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PA Number:  PA-00-107 (superceded by PA-02-157)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. 



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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