METHODOLOGY AND MEASUREMENT IN THE BEHAVIORAL AND SOCIAL SCIENCES

PA NUMBER:  PA-02-072 (This PA has been reissued, see PA-05-090)

RELEASE DATE:  March 7, 2002

EXPIRATION DATE:  March 10, 2005

Office of Behavioral and Social Sciences Research (OBSSR) 
 (http://obssr.od.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM) 
 (http://www.nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) 
 (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) 
 (http://www.ninds.nih.gov)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)
John E. Fogarty International Center for Advanced Study in the Health Sciences 
(FIC)
 (http://www.nih.gov/fic)


THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The participating Institutes and Centers invite qualified researchers to submit 
research grant applications on methodology and measurement in the behavioral 
and social sciences.  Methodology and measurement issues include the processes 
that underlie research design, data collection techniques, measurement, and 
data analysis techniques in the social and behavioral sciences.  The goal of 
this program announcement is to encourage research that will improve the 
quality and scientific power of data collected in the behavioral and social 
sciences, relevant to the missions of the NIH Institutes and Centers.  Research 
that addresses methodology and measurement issues in diverse populations, 
issues in studying sensitive behaviors, issues of ethics in research, issues 
related to confidential data and the protection of research subjects, and 
issues in developing multidisciplinary, multimethod, and multilevel approaches 
to behavioral and social science research is particularly encouraged.  
Applicants are strongly encouraged to contact the Program Contact for 
Scientific/Research issues (listed under WHERE TO SEND INQUIRES) of the IC that 
most closely matches their research focus to determine the IC's interest in the 
research topic.

RESEARCH OBJECTIVES

This program announcement encourages applications in four general areas of 
methodology and measurement research in the social and behavioral sciences.  
These areas, discussed in detail below, include the processes that underlie 
research design, data collection techniques, measurement, and data analysis 
techniques.  Within the broad spectrum of research defined by these areas, 
applicants are particularly encouraged (but are not required) to consider 
studies that address one or more of the following key issues:

Methodology and measurement issues in developing innovative multidisciplinary, 
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.

Methodology and measurement issues in research relating to diverse populations, 
for example, populations that are distinctive by virtue of age, gender, sexual 
orientation, ethnicity, culture, socio-economic status, literacy, language, or 
disability.

Methodology and measurement issues in developing designs to study how dramatic 
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. 

Methodology and measurement issues in studying potentially sensitive behaviors, 
such as sexual behavior and abortion, and covert or illegal behaviors such as 
drug use, abuse, and violence.

Methodology and measurement issues concerning ethics in research, with emphasis 
on the topics of informed consent, assessment of risk and benefit, and 
selection and retention of subjects.  Potential applicants specifically 
concerned with ethics topics should be aware that future ethics initiatives are 
forthcoming. 
 
Multidisciplinary approaches are strongly encouraged.  Potential applicants are 
urged to explore the ideas and methods developed in social science and 
behavioral fields other than their own.  Particular emphasis is placed on the 
development and integration of biomedical measures in the service of behavioral 
and social science research (although applicants are not limited to the 
inclusion of biomedical measures). Consulting relevant literature and 
collaborating with colleagues from other disciplines may provide important 
opportunities for cross-fertilization in developing improved methodology and 
measurement.

A. RESEARCH DESIGN

Broadly stated, research design determines how well a research plan can 
accomplish stated purposes and test hypotheses.  How the research is designed 
depends on the central research questions.  Thus, 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 are, but are not limited to, the 
following:

o  Conceptual design strategies appropriate for the study of culture.

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

o  Research addressing the efficacy of multilevel designs.

o  Methods for improving the design and evaluation of community-based 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 may include 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  Ethical considerations in research design including, but not limited to 
issues of informed consent, assessment of risk and benefit, and selection of 
subjects.

o  Methods for archiving and disseminating complex datasets, especially 
longitudinal datasets, data sets including social network data, and datasets 
including geographic identifiers, 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 ISSUES

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.  Specific consideration of 
the processes underlying potential bias in self-report data collection remains 
a measurement issue.  Such processes include perceptual, cognitive, cultural, 
demographic, motivational, and affective influences on self-report data.  
Finally, continued improvement and innovation in developing and validating data 
collection instruments is 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 
an eye for 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.

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 open the door 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 intrapsychic 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.  In addition, more research is needed to understand how 
various methods work in diverse populations, and how they can be modified to 
address the specific needs of populations.

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

o  Methods to improve data collection in surveys and, epidemiologic self-report 
studies, ethnographic and other qualitative studies, participatory action 
research methods, and multi-method 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  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.

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, and 
to improve response rates on sensitive items.

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 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  Issues surrounding the collection of self-report data from different 
settings (e.g., alone, in groups), different collection methods (e.g., oral, 
written), from different parties (e.g., participants, third parties), and the 
use of implicit and explicit measures.

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 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   Research to improve the 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).

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

o   Methodological research to improve the analysis of complex survey data, 
including the statistical modeling of non-response and other survey errors.

o  Analytic issues in and innovative techniques for improving causal inference 
from non-experimental research.

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 addition, in June, 2000 the Office of Behavioral and Social Sciences 
Research 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: 
https://grants.nih.gov/grants/guide/pa-files/PA-02-043.html.  However, the 
research agenda also included detailed recommendations relating to needed 
methodological research related to 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

Finally, in September, 2001, NIH sponsored an International Conference 
entitled: Stigma and Global Health: Developing a Research Agenda. Among 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: 
www.stigmaconference.nih.gov for further resources and information.

MECHANISM(S) OF SUPPORT

The primary mechanism of support will be the investigator-initiated research 
project grant (R01).  Potential applications should note that R01's of shorter 
duration and with small budgets are often appropriate for the kind of work 
encouraged in this PA.  In addition, the announcement will support competing 
supplements for existing grants.  Applicants are encouraged to contact specific 
IC representatives regarding their funding mechanisms (the IC contact list is 
provided below).  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 PA may not exceed 5 
years. 

Specific application instructions have been modified to reflect MODULAR GRANT 
and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and 
detailed instructions and information on Modular Grant applications can be 
found at https://grants.nih.gov/grants/funding/modular/modular.htm.  

Applicants may consult with program staff listed under INQUIRIES regarding 
other mechanisms and relevant announcements on topics related to this program 
announcement.

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
o Faith-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

WHERE TO SEND INQUIRIES

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

o  Direct your questions about scientific/research issues to (be sure to 
contact the IC that most closely matches your topic material):

National Cancer Institute
Michael Stefanek, Ph.D.
Division of Cancer Control and Population Sciences
6130 Executive Boulevard, Room 4066
Rockville, MD 20852
Telephone: (301) 496-8776
Fax: (301) 435-7547
Email:  ms496r@nih.gov

National Center for Complementary and Alternative Medicine
Morgan Jackson, Ph.D.
Division of Extramural Research and Training
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 402-1278
Fax: (301) 480-3621
Email:  mj145m@nih.gov

National Heart, Lung, and Blood Institute
Jared B. Jobe, Ph.D.
Division of Epidemiology and Clinical Applications
7201 Rockledge Drive, Room 8122, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0407
Fax: (301) 480-1773 
E-mail: JobeJ@nhlbi.nih.gov

National Institute on Aging
Sidney Stahl, Ph.D.
Behavioral and Social Research Program
Gateway Building, Room 533
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
E-mail: Stahls@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism
Judith A. Arroyo, Ph.D.
Office of Collaborative Research
Research Development and Health Disparities Programs
6000 Executive Blvd., Suite 302
Bethesda, MD 20892-7003
Express mail/courier use Rockville, MD ZIP 20852
Tel. 301-402-0717
Fax 301-480-2358
email:  jarroyo@mail.nih.gov

National Institute of Biomedical Imaging and Bioengineering
Richard E. Swaja, Ph.D.
31 Center Drive, Room 1B37
Bethesda, MD 20892-2077
Telephone: (301) 451-6768
Fax: (301) 480-4515
E-mail: Swajar@nibib.nih.gov

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

National Institute of Dental and Craniofacial Research
Patricia Bryant, Ph.D.
Division of Population and Health Promotion Sciences
Natcher Building, Room 4AN-24E
Bethesda, MD 20892-6500
Telephone: (301) 594-2095
Fax: (301) 480-8318
Email:  BryantP@DE45.nidr.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
Sanford Garfield, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
6707 Democracy Boulevard, Room 685
Bethesda, MD 20892-5460
Telephone: (301) 594-8803
Fax: (301) 480-3503
Email: garfields@extra.niddk.nih.gov

National Institute on Drug Abuse
Jacques Normand, Ph.D.
Division of Epidemiology, Services and Prevention Research
6001 Executive Boulevard, Room 5153
Bethesda, MD 20892-9589
Telephone: (301) 402-1919
Fax: (301) 480-4544
Email: jnormand@nida.nih.gov

National Institute of Environmental Health Sciences 
Shobha Srinivasan, Ph.D. 
Division of Extramural Research and Training 
P.O. Box 12233, MD EC-21 
111 T.W. Alexander Drive 
Research Triangle Park, NC 27709 
Telephone: (919) 541-2506 
Fax: (919) 316-4606 
E-mail: sriniva2@niehs.nih.gov  

National Institute of Mental Health
Carolyn C. Morf, Ph.D.
Division of Neuroscience and Basic Behavioral Science 
6001 Executive Boulevard, Room 7216, MSC 9651
Bethesda, MD 20892
Telephone: (301) 443-3942
Fax: (301) 443-9876
E-mail: cmorf@mail.nih.gov

National Institute of Neurological Disorders and Stroke 
Emmeline Edwards, Ph.D.
Systems and Cognitive Neuroscience Cluster 
6001 Executive Boulevard, Room 2109 
Bethesda, MD 20892-9521 
Telephone: (301) 496-9964 
Fax: (30l) 402-2060 
Email: ee48r@nih.gov

National Institute of Nursing Research
Nell Armstrong, Ph.D., R.N.
Office of Extramural Programs
Building 45, Room 3AN12
Bethesda MD 20814-9692
Telephone: (301) 594-5973
Fax: (301) 480-8260
email:  nell.armstrong@nih.gov

John E. Fogarty International Center for Advanced Study in the Health Sciences
Rachel Nugent, Ph.D.
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-8733
Fax: (301) 402-0779
Email: nugentra@mail.nih.gov

Office of Behavioral and Social Sciences Research
Stephen M. Drigotas, Ph.D.
1 Center Drive, Room 256
Bethesda, MD 20892-1146
Telephone: (301) 402-3930
Fax: (301) 402-1150
Email:  Drigotas@od.nih.gov

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

National Cancer Institute
Ms. Crystal Wolfrey
Grants Administration Branch
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892
Telephone:(301) 496-8634
Fax: (301) 496-8601

National Center for Complementary and Alternative Medicine
Mr. Marc Pitts
Grants Administration Branch
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301) 594-9095
Fax: (301) 480-3621
Email: pittsm@mail.nih.gov

National Heart, Lung, and Blood Institute
Mr. Owen Bobbitt
Division of Extramural Affairs
6701 Rockledge Drive, Room 7142, MSC 7924
Bethesda, MD 20892-7924
Telephone: (301) 435-0177
Fax:  (301) 480-0422
Email: BobbittO@nhlbi.nih.gov

National Institute on Aging
Ms. Linda Whipp
Grants and Contracts Management Office
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-1472
Fax: (301) 402-3672
E-mail: whippl@nia.nih.gov

National Institute on Alcohol Abuse and Alcoholism
Ms. Judy Fox Simons
6000 Executive Boulevard, Suite 504
Bethesda, MD 20892-7003
Telephone: (301) 443-4706
Fax: (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

National Institute of Biomedical Imaging and Bioengineering
Ms. Annette Hanopole
Grants Management Office
31 Center Drive, Room 1B37
Bethesda, MD 20892-2077
Telephone: (301) 451-6768
Fax: (301) 480-4515
E-mail: hanpola@nibib.nih.gov

National Institute of Child Health and Human Development
Ms. Melinda Nelson
Grants Management Branch
Building 61E, Room 8A17
Bethesda, MD 20892
Telephone: (301) 496-5481
Fax: (301) 402-0915
Email:  nelsonm@hd01.nichd.nih.gov

National Institute of Dental and Craniofacial Research
Mr. Martin R. Rubinstein
Division of Extramural Research
Natcher Building, Room 4AN-44A
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
Fax: (301) 402-1517
Email:  RubensteinM@DE45.nidr.nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases
Ms. Mary Rosenberg
Division of Extramural Affairs
6707 Democracy Boulevard, Room 722
Bethesda, MD 20892-5456
Telephone: (301) 594-8891
Fax: (301) 480-3504
Email: rosenberm@extra.niddk.nih.gov

National Institute on Drug Abuse
Gary Fleming, J.D., M.A.
6001 Executive Boulevard, Room 3131
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6847
E-mail: gf6s@nih.gov

National Institute of Environmental Health Sciences
Ms. Carolyn Winters
Grants Management Branch
Division of Extramural Research and Training
P.O. Box 12233, MD EC-24
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-7823
Fax: (919) 541-2860
Email:  winters@niehs.nih.gov

National Institute of Mental Health
Ms. Carol J. Robinson
Division of Extramural Affairs
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3858
Fax: (301) 443-6885
E-mail: crobinso@mail.nih.gov

National Institute of Neurological Disorders and Stroke 
Ms. Kim Pendleton 
Grants Management Branch 
6001 Executive Boulevard, Room 3290 
Bethesda, MD 20892 
Telephone: (301) 496-9231 
Fax: (301) 402-0219 
Email: kp33e@ninds.nih.gov

National Institute of Nursing Research
Ms. Cindy McDermott
45 Center Drive
Bethesda, MD 20892-6301
Telephone: (301) 594-6869
Fax: (301) 451-8260
Email:  cindy.mcdermott@nih.gov

John E. Fogarty International Center for Advanced Study in the Health Sciences
Mr. Bruce R. Butrum
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
E-mail: butrumb@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at https://grants.nih.gov/grants/dates.htm.  Application deadlines are 
also indicated in the PHS 398 application kit.

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

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

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

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

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

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

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

PEER REVIEW PROCESS

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

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

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council or 
board

REVIEW CRITERIA 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In the 
written comments, reviewers will be asked to discuss the following aspects of 
your application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as appropriate for 
each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus deserve 
a high priority score.  For example, you may propose to carry out important 
work that by its nature is not innovative but is essential to move a field 
forward.

(1) Significance: Does 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 of the concepts or methods that drive this 
field? 

(2) Approach: Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics? 

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

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

(5) Environment: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support? 

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

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

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

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

AWARD CRITERIA 

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

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

REQUIRED FEDERAL CITATIONS 

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

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the 
NIH that women and members of minority groups and their sub-populations must be 
included in all NIH-supported clinical research projects unless a clear and 
compelling justification is provided indicating that inclusion is inappropriate 
with respect to the health of the subjects or the purpose of the research. This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public 
Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at 
https://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 
https://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 
https://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 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

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

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

HEALTHY PEOPLE 2010 

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS led national 
activity for setting priority areas. This Program Announcement (PA) is related 
to one or more of the priority areas. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.  

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.866, 93.399, 93.273, 93.393, 93.396, 93.399, 93.242, 93.865, 93.361, and 
93.837, 93.121.  Awards are made under authorization of the Public Health 
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-
158, 42 USC 241 and 285) and administered under PHS grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products. In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early childhood 
development services are provided to children.  This is consistent with the PHS 
mission to protect and advance the physical and mental health of the American 
people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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