MINORITY ORGAN AND TISSUE DONATION Release Date: September 27, 2001 RFA: RFA-DK-02-019 (See Notice NOT-DK-06-019) NIDDK intends to reissue this FOA, it is expected to be published in November of 2006. National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) Letter of Intent Receipt Date: November 1, 2001 Application Receipt Date: December 13, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT https://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites investigators to apply for a grant to develop educational programs to increase the number of organs and tissue donated for transplantation in racial and ethnic minority communities, and other underserved populations. This RFA is intended to stimulate investigators to develop educational programs to improve understanding and the benefits of organ and tissue transplantation, and the need, especially in racial and ethnic minority communities, and other underserved populations to participate in giving organs and tissues for transplantation. The grant will provide support for the development of educational programs in the relevant communities to promote health, to enhance understanding of organ and tissue donation, and to initiate programs that will lead to increased participation in the process of donation. This RFA is based on recommendations made by investigators and community leaders, and through comments provided on the NIDDK strategic plan to reduce and eliminate health disparities in racial and ethnic minority communities. Subsequently, the National Advisory Council of the NIDDK approved the concept. 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 Request for Applications (RFA), MINORITY ORGAN AND TISSUE DONATION, 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/. ELIGIBILITY REQUIREMENTS Any investigator at a domestic institution capable of supporting the program may submit applications. Faith-based organizations are eligible to apply for these grants. Racial and ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Program Directors and/or to be included on the research team. Prospective applicants should also consult the NIH granting mechanisms and guidelines for more information at: https://grants.nih.gov/grants/oer.htm MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. The process of planning, direction, and execution of the proposed project will be the responsibility of the applicant. The program award provides support up to five years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at https://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE A total budget for FY 2001 of approximately $1,000,000 will be committed to fund applications submitted in response to this RFA. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. The maximum allowable requested annual direct cost per application is $150,000. It is anticipated that approximately 5 awards will be made in FY 2002. The anticipated award date is July 1, 2002. OBJECTIVES Background Racial and ethnic minorities, particularly African American, American Indians, Alaskan Natives, and Hispanic Americans, are disproportionately afflicted with end-stage renal disease (ESRD). Although transplantation is the preferred renal replacement therapy because of the improved survival and improved quality of life for successful transplant recipients, these racial and ethnic minority groups are less frequently transplanted. A frequently cited reason for the lower transplantation rate in these minority groups is that their organ donation rate is much lower than their representation in the ESRD patient population, and that with increased number of minority organs in the pool, there would be a better match, and ultimately, better graft survival. Over the past 5 – 8 years, several programs have been initiated to increase minority organ and tissue donation. The NCMHD/NIDDK funded Minority Organ and Tissue Transplant Education Program (MOTTEP) was established in which intensive educational and information activities have occurred in 15 cities across the US. During the same period, the Department of Health and Human Services has intensified educational and information programs throughout the USA through the Organ and Tissue Donation initiative. Perhaps as the result of these combined efforts, organ and tissue donation has increased, especially in the minority communities. However, the rate of organ and tissue donation from minorities is lower than their representation in the population with organ failure, especially, ESRD. By increasing the educational activities in the racial and ethnic minority communities, as well as in underserved populations, this will enhance their proportion of organs in the pool, and hence increase the chances of a better match and improved graft survival. Program The program is intended to create an environment supportive of organ donation by: 1. increasing exposure to donation messages and opportunities to express donation commitments. This could be accomplished through a) increasing exposure in national and local media, b) increasing community interventions (at schools, churches, etc.), c) increasing promotion of organ donation through health promotion and disease prevention efforts, and d) disseminating and replicating best practices identified through research and evaluation; 2. evaluating the impact of increased support for living organ donation (e.g., provisions to cover child care, travel, and other expenses for living donors) 3. increasing minority cadaveric and living organ donation; and 4. increasing donation from non-traditional donors (older donors, living donors, etc.) SPECIAL REQUIREMENTS Critical elements of the Program Plan include the qualifications of the Program Director, the Institutional Environment, and the proposed plan for developing the relevant message for increased awareness for the need for increased organ and tissue donation. The applicant must address the REVIEW CRITERIA listed in this RFA. Program Director: The Program Director should possess the expertise, leadership and administrative capabilities required to lead the educational objectives described in this RFA. Institutional Environment: The Program Director should document the institutional environment for developing the relevant educational program. The Program Director may bring in consultants from other institutions. Potential collaborations with other institutions and/or investigators should also be documented. Plan: The Program Director should describe a plan for developing the educational program as described in this RFA. This should include any proposed use of existing resources, building partnerships with other institutions, use of consultants, and plans for critical review of the program. 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 are 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 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 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 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone, FAX, and E-mail numbers of the Program Director, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 NIH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch, National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 2 Democracy, Room 752, MSC 5452 6707 Democracy Boulevard Bethesda, Maryland 20892 Telephone: (302) 594-8885 FAX: (301) 480-3505 E-mail: fc15y@nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. It is strongly recommended that prospective applicants contact the staff person listed under INQUIRIES early in the planning phase of the grant application. Such contact will help ensure that applications are responsive to the overall intent of this award. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at https://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW (CSR) 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: Francisco O. Calvo, Ph.D. Chief, Review Branch, National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 2 Democracy, Room 752, MSC 5452 6707 Democracy Boulevard Bethesda, Maryland 20892 Telephone: (302) 594-8885 FAX: (301) 480-3505 E-Mail: fc15y@nih.gov Applications must be received by the application receipt date of December 13, 2001. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by Institute staff. 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 NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIDDK Advisory Council. Review Criteria The review criteria for the Minority Organ and Tissue Donation Education Program are as follows: o administrative, leadership qualifications and experience of the Program Director. o adequacy and availability of any necessary institutional facilities and resources. o adequacy of the plan for developing a relevant and culturally sensitive educational program in racial and ethnic minority communities, including use of existing resources, building partnerships with other institutions, and the use of consultants. o plans for critical review of the impact of the program on awareness and increased organ and tissue donation. o documentation of potential participants for the educational program. Schedule Letter of Intent Receipt Date: November 1, 2001 Application Receipt Date: December 13, 2001 Peer Review Date: March-April, 2002 Council Review: May 30-31, 2002 Earliest Anticipated Start Date: July 01, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific and educational merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Lawrence Agodoa, M.D. Director, Office of Minority Health Research Coordination National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 2 Democracy, Room 653 6707 Democracy Boulevard Bethesda, Maryland 20892-5454 Telephone: (301) 594-9652 FAX: (301) 594-9358 E-mail: la21j@nih.gov Direct inquiries regarding financial matter to: Trude Hilliard Grants Management Specialist, DEA National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 2 Democracy, Room 717, MSC 5456 6707 Democracy Boulevard Bethesda, Maryland 20892 Telephone: (301) 594-8859 FAX: (301) 480-4237 E-mail: th105x@nih.gov Direct inquiries regarding review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch, National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 2 Democracy, Room 752, MSC 5452 6707 Democracy Boulevard Bethesda, Maryland 20892 Telephone: (301) 594-8885 FAX: (301) 480-3505 E-mail: fc15y@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of title III, Section 301 of the Public Health Service Act as amended. The Code of Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 are applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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