UNDERSTANDING AND PROMOTING HEALTH LITERACY (R01)

RELEASE DATE:  June 22, 2004

PA NUMBER: PAR-04-116

EXPIRATION DATE:  October 14, 2006, unless reissued. 
November 21, 2006 - The R01 portion of this funding opportunity has been replaced by PAR-07-020, 
which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
Agency for Healthcare Research and Quality (AHRQ)
 (http://www.ahrq.gov/)  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
National Cancer Institute (NCI) 
 (http://www.nci.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 for 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 on Deafness and Other Communication Disorders (NIDCD) 
 (http://www.nidcd.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 Library of Medicine (NLM) 
 (http://www.nlm.nih.gov/)

Note:  The policies, guidelines, terms, and conditions stated in this
       announcement may differ from those used by the NIH.
 
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  
93.113, 93.121, 93.173, 93.242, 93.279, 93.286, 93.393, 93.837, 93.847, 
93.865, 93.866, 93.879  

LETTER OF INTENT RECEIPT DATE:  September 13, 2004; September 13, 2005; 
September 13, 2006

APPLICATION RECEIPT DATE: October 13, 2004; October 13, 2005; October 13, 2006

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA  

The participating Institutes, Centers and Offices of the National Institutes 
of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) 
invite investigators to submit R01 research grant applications on health 
literacy. The goal of this Program Announcement is to increase scientific 
understanding of the nature of health literacy and its relationship to 
healthy behaviors, illness prevention and treatment, chronic disease 
management, health disparities, risk assessment of environmental factors, and 
health outcomes including mental and oral health.  Increased scientific 
knowledge of interventions that can strengthen health literacy and improve 
the positive health impacts of communications between healthcare and public 
health professionals (including dentists, healthcare delivery organizations, 
and public health entities), and consumer or patient audiences that vary in 
health literacy, is needed. Such knowledge will help enable healthcare and 
public health systems serve individuals and populations more effectively, and 
employ strategies that reduce health disparities in the population.  

Healthy People 2010 defines health literacy as the “degree to which 
individuals have the capacity to obtain, process and understand basic health 
information and services needed to make appropriate health decisions” (U.S. 
Department of Health and Human Services, 2000).  Many factors affect 
individuals’ ability to comprehend, and in turn use or act on, health 
information and communication.  Proficiency in reading, writing, listening, 
interpreting, oral communication, and visual analysis is necessary as the 
modern health system typically relies on a variety of interpersonal, textual, 
and electronic media to present health information.  Individuals and families 
both must be able to: communicate with health professionals; understand the 
health information in mass communication; understand how to use health-
related print, audiovisual, graphical and electronic materials; understand 
basic health concepts (e.g., many health problems can be prevented or 
minimized) and vocabulary (e.g., about the body, diseases, medical 
treatments, etc.); and connect this health-related knowledge to health 
decision-making and action-taking.  Access to and understanding of health 
information and services is a reciprocal process among health professionals, 
communication professionals and patients.  For instance, these professionals 
must use science-based strategies and tactics, develop resources and 
materials, and understand communication interactions between providers and 
patients.  

Research on health literacy should assist NIH in its mission of communicating 
scientifically-based health information to the public and to the health care 
providers and related professionals who serve the public.  The application of 
scientific knowledge from health literacy research may also strengthen the 
health information knowledge and communication skills of the public, and 
further one of the national goals of Healthy People 2010, to improve health 
literacy by the decade’s end.

RESEARCH OBJECTIVES

Background

Health literacy is a complex phenomenon that involves individuals, families, 
communities and systems.  For instance, consumers, patients, caregivers, or 
other laypersons may vary with respect to: 
o Access (e.g., to audience-appropriate information, media or professionals); 
o Skills (e.g., to gather and comprehend health information; to speak and 
share personal information about health history and symptoms; to act on 
information by initiating appropriate follow-up visits and conveying 
understanding back to the information source; to make decisions about basic 
healthy behaviors, such as healthy eating and exercise; to engage in self-
care and chronic disease management); 
o Knowledge (e.g., of health and medical vocabulary, concepts such as “risk”, 
the organization and functioning of healthcare systems); 
o Disabilities (e.g., sensory, communication, cognitive or physical 
challenges or limitations); 
o The features of their health care providers and the public health systems 
in which these providers practice (e.g., the communication skills of health 
professionals, platforms employed for patient education, built environments 
and signage);  
o Other important characteristics including developmental or life stage, 
cultural, linguistic or educational differences that affect health beliefs, 
knowledge and communication.

Too often people with the greatest health burdens have limited access to 
relevant health information.  In part, this is due to the complex and 
cumbersome ways health information often is presented, and due to 
individuals’ limited abilities to fully interpret and understand complex 
health terminology and instructions, and to make personal decisions related 
to risk avoidance or risk reduction strategies.  For instance, to follow 
health care instructions, patients need to be able to comprehend written and 
oral prescription instructions, directions for self-care, and plans for 
follow-up tests and appointments.  In addition, health care providers may not 
communicate effectively with individuals with limited levels of literacy.  
For instance, achieving informed consent for treatment is difficult when 
health care personnel cannot explain biological processes or treatment 
procedures in simplified language and patients cannot interpret health 
information.  These situations hamper the effectiveness of health 
professionals’ efforts to prevent, diagnose and treat medical conditions, and 
limit many health care consumers’ abilities to make important health care 
decisions.

Low health literacy is a wide spread problem, affecting more than 90 million 
adults in the United States (Kirsch, Jungeblut, Jenkins & Kolstad, 1993).  
Low health literacy results in patients’ inadequate engagement in, and 
benefit from, health care advances as well as medical errors.  Low health 
literacy is likely to be a major contributor of adverse health outcomes (AMA, 
1999; Baker, Gazmararian, Williams, Scott, Parker, Green, Ren, & Peel, 2002; 
Baker, Parker, Williams, & Clark, 1998).  Research has linked low or limited 
health literacy with such adverse outcomes as poorer self-management of 
chronic diseases, less healthy behaviors, higher rates of hospitalizations, 
and overall poorer health (Gazmararian, Baker, Williams, Parker, Scott, 
Green, Fehrenbach, Ren, & Koplan, 1999; Schillinger, Grumbach, Piette, Wang, 
Osmond, Daher, Palacios, Sullivan, & Bindman, 2002; Williams, Parker, Baker, 
Pitkin, Coates, & Nurss, 1995).

Specific Objectives 

This Program Announcement invites applications to develop research on health 
literacy in general areas that include, but are not limited to, the 
following: 
o Modeling and measuring the nature and scope of health literacy; 
o Variation in health literacy over the life course or among native and non-
native speakers of English; 
o Mediators and moderators of low health literacy;
o The impact of low health literacy on health outcomes, diseases, behaviors 
and treatments, including the contribution of health literacy to informed 
decision-making, adherence to preventative or therapeutic regimens, 
utilization of health care services, risk avoidance strategies, and other 
consumer health-care related actions; 
o The identification of effective preventive and other interventions to 
improve health literacy among populations and to enable the healthcare and 
public health systems to communicate effectively across different health 
literacy levels; and 
o The development of effective methods and new technologies in health 
literacy research. 

Applications should be relevant to both the objectives of the PA and to at 
least one of the participating institute’s general research interests.  Prior 
to preparing an application, researchers are strongly encouraged to both 
review the general research interests of the participating institutes, and to 
contact program staff of the relevant institutes to discuss the proposed 
research.

1. Nature and Scope 

o Assess the prevalence and causes of low health literacy; 
o Identify the nature of the mix of abilities and skills required to be 
functionally “health literate” (e.g., including media and health care system 
navigation skills, etc.), and the roles of basic literacy (i.e., reading, 
writing, speaking, listening, visual interpretation skills) and mathematics 
abilities (e.g., graphical interpretation and other quantitative skills) in 
health literacy.
o Explore the magnitude and variation, by socioeconomic and/or other group 
characteristics, in accessing, seeking, evaluating, interpreting, and using 
health information from a variety of sources. 
o Examine the problems and factors involved in the presentation and 
interpretation of quantitative information (e.g., graphic interpretation, 
“risk” or probability statistics, the influence of information context and 
information formats, etc.) from either the provider or user perspective, or 
investigate how specific health referents, such as basic genetics and/or 
environmental risk concepts, are best understood and conveyed.
o Create a conceptual model of “health literacy” or the skill sets that 
influence the comprehension of relevant health information (e.g., visual 
information comprehension skills that permit understanding of such visual 
messages as color-coding, representation of risk, or disease processes).
o Evaluate the different strategies and channels available, including the 
role of information technologies,  that enable consumers  to seek, access, 
and interpret relevant health information effectively, and how these may 
differ by cultural and health literacy backgrounds (e.g., research on the 
information seeking or service utilization characteristics among health 
consumers with different levels of health literacy).

2. Lifespan and Cultural Differences

Applications addressing health literacy as an age-differentiated phenomenon 
might explore the developmental precursors of low health literacy and the 
age-related changes in reading and other cognitive skills throughout the life 
course that may contribute to these difficulties.  Research might include, 
but is not limited to:  
o Identify the reading and oral language comprehension skills crucial for the 
satisfactory acquisition and understanding of basic health information by 
children, adolescents, and adults of various ages.  
o Determining how intuitive or everyday notions of germs, contagion, 
environmental exposures, disease, drugs, bodily processes and other health-
related concepts influence health literacy and consequent illness-prevention 
behaviors across the life-course, and identifying age-appropriate 
intervention techniques that can be used to mitigate these problems.
o Examine the role of social and cultural factors in the development of 
health literacy.  For example, how do children acquire health-related 
knowledge (e.g., through the media, family socialization) as they age, 
especially those children in households where their parents speak limited 
English and the children serve as interpreters?  
o Explore how the quantity and quality of structured interactions with adult 
caregivers affects the health literacy of the child from birth to age three.
o Examine the effect of current age-related differences in media use (e.g., 
children versus elderly) on health literacy. 

3. Mediators and Moderators of Health Literacy: Protective and Risk Factors

o Describe how patients’ information seeking abilities and health information 
interpretation mediates or moderates the effects of provider practices on 
health literacy.
o Examine bi-directional communication processes between providers and 
patients/clients in the health care/health promotion system that affect 
health literacy, including systemic and cultural barriers that help create 
and sustain health literacy problems, as well as adaptation strategies used 
by providers and consumers to minimize health literacy problems.  How does 
patients’ use of print and electronic health information mediate or moderate 
their communication with providers?
o Examine how physicians’ or dentists’ nonverbal communication influences  
patients’ comprehension and implementation of health-related information.
o Examine the influence of social, contextual, and environmental factors 
(e.g., urban versus rural, housing types, workplace features, social support 
and social network members, etc.) on health literacy outcomes.
o Examine the media (including TV, radio, movies, newspapers, the Internet, 
and interactive systems) as a socializing agent of health literacy.  For 
example, determine how newspaper articles, TV drug advertising, soap operas, 
and medical dramas affect health literacy.  How can different media be used 
to communicate more effectively with consumers varying in health literacy 
levels?
o Examine the factors that influence the desire for, or processing of, health 
literacy information.  For example, how does self-efficacy in decision making 
and/or financial planning, time perspectives as presented in socio-emotional 
selectivity theory, ease of cognitive access via intuitive and reasoning 
processes, and coping and anxiety reduction behaviors influence the use of, 
or desire to access, health-care knowledge?

4. Impacts and Consequences of Low Health Literacy

o Examine the relationship between health literacy and health disparities.
o Analyze the role of health literacy in the prevention and treatment of 
chronic diseases.  
o Identify the relationship between health literacy variation and the ability 
to engage in informed decision making for a variety of health issues, such as 
chronic disease management or participation in clinical trials.
o Evaluate the magnitude of the problems caused by low levels of health 
literacy, or by professionals’ lack of effective communication skills for 
adapting to the communication needs of consumers with differing levels of 
literacy.  
o Assess the role of health literacy as a mediator or moderator of health-
care access across adulthood.

5. Preventative Interventions: Education and Training

o Explore the role of K-12 education systems in increasing levels of health 
literacy and improving health communication skills.  For example, researchers 
might examine the treatment of health literacy in K-12 health education and 
biology or general science classes, and assess the effectiveness of such 
coursework, curricula, and pedagogy on improving health literacy among 
school-age children, or evaluate the effectiveness of arts-based 
interventions on children’s development of health literacy.
o Assess the role of K-12 education (e.g., in basic literacy skills such as 
reading, writing, comprehension, speaking, and listening skills, or in 
mathematics) on health literacy.
o Determine the specific content and components of undergraduate, graduate 
and in-service training experiences needed to adequately prepare provider 
groups (e.g., pharmacists, social workers, nurses, dentists, etc.) in 
communications with low literate patient populations (e.g., assess cultural 
competence’s effect on provider communication skills, or assess training 
innovative approaches that allow providers to help patients deal with shame 
over low health literacy and facilitate negotiating the modern health care 
system).  Examine policies that support the development, implementation and 
effectiveness of such training experiences.  Evaluate the roles of 
information technology in training to improve health literacy.

6. Other Health Literacy Interventions

o Evaluate the effectiveness of health literacy interventions directed at the 
general public, different audience segments, patients, providers, or the 
health care or public health systems.  For instance, how can health care 
systems be designed to better support the information needs of consumers with 
different levels of health literacy?  How effective are interventions within 
the healthcare system that are designed to increase the access of intended 
audiences to relevant health information and appropriate materials (e.g., 
print or audiovisual materials, Internet-based information, translators, 
library information resources and services, and patient advocates)?
o Examine the development and dissemination of effective information sources 
and materials for audiences with different levels of health literacy (e.g., 
how should prevention campaigns be designed to effectively communicate with 
audiences with differing levels of health literacy?). 
o Design and evaluate health literacy diagnostic and/or communication tools 
to help health care professionals identify, and communicate more effectively 
with, consumers with different levels of health literacy.  For instance, 
develop and pilot tools and/or strategies to help make complex quantitative 
health information more understandable (e.g., technology tools for 
automatically converting health information to a variety of appropriate 
levels).
o Identify innovative strategies, practices and policies currently in use 
that can be disseminated immediately to promote health literacy across the 
various participants in the health care systems. 
o Conduct cost/effectiveness analyses of various health literacy 
interventions.
o Further multi-level health literacy intervention approaches, for instance, 
by developing paradigms and/or statistical models to test the interaction of 
such variables as knowledge, prior education, cognitive status, social 
support, community influence, technology, and health-care access on health-
care decisions.

7. Methodology and Research Technology Development

o Assess the efficacy of current methods of health literacy assessment; 
develop, as needed, audience-appropriate methodologies to understand the 
prevalence of low health literacy in different populations, the interaction 
of low health literacy with other demographic and social factors, and the 
contribution of low health literacy to healthcare costs and health outcomes.  
o Identify effective approaches of combining qualitative and quantitative 
methods to further knowledge of health literacy.
o Identify a core set of constructs, variables, and quantitative measures for 
conducting health literacy research.
o Develop and pilot new tools and technologies to identify health literacy 
barriers (e.g., an assessment to distinguish, among persons with low literacy 
skills, those who have learning disabilities or communication disorders such 
as auditory processing, aphasia, or hearing loss).
o In the context of understanding and promoting health literacy: develop 
technologies related to data reduction, data mining, and knowledge 
extraction; develop tools for meta-databases and integrative services to 
enhance the utility of existing databases; develop new methods or 
technologies for timely, appropriate communication of pertinent health 
information and knowledge (e.g., as seen through the creation of 
telemedicine, or to enhance patient, doctor, or administrator decision-making 
regarding health literacy, etc.).

Approaches

A wide variety of research approaches are encouraged under this Program 
Announcement: basic research that investigates or describes the nature of 
health literacy and the magnitude of health literacy problems, and applied 
research addressing issues pertinent to health literacy practices (e.g., 
systems level interventions) and research-in-practice (e.g., active potential 
end users participate as supportive research partners).  Applications also 
may develop theoretical models, refine research constructs, improve methods 
and measurements, and establish causal relationships (e.g., between low 
health literacy and lack of effective health promotion). Researchers also may 
address the effectiveness of interventions, or adapt and test existing 
programs (including those that are not research-based) to reduce low health 
literacy and its adverse consequences (e.g., interventions implemented by 
health care systems and systems outside of health care such as systems of 
public education). 

The research must involve either: a) health literacy, or one of its many 
components, as a key outcome, b) health literacy as a key explanatory 
variable for some other outcome, c) methodological or technological 
improvement to strengthen research on health literacy, or d) health literacy-
focused preventions and interventions.  Studies to develop, or evaluate, the 
readability or utility of specific materials that are intended for single 
uses or single audiences are not responsive to this program announcement 
unless these investigations are integral to testing a significant research 
hypothesis related to health literacy.  

Projects may employ any one or combination of study designs, research 
approaches, and data collection techniques.  Secondary analyses of existing 
datasets as well as meta-analytic studies are also suitable for this 
announcement.  Multilevel, multidisciplinary, and interdisciplinary research 
is also encouraged, especially studies that incorporate individual, family, 
community and societal mediators of health literacy in childhood and 
adulthood, or state-of-the-art health communication theory and knowledge.  
Researchers are encouraged to address ongoing investigations of prevention, 
healthy living, chronic disease management, patient-based health care, 
cultural competence, and health disparities to inform the research on health 
literacy.  Research questions can focus on consumers, patients, clients or 
other population groups; the strategies and tactics used by providers of 
medical and health information/communication to enable them to effectively 
reach literacy challenged population; or the influences of health literacy 
upon interactions between consumers, patients, clients, providers, and 
organizations or systems.

Additional Resources:

Federally Qualified Health Centers (FQHCs) may provide a valuable resource to 
applicants interested in responding to this PA, particularly those that have 
an active collaboration with colleges and universities.  These FQHCs include 
Community Health Centers and Migrant Health Centers across the country.   
Information may be found at the DHHS Health Resources and Services 
Administration website for the Bureau of Primary Health Care: 
http://pubs.niaaa.nih.gov/publications/datasys.htm

The Indian Health Service (IHS) through its direct federal programs, Tribal 
programs and urban programs serves more than 1.6 million American Indian and 
Alaska Native people. These programs may also be of interest to applicants. 
Information can be found at the IHS website at: www.ihs.gov

In addition to this PA, the NIH has published another PA titled 
“Understanding and Promoting Health Literacy (R03)”, [PAR-04-117].  That 
Program announcement (with special review) covers the same research 
objectives and has the same receipt dates, but it is an announcement 
specifically designed for R03 applications.  NHLBI and NIDCD do not 
participate in the PA for R03 applications. 

Reference Report:

The Institute of Medicine’s recent report, Health Literacy: A Prescription to 
End Confusion (2004) reviews the current body of knowledge about health 
literacy, and identifies actions for the promotion of health literacy in 
society.   Potential applicants are encouraged to consult this report as a 
general reference: Health Literacy: A Prescription to End Confusion. (2004). 
L. Nielsen-Bohlman, A. M. Panzer, and D. A. Kindig, Editors. Committee on 
Health Literacy, Board on Neuroscience and Behavioral Health, Institute of 
Medicine.  (Available at http://www.iom.edu/report.asp?id=19723) 

MECHANISM(S) OF SUPPORT 

This PA will use the NIH R01 award mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular budget format.  This program does 
not require cost sharing as defined in the current NIH Grants Policy 
Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

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
o Faith-based or community-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.   

SPECIAL REQUIREMENTS

The research must involve either: a) health literacy, or one of its many 
components, as a key outcome, b) health literacy as a key explanatory 
variable for some other outcome, c) methodological or technological 
improvement to strengthen research on health literacy, or d) health literacy-
focused preventions and interventions.  

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:
Rosaly Correa-de-Araujo, MD, MSc, PhD
Senior Advisor on Women's Health 
Agency for Healthcare Research and Quality
John M. Eisenberg Building
540 Gaither Road
Rockville, Maryland 20850
Phone (301) 427-1550   
Fax (301) 427-1562
Email: rcorrea@ahrq.gov

Sabra Woolley, Ph.D.
Health Promotion Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4078 
Bethesda, Maryland 20892
Telephone: 301-435-4589
Email: woolleys@mail.nih.gov

Gary L. Kreps, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
Building EPN, Room 4084
Bethesda, MD  20892-7365
Telephone:  (301) 496-7984
FAX: (301) 480-2198
Email: Gary.Kreps@nih.gov

Dr. Peter Kaufmann
Division of Epidemiology and Clinical Applications, Clinical Applications and 
Prevention Program
National Heart, Lung, and Blood Institute
Building RK2, Room 8118
Bethesda, MD 20817
Telephone: 301-435-0404
Email: kaufmanp@nhlbi.nih.gov

Dr. Jeffrey Elias
Behavioral and Social Research Program
National Institute of Aging
Gateway/533
Bethesda, MD 20892
Telephone: 301-402-4156
Email: eliasj@nia.nih.gov

Peter M. Lyster, Ph.D.
Division of Discovery Science & Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Bvd. Suite 200
Bethesda, MD  20892-5469
Telephone: (301)402-1337
FAX: (301)480-1614
Email: lysterp@mail.nih.gov 

Daniel B. Berch, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B05
Bethesda, MD 20892-7510
Tel:  (301) 402-0699
FAX: (301) 480-0230
Email: berchd2@mail.nih.gov

Marin P. Allen, Ph.D.
Office of Health Communication and Public Liaison
National Institute on Deafness and Other Communication Disorders
31 Center Drive, Room 3C-35 
Bethesda, MD  20892-2320
Tel: 301-496-7243
FAX: 301-402-0018
Email: allenma@nidcd.nih.gov

Patricia S. Bryant, Ph.D.
Division of Clinical Research
National Institute of Dental and Craniofacial Research   
Bldg. 45 Rm. 4AS-43A
Bethesda, MD 20892-6401
Telephone: (301) 594-2095
FAX: (301) 480-8322
Email: Patricia.Bryant@nih.gov
(Note: Appropriate NIDCR contact if application emphasizes behavioral or 
social science methods and issues)

Lonnie L. Lisle
Office of Health Communication and Public Liaison 
National Institute of Deafness and Other Communication Disorders 
31 Center Drive, MSC 2320
Bldg. 31, Rm. 3C-35
Bethesda, MD 20892-2320
301-496-9682
lislel@nidcd.nih.gov

Ruth Nowjack-Raymer, MPH, PhD
Clinical Research Branch
National Institute of Dental and Craniofacial Research   
Bldg. 45 Rm. 4AS-43J
Bethesda, MD 20892-6401
Telephone: 301-594-5394
FAX: 301-480-8322
Email: ruth.nowjack-raymer@nih.gov
(Note: Appropriate NIDCR contact if application emphasizes health 
disparities)

Dr. Sanford Garfield
Biometry and Behavioral Research Program
Division of Diabetes, Endocrinology, and Metabolic Diseases (DDEMD)
National Institute of Diabetes and Digestive and Kidney Diseases
2 Democracy Plaza, Room 685
6707 Democracy Blvd
Bethesda, MD 20892-5460
Telephone: 301-594-8803
Email: sg50o@nih.gov 

Susan Martin, Ph.D.
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research (DESPR)
National Institute on Drug Abuse
6001 Executive Blvd, Room 5163
Rockville, MD 20892
Telephone: 301-443-1514
Email: smartin@mail.nih.gov

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

Emeline Otey, Ph.D.
Adult Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research
National Institute of Mental Health
6001 Executive Blvd, Room 6180
Bethesda, MD 20892
Telephone: 301- 443-1636
Email: eotey@mail.nih.gov
(Note:  Appropriate NIMH contact for applicants interested in promoting 
health literacy about the causes, risk for, and diagnosis of mental disorders 
or in health literacy about HIV/AIDS.)

Carmen Moten, Ph.D.
Services Research and Clinical Epidemiology Research Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Blvd, Room 7146, MSC 9631
Bethesda, MD, 20892
Telephone: 301-443-3364
Email: cmotem@mail.nih.gov
(Note:  Appropriate NIMH contact for applicants interested in promoting 
health literacy in the context of mental health services.)

Valerie Florance, Ph.D. 
NLM Extramural Programs
National Library of Medicine 
Rockledge 1, Suite 301  
6705 Rockledge Drive  
Bethesda, MD 20892  
Telephone: 301.594.4882 
FAX: 301.402.2952
Email: floranv@mail.nih.gov

Dr. Lawrence Fine
Office of Behavioral and Social Sciences Research
National Institutes of Health
Building 1, Room 256
Bethesda, MD  20892
Telephone:  (301) 435-6780 
FAX:  (301) 402-1150
Email: finel@od.nih.gov

o Direct your questions about peer review issues to: 

Michael Micklin, Ph.D.  
Chief  
Risk, Prevention, & Health Behavior Integrated Review Group  
SRA for SPIP Study Section  
Center for Scientific Review  
National Institutes of Health  
6701 Rockledge Drive, Rm. 3136 MSC 7759  
Bethesda, MD 20892 (20817 for overnight mail)  
Tel: 301-435-1258  
FAX: 301-594-6363
Email: micklinm@csr.nih.gov

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

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Building EPS, Room 243
Rockville, MD  20852
Tel: 301-496-8634
FAX: 301-496-8601    
Email: crystal.wolfrey@nih.gov

Angelos Bacas
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07F
6100 Executive Boulevard, MSC 7510
Bethesda, Maryland 20892-7510 
Tel: (301) 435-6976
FAX: (301) 480-4783
Email: ab329b@nih.gov

Sara Stone
Grants Management
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400B 
6120 Executive Boulevard, MSC 7180 
Rockville, Maryland 20892-7180
Tel: 301-402-0909 
Email:  stones@nidcd.nih.gov 

Mr. Brian Albertini
Grants Management Branch
National Institute of Mental Health
6001 Executive boulevard, Room 6115
Bethesda, MD 20892
Telephone: (301) 443-0004
Fax: (301) 443-0219
Email: albertib2@mail.nih.gov

LETTER OF INTENT:

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

o  Descriptive title of the proposed research
o  Name, address and telephone numbers of the Principal Investigator  
o  Names of other key personnel
o  Name and address of participating institutions
o  Number and title of this PAR

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

The letter of intent should be sent by the date listed on the first page.  The 
letter of intent should be sent to:

Lawrence Fine, M.D., Dr.P.H.
Office of Behavioral and Social Sciences Research
National Institutes of Health
Building 1, Room 256
1 Center Drive
Bethesda, MD  20892

SUBMITTING AN APPLICATION

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

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the following receipt dates:  October 13, 
2004, October 13, 2005, and October 13, 2006.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS INCLUDING RANDOMIZED CLINICAL TRIALS: 
Applicants are encouraged to contact the relevant IC’s prior to submission to 
obtain IC-specific guidelines for applications proposing a randomized 
clinical trial.

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and 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 the receipt dates 
listed on the first page of the PAR. The CSR will not accept any application 
in response to this PAR 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 unfunded version of an application already reviewed, but such 
application must include an Introduction addressing the previous critique.  

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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines and specific program interests.  Upon 
receipt, applications will be reviewed for completeness by the Center for 
Scientific Review (CSR) and responsiveness by the participating institutes.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.  An appropriate special scientific 
review group convened by the CSR 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 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 written critique
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 evaluate 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 scientific merit and the 
priority score:

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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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 will be assessed.  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 

Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.  

Applicants are encouraged to discuss their data sharing plan with their 
program contact at the time they negotiate an agreement with the 
Institute/Center (IC) staff to accept assignment of their application as 
described at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Applicants are reminded that agreement to accept assignment of 
applications over $500,000 must be obtained at least six weeks in advance of 
the anticipated submission date.  Program staff will be responsible for 
overseeing the data sharing policy and for assessing the appropriateness and 
adequacy of the proposed data-sharing plan.   For more information see the 
Final NIH Statement on Sharing Research Data 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). 
 
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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing 
Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

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. 

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 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.

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).  

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 PA 
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.

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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