible for normal stewardship of the award and may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative. In addition, the NCRR Program Official, and the NIMH Program Official as needed, will have substantial scientific- programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination as follows: a. Receive information from the PAC and provide advice as necessary. b. Work closely with individual investigators and partners to facilitate collaborations. c. Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by the NIH, industry, private foundations, and other federal funding agencies. d. Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer-reviewed funding mechanisms. e. Interact with each partner, coordinate approaches between partners, and contribute to the adjustment of projects/programs or approaches as warranted. f. Provide assistance in reviewing and commenting on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of this RFA. g. Coordinate activities with other ongoing studies supported by the NIH to avoid duplication of effort and encourage sharing and collaboration in the development of new, clinically useful agents and methodologies. h. Coordinate access to other resources provided by the NIH for pre- clinical and clinical testing. i. Link the approaches developed from these partnerships to each other and to other NIH-supported Centers to ensure that information is shared and utilized on the widest basis possible. j. Help re-program efforts within the peer-reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the time-line for achieving the objectives of the RFA. k. Assist the Program Advisory Committee in the evaluation of new pilot and full projects/ programs when requested as replacements for ongoing activities. l. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success. m. Assist in the organization of an annual meeting that engages all of the partnerships and other participants as needed. This meeting will be held for all CCHD-funded investigators to share progress and research insights that may benefit all of the projects. 3. Collaborative Responsibilities of the Program Advisory Committee A Program Advisory Committee (PAC) must include representation from each partnering institution, and external advisors with the scientific expertise necessary to provide objective advice relative to the CCHD. The committee must be composed of two subcommittees: a) an external committee, and b) an internal committee. Depending on the scope and complexity of the CCHD Program, each of these subcommittees may consist of eight to twelve members. Ideally, the members should be appointed on a rotating basis. The efforts and recommendations of these subcommittees must be coordinated. Meetings of the external subcommittee must be held at least annually; the internal subcommittee must meet at least quarterly. The PAC may establish subcommittees with additional ad hoc advisors in order to meet its planning, priority setting, and evaluation responsibilities. The PAC will serve as the primary advisory board of the CCHD Program and will have the responsibility of developing criteria to be used in establishing priorities, changing directions, approving new faculty recruits within the prioritized areas, and identifying areas of new opportunity based on continuing evaluation. The PI may not be a voting member of the PAC. The PI and NCRR Program Official receive recommendations from the PAC, and provide advice as necessary. The PAC must submit at least one written annual report to the PI and to the NCRR Program Official. These recommendations are to be used by the Principal Investigator to guide and direct the development of the CCHD program. Awardees generally will be expected to accept and implement the recommendations of the PAC; in those situations where the recommendations are not feasible to implement, the Principal Investigator must provide a thorough explanation and rationale to the NCRR Program Official. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIH IC may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Advisory Committee (with the NIH Program Official not voting), a second member selected by the NIH IC, and a third member selected by the other two selected members. This special arbitration procedure is not intended to affect 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 DHHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Shelia McClure Division of Research Infrastructure National Center for Research Resources 6705 Rockledge Drive, Suite 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 451-6536 FAX: (301) 480-3770 E-mail: firstname.lastname@example.org Dr. David M. Stoff Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda MD 20892-9619 Telephone: (301) 443-4625 FAX: (301) 443-9719 E-mail: email@example.com o Direct your questions about peer review issues to: Dr. Eric Brown Scientific Review Administrator National Center for Research Resources 6701 Rockledge Drive, Room 6018 Bethesda, MD 20892-7965 Telephone: 301-435-0815 Fax: 301-480-3660 E-mail: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Ms. Irene Grissom Office of Grants Management National Center for Research Resources 6701 Rockledge Drive, Room 6086 Bethesda, MD 20892-7965 Telephone: 301-435-0844 Fax: 301-480-3777 E-mail: email@example.com Mr. Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-0219 E-mail: firstname.lastname@example.org 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 IC 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: Dr. Eric Brown Scientific Review Administrator National Center for Research Resources 6701 Rockledge Drive, Room 6018 Bethesda, MD 20892-7965 Telephone: 301-435-0815 Fax: 301-480-3660 E-mail: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: The proposed application must be presented in two parts, Phase I and Phase II. Phase I, consisting of up to two years, will be a recruitment phase, whereby staff at the applicant institution will develop and implement plans to recruit the PI and/or other essential scientific personnel; establish institutional and collaborative research links and partnerships; and develop the overall administrative structure of the proposed CCHD Program. Phase I may also include the initiation of developmental clinical research projects by participating investigators. By the end of Phase I, a PI should have been hired and the NCRR, NIMH, or other collaborating Institutes and Centers at NIH, and the PAC should have approved the research plans and budgets for the exploratory prevention/intervention research studies to be conducted during Phase II. Phase II, lasting up to four years, will be a research development phase whereby CCHD research faculty and their collaborators will conduct exploratory studies. These exploratory studies will allow investigators to develop preliminary data necessary to compete for research funding through conventional granting mechanisms (e.g., R- series or P-series). The PI and CCHD research faculty will select, and the PAC will review the Phase II exploratory prevention/intervention research studies prior to implementation. The CCHD application must address the following key elements: 1. Administration o Define the chain of responsibility for decision-making and administration, beginning at the level of the institution's President and including all key staff (e.g., Sponsored Programs Administrator, Department Chair, and Dean). Describe the plans for day-to-day administration of the CCHD, including program coordination, planning, and evaluation. Describe the proposed relationship of the CCHD to the RCMI Clinical Research Infrastructure Initiative (RCRII), Centers of Clinical Research Excellence (CCRE) and other clinical research activities, and explain, in detail, how the CCHD initiative will augment and strengthen the existing research infrastructure. o Identify all support staff (e.g., grants management, administrative, and technical) and outline plans to ensure the timely ordering of research supplies, equipment, and other resources essential to the scientific productivity of the research award. If these resources are provided via an existing RCMI or other awards, they may not be requested in this application. 2. Program Direction/Advisory Committee o Describe a process for the selection and appointment of a CCHD Principal Investigator who has active clinical research funding and research training experience. o Appoint a Program Advisory Committee whose composition consists of clinical investigators whose research experience and expertise complement the research focus of the CCHD. o Develop a plan for up to six years (two years planning; four years research) that includes the proposed organization and component functions of the CCHD. The plan should demonstrate the applicant's knowledge regarding minority health or health disparities, and ingenuity and commitment to developing a productive, competitive clinical research program. The plan should include a timeline that details the specific activities of the CCHD for each year and should describe how the proposed activities enhance the scientific capabilities of faculty and fellows involved in clinical research. o Propose three to five meritorious developmental clinical research projects that are relevant to the focus of the Center. Competitive applications will develop new and/or strengthen existing collaborative projects with NIH/PHS grantees from research-intensive institutions. Applicants must clearly define the nature and extent of the research collaboration, such that the necessary fiscal and scientific aspects are fully explained in the application. o Describe the research and research training goals and capabilities of the proposed CCHD. The Principal Investigator and the PAC must establish a timeline for developmental project investigators to prepare and submit proposals for traditional research grant review during the performance period of the CCHD award. The timeline must require each subproject investigator to submit R-series or P-series type applications by the end of the third year of funding to the investigator. 3. Institutional Commitment/Supporting Infrastructure o Provide evidence that the senior leadership at the applicant institution has addressed issues such as tenure, promotion, release- time, and other personnel matters pertaining to the scientific success of the CCHD. o Include a research plan for up to four years in Phase II that includes the proposed organization and component functions of the CCHD, and demonstrates the institution's commitment to developing a significant and productive research program. o Document evidence of institutional commitment and the availability of technical resources and facilities for the long-term support of the CCHD. Describe features of the institutional environment that are relevant to effective accomplishment of the CCHD overall goals. o Provide a letter of support from a senior institution official (e.g., President or Dean) outlining the commitment of resources and facilities to sustain and support the CCHD throughout the period of funding and beyond the performance period of this award. o Provide a description of the current research infrastructure (laboratory space, clinical facilities, major equipment, research support services, computer resources, patient populations, geographic distributions of space and personnel) and collaborative resources for conducting studies aimed at developing a competitive CCHD. o Delineate needed enhancements to the existing research infrastructure. o Describe previous (past five years) and current research support used for clinical research. 4. Developmental Projects and Research Collaborations o The CCHD must include three to five developmental clinical research projects. These projects should focus on one of the diseases that disproportionately affect the health status of minority populations and addresses the impact of sex and gender differences within these populations. o Projects should be led by a junior investigator who is responsible for insuring that the specific aims of that project are met. For the purpose of eligibility, a junior investigator is defined either as (1) an individual who does not have or has not previously had an external, peer-reviewed research project grant from either a Federal or non- Federal source that names that investigator as the PI or (2) an established investigator who is making a significant change to his/her career. Investigators are required to devote a minimum of 50-percent research effort to their respective projects. With respect to the item (1), grants that name an individual as a co- investigator, collaborator or consultant do not disqualify that investigator. Starter grants (such as NIH's FIRST award mechanism, R29), Academic Research Enhancement Award grants (AREA, R15), or exploratory/pilot project grants (such as NIH R03 or R21 awards) also do not disqualify the investigator. The investigator must hold either a tenure track or non-tenure track faculty appointment of any rank at the time that the award is made. Furthermore, a clear commitment to support this faculty appointment must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status will disqualify that individual and his/her research project from further consideration. With respect to the item (2), support may be provided to an individual who is making a significant change to his/her career goals by initiating a new line of research that is distinctly and significantly different from his/her current investigative program. In this case a current or previous history of independent peer-reviewed research support in a different investigative area from that proposed in this application does not disqualify the investigator. Moreover, this individual can be of any faculty rank. This initiative is not intended to replace support for ongoing investigator-initiated research programs of established investigators, nor are established investigators eligible for support. Instead, established investigators should serve as mentors to advance the junior investigators' careers. o Each project must involve collaboration with an investigator at a research-intensive institution who has an R01 or other similar PHS support. Investigators must clearly define the nature and extent of the research collaboration, by fully explaining the necessary administrative, fiscal, and scientific aspects in the application. o Collaborating investigators must devote a minimum of 15-20 percent research effort to the respective projects. These costs may be paid via a subcontract. o Each project must be presented in the format of an R01 application. The research plan should be limited to 15 pages (a-d in the PHS 398). The maximum allowable direct cost is $200,000 per year/project. These projects must involve clinical investigators at nearby institutions as collaborators. o The application should show clear collaborations between key components within the institution, especially those activities supported via the NCRR Research Centers in Minority Institutions Program, and other NIH- supported programs that may complement the proposed program. If in place, programs such as the RCMI Centers of Clinical Research Excellence (CCRE) grants may complement this CCHD initiative. o The applicant organization should also identify collaborating research institutions and community health centers as partners that may be non-profit organizations, Federal or non-Federal, public or private. Because the applicant institution may need continuous and substantial research collaboration to achieve the objectives of this initiative, the collaborating organizations should be in the U.S., its possessions, or its territories. o Each applicant must provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. ALLOWABLE COSTS: Phase I costs may include the planning and recruitment of essential personnel (e.g., PI) for the administrative activities. The costs for these activities should not exceed 20 percent of the direct costs of $500,000 per year. Other allowable costs include salaries for key research support personnel; equipment and supplies to support the administrative structure; planning and coordination activities for travel of advisory committees; workshops and seminars; consortium interactions; and if appropriate, developmental research projects by participating CCHD faculty. Phase II costs may include funds for the newly hired PI; funds to recruit and support magnet clinical investigators; support for research staff; support for research resources and infrastructure to enhance scientific collaborations; and support for developmental clinical research projects, that should lead to independent research funding for the CCHD investigator. Training and career development activities may also be considered for funding. CONSORTIUM ARRANGEMENTS: When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the CCHD grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the CCHD thematic focus must be evident in the application. Applicants for CCHD grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside of the group at the parent institution. For the purposes of this RFA, Facilities and Administrative (F&A) costs for the consortium organization(s) are excluded from the limit on the amount of direct costs that can be requested for the entire application. Applicants are encouraged to review the NIH policy and procedures applicable to consortium agreements, which are published as part of the NIH Grants Policy Statement, Part III, available on the NIH homepage at http://grants.nih.gov/grants/policy/nihgps_2001?index.htm Questions may be directed to the fiscal contact identified below under Inquiries. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Eric Brown Scientific Review Administrator National Center for Research Resources 6701 Rockledge Drive, Room 6018 Bethesda, MD 20892-7965 Telephone: 301-435-0815 Fax: 301-480-3660 E-mail: firstname.lastname@example.org 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 Center for Scientific Review and responsiveness by the NCRR. Incomplete and/or non-responsive 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 the NCRR 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 Receive a second-level review by an appropriate National Advisory Council or Board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: The review of the CCHD application is based not only on the traditional review criteria for research projects, but also considerers the plans for the recruitment of a Principal Investigator to provide leadership, both scientific and administrative; the plans for establishing thematic collaborative clinical research programs; as well as the feasibility and potential for investigators to become competitive for independent funding. Phase I will be evaluated for appropriate measurable goals and objectives that should be achieved prior to initiating Phase II. Phase I will be evaluated based on the following: o adequacy of the plans to develop the overall administrative structure of the proposed CCHD Program; o the nature, scope, and effectiveness of plans to recruit the Principal Investigator and/or other essential scientific staff; o the nature and effectiveness of plans to establish institutional and collaborative research links and partnerships necessary to achieve program goals; o the need for proposed core facilities or other infrastructure improvements and the effectiveness of these improvements in enhancing the proposed research efforts; Phase II will be evaluated based on the following: o significance, approach, and innovation of the proposed clinical research projects and of the CCHD as a whole; o quality of the career development and mentoring plan for the junior investigators in the center; o the ability to augment and strengthen the institutional clinical research capacity; o evidence of collaborations with other NIH -supported disease specific research centers and with community health centers; o adequacy of the plans for the dissemination of research results; o the evaluation strategies, with specific milestones, to measure progress in attaining long-range goals; The following criteria will be used to evaluate the 1) administration and overall potential for strengthening the institutional clinical research capabilities; 2) program direction and advisory committee structure; 3) institutional commitment and supporting infrastructure; and 4) scientific merit of collaborative clinical research projects. 1. Administration o The chain of command in the administration of the grant and the Center; o The day-to-day administration of the Center, coordination of research activities and planning; o The plans for the establishment and utilization of the support structures (grants management, administrative, technical) to provide resources essential to carry out the scientific projects; o The relationship of the proposed program to the already existing RCMI, RCRII, and CCRE, as applicable; o The evaluation strategies, with specific milestones, to measure progress in attaining long-range goals. 2. Program Direction/Advisory Committee o The qualifications and track record of the proposed CCHD Principal Investigator; his/her experience and publication record in clinical research as a funded clinical investigator; previous experience as mentor of junior investigators; and the administrative qualifications to direct the Center; o Institutional plans for the recruitment of a Principal Investigator for the CCHD during Phase I, including a description of the qualifications, roles and responsibilities of the CCHD Principal Investigator; a timeline for the recruitment efforts; and criteria used in the selection process. o Selection and appointment of members of the PAC; the proposed oversight role of the PAC in the functioning of the Center 3. Institutional Commitment/Supporting Infrastructure o Documentation of institutional endorsement of the proposed plan, including a letter of support from a senior institutional official; features of the institutional environment that are relevant or unique in assuring the success of the program; o Existing research infrastructure (e.g. laboratory space, equipment, clinical facilities, computer resources) and its commitment to the proposed CCHD program that would facilitate and support the proposed clinical research; o Justification for any proposed infrastructure enhancement; o Availability of patient population and plans for patient recruitment. 4. Overall Program Quality o Past and current clinical research support, including institutional grant support for clinical research; o Recruitment of senior clinical investigators who would facilitate the development of clinical research on diseases that have a disproportionate effect on minority populations; o Research training or career development goals and capabilities of the CCHD. The potential for enriching the academic and intellectual milieu for doing clinical research and the feasibility and potential for junior investigators to gain scientific independence under the mentorship of senior clinical investigators; o The proposed research plan and plans to prepare junior investigators to write their own grant proposals and become independent investigators. 5. Collaboration o Evidence of existing collaborative research links and partnerships or plans to establish such links and partnerships during Phase I; o The strength of the relationship between the applicant investigators and collaborating researchers, particularly the academic qualifications, research experience, expertise, and research productivity of the collaborators; o The administrative and fiscal relationships between the applicant investigators and collaborating researchers; o The importance and relevance of each collaborative project to the achievement of CCHD program objectives. 6. Developmental Projects Bearing in mind that the proposed research projects are exploratory studies for which significant amounts of preliminary data may not be available, the reviewers will evaluate these projects using the standard NIH review criteria (described under the review criteria section of this RFA). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 17, 2003 Application Receipt Date: April 16, 2003 Peer Review Date: June 25, 2003 (subject to change) Council Review: September 11, 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include the following: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and Phase II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects, unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10 _2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH- defined Phase III clinical trials consistent with the new PHS form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for Federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding. (See http://escr.nih.gov.) It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds, and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. The NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures, given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review, because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.389, Research Infrastructure and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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