NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS  

RELEASE DATE:  August 27, 2002

PA NUMBER:  PA–02–157

EXPIRATION DATE: OCTOBER 2005, unless reissued. 

National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov)
 
THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This document, which supersedes PA–00–107 (June 22, 2000), announces the 
continued willingness of the National Institute on Deafness and Other 
Communication Disorders (NIDCD) to accept applications for the conduct of 
phase III clinical trials related to disorders of hearing, balance, smell, 
taste, voice, speech and language. This document provides a synopsis of the 
requirements placed on the receipt, review and funding of these applications. 
For more detailed information potential applicants should also review "NIDCD 
Policy and Procedures for Investigator-initiated Clinical Trials", which can 
be found at http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.
 
RESEARCH OBJECTIVES

The objective of this PA is to continue to encourage the submission of 
investigator-initiated phase III 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 Trial Planning Grant Program Announcement. A 
planning grant is intended to support the development of a Manual of 
Operations and 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-02-158.html)

MECHANISMS OF SUPPORT 

This PA will use the NIH RO1 award mechanism. As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  

For those applications that are to be awarded $500,000 or more in direct 
costs in any year or support a multicenter clinical trial, the RO1 will be 
converted to the UO1 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. The NIH (UO1) is a cooperative agreement award mechanism in 
which the Principal Investigator retains the primary responsibility and 
dominant role for planning, directing, and executing the proposed project, 
with NIH staff being substantially involved as a partner with the Principal 
Investigator, as described under the section "Cooperative Agreement Terms and 
Conditions of Award" 

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 Grant Award.

This PA uses just-in-time concepts. 

As it is anticipated that applications responsive to this program 
announcement (NIDCD INVESTIGATOR-INITIATED CLINICAL TRIALS) will request 
funds exceeding $250,000 per annum, modular grant instructions do not apply.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic (Domestic applications may include international components, 
however, the domestic components must constitute the majority of the 
application. Foreign institutions are not eligible to apply. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  

SPECIAL REQUIREMENTS

LETTER OF INTENT  

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this PA 

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 no later than 30 days before planned 
submission date. The letter of intent should be sent to:

Dr. A. Julianna Gulya
Division:  Clinical Trials, Epidemiology and Biostatistics Section 
Institute: NIDCD
Building: EPS Room: 400D-7
Bethesda, MD  20892-7180
Telephone:  (301)435-4085
FAX: (301) 402-6251
Email: Julie_Gulya@nih.gov

Please refer to http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp for 
additional special requirements relevant to NIDCD Investigator-Initiated 
Clinical Trials. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Staff Contact: A. Julianna Gulya, MD
Division: Division of Extramural Research
Institute or Center: NIDCD
Building EPS, Room 400D
Bethesda, MD  20892-7180
Telephone:  (301) 435-4085
FAX: (301) 402-6251
Email: gulyaj@mail.nih.gov

o Direct your questions about peer review issues to: 

Staff Contact: Craig Jordan, PhD
Division: Division of Extramural Research
Institute or Center: NIDCD
Building EPS, Room 400C
Bethesda, MD  20892-7180
Telephone:  (301) 496-8683
FAX: (301) 402-6250
Email: jordanc@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Staff Contact: Sara Stone
Division: Division of Extramural Research
Institute or Center: NIDCD
Building EPS, Room 400B
Bethesda, MD  20892-7180
Telephone:  (301)402-0909
FAX: (301) 402-1758
Email: stones@nidcd.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted according to the schedule provided at 
http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of the NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
	
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 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:

Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
EPS, 400C
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.

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board
	
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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application. In keeping with NIH policy (see "MONITORING PLAN 
AND DATA SAFETY AND [sic] MONITORING BOARD" below) all clinical trials 
require data and safety monitoring.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data.
 
BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA: Please refer to 
http://www.nidcd.nih.gov/research/clinicaltrials/clin_policy.asp.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete 
copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 
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.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.173, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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