SUPPLEMENTS FOR METHODOLOGICAL INNOVATIONS IN THE BEHAVIORAL AND SOCIAL 
SCIENCES

RELEASE DATE:  December 1, 2003 

RFA NUMBER:  RFA-RM-04-013

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

This RFA is developed as an NIH Roadmap initiative 
(http://nihroadmap.nih.gov/). All NIH Institutes and Centers participate in 
Roadmap initiatives. The RFA will be administered by the National Institute of 
Child Health and Human Development (NICHD) on behalf of the NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.864

LETTER OF INTENT RECEIPT DATE: January 13, 2004
APPLICATION RECEIPT DATE:  February 13, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The Institutes, Centers and Offices of the National Institutes of Health (NIH) 
invite NIH-funded investigators to submit supplemental research grant 
applications to develop methodological innovations in the behavioral and social 
sciences.  These modest supplements will support the addition of a 
methodological development component to already-funded NIH research projects. 
Methodology issues include research design, data collection techniques, 
measurement, and data analysis techniques in the social and behavioral 
sciences.  The goal of this RFA is to encourage methodological and 
technological innovation that will improve the quality and scientific power of 
data collected in the behavioral and social sciences.  Development of 
methodology and technology for multidisciplinary, interdisciplinary, 
multimethod, and multilevel analytic approaches that integrate behavioral and 
social science research with biomedical research is particularly encouraged.  

PROGRAM OBJECTIVES

The National Institutes of Health (NIH) are engaged in a series of activities 
collectively known as the  NIH Roadmap .  The Roadmap’s goal-- in keeping with 
the NIH mission of uncovering new knowledge about the prevention, detection, 
diagnosis, and treatment of disease and disability -- is to accelerate both the 
pace of discovery in these key areas and the translation of therapies from 
bench to bedside.  In the course of developing the NIH Roadmap, it has become 
clear that increasingly, scientific advances are being made at the interfaces 
of traditional disciplines, and that approaches to science are becoming more 
integrative.  (Additional information about the NIH Roadmap can be found on the 
NIH website at http://nihroadmap.nih.gov/).

The behavioral and social sciences have broad significance and are fundamental 
to the comprehensive understanding of disease etiology and treatment as well as 
to promotion of health and well-being.  Behavioral and social factors have a 
significant impact across the lifespan on diseases ranging from cardiovascular 
disease, to cancer, to diabetes, and to oral and mental health.  The 
development of innovative methodology and technology in the behavioral and 
social sciences will allow investigation of the full impact of these factors on 
health and facilitate the performance of interdisciplinary research at the 
intersection of the behavioral, social and biomedical sciences.

RESEARCH OBJECTIVES

This Request for Applications encourages applications to develop innovative 
methodology in four general areas of social and behavioral sciences research.  
These areas, discussed in detail below, include research design, data 
collection techniques, measurement, and data analysis techniques.  Each 
application is not expected to focus on all four of these areas; an application 
may focus on only one of the four areas and still be responsive to this RFA.

Examples of methodological and measurement development congruent with the 
intent of this RFA include, but are not limited to, the following:

o Multidisciplinary, interdisciplinary, multimethod, and multilevel research 
designs for use in behavioral and social science research, with special 
emphasis on both the development of new technologies and the analytical 
complexities associated with the integration of behavioral, social, genetic, 
and biomedical data (e.g., developing new measures to study gene-environment 
interactions).

o Improved methods for performing research on diverse populations (e.g., 
populations that are distinctive by virtue of age, gender, sexual orientation, 
ethnicity, culture, socio-economic status, literacy, language, or disability) 
or on potentially sensitive or covert behaviors such as drug use, abuse, and 
violence. 

o Innovative experimental designs to study how changes in economic, social, 
environmental, physical, or political context affect all aspects of ongoing 
research, including, but not limited to research design, measurement, data 
collection, and analytic strategies. 

o Multidisciplinary and interdisciplinary approaches that allow applicants to 
explore the ideas and methods developed in social science and behavioral fields 
other than their own are encouraged.  Particular emphasis is placed on the 
development and integration of behavioral and social sciences measures with 
those of the biomedical disciplines. Consulting relevant literature and 
collaborating with colleagues from other disciplines may provide important 
opportunities for developing improved methodology and measurement to better 
understand the impact of behavioral and social factors on disease and health.

A. RESEARCH DESIGN

Broadly stated, research design determines how well a research plan can 
accomplish stated purposes and test hypotheses.  Research design encompasses 
many decisions including the sampling plan; selection of appropriate study 
designs, methods, procedures and measures; and, assuring confidence in the 
study’s internal and external validity.  An innovative sample design and/or 
sampling frame can be the centerpiece of a research design.

Examples of topics within research design include, but are not limited to, the 
following:

o  Conceptual design strategies for the study of culture in the context of 
health. Culture may include but is not limited to ethnic group, professional 
affiliation (e.g., culture of biomedicine), or interaction of multiple sub-
cultures within a health-related context.

o  Designs to improve causal inference from non-experimental and quasi-
experimental research.

o  Research to improve the efficacy of multilevel designs (e.g., sample size 
estimation techniques).

o  Methods for improving the design and evaluation of community-based, 
participatory research and intervention trials (e.g., health promotion/disease 
prevention programs).

o  Conceptual, methodological, and ethical issues in designing studies that use 
different sources of information; for example, studies comparing self- and 
third-party reports (e.g., from participants  family or friends).

o  Designs to improve and compare various approaches to economic analysis, 
including cost analysis, cost-effectiveness, cost-benefit, and conjoint 
analysis for improving decision-making in health policy and health care 
systems.

o  Designs to improve the inclusion of underrepresented groups in research. 
Examples of these groups are women, children, the elderly, ethnic and racial 
minorities, sexual minority groups, and language minority populations - that 
is, individuals who do not speak the most common language or languages in a 
country or region (e.g., in the United States, individuals who speak neither 
English nor Spanish).

o  Designs that will allow for the meaningful integration of biological, 
behavioral and social science data (e.g., the use of factorial designs to 
assess interacting and modulatory behavioral and neural systems).
 
o  Methods for archiving and disseminating complex datasets, especially 
longitudinal datasets, datasets containing social network data, geographic 
identifiers, and/or biological measures so that the identities of study 
participants are protected and so that the datasets can be used by 
investigators who were not part of the original research team. 

B.  MEASUREMENT

Developing and validating research instruments and questions are vitally 
important for collecting reliable information, and have obvious impact on data 
validity and reliability.  For example, health care practitioners must collect 
reliable reports of symptoms from their patients in order to accurately 
diagnose disease.  In addition, data collection instruments and questions 
developed for a particular age, gender, or cultural group may not be valid for 
other groups.  For example, a dietary history questionnaire developed for 
Americans of European descent may not contain the foods commonly eaten by 
Americans of African, Asian, or Hispanic descent.  Methods to collect 
information regarding child rearing should take into account the fact that such 
practices will vary in different cultures.  Finally, continued improvement and 
innovation in developing and validating data collection instruments are  
important for all types of research settings, ranging from the clinical 
interview and observational study to the survey.

Examples of measurement issues include, but are not limited to, the following:

o  Development and refinement of measures/instruments/surveys used in 
behavioral and social science research that fill a gap in research needs, with 
a goal of developing and validating core sets of items to reduce redundancy 
across measures.  

o  Instrument design, calibration, and refinement; instrument design issues in 
studying age, gender, and culture, including methods of studying culture and 
self-identification of race/ethnicity, as well as the psychometric properties 
underlying data collection instruments.

o  Measurement issues in using technology such as computer assisted data 
collection and web-based technology.

o  Direct and indirect measurement of attitudes, values, self-esteem, and other 
psychological variables.  This includes examination of economic values, 
including willingness-to-pay, as means of evaluating benefits, including health 
services.

o  Development of instruments that assess not only degree of change, but also 
rate and variable direction of change.

o  Development of instruments that measure behavior objectively or reduce self-
report burden (e.g., development of the pedometer or accelerometer for the  
measurement of physical activity). 

o  Development of objective measures of components of the built environment 
that impact health and how people interact with those environmental components 
(e.g., measures of neighborhood design that may affect physical activity).

o  Methodology to objectively measure the social environment (e.g., imaging 
devices to measure social interactions), including aspects of the community 
environment that impact health.

o Assessment of the relationship of self-report measures to behavioral, neural 
and other biological measures (because self-report routinely is used by health 
practitioners as a method of assessing physical and mental health).

C. DATA COLLECTION TECHNIQUES

Data collection techniques are the tools and procedures scientists use for 
implementing research designs and obtaining measurements.  Methods for 
collecting research data have an important impact on data validity and 
reliability.  For example, studies have suggested that use of self-administered 
instruments can facilitate the reporting of sensitive or illegal behaviors.  
Innovative methodologies can also lead to the collection of new or more complex 
types of data by behavioral scientists.  For example, recent developments in 
computer-assisted interviewing have permitted more complex question sequences 
in survey research, and the development of hand-held "beepers" programmed for 
data entry have permitted the collection of time-specific data on activities 
such as cigarette smoking.  In addition, implicit measures have allowed 
researchers to examine processes of which people themselves have been unaware.  
Continued improvement and innovation in data collection methods is important 
for all types of research settings, including clinical interviews, 
observational studies, participatory action research, and surveys.  

Potential topics within data collection techniques include, but are not limited 
to the following:

o  Methods to improve data collection in surveys, epidemiologic self-report 
studies, ethnographic and other qualitative studies, participatory action 
research methods, and multimethod studies; this may include new approaches to 
instrument design and manipulation of method and mode of data collection, 
length, setting, and interpersonal factors in data collection exchanges.

o Methods to develop innovative gold standards to assess the accuracy of and 
improve the accuracy of self reports, in the absence of health record checks (a 
possible consequence of the Privacy Rule regulation of the Health Insurance 
Portability and Accountability Act of 1996).

o Development of web-based methods for collecting outcome data in randomized 
controlled trials and in observational studies.

o  New methods for qualitative research; techniques for validating and 
replicating findings from qualitative research, including collection 
strategies, development of coding protocols, and techniques that facilitate the 
integration and validation of qualitative and quantitative measurement; optimal 
timing and integration of multiple quantitative and/or qualitative 
methodologies. 

o  Methods to reduce sampling, survey, and item non-response bias in research 
studies, including techniques to improve the coverage of relevant populations 
in household surveys, to increase the voluntary participation of eligible 
subjects, to reduce attrition in longitudinal studies and clinical trials, to 
improve response rates on sensitive items, and to impute missing values.

o  Techniques for collecting contextual data (e.g., neighborhood composition, 
peer group characteristics, geographic and environmental information) and for 
operationalizing the boundaries of particular social, economic, physical, and 
cultural contexts.

o  Development or refinement of varying technologies for data collection, 
including automated collection and reporting technologies, and research on how 
the method/mode used to collect data affects quality in a variety of 
populations, contexts and substantive areas.

o  Data collection techniques that address the needs of special populations 
(e.g., physically or mentally disabled, non-literate populations, non-English 
speaking populations, the homeless and incarcerated, children and the elderly, 
critically ill patients) and that address how these methods affect data quality 
and completeness across diverse populations.

o  Development of research designs, sampling techniques, and statistical 
methods for studies that involve populations that are small or difficult to 
access.

D.  ANALYTIC METHODS

Analytic methods encompass the concepts and techniques used in analyzing data 
and interpreting and reporting results.  The goal of new and improved analytic 
methods is to help make estimation, hypothesis testing, and causal modeling 
based on scientific data as sound as possible.  Challenges include developing 
techniques that distinguish underlying regularities from the noise created by 
variability and imprecise measurement; developing causal inferences from quasi-
experimental or non-experimental data; improving both the internal validity and 
external validity (generalizability) of measures and studies; and developing 
appropriate analytic techniques for use with new kinds of data and new 
approaches to behavioral and social science research.

Examples of topics within analytic methods include, but are not limited to the 
following:

o   Improved analysis of longitudinal data, in particular, the analysis of 
correlated data, the modeling of different sources of error, and techniques for 
dealing with missing data (as seen in the use of growth curve models for 
analyzing longitudinal data for each individual participant).

o   Methods for improving the analysis of multicultural community-based multi-
level intervention trials (e.g., health promotion/disease prevention programs).

o   Improved methodology for the analysis of complex survey data, including the 
statistical modeling of non-response and other survey errors.

o  Innovative techniques for improving causal inference from non-experimental 
research and for determination of if/when noise is really context.

o  Analytic methods for integrating evidence from qualitative and quantitative 
research, such as research examining the complex relationships among multiple 
sources of information on a single construct (e.g., self- and third-party 
reports, clinical examinations and testing, laboratory tests, and other record 
sources).

o  Analytic methods that appropriately model social structures, social 
processes, and spatial relationships such as social networks, social influence, 
diffusion, and contextual effects.

o  Statistical procedures for accurately estimating multilevel models.  

o  Development of novel mathematical and computational techniques for analyzing 
and modeling behavioral and social processes.

o  Methods for improving the analysis of non-independent data, such as data 
examining processes in interactions between couples, families, or other groups.

RELEVANT RESEARCH LINKS

Potential applicants specifically concerned with research regarding the 
inclusion of language minorities (e.g., people who do not speak the most common 
national language or languages) should also see the recent report on the 
conference  Diverse Voices - The Inclusion of Language-Minority Populations in 
National Studies: Challenges and Opportunities,  sponsored by National 
Institute on Aging, the National Institute of Child Health and Human 
Development, and the National Center on Minority Health and Health Disparities:  
http://www.nichd.nih.gov/publications/pubs/diverse_voices.cfm.

In June, 2000 the Office of Behavioral and Social Sciences Research (OBSSR) 
held a conference "Toward Higher Levels of Analysis: Progress and Promise in 
Research on Social and Cultural Dimensions of Health."  In an agenda-setting 
activity that followed the conference, a panel of scientists developed an 
ambitious research agenda on the social and cultural dimensions of health. A 
program announcement based on the panel's recommendations for substantive 
research has been issued by the OBSSR and can be found at: 
http://grants.nih.gov/grants/guide/pa-files/PA-02-043.html.  However, the 
research agenda also included detailed recommendations relating to needed 
methodological development to address the social and cultural dimensions of 
health.  Potential applicants are encouraged to consult this report, available 
at http://obssr.od.nih.gov/Conf_Wkshp/higherlevel/conference.html

In September 2001, NIH sponsored an International Conference entitled: Stigma 
and Global Health: Developing a Research Agenda.  One of the recommendations 
was to encourage research intended to develop methodological, evaluative and 
analytic tools for 1) studying stigma and its consequences with respect to 
health, and 2) development, evaluation and optimization of interventions to 
prevent or mitigate the negative effects of stigma and discrimination on 
health. In both areas it was recommended that the social and cultural 
dimensions of stigma and its manifestations be included. Applicants are 
encouraged to refer to the stigma conference website: 
http://www.stigmaconference.nih.gov 
for further resources and information.

Finally, the following reports may be useful as general references on behavior 
and social sciences research as it relates to health:

New Horizons in Health: An Integrative Approach. (2001).  Burton H. Singer and 
Carol D. Ryff, Editors, Committee on Future Directions for Behavioral and 
Social Sciences Research at the National Institutes of Health, Board on 
Behavioral, Cognitive, and Sensory Sciences, National Research Council 
(http://www.nap.edu/catalog/10002.html).

Health and Behavior: The Interplay of Biological, Behavioral, and Societal 
Influences (2001).  Committee on Health and Behavior: Research, Practice and 
Policy, Board on Neuroscience and Behavioral Health, Institute of Medicine 
(http://www.nap.edu/catalog/9838.html).

From Neurons to Neighborhoods: The Science of Early Childhood Development  
(2000).  Jack P. Shonkoff and Deborah A. Phillips, Editors; Committee on 
Integrating the Science of Early Childhood Development, Board on Children, 
Youth, and Families, National Research Council 
(http://books.nap.edu/catalog/9824.html).

Bridging Disciplines in the Brain, Behavioral, and Clinical Sciences (2000). 
Terry C. Pellmar and Leon Eisenberg, Editors; Committee on Building Bridges in 
the Brain, Behavioral, and Clinical Sciences; Division of Neuroscience and 
Behavioral Health, Institute of Medicine 
(http://books.nap.edu/catalog/9942.html).

Expanding the Boundaries of Health and Social Science:  Case Studies in 
Interdisciplinary Innovation (2003).  Frank Kessel, Patricia Rosenfield and 
Norman Anderson, Editors.  New York: Oxford University Press.

Rebuilding the Unity of Health and the Environment (2001). Kathi Hanna and 
Christine Coussens, Editors; Roundtable on Environmental Health Sciences, 
Research, and Medicine, Division of Health Sciences Policy, Institute of 
Medicine (http://www.nap.edu/books/030907259X/html/).

Cells and Surveys. Should Biological Measures be Included in Social Science 
Research? (2001). Caleb E. Finch, James W. Vaupel and Kevin Kinsella, Editors; 
Committee on Population, National Research Council 
(http://www.nap.edu/books/0309071992/html/).

Applicants may also wish to consult the following report on the protection of 
human subjects in behavioral and social sciences research: 

Protecting Participants and Facilitating Social and Behavioral Sciences 
Research (2003). Constance F. Citro, Daniel R. Ilgen, and Cora B. Marrett, 
Editors, Panel on Institutional Review Boards, Surveys, and Social Science 
Research, National Research Council 
(http://www.nap.edu/books/0309088526/html/).

MECHANISM OF SUPPORT

This RFA will use the NIH competing supplement mechanism to ongoing R01, R37, P01, 
R21 or U01 grants. Responsibility for the planning, direction, and execution of 
the proposed project will be solely that of the applicant. This RFA uses just-
in-time concepts.  It also uses the modular budgeting format (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Since the direct 
costs of the supplements will always be less than $250,000 yearly, the modular 
format is required. This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

The NIH intends to commit approximately $600,000 in FY 2004 to fund 4-6 
competitive supplements in response to this RFA. Support will be offered for a 
maximum of two years through competing supplements to existing grants.  
Requests should not exceed $150,000 total direct costs for the entire two years 
of support. Facilities and Administrative (F&A) costs are limited to 8 percent 
of allowable direct costs.

As the nature and scope of the research proposed in response to this RFA may 
vary, it is anticipated that the size of supplements will vary, but in any case 
are non-renewable; continuation of projects developed under this program must 
be through other grant mechanisms. Awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications. The number of awards made will depend on 
institutional need, the number of highly meritorious applications received, and 
the size of individual awards.

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 institutions/organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Because this grant will be awarded as a supplement to existing NIH-funded 
research project grants (R01), Method to Extend Research in Time (MERIT) 
awards (R37), program projects (P01), exploratory/developmental grants (R21), 
or cooperative agreements (U01), only current Principal Investigators of an 
active award are eligible to be the Principal Investigators of a proposal 
submitted in response to this RFA. Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS

Grants that are eligible for supplementation in response to this RFA are NIH-
funded R01, R37, P01, R21 and U01 grants whose project end dates are 
September 30, 2005 or later. The existing grant must have at least 12 months 
of support remaining on September 30, 2004, the anticipated start date of the 
supplement award.  A supplemental application will not be accepted until after 
the original application for the parent grant has been awarded, and the 
supplement may not extend beyond the term of the parent grant.  The PI must be 
the same individual as on parent grant.  The work should be a logical extension 
of the goals and objectives of the parent grant, but should constitute new 
methodological development.  A research plan redundant with any portion of the 
studies approved under the parent grant will not be supported under this 
supplement program. Applicants are strongly encouraged to consult with program 
staff from the appropriate awarding component of the parent grant prior to 
submitting an application for a supplement. 
 
Annual project reports and final reports of the parent project should include a 
specific discussion of the progress made from the supplemental award.

WHERE TO SEND INQUIRIES

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

o  Direct your general questions about scientific/research issues to:

Deborah H. Olster, Ph.D.
Office of Behavioral and Social Sciences Research
National Institutes of Health
One Center Drive, Room 256
Bethesda, MD 20892-0183
Telephone: (301) 451-4286
Fax: (301) 402-1150
Email:  [email protected]

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch (DBSB)
Center for Population Research (CPR)
National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone:  301-496-1175
Fax:  301-496-0962
E-mail: [email protected]

o Direct your questions about peer review issues to:

Anita Miller Sostek, Ph.D.
Division Director  
Clinical and Population-Based Studies  
Center for Scientific Review  
6701 Rockledge Drive, Room 4100, MSC 7814  
Bethesda, MD  20892  (20817 for overnight mail) 
Telephone: (301) 435-1260
FAX: (301) 480-2644
Email: [email protected]

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

Annette Hanopole
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6975 
FAX:  (301) 402-0915  
E-mail:  [email protected]

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 (same as parent grant)
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 IC staff to estimate the potential workload and plan the review.

The letter of intent is to be sent by January 13, 2004.  The letter of intent 
should be sent to:

Rebecca L. Clark, Ph.D.
Demographic and Behavioral Sciences Branch (DBSB)
Center for Population Research (CPR)
National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone:  301-496-1175
Fax:  301-496-0962
E-mail:  [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001), according to the SUPPLEMENTARY 
INSTRUCTIONS described below. Applications must have a DUN and Bradstreet (D&B) 
Data Universal Numbering System (DUNS) number as the Universal Identifier when 
applying for Federal grants or cooperative agreements. The DUNS number can be 
obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 
of the face page of the PHS 398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: [email protected].

SUPPLEMENTARY INSTRUCTIONS

To apply for a competitive supplement, the PI must submit the following 
information:

o  A completed Grant Application PHS 398 with appropriate signatures on the 
face page.  Include the title and grant number of the parent grant on line 1 
and the RFA Number of this program on line 2.  

o  Applications should have the normal Description on page 2 as described in 
PHS 398 which should describe the proposed supplemental activity and how it 
relates to the parent grant.

o  A one page introduction, prepared by the Principal investigator, that 
includes the grant number of the funded grant or project, summary or abstract, 
and specific aims.

o  The Research Plan should provide a description of the supplemental project, 
including:

a.  A description of the methodological development being proposed, how it is 
innovative or critical to advancing the state of the science in the field.

b.  A description of how the proposed methodological development advances the 
specific research goals and objectives of the parent grant.

c.  A description of the overall impact the proposed methodology will have on 
the general scientific field, and on future research efforts to integrate 
behavioral and social sciences in the study of health. 

IT IS A REQUIREMENT THAT SECTIONS A-D OF THE RESEARCH PLAN NOT EXCEED 10 PAGES.

o  In addition to completing all portions of the PHS 398, applicants should 
also include a cover letter requesting the competing supplement and identifying 
this RFA.

o  Facilities and Administrative (F&A) Costs:  These costs are limited to 8 
percent of allowable direct costs. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All applications 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/labels.pdf.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the checklist, five signed photocopies, and appendix 
materials 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)

APPLICATION PROCESSING: Applications must be received on or before 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. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the previous 
unfunded version of the application.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD. Incomplete and/or nonresponsive applications will 
not be reviewed. Applications that are complete and responsive to the RFA will 
be evaluated for scientific and technical merit by an appropriate peer review 
group, in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

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 written critique
o Receive a second level review by an 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 evaluate the application in order 
to judge the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals. The scientific review group will address 
and consider each of the following criteria in assigning the application’s 
overall score, weighting them as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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.

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?

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?

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?

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)?
 
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?  

ADDITIONAL REVIEW CRITERIA

In addition to the above criteria, the following items will be considered in 
the determination of the scientific merit and the priority score:

o The benefits of the methodological development to the aims of the parent 
grant;
o The potential application of the methodological innovation to other health 
research;
o The broad impact of the methodological innovation to the general scientific 
field;
o The quality of the innovation and the potential benefits the innovation may 
provide (e.g., the need for objective versus subjective measures; the potential 
increase in research capacity or data collection efficiency; the potential to 
improve reliability or validity, etc.).

Each application is not expected to focus on all four of the areas identified 
for methodological development (i.e., research design, measurement, data 
collection techniques, analytic methods). An application that focuses on only 
one of these areas may still be competitive.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

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: January 13, 2004
Application Receipt Date: February 13, 2004
Peer Review Date: June/July, 2004
Council Review: September, 2004
Earliest Anticipated Start Date: September 30, 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 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and others, 
and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING  PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-finding 
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and 
comparative trials (phase III).  The establishment of data and safety 
monitoring boards (DSMBs) is required for multi-site clinical trials involving 
interventions that entail potential risk to the participants.   (NIH Policy for 
Data and Safety 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 "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://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
 Standards for Privacy of Individually Identifiable Health Information , the 
 Privacy Rule,  on August 14, 2002.  The Privacy Rule is a federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health information, 
and is administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule as 
 covered entities ) must do so by April 14, 2003 (with the exception of small 
health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a 
complete Regulation Text and a set of decision tools on  Am I a covered 
entity?   Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are 
subject to the terms and conditions, cost principles, and other considerations 
described in the NIH Grants Policy Statement.  The NIH Grants Policy Statement 
can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.

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