RESEARCH ON MIND-BODY INTERACTIONS AND HEALTH

RELEASE DATE:  July 14, 2003 (see addendum NOT-OD-04-001)

RFA:  OD-03-008

Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) 
 (http://www.niehs.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.213, 93.837, 93.866, 
93.273, 93.279, 93.864, 93.865, 93.399, 93.113, 93.114, 93.121

LETTER OF INTENT RECEIPT DATE:  November 17, 2003

APPLICATION RECEIPT DATE:  December 17, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institutes of Health (NIH), through the participating 
Institutes, Centers, and Offices listed above, invite applications in 
support of research on mind-body interactions and health. "Mind-body 
interactions and health" refers to the relationships among cognitions, 
emotions, personality, social relationships, and health. Applicant 
institutions may request funds to conduct regular research projects 
(R01). A central goal of this program is to encourage interdisciplinary 
collaboration and innovation towards understanding the processes 
underlying mind-body interactions and health as well as towards the 
application of such basic knowledge into interventions and clinical 
practice in the promotion of health and the prevention or treatment of 
disease and disabilities.

RESEARCH OBJECTIVES

The Public Health Service has documented that many of the leading 
causes of morbidity and mortality in the U.S. are attributable to 
social, behavioral, and lifestyle factors (e.g., tobacco use, lack of 
exercise, poor diet, and drug and alcohol abuse). Numerous studies have 
also documented that psychological stress is linked to a variety of 
health outcomes, and researchers and public health officials are 
becoming increasingly interested in understanding the nature of this 
relationship. Research has shown, for example, that psychological 
stress can contribute to increased heart disease and decreased immune 
system functioning. Other research has demonstrated that cognitions 
(attitudes, beliefs values), social support, prayer, and meditation can 
reduce psychological stress and contribute to positive health outcomes. 
Consequently, over the past decade the National Institutes of Health 
have increased efforts to encourage and support health and behavior 
research (e.g., Innovative Approaches to Disease Prevention Through 
Behavior Change, NIH Guide to Grants and Contracts, October 24, 1997; 
Maintenance of Behavioral Change, NIH Guide to Grants and Contracts, 
January 15, 2003). Mind-body research is viewed as one component of 
health and behavior research. In 1999, using funds especially 
appropriated by Congress to the OBSSR, the NIH issued a Request for 
Applications (RFA) for Centers for Mind-Body Interactions and Health 
(OD-99-005) and subsequently awarded five P50 Center Grants 
(http://obssr.od.nih.gov/Content/Research/Request_for_Applications_(RFAs)/mbpage.htm). On January 9 
2003, NIH issued two related RFAs on Mind-Body Interactions and Health: 
Research Infrastructure Program (OB-03-004)(see 
http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-004.html) and 
Mind-Body Interactions and Health: Exploratory/developmental Research 
Program (OB-03-005) (see
http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-005.html).

During approximately the same time period, the NIH has commissioned a 
series of reports from the National Research Council and the Institute 
of Medicine, such as "New Horizons in Health:  An Integrative Approach" 
(National Academy Press, 2001) and "Health and Behavior:  The Interplay 
of Biological, Behavioral, and Societal Influences (National Academy 
Press, 2001). These reports include calls for expansion of 
interdisciplinary health research on mind-body topics. (See summary of 
recommendations at http://obssr.od.nih.gov/Publications/NRC-Reports.htm 

Research Topics

Three areas of research are emphasized. In addition, special importance 
is given to mind-body research in diverse racial/ethnic and 
socioeconomic status populations (e.g., cultural beliefs regarding 
health; perceived racism and health; distrust of health care systems 
and health care utilization, perceived disability and health). The 
formation of multidisciplinary teams to perform the research of this 
initiative is viewed as essential.

1) The first area of emphasis is the effect of cognitions or 
personality (e.g., beliefs, attitudes, and values; modes of thinking) 
and of emotions on physical health. Included is research on social, 
psychological, behavioral, affective, and biological factors mediating 
these effects. What are the physiological, behavioral, and social 
pathways by which beliefs, attitudes, and values or particular stress-
management interventions affect health?  How do emotions, personality, 
and cognitions interact to affect health?

2) The second emphasis is on determinants or antecedents of health-
related cognitions (beliefs, attitudes, or values; modes of thinking; 
decision-making styles). That is, given that some beliefs and attitudes 
have been shown to affect health, how are these beliefs, attitudes, and 
values developed, maintained, or changed?

Specifically, this RFA will support research that addresses issues such 
as:  What contributes to individual differences in the beliefs, 
attitudes, and values that affect health and biological processes?  How 
are health-related beliefs, attitudes, and values formed, maintained, 
and changed?  How do social class, family, culture, disability, age, 
gender, or ethnicity influence health-related beliefs, attitudes, 
values, or cognitive styles?

3) The third is on how stress influences physical health, including:  
(a) basic research investigating how affect, attitudes, beliefs, and 
values influence perceived stress, individual differences in the 
biology of stress, and interactions between stress and behavioral risk 
factors for disease; (b) behavioral, affective, and biological 
mediators of the relationship between stress and health or disease, (c) 
the evaluation of mind-body interventions (e.g., relaxation-based, 
cognitive therapy, or support group) for physical illness and/or 
biological functioning, and (d) the translation of successful 
interventions into programs deliverable in clinical settings. These 
interventions may be examined alone or in conjunction with other stress 
management techniques.

Issues such as the following would be appropriate here:  Through which 
psychological or physiological pathways do stress management approaches 
affect health?  What are the effective components in successful stress-
management practices?  Does the combination of various stress 
management techniques improve outcome?  Are particular stress-
management interventions more effective for certain individuals, 
populations, or health outcomes?  Can successful stress-management 
practices be effectively implemented in natural settings?  What are the 
possible economic implications of utilizing stress management 
interventions?  What are the factors that lead to individual 
differences in how stress is experienced and managed as well as in the 
health consequences of stress?

Examples of topics of interest specific to the Institutes that have 
joined with OBSSR in supporting this initiative are:

o  NATIONAL CANCER INSTITUTE
NCI is interested in research that examines how interactions among 
environmental, psychosocial, immune, neuroendocrine, genetic, and other 
biological factors affect the disease, its treatment and side-
effects, and/or outcome. Research may involve cancer detection, 
prevention, treatment, or survivorship. Examples of relevant topics 
include host differences, sickness behaviors (e.g., nausea, fatigue, 
depression), and biological factors impacting tumor growth or 
metastasis (e.g., DNA damage and repair, apoptosis, angiogenesis). 
Interdisciplinary research and research that includes integrative 
conceptual models are encouraged.

o  NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE
Mind-body interventions represent one of the major domains of 
complementary and alternative medicine (CAM). This domain includes CAM 
practices that intend to facilitate the mind's capacity to affect 
bodily functions and lessen symptoms of disease. These diverse 
practices are of interest to NCCAM and include, but are not limited to, 
various types of meditation; unconventional uses of hypnosis; prayer 
and other forms of mental healing; and art therapy. In addition, many 
traditional medical systems, such as Traditional Chinese and Ayurvedic 
Medicine utilize mind-body CAM techniques. NCCAM is also interested in 
research on the placebo effect and studies on practitioner-patient 
interactions. Specifically related to this RFA, NCCAM is interested in 
research involving the types of mind-body interventions described above 
that can help elucidate how personality, cognitions, emotions, as well 
as beliefs and attitudes, can effect physical health; and how and 
whether CAM mind-body interventions can enhance healing and reduce the 
physical manifestations of illness. In addition, certain mind-body 
interventions, including cognitive-behavioral therapies and various 
means of stress reduction, which are being adopted in some settings by 
mainstream medicine, continue to be of interest to NCCAM. NCCAM 
encourages CAM-related mind-body research that draws upon contemporary 
tools of neurobiology, neuroimmunology, and neuroendocrinology using 
state-of-the-art imaging, cellular, biochemical and molecular 
approaches.

o  NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
The NHLBI supports behavioral research designed to investigate the 
relationship between psychosocial factors (e.g., depression, social 
support, hostility, stress, emotions) and diseases and disorders of the 
circulation, respiratory system, blood, and sleep, including the 
mechanisms that mediate these associations.  Other areas include 
motivational, (e.g., beliefs, attitudes and values), emotional and 
cognitive processes involved in the formation, change, or maintenance 
of health related behaviors.  The interactions of these processes with 
sociocultural and socioeconomic factors are also important.  Finally, 
the study of gene /environment interactions is important.  This 
includes not only the influence of genes on behavior, but also the 
neurohormonal pathways through which psychosocial factors influence 
gene expression.  In all of these areas, translation of basic research 
into clinical applications is also encouraged.

o  NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
NIDCR encourages studies that investigate mind-body interactions with 
regard to oral and craniofacial diseases and disorders or dental 
treatments.  Examples include, but are not limited to, studies of the 
effects of beliefs, affective states, or stress on the immune system as 
related to the onset, progression, or treatment of oral diseases or 
conditions such as the periodontal diseases, caries, head and neck 
cancers, temporomandibular joint and/or muscle disorders, herpetic and 
apthous lesions, oral manifestations of HIV infection, or oral mucosal 
wound healing following oral surgery. Studies identifying linkages 
between changes in orofacial appearance or function and psychosocial 
outcomes are also of interest, as are studies of the psychosocial 
impacts of acquired or congenital craniofacial conditions (e.g., cleft 
lip/palate) or studies of the range of psychosocial impacts associated 
with head/neck cancers and ablative or other treatments. The NIDCR also 
encourages studies that integrate oral biomarkers into the evaluation 
of effects of stress-management or other therapeutic interventions.  
Changes in salivary composition and flow are examples of oral 
biomarkers shown to be relevant to stress and its physiological impact.  
The relative accessibility of the oral cavity provides unique 
opportunities for non-invasive studies of psychophysiological responses 
associated with positive or negative life events, acute or chronic 
stress-inducing conditions, and psychological characteristics or 
psychiatric conditions.

o  NATIONAL INSTITUTE ON AGING
The NIA's mission is to improve the health and well-being of older 
Americans through research. The NIA is interested in a developmental 
life-course perspective of aging and mind-body effects on acute and 
chronic health, quality of life, functional capacity, and life 
expectancy/mortality. Research linking cognitive, affective, and/or 
perceived events (past, present, or ongoing) to maintenance of health, 
function, and quality of life in older adults is desired. How diseases 
common in late-life (e.g. hypertension, Type II diabetes, 
osteoarthritis, Alzheimer's disease) are modulated by the interactions 
of (a) physiological and neurological mechanisms with (b) cognitive, 
affective, perceptual, and social factors experienced by the older 
individual is of high interest. Research on how mind-body processes 
affect health disparities is especially encouraged, as is multilevel, 
multi-system and interdisciplinary research. Illustrative examples 
include: mind-body effects on longevity; early life experiences 
mediated via mind-body interactions and their effects on late-life 
health; the pathways and mechanisms through which mind-body 
interactions modulate behavior and cognitive functions in older 
individuals; the modulatory effects of age upon mind-body process, 
especially in relation to stress and cognitive processes; mind-body 
effects that are predictive of adherence to and benefit from an 
intervention; the cumulative effects of stress on the health of the 
elderly; the impact of optimism, happiness, or a positive attitude on 
well-being and health; the cognitive impact of social exclusion and 
disruptions to social functioning on health; the percepts and affective 
responses to one's socioeconomic and occupational environment and their 
effects on health; and the cumulative impact of extreme stress on 
health in low resource/low income and in-transition countries.

o  NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM
The NIAAA is particularly interested in mind-body interactions as they 
may impact the prevalence and incidence of alcohol abuse and 
alcoholism; as they may be disrupted by alcohol use; and as they may 
play a critical role in recovery from alcoholism. Mind-body 
interactions of importance include, spirituality, motivation, and 
craving, as well as the effects of stress, alienation or 
stigmatization. For example, the role of spirituality in achieving and 
maintaining sobriety is widely acknowledged, but well-designed research 
is needed to determine the underlying mechanisms. Such studies may lead 
to new strategies to improve alcoholism treatment or enhance relapse 
prevention. We need to understand how mind-body interactions may 
influence the risk for harmful drinking or contribute to protective 
factors. Mind-body interactions may also influence progress through 
stages of change, help-seeking behavior, or readiness for cognitive-
behavioral therapy. It is anticipated that such knowledge could be 
incorporated into more effective means of preventing and treating 
alcohol disorders among adolescents as well as adult populations. In 
addition, the NIAAA is committed to reducing alcohol-related health 
disparities in vulnerable populations. The mind-body interaction may 
enhance understanding of how reactions to stress, stigma, racism, and 
discrimination may influence the incidence of alcohol abuse and 
alcoholism.

o  NATIONAL INSTITUTE ON DRUG ABUSE
Behavioral and social sciences research plays an important role in the 
NIDA's search for solutions to the complex social and public health 
problems posed by drug abuse and addiction. These scientific 
disciplines provide NIDA with the knowledge necessary to better 
predict, prevent, and treat drug abuse and addiction problems. NIDA is 
interested in supporting research that investigates the role of 
cognitive and/or emotional variables mediating or moderating the 
development of drug abuse and addiction from the initiation of drug 
abuse ("chipping" or occasional drug use), the maintenance or 
continuation of drug taking behaviors (chronic abuse, including 
escalation to compulsive abuse and its associated negative 
consequences), relapse, and characteristics of sustained abstinence. 
The study of cognitive and/or emotional factors (e.g., self-regulation, 
beliefs, self-attributes, perceived risks or benefit), that influence 
vulnerability or resilience to drug abuse, is also of interest. 
Investigators may study responsivity to acute drug challenge, including 
the examination of how physiological, motivational or subjective 
responses to drugs of abuse are influenced by cognitive and emotional 
variables (e.g., expectancy, affective state, emotional context, etc.). 
Also appropriate would be studies examining cognitive and emotional 
variables (e.g., coping, emotional regulation, self-efficacy) in the 
context of treatment or preventive interventions (e.g., role in 
adherence or compliance). The study of decisions and other cognitive 
processes, and their associated neural substrates, which give rise to 
sexual risk behavior, is also an area of research interest. Studies on 
the influence of physiological indicators of stress, stress perception 
or stress reactivity on drug abuse vulnerability or clinical outcome, 
may be included in proposed investigations. NIDA has an interest in 
supporting research that investigates the epidemiology, prevention, and 
treatment of medical, behavioral, health, and other consequences of 
drug abuse, including but not limited to HIV/AIDS, hepatitis B, and 
STD's. Research of interest includes, for example, identifying how drug 
use affects the sensory perceptual system and cognitive abilities such 
as planning and organizing in terms of risk behaviors. Given that drug 
users and their sex partners account for a substantial proportion of 
new HIV infections in the US each year, studies to improve under-
standing of the behavioral, social, and environmental mechanisms that 
facilitate HIV transmission and other infectious diseases among drug 
users are welcome. NIDA's focus on health promotion and disease 
prevention encourages researchers to investigate strategies for 
tailoring interventions to optimize their beneficial effects to 
determine which interventions work, for whom, and under what 
conditions.

o  NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
NIEHS is particularly interested in stimulating interdisciplinary 
research that seeks to prevent and reduce morbidity and mortality of 
environmentally induced diseases.  In order to better understand the 
linkage between exposures to environmental agents and human disease, 
consideration should be given to behaviors that place individuals at 
risk of these exposures.  NIEHS is interested in better understanding 
beliefs, knowledge, and attitudes associated with these exposures which 
will help elucidate the sources of body burden and allow scientists to 
design appropriate and effective strategies to reduce or eliminate 
exposure from one's environment.  With regards to housing and the built 
environment where there are multiple environmental stressors (social, 
chemical, physical and biological), NIEHS is interested in exploring 
how these stressors impact health.  New programs that seek to 
understand how health promotion activities (i.e. healthier nutritional 
choices, physical activity) and behavior change to reduce exposures can 
mitigate some of the untoward health outcomes in these environments are 
of particular interest.  In general NIEHS is interested in exploring 
further the impact of social and economic factors on the health of the 
community and the individual, especially issues related to minority and 
immigrant communities who generally work in high injury and high stress 
jobs and live in substandard housing and environments. It is also 
important to NIEHS that these projects are able to communicate and 
disseminate their findings to have public health and policy impacts.

MECHANISM OF SUPPORT

This RFA is restricted to the NIH R01 award mechanism. As an applicant 
you will be solely responsible for planning, directing, and executing 
the proposed project. This RFA is a one-time solicitation. Future 
unsolicited, competing-continuation applications based on your project 
will compete with all investigator-initiated applications and will be 
reviewed according to the customary peer review procedures. The 
anticipated award date is September through October 2004. Applications 
that are not funded in the competition described in this RFA may be 
resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the 
instructions to the PHS 398 application.

This RFA uses just-in-time concepts. It also uses the modular as well 
as the non-modular budgeting formats (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 format. Otherwise follow 
the instructions for non-modular research grant applications. This 
program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm .

FUNDS AVAILABLE 

The participating ICs intend to commit at least $3,500,000 in FY 2004 
or FY 2005 to fund approximately eleven (11) new grants in response to 
this RFA. You may request a project period of up to five years. Because 
the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and 
duration of each award will also vary. Although the financial plans of 
the IC(s) provide support for this program, awards pursuant to this RFA 
are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government 
o Domestic or foreign
o Faith-based 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 

a) ANNUAL MEETINGS AND COLLABORATION. You will be asked to participate 
in yearly meetings to report progress, discuss problems, and share 
information related to the conduct of your grant. Previous experience 
with such meetings has shown that they can provide opportunities for 
grantees to work collaboratively in various areas such as measurement 
of treatment fidelity and adherence, techniques for participant 
recruitment and retention, development and implementation of 
interventions, and data archiving and sharing. Cooperation across 
funded studies increases their value by facilitating the accumulation 
of comparable knowledge and experience. You should include in your 
budget funds for two or three investigators to attend the annual 
meetings to be held in Bethesda, MD, at or near the NIH.

b) DATA SHARING. NIH expects and supports the timely release and 
sharing of final research data from NIH-supported studies for use by 
other researchers. Starting with the October 1, 2003 receipt date, 
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 data sharing is not possible. See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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 inquiries regarding GENERAL ISSUES to:

Ronald P. Abeles, Ph.D.
Office of Behavioral and Social Research
Office of the Director
National Institutes of Health
Gateway Building, Room 2C234, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Phone:  301-496-7859
E-mail:  abeles@nih.gov

o  Direct inquiries regarding research interests and topics of SPECIFIC 
INSTITUTES AND CENTERS to:

NATIONAL CANCER INSTITUTE
Paige A. McDonald, Ph.D. 
Basic Biobehavioral Research Branch 
Behavioral Research Program 
Division of Cancer Control and Population Sciences 
National Cancer Institute
6130 Executive Boulevard, MSC 7363 
Executive Plaza North, Room 4062 
Bethesda, MD 20892-7363 
Phone:  301-496-8776 
Fax:  301-435-7547
E-mail:  pm252v@nih.gov

NATIONAL CENTER FOR COMPLEMENTARY AND ALTNERNATIVE MEDICINE
Nancy J. Pearson, Ph.D.
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD  20892
Phone:  301-594-0519 
Fax: 301-480-3621
E-mail:  pearsonn@mail.nih.gov

NATIONAL HEART, LUNG AND BLOOD INSTITUTE
Sarah Knox, Ph.D.
Behavioral Medicine Research Group
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive - MSC 7936
Bethesda, MD 20892-7936
Phone:  301-435-0409
E-mail:  knoxs@nhlbi.nih.gov 

NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
Patricia S. Bryant, Ph.D.
Clinical, Epidemiology, and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AS.43A
Bethesda, MD 20892-6402
Phone:  301-594-2095
Fax:  301-480-8322
Email Patricia.Bryant@nih.gov

NATIONAL INSTITUTE ON AGING
Jeffrey W. Elias, Ph.D.
Individual Behavioral Processes Branch
Behavioral & Social Research Program
National Institute on Aging
Gateway Bldg., Suite 533
Bethesda, MD 20892
Phone: 301-402-4156
Fax: 301-402-0051
Email: EliasJ@nia.nih.gov

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
R. Thomas Gentry, Ph.D.
Chief, Research Development and Health Disparities Programs 
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 302
6000 Executive Boulevard MSC 7003
Bethesda, MD 20892-7003 
Phone: (301) 443-6009 
Fax: (301) 480-2358
Email: tgentry@niaaa.nih.gov

NATIONAL INSTITUTE ON DRUG ABUSE
Ro Nemeth-Coslett, PhD
National Institute on Drug Abuse
Division of Treatment Research and Development
Clinical Neurobiology Branch
NSC Rm 4234 MSC 9551
6001 Executive Blvd,
Bethesda, MD 20892-9551
Phone:  301-402-1746
Fax:  301-443-6814
E-mail:  rn29e@nih.gov

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Shobha Srinivasan, Ph.D.
Susceptibility and Population Health Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Phone: 919-541-2506
Fax: 919-316-4606
E-mail: ss688k@nih.gov

o Direct your questions about peer review issues to:

Michael Micklin, Ph.D.  
Chief of 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 20814-9692  
Phone: 301-435-1258  
Fax: 301-594-6363
E-mail: micklinm@mail.nih.gov

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

NATIONAL CANCER INSTITUTE
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, Maryland 20892
Phone:  301-496-8634
E-mail:  wolfreyc@mail.nih.gov

NATIONAL CENTER FOR COMPLEMENTARY AND ALTNERNATIVE MEDICINE
Victoria Carper
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892
Phone:  301-594-9102
E-mail:  carperv@nccam.nih.gov

NATIONAL HEART LUNG AND BLOOD INSTITUTE
Tanya McCoy
Grants Operations Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive - MSC 7926
Bethesda, MD 20892-7926
Phone:  301-435-0171

NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
Mary E. Daley
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone:  301-594-4800
Fax:  301-480-8303
E-mail:  md74u@nih.gov

NATIONAL INSTITUTE ON AGING
Traci Lafferty
Grants Management Specialist
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Phone:  301-496-8987
Fax:  301-402-3672
Email:  laffertt@nia.nih.gov

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Judy Fox (formerly, Simons)
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
Phone:  301-443-4704 
Fax:  301-443-3891 
Email:  jsimons@niaaa.nih.gov

NATIONAL INSTITUTE ON DRUG ABUSE
Gary Fleming, J.D., M.A.
National Institute on Drug Abuse
Office of Planning and Resource Management
Grants Management Branch
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, MD  20892-9541
Phone:  301-443-6710
Fax:  301-594-6847
E-mail:  gfleming@mail.nih.gov

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
Susan Ricci
Grants Management Office
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC  27709
Phone:  919-316-4666
Fax:  919-541-2860
E-mail:  ricci@niehs.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 number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows us to estimate the potential review workload 
and plan the review.

You should send your letter of intent by the November 17, 2003 to:

Ronald P. Abeles, Ph.D.
Office of Behavioral and Social Research
Office of the Director
National Institutes of Health
Gateway Building, Room 2C234, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Phone:  301-496-7859
E-mail:  abeles@nih.gov

SUBMITTING AN APPLICATION

You must prepare applications using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). 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 .

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format. The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail. Applicants request direct costs in $25,000 
modules. Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application. Type the RFA number on the label. Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review. In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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 on or before the 
application receipt date listed in the heading of this RFA. If an 
application is received after that date, it will be returned to the 
applicant without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application. However, when a previously unfunded application, originally 
submitted as an investigator-initiated application, is to be submitted 
in response to an RFA, it is to be prepared as a NEW application. That 
is the application for the RFA must not include an Introduction 
describing the changes and improvements made, and the text must not be 
marked to indicate the changes. While the investigator may still benefit 
from the previous review, the RFA application is not to state explicitly 
how.

PEER REVIEW PROCESS 

Upon receipt, CSR will review applications for completeness, and OBSSR 
will review applications for responsiveness. CSR will return incomplete 
applications to the applicant without further consideration. 
Furthermore, if the application is not responsive to the RFA, NIH staff 
may contact you to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

An appropriate peer review group will evaluate applications, which are 
complete and responsive to the RFA, for scientific and technical merit 
in accordance with the review criteria stated below. As part of the 
initial merit review, all applications will:

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

REVIEW CRITERIA

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

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application. 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? 

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

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

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

ADDITIONAL CONSIDERATIONS

o  DATA SHARING:  The adequacy of any proposed plan to share data in 
accordance with the NIH Statement on Sharing of Research Data, 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  November 17, 2003
Application Receipt Date:  December 17, 2003
Peer Review Date:  April 2004
Council Review:  June/September 2004
Earliest Anticipated Start Date:  October 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities.

REQUIRED FEDERAL CITATIONS

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

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

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  
NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects. You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances. Data that are (1) first 
produced in a project that is supported in whole or in part with Federal 
funds and (2) cited publicly and officially by a Federal agency in 
support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA. It is important for applicants 
to understand the basic scope of this amendment. NIH has provided 
guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award. Also see
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

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

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

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

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


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