Full Text PAR-95-078

SMALL GRANTS FOR CLINICAL TRIALS IN DIGESTIVE AND NUTRITIONAL DISORDERS

NIH GUIDE, Volume 24, Number 27, July 28, 1995

PA NUMBER:  PAR-95-078

P.T. 34

Keywords: 
  0755915 
  Digestive Diseases & Disorders 
  Nutrition/Dietetics 
  Obesity 
  Disease Prevention+ 


National Institute of Diabetes and Digestive and Kidney Diseases

PURPOSE

The Division of Digestive Diseases and Nutrition (DDDN), National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
announces a small grants program to encourage the submission of small
grant applications for clinical trials relating to digestive diseases
and nutritional disorders.  These clinical trials may use
pharmacologic, dietary, surgical, or behavioral interventions given
for disease therapy or prevention. New and experienced investigators
in relevant fields and disciplines (clinical and surgical) may apply
for small grants to test new treatment strategies or do pilot
clinical studies or plan a larger clinical trial.  Investigators are
encouraged to take advantage of recent laboratory developments.

Areas of special interest are obesity, eating disorders and other
nutritional disorders; Helicobacter pylori and dyspepsic conditions;
gastroesophageal reflux disease and Barrett's esophagus; biliary
atresia and neonatal hepatitis; primary biliary cirrhosis, autoimmune
hepatitis, sclerosing cholangitis; inflammatory bowel disease (IBD),
irritable bowel syndrome (IBS); gallstone disease; and chronic
pancreatitis.

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,
Small Grants for Clinical Trials in Digestive Diseases, is related to
the priority area of chronic disabling conditions.  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 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  An application may be
from one institution or several institutions (collaborating
institutions or consortia), if appropriate.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.

MECHANISM OF SUPPORT

Support for this Program Announcement will be through the NIH small
grants (R03) mechanism.  However, specific application instructions
have been modified to reflect streamlining efforts being examined by
the NIH.  It is hoped that these changes will relieve the burden for
the applicants, reviewers, and institute staff.

The small grants research program provides limited funds (maximum of
$50,000 direct costs per year) for short-term (up to two years)
research projects.  Only limited budget information will be requested
and the Initial Review Group can make budget recommendations
concerning level of effort (e.g., if the IRG recommends reduction of
personnel, those funds could be shifted to other categories).
Instructions for completing the Biographical Sketch have also been
modified.  In addition, Other Support information and the application
Checklist page will be requested by NIDDK Staff only if and when an
application is considered for an award.  The APPLICATION PROCEDURES
section of this PA provides specific details of modifications to
standard application instructions.

These grants are non-renewable, but continuation of projects
developed under this program can be supported by the regular research
project grant (R01) program.  Applicants will be responsible for the
planning, direction, and execution of the proposed project.
Applications submitted in response to this PA will compete for funds
with all other R03 and regular research project (R01 and R29) grant
applications assigned to NIDDK.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator should be included
with the application.

Applicants are encouraged to collaborate with the Directors of the
Silvio O. Conte Digestive Diseases Centers, Clinical Nutrition
Research Centers, and Obesity/Nutrition Research Centers for
consultation in experimental design, intervention, and methodology,
as well as use of core facilities appropriate for carrying out the
proposed projects.  Information describing the centers and their
cores may be requested from the person listed under INQUIRIES.

The award of grants in response to this PA is also contingent upon
the availability of funds.  Awards will be administered under PHS
grants policy as stated in the PHS Grants Policy Statement (rev.
4/94).

Projects with substantial scientific merit that are not funded by the
NIDDK are eligible for support by the American Digestive Health
Foundation (ADHF).  Principal investigators will be responsible for
forwarding copies of their summary statements and applications to the
ADHF for consideration for award.  The amount of ADHF support will be
determined by project scope, and duration of funding will be limited
to two years.  No funds for indirect costs will be provided.

RESEARCH OBJECTIVES

Background

The NIDDK supports an extensive network of clinical and laboratory
research studies related to digestive diseases and nutritional
disorders, mostly through the R01 and R29 funding mechanisms.  At
present, there is no mechanism targeted to stimulate the
communication of promising and potentially relevant new developments
from the laboratory to the clinical setting.  There is a need for a
mechanism to fund short-term studies and obtain preliminary clinical
data rapidly.  It is expected that these R03 grants will serve as a
basis for planning future clinical research project grant
applications (R01) or cooperative clinical trial group studies.

The small grants (R03) mechanism provides research support
specifically limited in time and amount for studies in categorical
program areas (see Research Goals and Scope).  Small grants provide
flexibility for initiating preliminary, short-term studies and are
non-renewable.  Furthermore, the time interval from application to
funding is shortened under the R03 mechanism, thus allowing new ideas
to be investigated in a more expeditious manner.  Support is needed
to encourage new as well as experienced investigators to apply new
treatment approaches.

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 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 applications 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.

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,
National Institute of Health, 6701 Rockledge Drive, Room 3034, MSC
7762, Bethesda, MD 20892-7762, telephone 301/710-0267.  The title and
number of this program announcement must be typed in Item 2 on the
face page of the application.

Applications will be accepted at the regular application deadlines
indicated in the application kit.  The receipt dates for applications
for AIDS-related research are found in the PHS 398 (rev. 5/95)
instructions.

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)

Special Instructions for Completion of PHS 398 Application

The NIH has been designated a "reinvention laboratory" by the Public
Health Service.  One effort to streamline NIH operations is to
simplify the grant application and review process.  Therefore, an
experiment is being conducted to test ways to reduce the
administrative burden of applying for an NIH grant without
compromising those elements needed by the initial scientific peer
review group to assess the scientific merit of the application and
the reasonableness of the proposed budget.

The following are specific instructions for sections of the PHS 398
application form (rev. 5/95) that should be completed differently
from usual, in response to this PA.  Some sections are modified, and
others do not need to be completed for the submission of the
application, but WILL be requested if the application receives a
priority score in the fundable range.  For items in the application
not identified here, follow the instructions on pages 5-20 of the PHS
398 booklet.

FACE PAGE (Form AA) - The title and number of the PA must be typed in
Item 2.  Failure to do so could result in delayed processing of the
application such that it may not reach the review committee in time
for review.

FORM DD - PAGE 4 - DETAILED BUDGET PAGE FOR INITIAL BUDGET PERIOD

Enter the following information without the associated costs:

o  Only personnel and level of effort of each should be itemized in
the Personnel section.

o  In addition, list consultants, equipment, supplies, travel
(especially for personnel assisting in preparation of the Manual of
Procedures), patient care activities, and other items as appropriate.

However, the costs associated with the individual items or categories
must not be listed.  Enter only the total direct costs.

Applications that do not conform to these special instructions will
be returned to the applicant without further review.

Form EE - Page 5 -  BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD - Do
not complete this page.  The budget for the second year will be the
same as that for the first year.

Form FF - Page 6 -  BIOGRAPHICAL SKETCH - For each KEY person only,
provide a two-page biographical sketch.  Name, Position Title,
Education - Identify the research background and experience relevant
to the research proposed.  Specifically, provide:

o  A list of previous research positions that are felt to be of
significance or relevance for the review of the proposed research;

o  Complete references, titles, and authors on all peer-reviewed
publications representative of the research career or pertinent to
the research proposed of each key person.

o  The title and funding source of all active research grants or
contracts on which each key person is principal investigator, co-
investigator, or project leader.  Indicate current percent effort for
each award.

o  The title and length of service on any peer review group, council,
or program advisory committee.

The purpose of this section is to demonstrate the professional
credentials of the organizers, as briefly as possible, indicating
experience in such areas as:

o  The problem under study
o  Clinical trial administration
o  Methodology
o  Adequate and similar patient recruitment potential
o  The proposed procedures.

o  Professional credentials of the participating center investigators
in the clinical problem and in clinical trial participation.
Verification of the cooperating investigators and their institutions
will be required later, if the application is considered for funding.

Form GG - Page 7 -  OTHER SUPPORT - Do not complete. Other Support
information relevant to the proposed research may be included in the
Biographical Sketch as indicated above.  Current information will be
requested by NIDDK staff from only those applicants being considered
for funding.

Form HH - Page 8 -  RESOURCES - Complete item(s) only if proposed
research requires specialized resources unique for the proposed
research.

RESEARCH PLAN (Booklet Pages 15-19)

 - Applications in response to this PA should be concise and
substantially shorter than regular research project grant
applications.  Items a-d may not exceed a total of 16 pages.

(a) - Specific Aims - Within one page, list in order of priority, the
broad, long-range objectives.  Describe concisely and realistically
the hypothesis to be tested and what the specific research described
in this application is intended to accomplish.

(b) - Background and Significance - Within three pages, describe (1)
how the proposed research will contribute to meeting the goals and
objectives of the PA; and, (2) explain the rationale for the
selection of the general methods and approaches proposed to
accomplish the specific aims.

(c-d) - Preliminary Studies/Progress Report, Research Design and
Methods - Within twelve pages, complete as instructed on pages 16-17
of the PHS 398 (rev. 5/95) booklet, that with the modification that
the clinical protocol(s) and up to three publications, manuscripts
submitted or accepted for publication, patents, or invention reports
can be included in the Appendix (see below).

The investigator may use this section to address, even though
briefly, issues such as the following:

o  Merit of the study design.

o  Appropriateness of intervention groups.

o  Plans to minimize bias through randomization, stratification,
choice of controls, and masking of treatment or results.

o  Identification of appropriate primary and secondary outcomes for
the trial.

o  Recognition of possible problems inherent in the design and the
adequacy of plans for dealing with them.

o  Quality of plans (even if broadly described) for recruitment and
retention of patients, identification of eligibility and exclusion
criteria, and standardization and maintenance of quality control
among participating centers.

o  Patient protection, including informed consent and monitoring data
for safety and efficacy.  Plans for early termination if it becomes
necessary.

o  Documentation of potential availability of patients at each of the
participating centers.

o  Plans for the preparation of a Manual of Procedures that must be
submitted with any future application for support of the actual
conduct of the randomized controlled trials.

o  Preliminary studies pertinent to the application;

o  The study group's suitability for providing the necessary
supporting data for preliminary studies.

o  The feasibility of the study group, particularly in conducting
preliminary studies.

o  Rationale and hypothesis for the clinical trial and laboratory
studies such as the following:  Clinical importance of the disease or
condition being studied, rationale for therapy being applied, ethical
considerations of treatment.

o  General methods that will be utilized; provide specific details
for those techniques that are unique or where a significant departure
from a generally accepted technique is important for reviewers to
know;

o  Plans for the rigorous data management and verification of
research data including rationale and validity of sample size and
general methods to be used for data analyses.

o  Potential pitfalls in the experimental design and alternative
studies that will be done if the proposed experiments fail.

(e-f) - Human Subjects, Vertebrate Animals - Complete as described on
pages 17-18.  State clearly the plans for early detection of and
protection against adverse effects on human subjects.

(g) - Literature Cited - Within two pages, give full literature
citations including the title of each article.

(h) - Consortium/Contractual Arrangements - Within one page, provide
a brief explanation of the programmatic, fiscal, and administrative
arrangements made with collaborating organizations.

(i) - Consultants - Biographical sketches should conform to the brief
format described previously for key personnel on Form FF.

APPENDIX (Page 19) - Up to three publications, manuscripts submitted
or accepted for publication, patents, and invention reports should be
provided.  Clinical protocol(s) must be included in this section.
Other than this change, complete as instructed.

CHECKLIST (Form II and JJ) - Do not complete.  Information will be
requested by NIDDK staff from only those applicants being considered
for funding.

If the applicant or the institutional business office has any
questions regarding these instructions, contact the program staff
listed under INQUIRIES.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit by an appropriate peer review group convened by
the NIDDK, 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 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.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to the NIDDK.  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.  Administrative
suggestions for preparing an R01 clinical trial grant application
that include review criteria for full-scale clinical trials are
available.  These could be useful in preparing the small grant
application because the proposed research may be the first phase of a
subsequent larger full-scale clinical trial.

Direct inquiries regarding programmatic issues to:

Ms. Tommie Sue Tralka
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases 45
Center Drive, Room 6AN/12K - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8879
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Sharon Bourque
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases 45
Center Drive, Room 6AS/49H - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8846
Email:  [email protected]

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 routing 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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