NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS
Release Date: June 22, 2000
PA Number: PA-00-107 (superceded by PA-02-157)
National Institute on Deafness and Other Communication Disorders
PURPOSE
This document announces the willingness of the National Institute on Deafness
and Other Communication Disorders (NIDCD) to accept applications for the
conduct of clinical trials related to disorders of hearing, balance, smell,
taste, voice, speech and language. It lists the requirements placed on the
receipt, review, and funding of these applications. NIDCD policy and
procedures for investigator-initiated clinical trials can be found at
http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.
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 PA, NIDCD
Investigator-Initiated Clinical Trials, 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
Applications may be submitted by domestic for-profit and non-profit
organizations (including consortia of institutions), public and private, such
as universities, colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government. Foreign
organizations are not eligible to apply. Domestic applications may include
international components, however, the domestic components must constitute
the majority of the application. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
All responses to this program announcement must be submitted as applications
using the R01 mechanism. For those applications that are to be awarded
$500,000 or more in direct costs in any year or support for a multi-center
clinical trial, the R01 will be converted to the U01 mechanism (a cooperative
agreement), indicating substantial NIDCD staff involvement and the Terms and
Conditions of Grant Award will reflect that arrangement. See
http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp for further information.
Regardless of the mechanism of support, NIDCD staff will closely monitor
progress during the award period. This monitoring may include regular
communication with the principal investigator and staff, as well as, in the
case of the cooperative agreement, participation in the steering committee,
data and safety monitoring committee, and related committee meetings. The
level of NIDCD staff participation will be specified in the Terms and
Conditions of Award.
As it is anticipated that applications responsive to this program
announcement (NIDCD Investigator-Initiated Clinical Trials) will request
funds exceeding $250,000 direct costs per annum, modular grant instructions
do not apply.
RESEARCH OBJECTIVES
The objective of this PA is to encourage the submission of investigator-
initiated clinical trial applications assessing the treatment or prevention
of diseases and disorders of hearing, balance, smell, taste, voice, speech
and language. Progress in basic research, with expanding knowledge of
biological and other factors influencing disease initiation, progression, and
response to treatment affords an unparalleled opportunity to translate these
advances into interventions that can improve the health of the American
people.
This initiative is designed to encourage the development and implementation
of protocols examining the efficacy of interventions aiming to treat or
prevent disorders of human communication.
NIDCD does not accept, review, or fund pilot studies. A pilot study is one
whose major purpose is to demonstrate the feasibility of further studies.
The NIDCD will accept, review, and fund clinical trial planning grants, in
response to the NIDCD Clinical Trials Planning Grant Program Announcement. A
planning grant is intended to support the development of a Manual of
Procedures amongst other activities necessary to develop a complete clinical
trial application package. For further information regarding the NIDCD
Clinical Trial Planning Grant, see
http://grants.nih.gov/grants/guide/pa-files/PAR-00-007.html.
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 are 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).
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 20,
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol.
23, No. 11, March 18, 1994, available on the web at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
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 may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information regarding the policy.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel
and participating institutions, and the number and title of the PA 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 IC staff to
estimate the potential review workload and plan the review. The letter of
intent is to be sent to the Director, Clinical Trials Program, at the address
indicated under INQUIRIES.
Applicants planning to submit an investigator-initiated application (or a
group of applications for a multi-site clinical trial) requesting $500,000 or
more in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.
Regardless of anticipated application cost level, applicants are encouraged
to consult with program staff listed under INQUIRIES below.
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit, through special arrangement, by the Clinical Trials Review Committee
of the National Heart Lung and Blood Institute, in accordance with the
standard 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 of review by an
appropriate National Advisory Council.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches or method?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to additional criteria,
listed in the document NIDCD INVESTIGATOR INITIATED CLINICAL TRIALS at the
following URL: http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.
The original and THREE copies of the completed application must be mailed to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040-MSC-7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
In addition to the copies submitted to the Center for Scientific Review, two
copies should be sent, under separate cover to:
Craig A. Jordan, Ph.D.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400-C, MSC 7180
6120 Executive Boulevard
Bethesda, MD 20892-7180
Rockville, MD 20852 (for express/courier service)
Submission of separate copies to the Chief, Scientific Review Branch, will
allow more time to study the application and plan for its review.
INQUIRIES
Inquiries are strongly encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
A. Julianna Gulya, MD
Director, Clinical Trials Program
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, 400D-7, MSC 7180
6120 Executive Blvd
Bethesda, Maryland 20892-7180
Telephone: 301-435-4085
Fax: 301-402-6251
E-mail: julie_gulya@nih.gov
Direct inquiries regarding scientific review issues to:
Craig A. Jordan, Ph.D.
Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, 400-C, MSC-7180
6120 Executive Boulevard
Bethesda, Maryland 20892-7180
Telephone: 301-496-8693
FAX: 301-402-6250
E-mail: cj34b@nih.gov
Direct inquiries regarding fiscal issues to:
Ms. Sharon Hunt
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
EPS, 400-B, MSC-7180
6120 Executive Boulevard
Bethesda, Maryland 20892-7180
Telephone: 301-402-0909
FAX: 301-402-1758
E-mail: SH79F@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance, No.
93.173. Awards will be made under the authority 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 NIH grants policies and Federal
Regulations 42 CFR part 52 and 45 CFR Parts 74 and 92. 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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