Full Text PA-95-088

ETIOLOGY AND PREVENTION OF GALLSTONES DURING PERIODS OF HIGH RISK

NIH GUIDE, Volume 24, Number 32, September 1, 1995

PA NUMBER:  PA-95-088

P.T. 34

Keywords: 
  Digestive Diseases & Disorders 
  Etiology 
  Disease Prevention+ 


National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The purpose of this Program Announcement (PA) is to encourage
research into the etiology and prevention of gallstone formation
during periods of high risk.  Applications are encouraged that range
from careful prospective studies of the mechanisms of gallstone
formation in humans to clinical trials aimed at the prevention of
gallstones.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
in a PHS-led national activity for setting priority areas.  This PA,
Etiology and Prevention of Gallstones During Periods of High Risk, is
related to the priority areas of chronic disabling conditions and
nutrition.  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.  Applications from
minority individuals and women are encouraged.

MECHANISM OF SUPPORT

Support for this Program Announcement will be through the NIH
research project grant (R01) and FIRST awards (R29).

RESEARCH OBJECTIVES

Gallstones are a highly prevalent condition, responsible for over
half a million cholecystectomies in the U.S. each year.  It has been
suggested that persons with recently formed gallstones are at more
risk of symptomatic illness than persons who have had gallstones for
years.  The following are among the situations that acutely increase
the risk of gallstones:  (1) substantial, rapid weight loss, (2)
pregnancy, (3) total parenteral nutrition, (4) major abdominal
surgery, (5) treatment with the somatostatin analogue octreotide, and
(6) the period following dissolution of gallstones.  Prevention of
gallstone formation in these situations could eliminate a substantial
portion of symptomatic gallstone disease.

Despite the general acceptance that gallstone formation is caused by
defects in hepatic cholesterol processing, nucleation in the
gallbladder, and gallbladder motility, these and other factors have
not been systematically and prospectively evaluated in humans.
Situations in which the risk of gallstone formation is high and
well-defined lend themselves to the prospective study of gallstone
pathophysiology.  It is likely that the study of the process of
gallstone formation in humans at high risk would lead to effective
prevention strategies, and thus, eliminate the substantial morbidity
associated with the formation of gallstones.  Studies that would
better define the risk of gallstones in high risk populations are
also encouraged.  In addition, clinical trials that address safe and
cost-effective measures for the prevention of gallstones are
encouraged.  For clinical trials, administrative suggestions for
preparing an R01 clinical trial grant application are available (see
INQUIRIES).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy 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
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 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 applications proposing
research involving human subjects should read the "NIH Guidelines for
Inclusion of Women and Minorities as subjects in Clinical Research"
that were 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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  Application kits are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grants Information, Division of Research Grants, 6701
Rockledge Drive Suite 3032, MSC 7762, Bethesda, MD 20892-7762,
telephone 301/710-0267.  The title and number of this program
announcement must be typed in Section 2 on the face page of the
application.

For investigators applying for support through the FIRST award
mechanisms (R29), three letters of references must be submitted with
the application.  An applicant submitting a revised application in
response to this RFA must again submit reference letters.

Applications will be accepted at the regular application deadlines as
indicated in the application kit.  The receipt dates for applications
for AIDS-related research are also found in the PHS 398 instructions.

The completed original application and five legible copies must be
sent or delivered to:

OFFICE OF GRANTS INFORMATION
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 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 PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national
advisory council.

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 sexes 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.

AWARD CRITERIA

For other than clinical trials, applicants must limit their R01
requests to not more than $150,000 in direct costs for the first year
budget period.  For clinical trials the direct cost may not exceed
$500,000 for the first budget period.

Applications will compete for available funds with all 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.  For clinical trials,
administrative suggestions for preparing an R01 clinical trial grant
application are available.

Direct inquiries regarding programmatic issues to:

James Everhart, M.D., M.P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AN-12J
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8878
FAX:  (301) 480-8300
Email:  vjy@cu.nih.gov

Direct inquiries regarding fiscal matters to:

Mrs. Thelma Jones
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AS-44B
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8853
FAX:  (301) 480-3504
Email:  jonest@ep.niddk.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.848.  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 the PHS
mission to protect and advance the physical and mental health of the
American people.

.

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