RESEARCH ON ADULT AND FAMILY LITERACY

Release Date:  October 26, 2001

RFA:  RFA-HD-02-004

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)
National Institute on Aging
 (http://www.nia.nih.gov/)
National Institute for Literacy
 (http://www.nifl.gov/)

Letter of Intent Receipt Date:  April 15, 2002
Application Receipt Date:       May 15, 2002

THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Child Health and Human Development (NICHD), National 
Institute on Aging (NIA), and National Institute for Literacy (NIFL), in 
partnership with the Department of Education, Offices of Vocational and Adult 
Education (OVAE), Special Education and Rehabilitation Services (OSERS), 
Elementary and Secondary Education (OESE), and Office of Educational Research 
and Improvement (OERI), invite research grant applications to develop new 
knowledge on adult literacy learning and new knowledge relevant to the 
critical factors that influence the instruction and development of literacy 
(reading and writing) competencies in adults and in young children (birth 
through kindergarten entrance) through adult and family literacy program 
activities, to identify or design the most effective program structures and 
models of service delivery.

This RFA seeks to stimulate systematic, programmatic, multidisciplinary 
research to determine the most effective instructional methods and program 
organizational approaches for both adult literacy programs and family literacy 
programs.  Specifically, the co-sponsoring agencies seek research to increase 
understanding of the specific cognitive, sociocultural, and instructional 
factors, and the complex interactions among these factors, that promote or 
impede the acquisition of English reading and writing abilities within adult 
and family literacy programs and activities. It is expected that the research 
studies and programs stimulated by this initiative will contribute scientific 
data that bear directly on a number of public policy issues and instructional 
practices. 

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 Request for Applications (RFA) is 
related to one or more of the priority areas.  Potential applicants may obtain 
"Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 
Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) and Small Grant (R03) award mechanisms.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely that 
of the applicant.  The total project period for an application submitted in 
response to this RFA may not exceed five years for the R01 and may not exceed 
two years for the R03.   The Small Grant (R03) mechanism should be used when a 
full-scale study is premature, for example, when there is a need for 
feasibility or pilot data.   Further information on R03 application procedures 
is available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.  
This RFA is a one-time solicitation.  Future unsolicited competing 
continuation applications will compete with all investigator-initiated 
applications and be reviewed according to the customary peer review 
procedures.  The anticipated award date is September 2002. 

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH.  Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE 

The NICHD intends to commit approximately $1 million and the other cosponsors 
intend to commit approximately $2.3 for a total of $3.3 million in total costs 
[Direct plus Facilities and Administrative (F & A) costs] in FY 2002 to fund 
eight to ten new grants in response to this RFA.  An applicant may request a 
project period of up to five years and a budget for direct costs of up to 
$500,000 per year for the R01 and up to two years and $50,000 per year for the 
R03.   Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award will also vary.  Although the 
financial plans of the co-sponsors provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and the 
receipt of a sufficient number of meritorious applications. 

RESEARCH OBJECTIVES

Background

In November 2000, the National Institute for Literacy and the National Center 
for the Study of Adult Literacy and Learning co-sponsored a meeting in 
Cambridge, MA, to review the current state of research and instruction in 
adult literacy, and to identify gaps and research needs in the field.  This 
was followed by a practitioners’ meeting on adult literacy, held by NIFL and 
the NICHD in Rockville, MD, to review and discuss the draft document that was 
the outcome of the earlier Cambridge meeting.  The research priorities 
presented in this RFA and related documents draw in part from the draft 
document summarizing those two meetings.  In addition, NICHD, NIFL, OVAE, 
OESE, and OERI brought together leading researchers and practitioners from 
various fields to forge a joint research agenda in adult and family literacy. 
This meeting was held August 21-22, 2001, in Rockville, MD, and a summary 
document is available from the individual program representatives listed under 
INQUIRIES, below, and at http://www.nichd.nih.gov/crmc/cdb/reading.htm.

The combined conclusions and recommendations of these meetings are summarized 
as follows:

Literacy, and specifically English language literacy, is a complex learning 
process that everyone living in the United States must negotiate successfully 
in order to compete effectively in this country.  There are a compelling 
rationale and need for the development of a comprehensive program of research 
that can identify the full range of linguistic, cognitive, cultural, familial, 
socioeconomic, regional, and instructional factors, and the interactions among 
these factors, that are directly relevant to the development of reading and 
writing abilities in adults.  In addition, the unique value of family literacy 
programs, as compared to adult programs that encourage parent-child 
interactions around literacy and as compared to preschool programs that 
include emergent literacy activities and a focus on parent involvement, has 
yet to be clearly elucidated. Therefore, there is a need to document the 
effectiveness of adult and family literacy programs in terms of specific 
literacy outcomes for adults and young children and to develop and test new 
innovative interventions.

The complexity of understanding how language, cultural, and instructional 
factors influence literacy development in adults and in their children is 
compounded because these factors also interact in varying degrees with 
geographic and regional (urban vs. rural) location and, in many cases, 
immigrant status, migrant status, socioeconomic status, generation status of 
both young children and parents, the quality of the child’s oral language 
development, motivational factors, and for those whose native language is not 
English, the type, quality, and amount of each language spoken in the home and 
reinforced in the neighborhood and community, the linguistic and cultural 
characteristics of the instructor, the nature of previous literacy 
instruction, and individual differences in cognitive, linguistic, and 
neurobiological development.  Such complexity requires the development of a 
collaborative multidisciplinary, multi-level, and multi-contextual program of 
research.  More specifically, this program of research should foster the 
application of diverse research methodologies across varied contexts to 
develop models of adult and family literacy programs and instructional methods 
and to delineate the influences, and pathways of influence, on English-
language literacy development in both adults and their children at the 
individual level, the home/family level, and the classroom level. 

In addition, while many adults who are not literate may simply not have 
learned or not have been adequately taught to read and write, or may be 
literate in another language but in need of literacy instruction in English, 
there are also many adults who are not literate in any language due to 
learning difficulties. There is very little high quality, well-controlled 
research on the optimal methods of teaching and supporting the development of 
first or second language literacy in adults.  An in-depth understanding of the 
factors and conditions that hinder this learning process is also crucially 
important, and the development and testing of interventions to identify and 
remediate reading difficulties in adults is strongly encouraged. 

Research in Adult and Family Literacy:  An Overview:

The NICHD and the Department of Education have had a long-standing interest in 
the study of reading development, reading disorders, and reading instruction.  
Over the past 30 years, studies supported by the NICHD, OERI, and other 
agencies and sources have obtained substantial data that converge on the 
following findings with children for whom English is the primary language:  
Good readers have developed phonemic awareness and an understanding of the 
alphabetic principle, and can apply this knowledge in a fluent and automatic 
manner when reading words and text.  Given the ability to rapidly and 
accurately decode and recognize words, good readers bring strong vocabularies 
and well-developed syntactical and grammatical skills to the reading 
comprehension process, and actively relate what is being read to their 
background knowledge.  Evidence has also accrued that indicates learning to 
read is a relatively lengthy process that begins very early in development, 
before children enter formal schooling.  Children who are provided with 
stimulating oral language and literacy experiences from birth onward have an 
advantage in developing vocabulary, understanding the goals of reading, and 
acquiring an awareness of print and literacy concepts.  The data also suggest 
that children who are read to frequently at very young ages are exposed to the 
sounds of the language and to vocabulary which will serve as the building 
blocks for the development of the alphabetic principle.  The data converge in 
demonstrating that ultimately, children’s ability to comprehend what they read 
is inextricably linked to their skill in reading words accurately and rapidly, 
to the development of vocabulary and language comprehension abilities, and to 
their background knowledge.  In contrast, converging evidence indicates that 
reading failure is significantly related to deficits in phoneme awareness and 
the development of the alphabetic principle, difficulties in the rapid 
application of phoneme awareness, decoding, and word recognition skills when 
reading connected text, a non-strategic approach to reading comprehension, and 
the failure to develop and maintain motivation to learn and practice reading 
skills.

To date, there have not been comprehensive programmatic research efforts of 
this kind to address issues and questions relevant to (1) the learning of 
literacy in adulthood, including literacy learning by individuals for whom 
English is not their native language; (2) difficulties/disabilities 
encountered by this population in learning to read and write; and (3) the 
development of effective prevention, remediation, and reading and writing 
programs and instructional approaches and strategies for low-literate adults; 
(4) the value added by the integrative approach that underlies family literacy 
programs, both for adults and their young children, in terms of specific 
literacy outcomes, as compared to high quality adult literacy and child 
intervention programs. To address these critical research needs, studies that 
contribute effectively to the research focus described below are encouraged.

Research Scope

Against this background, a major goal of this research initiative is to obtain 
converging scientific evidence that ultimately can inform the development and 
application of assessment and instructional approaches and strategies to 
develop robust literacy skills and to prevent or remediate reading and writing 
difficulties and disabilities among adults who, for whatever reason, have 
reached adulthood without these vital skills. 

Another major goal is to determine the effectiveness of family literacy 
programs in providing unique services to families where adults have limited 
literacy skills that impede their providing nurturance and support of literacy 
skills in their young children. Within family literacy, there is a specific 
need to address the more fundamental issue of whether rigorous evidence can be 
obtained in support of the primary assumption, as yet untested, that underlies 
the family literacy approach – namely, that greater benefits to both adult and 
child learners will be attained by taking an integrated family literacy 
approach than by independently addressing adult and child needs through 
separate high quality adult literacy and child intervention programs. 

Through this initiative, the funding partner agencies hope to gain convergent 
evidence with which to address these overarching questions: 

o  What are the most effective instructional methods and program 
organizations/structures for which groups/subgroups of adults and under what 
conditions are these most efficiently implemented?  That is, what are the 
optimal instructional content, instructor qualifications and preparation, and 
timing, duration, and methods of delivery of instruction, for specific 
groups/subgroups of participants in adult literacy and family literacy 
programs in terms of specific literacy (reading and writing) outcomes, and 
which approaches, methods, and types of programs are most cost-effective for 
which participants?

o  What are the optimal instructional methods, contexts, and instructor 
characteristics that ensure the development of literacy in adults who are 
native speakers of English and adults who are not native speakers of English? 
What differences in these approaches may be required at different stages of 
adult development (i.e., young adulthood, midlife, and old age)? How should 
instructional approaches differ for adults who are literate at some level in 
their own language but seeking to develop literacy in English and adults whose 
native language does not have a  written form?     

o  What are the most effective methods for identifying and remediating adults 
with literacy (reading and writing) difficulties?  That is, what factors and 
measures are most useful in identifying adults with reading disabilities, and 
what instructional methods, types of instructors, and types of programs (in 
terms of structure, organization, and other characteristics) are most 
effective in achieving useful literacy outcomes for which participants?  In 
addition, what factors and measures are most useful in assessing and planning 
intervention for adults whose first language is not English?  To adequately 
address these questions, it will be important to indicate what are the most 
important literacy outcomes for specific participants, and how these might be 
measured. 

o  What are the best remedial procedures for circumventing the cognitive 
limitations of older adults that may otherwise interfere with the acquisition 
of literacy skills?  That is, what methods can be used for enhancing reading 
and writing skills that either avoid or compensate for the text- processing 
problems typically experienced by older adults?  For example, what 
compensatory strategies would aid these individuals in overcoming potential 
difficulties with reading comprehension that may occur as a result of declines 
in working memory capacity or decreased speed of information processing?               

o  To what extent can interventions for enhancing literacy skills in older 
adults yield improvements in cognitively-demanding, instrumental activities of 
daily living?  That is, what kinds of instructional methods may be required 
for ensuring the transfer of literacy competencies to the management of 
everyday problem-solving activities that are highly dependent on adequate 
reading and writing skills, such as grocery shopping, meal preparation, 
financial management, medication adherence, and health care management?

o  Are greater benefits to both adult and child learners attained by taking an 
integrated family literacy approach than by independently addressing adult and 
child needs through separate high quality adult literacy and parenting 
education/child intervention programs?  That is, can it be demonstrated that 
there is "value added" (in literacy gains, in reduced costs, or in 
recruitment/retention levels) from bundling services to families in which both 
adults and young children require intervention and, if so, why?  This will 
require addressing the issue of measurement of adult-child interaction, as 
well as careful measurement of other constructs and outcomes.

o  What are the optimal conditions under which family literacy programs can 
facilitate the development of literacy in adults and/or young children? What 
factors should be considered in selecting the language of first literacy in 
cases where the home language of a family is not English, and whether there 
are specific linguistic and cultural advantages that accrue with instructional 
approaches that develop oral language and literacy skills in two languages 
simultaneously (dual language-literacy approaches) for parents and/or young 
children within family literacy programs. What are the most effective 
intervention methods for parents with reading or other disabilities that 
impede their own literacy development and the most effective methods of 
helping these parents foster literacy development in their children?  

o  To the extent that it is not already known, who are the adults/families in 
this country requiring literacy instruction, and how can they be best 
identified, recruited, and served?  That is, what specific groups or subgroups 
of adults/families (in terms of racial/ethnic, cultural, linguistic, 
socioeconomic and geographic characteristics, as well as age and educational 
attainment) in the US are currently found in the various programs providing 
literacy instruction and, specifically, how can these populations be 
characterized to enable service providers to best identify them, to recruit 
and retain them, and to tailor the organization and structure of programs and 
specific instructional methods to optimally achieve defined literacy outcomes?  
Are there adults/families who can be identified who are not being served but 
would potentially benefit from such services?

Research Focus

The major focus of this RFA is to identify the conditions under which reading 
and writing skills are most efficiently and productively developed in low-
literate adults, including adults with learning disabilities and adults who 
are English language learners, and to address the fundamental issue of the 
value added by the integrative approach used in family literacy programs in 
contributing to both adult and child literacy.  Within this context, this 
collaborative, inter-agency research program seeks to increase understanding 
of the specific learner, instructional, linguistic, cognitive, sociocultural 
and socioenvironmental factors, and the interactions among these factors, that 
promote or impede the acquisition of literacy (reading and writing) skills of 
adults participating in adult education programs and/or family literacy 
programs.  An additional important focus of this RFA is the identification 
and/or development of reliable and valid measurement strategies and assessment 
instruments for all domains under study.  Descriptive and experimental studies 
employing quantitative and qualitative research methodologies are encouraged, 
and studies that combine methodologies are particularly sought. While 
longitudinal designs will be critical in addressing many of the research 
questions, cross-sectional studies and combinations of longitudinal and cross-
sectional studies are likewise encouraged.  It is not expected that each 
application will address the entire range of issues discussed in this RFA.  
However, applications must address issues that will contribute to the ultimate 
goal of answering the overarching questions under Research Scope, above, which 
place significant emphasis on the effects of different prevention, 
intervention, and instructional approaches and strategies, and of program 
models and organizational structures. 

Application Considerations

Each applicant should take care to ensure that the application addresses in 
depth the following methodological and organizational issues:

o  Research Population

The selection of the research population should be based on the scope of the 
study, the methodological requirements of the study, the specific research 
questions posed, and the nature and degree of integrated multidisciplinary 
effort.  Especially for the R01 funding mechanism, applicants are encouraged 
to select a core research population that provides the opportunity to conduct 
integrated, prospective, longitudinal as well as cross-sectional 
investigations of reading and writing development with an emphasis on the 
conditions under which literacy skills are best acquired and on the 
instructional, linguistic, cognitive, sociocultural, socioenvironmental, and 
familial factors that influence learning. 

It is expected that individuals within the research population will manifest 
different background characteristics and different strengths and weaknesses in 
skills critical for success in attaining reading and writing abilities.  As 
such, applicants should consider research protocols that are capable of 
detecting individual differences and well-defined subgroups and subtypes that 
may exist within any sample.  Applicants should also consider casting the 
sampling net wide enough to ensure a representative number of individuals or 
programs and contrast groups for study.  It is anticipated that the 
populations studied will include large numbers of individuals who are from 
minorities and/or who are from lower socio-economic levels, so that the 
research findings gained from this initiative will be useful in addressing the 
educational disparities that exist for these groups. 

o  Selection Criteria

The samples selected for study must be rigorously defined so that complete 
independent replication can be accomplished.  Within this context, applicants 
should provide clearly documented and operationalized definitions for their 
subject or program selection criteria.  Specifically, all participants 
selected for study should be defined with reference to age, grade level (if 
applicable), gender, ethnicity, socioeconomic status, immigrant/migrant 
status, generation status (of children and parents), geographic region, 
previous and concurrent educational placements and programs, type and severity 
of learning/ language/academic disabilities (if known), neurophysiological/ 
neuropsychological characteristics (if applicable), levels of academic 
achievement in oral language, reading, and writing, and presence of known 
learning or attention problems (if applicable).  To the extent possible, 
comparison groups should be equated on these characteristics. 

o  Measurement Criteria

Standardized tests, laboratory tasks, observational measures, interview 
schedules, and other assessment/observational procedures (e.g., dynamic 
assessments, case studies, ethnographic studies) should be selected on the 
basis of known reliability, validity, trustworthiness, and appropriateness to 
the samples under study.  If reliability, validity, and trustworthiness of the 
measurement/assessment/observational procedures are initially unknown, the 
application must include specific plans for establishing these measurement 
properties.  The valid measurement of change over time will be critical to 
much of the research solicited via this RFA since the study of the change over 
time and the documentation of specific literacy outcomes (reading and writing) 
under a variety of conditions and across a variety of settings are of 
significant interest.

o  Instructional Components and Definitions

One important dimension along which reading and writing instructional 
approaches and strategies are distributed is the explicitness and detail with 
which spoken and written language structures relevant to literacy acquisition 
are taught.  For the purposes of this RFA, the degree of implicitness-
explicitness inherent in the instruction should be described in detail.  For 
example, explicit instruction of language and literacy structures can be 
characterized by (1) deliberate organization of lesson format and content; (2) 
calibration of concept difficulty along both linguistic and educational level 
continua; (3) corrective feedback designed to foster linguistic insight and 
self-reliance in the student; (4) careful selection of textual reading 
material for practice; and (5) conscious interplay between spoken and written 
language during instruction.  

Another dimension along which reading instruction is distributed is the extent 
to which all components of a complete, integrated approach are included in 
each lesson, regardless of the student’s reading level.  Integration is one of 
the most important principles of instruction to emerge from reading research, 
yet instructional studies frequently overemphasize one instructional component 
to the detriment of others.  An example of this lack of integration can be 
found in several English-language reading instruction studies where 
instruction was provided to develop phonemic awareness and decoding skills 
without concomitant attention given to the application of these skills in text 
reading.  Even when integrated lesson designs are used, applicants should 
consider designing studies to demonstrate specifically which instructional 
components are most pivotal in learning to read at different phases of reading 
development, and to explicate any interactions between response to instruction 
and learner characteristics, language of instruction, stage of reading 
development, teacher/learner activities, ecological factors, and the like.

These examples of instructional dimensions are neither inclusive nor 
exhaustive, and applicants are encouraged to provide and define their 
particular frame of instructional reference in detail.  The important 
consideration is that most instructional characteristics vary dimensionally 
from highly explicit to highly implicit, and applicants are encouraged to 
define and describe these instructional dimensions in detail.  Likewise, 
applicants are encouraged to explicitly define and describe the types and 
nature of language, literacy, and learning interactions that occur in home and 
family settings.

o  Research Methodologies

New statistical methodologies are currently emerging to enhance the 
information gleaned from longitudinal studies and to bolster the 
interpretation of multivariate interactions that are identified in studies of 
behavioral/learning changes over time.  This is important given that it is 
sometimes difficult to interpret why and how gains were achieved in 
instructional studies.  This interpretation problem is frequently related to 
both instructional and non-instructional factors (social, economic, cultural, 
environmental, familial, etc.) that can interact to influence response to 
intervention.  A number of methodologies are now available for studying 
quantitative change and for studying the manner in which a variety of 
determinants, including instructional and ecological factors, influence rates 
and patterns of change over time.  Applicants are encouraged to apply 
methodologies that can illuminate these types of multivariate interactions.

Also of significant interest is the application of qualitative research 
methodologies to include open-ended interviews with students, teachers, 
parents, and administrators, teacher logs, stimulated recalls, student’s 
response journals, analysis of teacher’s daily plans, and videotaping and 
coding of instructional interactions.  When considering the use of qualitative 
methods, applicants must ensure the trustworthiness and credibility of the 
data, the transferability of the data, the adequacy of the research process 
for testing theory, and the empirical grounding of the research findings.  
Applicants are encouraged to combine quantitative and qualitative methods to 
optimize the validity and applicability of the findings.

Research Priorities and Examples of Research Questions

The NICHD, NIFL, OVAE, OSERS, OESE and OERI have developed a list of research 
priorities and examples of research questions to illuminate areas of 
particular interest to these agencies.  These examples are illustrative but 
not restrictive, nor are they inclusive or exhaustive.  The information on 
research priorities and examples of research questions may be obtained from 
the contact listed under INQUIRIES, below, or at 
http://www.nichd.nih.gov/crmc/cdb/reading.htm.

In addition, we encourage potential applicants to examine a Program 
Announcement that supports research complementary to this solicitation, 
entitled “Age-Related Changes in Reading and Oral Language Comprehension” 
(PA-01-002), available at 
http://grants.nih.gov/grants/guide/pa-files/PA-01-002.html.  
Applicants are encouraged to respond to whichever of these two notices that most 
closely fits their area of research interest.

SPECIAL REQUIREMENTS

Semi-Annual Meetings for Investigators

Because of the importance of cross-project communication and collaboration in 
this research effort, Principal Investigators from projects funded though this 
RFA will be expected to attend semi-annual meetings to be organized and 
managed by the funding partners, for investigators to share findings, research 
approaches, and core instrumentation.  The first meeting is expected to take 
place in November 2002.  Requests for funds for travel to these two meetings 
for the Principal Investigator and one research team member (for example, the 
team’s research methodologist) should be included in the application budget 
and budget justification.

Data Archives

Investigators who will collecting data on large numbers of subjects are 
encouraged to include in the application plans to archive data or to prepare 
public use files at the end of the project so that data can be shared with 
other investigators. While this is not a requirement of this RFA, it is 
strongly encouraged. 

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 sub-populations 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 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH-defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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,” published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available at: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.  This policy announcement is found 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 RFA 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.

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 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 NICHD staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent to Peggy McCardle, Ph.D., MPH, at the 
address listed under INQUIRIES, below, by April 15, 2002.

APPLICATION PROCEDURES

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

Application Instructions

Application instructions for the NICHD Small Grant (R03) mechanism must be 
followed in preparing applications for the R03 in response to this RFA.  These 
are available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.

Appendices for R01 applications should accompany the grant application.  Note 
that the R03 application does not allow appendices. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.   

Submission Instructions

The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-02-004.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  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.

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 should be 
sent to:

Director
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E-03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

Applications must be received by May 15, 2002.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  Incomplete and/or non-responsive 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 NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and may 
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, assigned a priority score, and receive a second level 
review by the National Advisory Child Health and Human Development Council and 
the National Advisory Council on Aging.

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 
methods?  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 the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  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  The adequacy of the proposed plan to share data, if appropriate.

SCHEDULE

Letter of Intent Receipt Date:    April  15, 2002
Application Receipt Date:         May 15, 2002
Peer Review Date:                 July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 2002

AWARD CRITERIA

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.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Peggy McCardle, Ph.D., MPH
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6863
FAX:  (301) 480-7773
Email:  pm43q@nih.gov

Daniel B. Berch, Ph.D.
Chief, Section on Cognitive Aging
Individual Behavioral Processes Branch
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533
Bethesda, MD  20892-9205
Telephone:  (301) 594-5942
FAX:  (301) 402-0051
Email:  Daniel_Berch@nih.gov

Sandra Baxter, Ed.D. 
National Institute for Literacy
1775 I Street, NW
Suite 730
Washington, DC  20006
Telephone:  (202) 233-2054
FAX:  (202) 233-2050
Email:  sbaxter@nifl.gov

Direct inquiries regarding review issues to:

Robert Stretch, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
Email:  rs365f@nih.gov

Direct inquiries regarding fiscal matters to:

Mary Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
Email:  md74u@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.865 (NICHD), 93.866 (NIA), and 84.257 (NIFL).  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 and 
Federal Regulations 42 CFR 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 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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