Full Text PA-96-062
 
RESEARCH ON HIV INFECTION IN THE GENITOURINARY TRACT
 
NIH Guide, Volume 25, Number 22, July 5, 1996
 
PA NUMBER:  PA-96-062
 
P.T. 34

Keywords: 
  AIDS 
  Biology, Cellular 
  Biology, Molecular 
  Urogenital System 

 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
 
PURPOSE
 
The Division of Kidney, Urologic, and Hematologic Diseases of the
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the National Institute of Child Health and Human
Development (NICHD) solicit research grant applications for support
of studies focused on infections of the Human Immunodeficiency
Viruses (HIV) and the effects of such infections on the genitourinary
tract.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  Potential
applicants may obtain a copy of "Healthy People 2000 (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock
No.017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government. Foreign
institutions are not eligible for First Independent Research Support
and Transition (FIRST) (R29) awards. Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.
 
MECHANISM OF SUPPORT
 
This Program Announcement (PA) will use the National Institutes of
Health (NIH) individual research project grant (R01) and FIRST (R29)
award mechanisms.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Because the nature and scope of the research proposed in
response to this PA may vary, it is anticipated that the size of an
award will vary also; however, the support of requests exceeding the
NIDDK average grant size of $160,000 direct cost for R01 grants would
be unusual and require ample justification. FIRST (R29) awards are
limited to $350,000 direct cost over the five year period.
 
RESEARCH OBJECTIVES
 
The purpose of this program announcement is to solicit applications
in order to support cellular and molecular studies which focus on the
effects of the HIV infection on the genitourinary tract.  Such
studies might include for example: tissues/fluid/secretions involving
the urine, semen, bladder, urethra, prostate, testes, seminal
vesicles, and epididymides.  Broad areas for investigation could
include the location of the HIV in such tissues and the effect(s) of
the HIV infection on the cellular structure/function of these
tissues.  It is also of interest to study the effectiveness of
pharmacological therapy on eradicating HIV infection in these tissues
and to study the pathogenesis and treatment of urological disorders
secondary to HIV infection. Studies that focus on the effect(s) of
HIV infections on the physiology of the genitourinary tract as
monitored by established clinical methodologies such as urodynamics,
radiographic and sonographic technologies are encouraged. The various
factors that influence the genitourinary manifestations of HIV
infections need to be elucidated as well as the effects on the
function(s) of the genitourinary tract as a result of the various
treatment modalities for HIV.
 
Applications for clinical studies in urodynamics and urinary tract
infections that have no relationship to HIV infection are not
requested.  Program project grant applications (P01) are not suited
to this announcement.
 
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 subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This new policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
 
Animal Welfare Considerations
 
Investigators are encouraged to consider alternative methods and
approaches in their research grant applications that do not require
the use of whole animals, use alternative species such as nonmammals
or invertebrates, reduce the number of animals required, and
incorporate refinements to procedures that will result in the
elimination or further minimization of pain and distress in animals.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, email: asknih@odrockm1.od.nih.gov.
 
The program announcement title and number must be typed on line 2 of
the face page of the application form and the YES box must be marked.
 
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application. FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
Potential R29 applicants should refer to the notice on Just-in-Time
Procedures for FIRST and Career Awards (NIH Guide for Grants and
Contracts, Vol. 25, No. 10, March 29, 1996) for information on recent
changes in guidelines for FIRST award format.
 
The completed original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines.  Applications that are complete
will be evaluated for scientific and technical merit by an
appropriate peer review group convened in accordance with NIH peer
review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the appropriate national advisory council or board.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects, and the safety of the
research environment.
 
For Applications from Foreign Organizations:
 
o  availability of special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries that are not readily
available in the United States or that provide augmentation of
existing U.S. resources.
 
AWARD CRITERIA
 
Applications will compete for available funds with other approved
applications.  The following will be considered in making funding
decisions:
 
o  Quality of the proposed project as determined by peer review;
o  Availability of funds;
o  Program priority.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome. Direct inquiries
regarding programmatic issues to:
 
Ralph L. Bain, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-19B MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7717
FAX:  (301) 480-3510
Email:  Ralph_Bain@nih.gov
 
Donna L. Vogel, M.D., Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
Building 61E, Room 8B01 MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-6515
FAX:  (301) 496-0962
Email:  Vogeld@hd01.nichd.nih.gov
 
Inquiries regarding fiscal matters may be directed to:
 
Trude Hillard
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AN-44J, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8859
Email:  HillardT@ep.niddk.nih.gov
 
Melinda Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-5481
FAX:  (301) 402-0915
Email:  Nelsonm@hd01.nichd.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.849 and 93.864.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74. 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 and contract 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 PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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