Full Text PA-96-024
 
NIDCD PROGRAM FOR POSTDOCTORAL RESEARCH TRAINING IN CLINICAL TRIALS
 
NIH GUIDE, Volume 25, Number 3, February 9, 1996
 
PA NUMBER:  PA-96-024
 
P.T. 44

Keywords: 
  Biomedical Research Training 
  Clinical Trial 

 
National Institute on Deafness and Other Communication Disorders
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders
(NIDCD) invites applications for the support of Institutional
National Research Service Award (NRSA) (T32) programs of postdoctoral
research training in the design and conduct of clinical trials for
individuals trained in the clinical disciplines of human
communication.  The purpose of this initiative is to foster the
development of trained professionals into independent investigators
capable of conducting clinical trials of the efficacy of treatment
for diseases and disorders affecting hearing, balance, smell, taste,
voice, speech, or language.
 
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.  This Program
Announcement (PA), NIDCD Program for Postdoctoral Research Training
in Clinical Trials, is related to the priority areas of clinical
prevention services.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-11474-0 or
Summary Report:  Stock No. 017-001-11473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC  20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications will be accepted from non-profit domestic public and
private institutions, such as schools of public health, universities
and research institutions.  Consortia arrangements are encouraged.
 
The trainees appointed under this training program must hold a
clinical doctoral degree (e.g., M.D., D.D.S., Ph.D. in a clinical
discipline, or comparable doctoral degree) from an accredited
domestic or foreign institution and have completed postgraduate
clinical training with specialty emphasis in one or more areas of
human communication, such as diseases and disorders of hearing,
balance, smell, taste, voice, speech or language.  In the case of
Ph.D.-level health professionals trained in the disciplines of human
communication, such as speech pathology, language pathology and
audiology, clinical training may have preceded the completion of the
doctoral degree.  Ideally, the trainees will have had prior
experience in clinical research.
 
MECHANISM OF SUPPORT
 
The support mechanism for grants made in response to this PA will be
the NIH Institutional National Research Service Award (NRSA) (T32),
often referred to as the institutional training grant.  The
provisions of this mechanism are detailed in the NIH-wide
announcement for NRSA Institutional Research Training Grants (T32),
published in the NIH Guide for Grants and Contracts, Vol, 23, No. 21,
June 3, 1994, and apply to this initiative, except as noted in this
program announcement.  The NIH-wide announcement is available 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:  girg@drgpo.drg.nih.gov.
 
RESEARCH OBJECTIVES
 
Background
 
The need to increase the number of clinical investigators in the
United States capable of transferring scientific knowledge from the
laboratory to the clinic has been underscored by several National
Institutes of Health (NIH) advisory groups and in recent reports from
the Institute of Medicine and the National Research Council.
Furthermore, the need for clinical trials addressing diseases and
disorders affecting human communication has been highlighted in all
sections of the National Strategic Research Plan published recently
by NIDCD.  This program announcement (PA) is one of several NIDCD
initiatives to address this public health need for clinical research
in human communication.  Another initiative is a Request for
Applications (RFA) issued on September 29, 1995 (NIH Guide for Grants
and Contracts, Vol. 24, No. 34), offering support for Clinical Trials
Cooperative Groups to conduct efficacy studies of new and improved
treatments for diseases and disorders affecting human communication.
 
The objective of this program is to train clinical investigators in
the development, conduct and interpretation of clinical trials in
order that they may function effectively as members of clinical
trials teams and eventually be capable of directing single- and
multicenter cooperative clinical trials of the efficacy of treatments
for diseases and disorders affecting human communication.  The
training program will provide each trainee with two years of
full-time research training, including didactic instruction,
mentoring, and supervised research experience in the conduct of a
clinical trial or trials of the efficacy of therapeutic approaches to
human disease.  The clinical trial of treatment efficacy in which the
trainee receives practical experience need not be in a disease or
disorder affecting hearing, balance, smell, taste, voice, speech or
language.  Plans must be presented for each trainee to be guided by a
qualified preceptorial team experienced in the conduct of clinical
trials.
 
Training should include, but not be limited to, instruction in the
following areas:  (1) clinical trials design and conduct; (2)
biostatistics; (3) data management and analysis; (4) epidemiology;
(5) experimental therapeutics; (6) reporting results of controlled
clinical trials; and (7) bioethics and the responsible conduct of
research, with emphasis on clinical trials.
 
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
be familiar with the "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which was reprinted in
the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct
typesetting and errors in the earlier publication, and reprinted in
the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994. 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
 
Applicants may request up to five years of support through the T32
mechanism. The number of full-time postdoctoral training positions
requested should be justified by the applicant.  Short-term research
training positions may not be requested through this PA.
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications 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:  girg@drgpo.drg.nih.gov.  The title and number of this program
announcement must be typed in Section 2 on the face page of the
application.
 
The completed original application and four legible copies must be
sent or delivered by May 10 of each year 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)
 
To ensure that the application is received in sufficient time for
the review, send one copy of the application to:
 
Acting Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard MSC-7180
BETHESDA, MD  20892-7180
 
REVIEW CONSIDERATIONS
 
Applications that are complete and responsive to this PA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCD in accordance with NIH peer review
procedures and criteria for T32 applications.  All applications
judged to be competitive during the initial merit review will be
discussed, assigned a priority score and receive a second level
review by the National Deafness and Other Communication Disorders
Advisory Council.
 
The applicant must have access to a training environment with ongoing
multi-institutional clinical trials of the efficacy of therapy.
Ideally, the applicant organization  serves as a coordinating center
which provides the clinical trials with ongoing biostatistical,
epidemiologic and research design expertise.
 
The review criteria for applications received in response to this PA
are similar to those for unsolicited T32 applications.  Specifically,
these are:
 
o  Past research training record of both the program, if applicable,
and the designated preceptors, as determined by the success of former
trainees in establishing independent and productive research careers
in the design and conduct of clinical trials;
 
o  Past research training record in terms of the success of former
trainees in obtaining individual research awards and career awards
for further development;
 
o  Commitment to the objectives, design and direction of a research
training program responsive to this PA;
 
o  Caliber of preceptors as investigators with expertise in
biostatistics, epidemiology, and clinical trials, including
successful competition for research support;
 
o  The training environment, including access to ongoing
multi-institutional clinical trials of treatment efficacy, the
institutional commitment, the quality of the facilities, the
availability of appropriate didactic courses, and the availability of
research support;
 
o  Recruitment and selection plans for trainees, and the availability
of eligible candidates;
 
o  The record of the research training program in retaining
health-professional postdoctoral trainees for at least two years in
research training activities.
 
Additional review considerations related to the recruitment of
trainees from underrepresented minority groups and training in the
responsible conduct of research are described in the above-referenced
NIH-wide PA for institutional NRSA applications.
 
AWARD CRITERIA
 
The NIDCD anticipates awarding up to three training grants in
response to this PA.  Applications for this program will compete for
available funds with other T32 applications received and reviewed by
the NIDCD.  The following will be considered in making funding
decisions:
 
o  Responsiveness to the purpose of this announcement
o  Quality of the proposed training program, as determined by peer
review
o  Availability of funds
 
INQUIRIES
 
Consultation with NIDCD staff is strongly encouraged, especially
during the planning phase of the application process, in order to
ensure that the application is responsive to the scientific mission
and the research training goals of the NIDCD.  The staff person
listed below is responsible for the NIDCD extramural research
training and career development program, and can respond to inquiries
concerning programmatic issues:
 
Daniel A. Sklare, Ph.D.
Division of Human Communication
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 496-1804
FAX:  (301) 402-6251
Email:  daniel_sklare@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Sharon Hunt
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-B
6120 Executive Boulevard, MSC 7180
Bethesda MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301)-402-1758
Email:  SH79F@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.173..  Awards are made under authorization of the
Public Health Service (PHS) 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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