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 
http://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: 
http://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 
http://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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted 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: http://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: 
http://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:
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.

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 http://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 301/435-0714, 
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 
http://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 
http://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: 
http://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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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