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.