and Human Services (HHS)
EXPIRED
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November 21, 2006 - The R01 portion of this funding opportunity has been replaced by PAR-07-020,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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Dr. Jeffrey Elias
Behavioral and Social Research Program
National Institute of Aging
Gateway/533
Bethesda, MD 20892
Telephone: 301-402-4156
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
(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
[email protected]
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: [email protected]
(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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
(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: [email protected]
(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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
LETTER OF INTENT:
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
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) 710-0267, Email: [email protected].
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
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