AUDITORY/PERCEPTUAL PROCESSING BY INFANTS WITH HEARING LOSS: ISSUES IN 
CLINICAL ASSESSMENT AND MANAGEMENT
 
RELEASE DATE:  June 13, 2002
 
RFA:  DC-02-004

National Institute on Deafness and Other Communication Disorders (NIDCD)
 (http://www.nidcd.nih.gov/)
 
LETTER OF INTENT RECEIPT DATES:  October 1, 2002 and June 1, 2003  

APPLICATION RECEIPT DATES:  October 17, 2002 and June 17, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA  
 
The purpose of this request for applications (RFA) is to support 
multidisciplinary research addressing auditory/perceptual processing in 
infants with hearing loss.   

As many as 33 children with significant hearing impairment are born 
every day in the United States and newborn hearing screening is now 
mandated in over 30 states. A new population of infants, i.e. those who 
have been identified with hearing impairment at a few weeks of age, has 
rapidly emerged.  These infants require clinical decisions regarding 
assessment and management at ages much younger than previously 
encountered. Yet there are no tools or techniques that are sufficiently 
sensitive or developed for measuring/evaluating progress or benefit of 
various habilitative strategies in these infants. There is little 
information available on the auditory/perceptual processing abilities 
of infants with hearing loss. Information is lacking regarding 
suprathreshold auditory behaviors, perception of complex sounds, 
acquisition and organization of information necessary for language 
acquisition, multimodal perceptual processes, and cognitive factors 
such as learning and memory.  Research that characterizes 
auditory/perceptual performance in infants with hearing loss is needed 
to guide clinicians as they evaluate and monitor an infant's auditory 
and linguistic development in order to identify optimal intervention 
strategies.  Such investigations hold great promise for the refinement 
of clinical assessment and management tools for these pressing issues 
in this unique population. 

RESEARCH OBJECTIVES

Background

As many as 33 children with significant hearing impairment are born 
every day in the United States. Without appropriate and timely 
intervention, early childhood hearing impairment interferes with the 
development of oral/aural communication, impedes academic performance, 
and limits long-term vocational opportunities.  NIDCD has a long-
standing interest in the early identification of hearing impairment. 
Much has happened since the 1993 NIH Consensus Conference, Early 
Identification of Hearing Impairment in Infants and Young Children, 
which recommended hearing screening of all newborns prior to hospital 
discharge.  Newborn hearing screening is now mandated in over 30 states 
and current estimates suggest that 65% of all newborns are screened for 
hearing loss prior to hospital discharge. The identification of infants 
with hearing loss has caused the emergence of new questions.

Prior to newborn hearing screening programs, intervention for neonatal 
hearing impairment typically was not begun until the child was at least 
twelve months of age and most often not until the child was two years 
or older.  These strategies typically involve the fitting of some form 
of assistive/prosthetic device (e.g., hearing aids, cochlear implants, 
vibrotactile devices, FM auditory and other assistive devices, or some 
combination of these devices) and a behavioral treatment program [e.g., 
a home or clinic-based program to facilitate speech, language (manual 
and/or aural/oral) and auditory skill development].  Hearing aids are 
the most commonly employed assistive device for most levels of 
sensorineural hearing impairment and are, in most instances, fitted 
only after the hearing impairment is well characterized.  For profound 
hearing impairment, cochlear implants are being used more commonly as 
the age limits for implantation have been lowered; vibrotactile and 
other assistive devices are less commonly used but remain important 
options in the intervention process.  In addition to fitting devices, 
behavioral treatment programs are often initiated to mitigate the 
effects of hearing impairment on the communicative, educational, and 
social development of the child.  These programs are varied, with some 
emphasizing a combination of signed and spoken language, while others 
focus on the development of oral and auditory communication only.  The 
degree of hearing impairment, as well as many other factors, influences 
the decision regarding the type of behavioral treatment program in 
which a given child is enrolled.  

NIDCD has an established "Working Group on the Early Identification of 
Hearing Impairment".  These established scientists have relevant and 
varied expertise, and they have met several times over the last few 
years.  In the course of the third meeting, held in September 2000, a 
list of seven research priorities relevant to the early identification 
of hearing impairment was established. The minutes from that meeting, 
from which this RFA evolved, can be found at: 
http://www.nidcd.nih.gov/funding/programs/hb/earlyid_00.asp
 
There is now a cohort of infants who have been identified with hearing 
impairment by a few weeks of age. There are numerous questions 
regarding intervention and management. Decisions regarding the type and 
effectiveness of various early intervention/management strategies are 
being made at ages much younger than previously encountered and the 
decision-making is difficult in the absence of data to guide those 
decisions.  Important clinical decisions about the fitting of hearing 
aids and cochlear implants are being made regarding habilitation of 
these infants.  Yet measurement tools and techniques that are 
sufficiently sensitive or refined for measuring/evaluating progress or 
benefit of various habilitative strategies in these infants do not 
exist.  There is no empirical database to guide decisions and the 
proactive approach to intervention does not allow for "wait and see" 
management.  Further, the time window in which the decision-making must 
occur is extremely short and the decisions are critical, such as 
whether a 12 month-old with profound hearing loss should continue 
wearing a hearing aid or undergo cochlear implantation.  Furthermore, 
if that infant is implanted, what are the auditory, linguistic, 
behavioral, and social cues that will signal a clinician to shift from 
a current strategy that is not working to a modified habilitation 
strategy, before that child is characterized a few years later as a 
"poor user" and critical windows for learning have passed?  There are 
almost no data to guide clinicians in their search of the optimal 
intervention strategy for these newly identified hearing impaired 
infants as they monitor and evaluate an infant's auditory and 
linguistic development. Large unexplained individual differences in 
both performance and outcome also contribute to this difficult clinical 
scenario.

Auditory perception begins in utero; well before infants begin to 
speak, their brains have been actively processing environmental 
auditory information to construct the speech and language of their 
native tongue.  Animal research, in both single and multimodal 
experiments, has clearly demonstrated the impact of the sensory 
experience in the prenatal and postnatal period on the development of 
specific neural, behavioral and perceptual processes.  Similarly, there 
is a large body of research on human infants' auditory and visual 
processing capabilities, as well as their multimodal processing 
abilities. Such experiments have demonstrated the impact of the sensory 
experience on developing perceptual processes and that perceptual 
systems influence one another in development.  For example, infants can 
utilize information that is redundant across two sensory modalities and 
further, the response to one stimulus can be altered by the presence of 
another stimulus in a differing perceptual modality. As the natural 
infant environment is one of simultaneous and dynamic multimodal 
stimulation, these issues are of fundamental importance in 
understanding infant development. 

Traditional clinical research on hearing impairment has focused 
primarily on audition and the acquisition of speech and language; 
however, current measurement and evaluation tools are not appropriate 
for the preverbal infant with hearing impairment, who has both an 
altered sensory system (in most instances both prenatally and 
postnatally) as well as altered environmental inputs during 
development. In order to assess and manage the hearing impaired infant 
as a "whole child" there is an urgent need for multidisciplinary 
investigations of auditory/perceptual processing abilities in this 
population.  Such investigations go beyond audition and speech/language 
in isolation, and include behavioral, psychological and cognitive 
development, such as multimodal integration, attention, memory and 
learning and require collaborations among many disciplines (including, 
but not limited to, audiology, speech-language pathology, linguistics, 
developmental psychology, cognitive psychology, pediatrics and 
otolaryngology).  These investigations require the utilization of the 
research base on the development of human infant sensory and perceptual 
processing when developing and designing an assessment and treatment 
regimen for the infant with hearing impairment. This RFA seeks to bring 
together researchers for multidisciplinary investigations on 
auditory/perceptual processing in the infant with hearing impairment. 
Such investigations hold great promise for the betterment of clinical 
assessment and management tools for this unique population. 
 
Research Needs

This RFA is intended to address pressing clinical issues.  Applications 
of a solely theoretical/conceptual nature should not be submitted in 
response to this RFA and should be submitted as a traditional 
investigator-initiated application using standard NIH receipt dates.  
NIDCD will only accept applications with potential significance and 
relevance to the clinical assessment and management of infants/young 
children with hearing impairment. 

Research needs, many of which are multidisciplinary, include:

Characterizing auditory/perceptual system capabilities of infants with 
varying degrees of hearing loss, with the long-term goal of determining 
appropriate/optimal habilitative strategies (both technical and 
behavioral) leading to the development of communication skills.

Developing new or enhanced techniques and methods for examining supra-
threshold auditory/linguistic/perceptual abilities for complex signals 
(speech), such as new uses of habituation and preferential 
looking/listening paradigms.

Investigating multimodal perception in infants with hearing impairment. 
Utilization of multimodal perception to design novel habilitative 
strategies with the goal of increasing the acquisition of linguistic 
and auditory function in infants with hearing loss.

Considering the effects of hearing impairment on the hierarchy of the 
acoustic-linguistic processes underlying normal development of language 
(e.g., acoustic, phonetic/phonological, lexical, and semantic).

Devising objective and subjective tools/methods to determine/evaluate 
auditory/linguistic development in infants with hearing loss (including 
infants with multiple disabilities and infants from varying ethnic 
backgrounds).  Determining the role of parental report, and its 
applicability to clinical decision making, is especially important.  

Understanding individual variability by examining contributing factors, 
such as, auditory status, age of onset/identification/intervention, 
etiology, cognitive status, physical status, parent/infant interaction, 
and social context.  In addition, there is a need to compare infants 
with similar experiences/developmental profiles and degree of hearing 
impairment to each other.  It is of benefit to study children across 
the full spectrum of performance (both low and high performers).

Examining ways to determine the appropriateness of various types of 
technologies and approaches to habilitation, the need for a change in 
technology or intervention strategy, and/or candidacy for cochlear 
implantation for individual infants with hearing loss.   This involves 
the ability of infants to modify perceptual learning strategies or 
acquire new strategies with changes in technology/programming schemes.  
Both absolute performance and the rate of change, whether positive or 
negative, need to be understood.   

Generating baseline data in infants with impaired hearing (normal 
hearing infants may be used for control/comparison data), describing 
the developmental stages of speech perception and production, 
particularly the trajectory of their rate of acquisition.  

MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) R21 
(EXPLORATORY/DEVELOPMENTAL GRANT) and R01 (INVESTIGATOR INITIATED 
RESEARCH GRANT) award mechanisms. As an applicant you will be solely 
responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation with two receipt dates:  
October 17, 2002 and June 17, 2003.   Beyond those dates, future 
unsolicited, competing-continuation applications based on this project 
will compete with all investigator-initiated applications and will be 
reviewed according to the customary peer review procedures. The 
anticipated award dates are July 1, 2003 and April 1, 2004. 
Applications submitted for the first submission date may be revised and 
resubmitted for the second submission date. 

Use of the R21 or R01 mechanism

Generally, applicants proposing exploratory/feasibility studies with 
limited preliminary data should use the R21 mechanism, while applicants 
proposing more extensive projects based on significant published and 
preliminary results should use the R01 mechanism. In addition, 
applicants are strongly encouraged to contact the scientific Program 
Officer listed below under INQUIRIES to discuss which mechanism (R21 or 
R01) would be most suitable for the proposed research project. 

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.

FUNDS AVAILABLE  
 
The NIDCD intends to commit approximately $750,000 in FY 2003 and 
$750,000 in FY 2004 to fund 3 to 5 new R21 and 3 to 5 new R01 grants in 
response to this RFA.  Because of the exploratory nature of the R21, 
applicants submitting an R21 may only request a budget for direct costs 
of up to $125,000 per year for a maximum of three (3) years. R01 
applicants may request a project period of up to five (5) years. 
Because the nature and scope of the research proposed are expected to 
vary for both R21s and R01s, it is anticipated that the size of each 
R21 and R01 award will vary. Additional specific application 
instructions, budget considerations and review criteria for the R21 and 
the R01 can be found below under APPLICATION PROCEDURES and REVIEW 
CONSIDERATIONS.  Although the financial plans of the NIDCD provide 
support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of meritorious 
applications. At this time, it is not expected that this RFA will be 
reissued.  
 
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 or foreign
 
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

Applications in response to this RFA must include infants/children less 
than 3 years of age with hearing impairment as part of the subject 
population. This RFA is intended to provide information relevant to the 
clinical management of infants/children with permanent sensorineural 
hearing loss of varying degrees. Additionally, a multidisciplinary 
research approach must be evident (including, but not limited to, 
audiology, speech, language, linguistics, developmental 
psychoacoustics, developmental psychology, cognitive psychology, 
pediatrics, and otolaryngology). Multi-center applications are 
encouraged. Applicants awarded grants in response to this RFA may be 
required to come to Washington, DC (or other location to be determined 
by the NIDCD/NICHD) annually to share their findings with other 
recipients of the RFA. Annual travel costs for up to 2 individuals from 
the awardee institution should be included as part of the overall 
requested budget.
  
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

Dr. Amy M. Donahue
Chief, Hearing and Balance/Vestibular Sciences Section  
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD  20892-7180
Telephone:  301-402-3458
Fax:  301-402-6251
Email:  amy_donahue@nih.gov

o Direct your questions about peer review issues to:

Dr. Craig Jordan
Chief, Scientific Review Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS Room 400C, MSC 7180
Bethesda, MD  20892-7180 
Telephone: 301-496-8683
Fax: 301-402-6250
Email:  jordanc@nih.gov

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

Ms. Sara Stone 
Chief, Grants Management Branch 
Division of Extramural Research 
National Institute on Deafness and Other Communication Disorders 
6120 Executive Boulevard, EPS Room 400B, MSC 7180 
Bethesda, MD  20892-7180 
Telephone:  (301) 402-0909 
Fax:  (301) 402-1758 
Email:  stones@nidcd.nih.gov

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 RFA 

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 Institute staff to estimate the potential 
review workload and plan the review.
 
The letter of intent is to be sent by October 1, 2002 for the October 
17, 2002 receipt date and by June 1, 2003 for the June 17, 2003 receipt 
date to the scientific program officer listed above under INQUIRIES.

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.
 
ADDITIONAL R21 APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 
5/2001) apply to the R21 with the following modifications: 

1. R21 applications may request up to five (5) $25,000 modules for a 
maximum direct cost of $125,000 per year for up to a maximum of three 
(3) years.
2. The Research Plan for the R21 application may not exceed 10 pages. 
Tables and Figures (color and black and white) must be included within 
the 10-page limit. However, to aid reviewers, duplicate original color 
figures should be included in the appendices if the data cannot be 
adequately evaluated when copied in black and white (see APPLICATION 
SUBMISSION.) Appendices must be sent to the NIDCD SCIENTIFIC REVIEW 
BRANCH, DIVISION OF EXTRAMURAL RESEARCH, whose address is below. 
Appendices should not be sent to CSR. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 
Applications requesting up to $250,000 per year in direct costs must be 
submitted in a modular grant format.  The modular grant format 
simplifies the preparation of the budget in these applications by 
limiting the level of budgetary detail.  Applicants request direct 
costs in $25,000 modules.  Section C of the research grant application 
instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
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)
 
At the time of submission, two additional copies of the application, in 
addition to all appendices, must be sent to:
 
CHIEF, SCIENTIFIC REVIEW BRANCH 
DIVISION OF EXTRAMURAL RESEARCH 
NATIONAL INSTITUTE ON DEAFNESS AND 
OTHER COMMUNICATION DISORDERS 
6120 EXECUTIVE BOULEVARD, ROOM 400-C, MSC 7180 
BETHESDA, MD  20892-7180 
ROCKVILLE, MD  20852 (for express/courier service) 
 
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA 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 substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and for responsiveness by the NIDCD. Incomplete and unresponsive 
applications will be returned to the applicant without further 
consideration.  

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIDCD in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique.
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score.
o Receive a second level review by the NDCD 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 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? Is there evidence of a multidisciplinary 
research approach/research team? 

(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:

o 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.

o 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, specifically, the 
inclusion of infants/young children with hearing loss.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    October 1, 2002    June 1, 2003
Application Receipt Date:         October 17, 2002   June 17, 2003
Peer Review Date:                 January, 2003      October 2003
Council Review:                   May 2003           January 2004
Earliest Anticipated Start Date:  July 1, 2003       April 1, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

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.

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 RFA 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


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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