and Human Services (HHS)
EXPIRED
MIND-BODY INTERACTIONS AND HEALTH: EXPLORATORY/DEVELOPMENTAL RESEARCH
PROGRAM (R21)
RELEASE DATE: January 9, 2003
RFA: OB-03-005
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov)
Fogarty International Center (FIC)
(http://www.fic.nih.gov)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM)
(http://nccam.nih.gov)
National Eye Institute (NEI)
(http://www.nei.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
LETTER OF INTENT RECEIPT DATE: June 16, 2003
APPLICATION RECEIPT DATE: July 16, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) 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 for
infrastructure grants 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
support infrastructure and research designed to (1) enhance the quality
and quantity of mind-body and health research and (2) develop new
research capabilities to advance mind-body and health research through
innovative approaches. These activities must reflect a research theme
that is driven by scientific questions within the context of "Mind-body
interactions and health" research. A central goal of this program is to
facilitate interdisciplinary collaboration and innovation in mind-body
and health research while providing essential and cost-effective core
services in support of the development, conduct, and translation into
practice of mind-body and health research based in centers or comparable
administrative units.
This announcement invites applications for R21 EXPLORATORY/DEVELOPMENTAL
AWARDS. Exploratory/Developmental Awards are intended to support the
development and demonstrate the feasibility of programs at institutions
that have high potential for advancing mind-body and health research,
but have not yet fully achieved the necessary resources and mechanisms
to qualify for a R24 Research Infrastructure Award. (See RFA-OB-03-004,
Mind-Body Interactions and Health: Research Infrastructure Program.)
RESEARCH OBJECTIVES
Background
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., RFA on Innovative Approaches to Disease
Prevention Through Behavior Change, NIH Guide to Grants and Contracts,
Volume 26, Number 36, October 24, 1997). 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).
More recently, 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.)
Objectives and Scope
The primary purposes of the Mind-body and Health
Exploratory/Developmental Research Program are to provide resources to
support and advance research that will improve the understanding of
mind-body interactions and health, facilitate interdisciplinary
collaboration among investigators conducting health-related mind-body
research, and promote innovative approaches to mind-body and health
research questions. An additional goal is to facilitate interaction
among scientists in locations throughout the United States in order to
contribute to the integration and coordination of mind-body and health
research.
The EXPLORATORY/DEVELOPMENTAL AWARD (R21) is intended to support the
improvement of research units that have high potential for advancing
mind-body and health research. The award provides such units the
opportunity to further develop the mechanisms and resources required to
support and facilitate significant new contributions to the field and to
build a substantial interdisciplinary portfolio of mind-body and health
research.
Applicant institutions responding to this RFA must articulate a
coherent, integrated, and interdisciplinary conceptual or substantive
research theme (e.g., an organizing set of questions and issues) that
underlies their activities and efforts to advance understanding of the
mechanisms involved in "Mind-body interactions and Health". The central
scientific objectives and themes of the unit must be relevant to the NIH
mission. Illustrative examples of mind-body and health research topics
that fall within the mission are listed below. Applicant institutions
are encouraged to consult with program staff listed under INQUIRIES to
determine the relevance of other topics to the NIH mission.
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). 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 FORGARTY INTERNATIONAL CENTER
The Fogarty International Center (FIC) is particularly interested in
Mind-Body programs that draw upon, enhance, or expand existing FIC-
funded biomedical and behavioral research collaborations between U.S.
scientists and scientists in low- to middle-income countries that
address global health issues. For example, research exploring the
impact of attitudes and values on Tobacco use initiation and cessation
in developing countries, the effects of beliefs and stress associated
with Stigma on health outcomes, and the potential influence of
attitudes and behaviors on susceptibility and response to treatment for
HIV/AIDS and other infectious diseases might complement and synergize
with existing FIC programs. In addition, many developing countries
have populations with considerable experience in the use of mind-body
interaction techniques in their traditional medicines and this may be
one avenue to explore within larger collaborative research programs.
Any area of research within existing FIC programs that can meaningfully
incorporate mind-body issues would be of interest (see FIC website).
FIC will not make independent awards, but will work in partnership with
other NIH components on this program.
o NATIONAL CANCER INSTITUTE
The National Cancer Institute is particularly interested in stimulating
research that examines interactions among environmental factors,
psychosocial variables, immune, neuroendocrine, genetic, and other
potential biological mediators and disease related outcomes. Such
research may scan the cancer control continuum, from prevention to
survivorship, and may include a focus on such relevant topics as host
individual differences, "sickness behaviors" (e.g., nausea, fatigue),
and biological factors impacting tumor growth or metastasis beyond
immune surveillance (e.g, DNA damage and repair, apoptosis,
angiogenesis). Special emphasis is place on interdisciplinary research
and integrative conceptual models.
o NATIONAL CENTER FOR COMPLEMENTARY AND ALTNERNATIVE 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 EYE INSTITUTE
The NEI is interested in supporting research that aims to investigate
the relationship between psychosocial factors and their relationship to
visual disorders. Most of the significant causes of blindness and
visual impairment are associated with aging, and age-related macular
degeneration (AMD) and diabetic retinopathy are major causes of severe
vision loss in the elderly. Decreased vision in the elderly and others
affects their quality of life and their ability to perform normal
activities of daily living, such as driving, reading, and interacting
socially. The dissemination and use of visual health information and
visual impairment rehabilitation are crosscutting areas of emphasis in
visual health that are impacted by social, psychological and behavioral
domains. Beliefs and values critically influence the use of vision
care services in at-risk populations. Research has shown that in some
at-risk populations, knowledge and access to dilated eye examinations
as an effective means of detecting treatable retinopathy nonetheless do
not get regular dilated eye examinations. Underlying social,
behavioral and psychological factors also influence compliance in the
use of assistive devices, environmental modifications and
rehabilitation strategies by visually impaired persons. Areas of
research that address these and other topics which meaningfully
incorporate mind-body issues relevant to visual health would be
considered responsive to this announcement.
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, stress, emotions) and diseases and disorders of the
circulation, respiratory system, and blood, or sleep disorders. Other
areas include the cognitive, emotional, motivational and other
processes involved in risk assessment, decision-making and formation,
change, or maintenance of health habits. Of particular interest are
interactions between any of the above and the social environment, and
translation of basic behavioral research to clinical applications.
Finally, study of the interaction between psychosocial factors and
genetic endowment is encouraged. The Institute supports a wide range
of research on the etiology, pathophysiology, treatment, and prevention
of these disorders, and welcomes integrative, multidisciplinary
behavioral research in any of these areas.
o NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM
The NIAAA is particularly interested in the mind-body interaction as it
enhances our understanding of alcohol abuse and alcoholism and the way
this interaction impacts the prevalence and incidence of alcohol abuse
and alcoholism. Studies of mind-body interactions may include, but not
be limited to, research on the influence of spirituality, stress, and
cognitive-behavioral factors on the development and maintenance of
drinking behavior, treatment of alcohol disorders, and relapse. While
the role of spirituality in achieving and maintaining sobriety is
widely acknowledged, research is needed to determine the underlying
mechanisms involved and thereby suggest new therapeutic strategies to
optimize treatment and enhance relapse prevention. We need to
understand how mind-body interactions may influence risk and resilience
factors, e.g., stress and self-reliance. The mind-body interaction may
influence the intervention process, particularly cognitive-behavioral
techniques. 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.
Additionally, 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 to alcohol abuse and
alcoholism.
o NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
NIAID is interested in research that will further our understanding of
the mind-body interrelationships as they relate to the susceptibility
of an individual to infectious diseases such as HIV-AIDS and malaria,
or the development of chronic diseases such as tuberculosis, hepatitis,
pneumonia, and sinusitis. Examples of topics of interest include: the
role of stress on reactivation of latent intracellular pathogens and
susceptibility or resistance to infectious diseases, characterization
of the effects of stress on microbial pathogenesis within the context
of co-infections or nutritional status, identification of molecules
regulating immune-nervous system interactions, the effects of stress on
innate and adaptive immunity including the effects on the secretion of
inflammatory mediators and the redistribution of immunocompetent
lymphocytes, and the impact of immune deficiency on function of the
nervous system. It is anticipated that these studies will be designed
on the basis of sound scientific arguments with clearly defined outcome
measures such as cytokine profiles, functional assays for humoral or
cell mediated immune responses, and assessment of intracellular
signaling molecules. The use of novel approaches, recent technologies
in genomics, proteomics, immunology and molecular biology as well as
the creation of collaborative scientific teams are particularly
encouraged.
o NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN
DISEASES
The NIAMS is interested in mind-body research relevant to arthritis and
other rheumatic diseases, muscle diseases, musculoskeletal disorders,
bone diseases including osteoporosis, and skin diseases. Research on
stress-related alterations in physiological function with potential
health consequences in autoimmune diseases (e.g., stress and flares in
systemic lupus erythematosus or rheumatoid arthritis) and evaluation of
mind-body interventions in diseases within the NIAMS mission are
especially of interest.
o NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPOMENT
The NICHD is particularly interested in interdisciplinary research
projects examining mind/body interactions that influence child health
and development. Studies are encouraged that: examine the
interrelationship of socio-economic status and/or poverty with child
health and development; examine the interrelation of mind/body
interactions as explanations of health disparities in children and
young adults; examine psychological stress and pain in children and
adolescents and their effects on the immune system and illness; examine
the influence of religiosity and spiritualism on risk behaviors and
health in children and adolescents; examine the use of complementary
medicines in the treatment of childhood illnesses and disorders (otitis
media, colds, chronic fatigue syndrome, ADHD, etc.); examine
infrequently used techniques in the treatment of childhood conditions
of pain or stress ( suggestive relaxation techniques for migraine
headaches and other painful conditions, massage therapy for infants
born at risk, acupuncture, hypnosis, etc.); examine children's
understanding of health and illness and how that understanding relates
(translates) to health behavior; study the behavioral treatment of
sleep disorders in children and adolescents; examine the impact of
mind/body interactions on the physiology of pregnancy and the infant in
relation to health outcome; study the effects of mind/body interactions
on fertility, maternal health during pregnancy, labor, delivery and
postpartum periods, breast feeding patterns, and nurturing and rearing
of infants and children by both parents- especially, fathers; examine
the role of health-related beliefs or attitudes on achieving and
maintaining health and well-being of children and youth with physical,
learning or developmental disabilities; examine mind/body interactions
in children with physical disabilities caused by injury and their
adaptation to the impairments.
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/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. Stress as a result of
living with craniofacial anomalies such as cleft lip and cleft palate
and disfigurement following treatment of head and neck cancers may also
have an adverse effect on the immune system and treatment outcomes;
studies examining these linkages and interventions to improve outcomes
are encouraged. 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 OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
The NIDDK is interested particularly in mind-body and health research
related to (a) obesity and (b) functional bowel disorders. Examples
relevant to OBESITY are: The influence of social stress, depression,
anxiety, fear, and insecurity leading to or resulting from significant
life events such as divorce, job loss, economic deprivation, social
discrimination, and related factors that predispose individuals to
inappropriate eating behaviors, inappropriate sedentary behaviors, and
inadequate physical activity behaviors associated with the development
of overweight and obesity. The role of self-confidence, self-esteem,
self-efficacy, self-motivation, self-image, self-perception,
religiosity/faith, social and family support networks, anger, conflict
resolution, cultural beliefs, and related factors in the primary
prevention of inappropriate weight gain, weight maintenance in those
already overweight, and prevention of weight regain in those who have
lost weight. Psycho-social factors that stimulate motivation and lead
to behavioral changes whereby individuals accept a greater
responsibility for their personal dietary and physical activity health
behaviors in the context of a challenging environment that promotes
overeating and sedentary behaviors. Psycho-social factors associated
with unfavorable behaviors such as night eating, binge eating, food
cravings, or sedentary behaviors such as television watching that lead
to energy imbalance attributable to excess caloric consumption and/or
insufficient energy expenditure. Examples relevant to FUNCTIONAL BOWEL
DISORDERS are: The influence of gestational hormonal changes and its
influences on visceral hypersensitivity in the setting of functional
bowel disorders. Studies on the role of peptide hormones released in
the circulation in response to either stress, chemical, or mechanical
stimulation of the gut mucosa may provide insights into treatment
options for patients with functional bowel disorders. Comparisons of
the efficacy of non-pharmacological (i.e. Cognitive behavioral therapy,
hypnosis) to pharmacological approaches in the management of functional
bowel disorders. Research on psychosocial factors such as depression,
low self-esteem, isolation, and how they impact on disease expression
and severity and quality of life of patients who have irritable bowel
syndrome and other functional gastrointestinal disorders.
o NATIONAL INSTITUTE OF MENTAL HEALTH
The mission of NIMH is to reduce the burden of mental illness and
behavioral disorders through research on mind, brain, and behavior.
With regard to this RFA, the following are illustrative topics:
Mechanisms accounting for the co-occurrence and co-morbidity of mental
disorders with physical disorders; identification of principles
motivating and sustaining behavior changes to reduce the risk for co-
occurring mental and physical disorders; relationships of pain to
mental disorder; interventions to prevent the occurrence of mental
health problems in individuals with physical disorders; tests of
innovative treatments for individuals with co-occurring mental and
physical disorders; social, psychological, and neurobiological factors
underlying stress responsivity; "social neuroscience" investigations to
uncover mechanisms underlying effects of interpersonal, social and
other environmental factors on mental and physical health and disease;
influences of cognitive, personality, interpersonal and cultural
factors on perceptions of risk, help-seeking, symptom reporting and
health-related behavior; identification of neural substrates underlying
cognitive functions that influence emotional and stress reactivity; and
identification of hormonal, biochemical, and cellular pathways
mediating effects of stress and illness on cognition and mood.
Experimental approaches should encompass the range of cutting-edge
methods in social and behavioral science as well as neuroscience.
o NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
The NINDS is interested in mind-body research relevant to: 1)
development of research strategies for stroke prevention and
appropriate management of recurrent stroke (behavior modification; life
style changes, role of psychosocial variables like stress, depression,
coping skills, social support/social isolation); 2) development and
evaluation of rehabilitation interventions for neurological disorders
(stroke, TBI, neurodegenerative disorders) - physiological behavioral
and social pathways influencing rehabilitation outcomes; 3) behavioral
and psychosocial intervention in randomized clinical trials of
neurological disorders (epilepsy, stroke, TBI, neurodegenerative) -
interactions of behavioral and biomedical treatments.
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. How diseases common in late-life (e.g.
hypertension, Type II diabetes, osteoarthritis, Alzheimer's disease)
are modulated by physiological, neurological, cognitive, affective,
perceptual, and psychosocial 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; 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 ON DRUG ABUSE
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. NIDA is interested in 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. To
address these questions, 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), including
studies on the influence of media and other forms of informational
messages. 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 (e.g., allosteric load) on drug abuse vulnerability
or clinical outcome, may be included in proposed investigations.
Studies in response to this RFA may be laboratory-based experiments
(i.e., with human substance abusing populations, or preclinical
models), or field based investigations in real world or clinical
settings.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH)
Exploratory/Developmental Grant (R21) mechanism for Developmental
Awards. The R21 mechanism is used to encourage the development of
promising research programs. As an applicant you will be solely
responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Currently, NIH does not
have a plan for re-issuing this RFA within the next five years.
The total project period for an application submitted in response to
this RFA is up to three (3) years. R21 awards are non-renewable. The
anticipated award date is April 2004.
This RFA uses just-in-time concepts and the modular budgeting format.
(See http://grants.nih.gov/grants/funding/modular/modular.htm).
Modifications to the standard application instructions, which are
provided under SUPPLEMENTAL INSTRUCTIONS below, must be used when
preparing applications in response to this RFA.
Institutions applying for a Developmental Award (R21) may request
support for (1) Research Support Activities and (2) Developmental
Activities. Although applicant institutions may NOT request support for
R01-like research projects, they may request support for developmental
research projects, similar to a pilot or small grant mechanism.
Applicant institutions must justify the types and amounts of support
requested in terms of: (a) the scope, objectives, and current and
potential impact of the institution's research program; (b) the
potential of the requested infrastructure to develop the resources and
mechanisms required to build a substantial interdisciplinary portfolio
of mind-body and health research and facilitate significant new
contributions to the field; and (c) the cost-effectiveness of the
requested support.
1. RESEARCH SUPPORT ACTIVIITES provide shared resources that support
the institution's research program. Research Support Activities should
be designed to advance the central scientific objectives and themes of
the applicant institution's research program while providing essential,
cost-effective services to support on-going research activities.
Activities and organizational structures should be designed to
facilitate and promote innovation in the science conducted by program
researchers in addition to responding to researcher needs. Equipment
and support services that are specific to (i.e., solely for) individual
research projects or researchers are not allowable. Examples include:
o ADMINISTRATIVE CORE, providing for coordination of research,
editorial services, and/or assistance with grant application development
and fiscal management of grants.
o COMPUTING CORE, providing equipment and/or services supporting shared
computing needs.
o INFORMATION CORE, providing support for retrieving information,
materials, and data commonly used in mind-body and health research.
o DESIGN, ANALYSIS, AND DATA SHARING CORES, providing support for
methodological and statistical issues as well as the preparation and
implementation of data sharing among investigators within and outside of
the applicant institution.
2. DEVELOPMENTAL ACTIVITIES promote the improvement and expansion of
research capabilities. Examples include:
o PILOT RESEARCH SUPPORT, providing funds for the development of new
research projects. Institutions proposing pilot research programs must
develop guidelines and eligibility requirements appropriate to the goals
of this RFA, and procedures and policies for administration of the
program. Issues that may be addressed include (but need not be limited
to): (1) priorities for allocating funds (e.g., junior researchers,
specified areas of research, interdisciplinary work, etc.); (2)
procedures for reviewing applications; 3) requirements for leveraging
funds or preparing research proposals to continue or expand the research
project; (4) size of awards; (5) length of award periods; (6) number of
awards permitted to an individual researcher; (7) mentoring
arrangements; and (8) cost-sharing arrangements with the parent
institution.
o FACULTY DEVELOPMENT, providing for partial salary support or other
support for the recruitment of new faculty in scientific areas critical
to the development of innovative and/or interdisciplinary research
directions (support for any one individual may not exceed three years in
duration);and/or training for faculty at alternative laboratories of
collaborative research units.
o NEW SERVICES, fostering the development of new core services. For
example, applicant institutions may propose to hire consultants to
assist with the design of research data acquisition services, or conduct
pilot studies to evaluate the cost-effectiveness of alternative modes of
core service delivery.
o RESEARCH AGENDA DEVELOPMENT, laying the groundwork for new
substantive work or foster new research collaborations through
workshops, conferences, seminar series, and visiting scholar programs;
hosting scientists of collaborative research units to facilitate grant
writing; meetings of interdisciplinary collaborators. The purpose of
these activities and meetings should be to refine conceptual frameworks
for organizing cross-disciplinary research projects and identifying
which specific research questions and experiments show the greatest
promise for advancement in the field of "Mind-Body" research.
FUNDS AVAILABLE
The NIH intends to commit approximately $2 million in total costs
[Direct plus Facilities and Administrative (F & A) costs] in FY 2004.
The NIH anticipates making up to four awards. Although the financial
plans of the NIH 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. At this time, it is
not known if this RFA will be reissued.
Because the nature and scope of the research proposed may vary, it is
anticipated that the size of each award will also vary. Applicant
institutions may request a project period of up to three years and a
budget for DIRECT costs of up to $300,000 per year.
Applicant institutions are strongly encouraged to discuss budget
requests with program staff listed under INQUIRIES prior to submission.
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 (foreign institutions are ineligible)
o Faith-based or community-based organizations.
To be eligible the applicant institution must have at least three (3)
researchers with a history of research activity related to mind-body and
health research in both of the following categories: (1) externally
funded research grants or contracts in the past three years and (2) one
or more publications in peer-reviewed journals during the past three
years. The "past three years" refers to the 36-month period preceding
the application submission date for this RFA. "Externally funded" means
funding is received from sources outside the institution; it may include
peer-reviewed funding from NIH, NSF, other federal agencies, state and
local governments, and private foundations. Include only projects on
which the individual has served as Principal Investigator or had
substantial involvement, comparable to that indicated by identification
of an investigator as "key personnel" on an NIH-funded grant.
Eligibility for R21 Developmental Infrastructure Awards is restricted to
institutions that have not held a P30 or P50 grant related to mind-body
and health research in the five years prior to the application date.
Institutions may not submit simultaneous applications in response to
this RFA and to RFA-OB-03-004 MIND-BODY INTERACTIONS AND HEALTH:
DEVELOPMENTAL INFRASTRUCTURE PROGRAM (for R24 awards).
Potential applicant institutions are strongly encouraged to contact
staff listed under INQUIRIES to discuss eligibility prior to submission
of an application.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to
carry out the proposed research are 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
Applicant institutions must already have in place or establish at the
time of an award a research center or other administrative unit
(referred to as the "research unit" or "unit") that serves as a focal
point for or coordinates mind-body and health research across the
institution. This unit must have a defined governance structure. The
Principal Investigator should be a scientist or science administrator
who can provide effective administrative and scientific leadership.
Because the "Mind-Body Interactions and Health: Developmental
Infrastructure Program" is expected to enhance the unit's
competitiveness for NIH funding, the institution and pertinent
departments are expected to show a strong commitment to the unit and to
match the requested infrastructure support at a level appropriate to the
resources of the institution and the scope of the proposed program
activities. Such commitment may be demonstrated by the provision of
dedicated space, faculty appointments in subject areas relevant to the
goals of the unit's research program, salary support for investigators
or core staff, dedicated equipment, or other financial support for the
proposed program. Applicant institutions are encouraged to consult with
program staff listed under INQUIRIES to discuss this requirement.
The research conducted at the unit should reflect scientific benefits
and cost-efficiencies resulting from cooperation and interaction among a
pool of scientists with shared interests in mind-body and health
research. Applicant institutions should have in place (or propose in
their applications) effective mechanisms for fostering the development
of an intellectual community that bridges investigators from different
disciplines and different projects and promotes innovation in mind-body
and health research.
Also see ELIGIBLE INSTITUTIONS (above) for minimum application
requirements. Note that these requirements take precedence over
requirements announced elsewhere (e.g., in the instructions for the
application kit PHS 398).
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: [email protected]
o Direct inquiries regarding research interests and topics of specific
INSTITUTES AND CENTERS to:
FORGARTY INTERNATIONAL CENTER
Flora N. Katz, Ph.D.
Fogarty International Center
National Institutes of Health
31 Center Drive
Bethesda, MD 20892-2220
Phone: 301-402-9591
Fax: 301-402-0779
E-mail: [email protected]
NATIONAL CANCER INSTITUTE
Michael Stefanek, Ph.D.
Chief, Basic Biobehavioral Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard/EPN 4066
Bethesda, Maryland 20892
Phone: 301-496-8776
Fax: 301-435-7547
E-mail: [email protected]
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
Bethesda, MD 20892
Phone: 301-594 0519
E-mail: [email protected]
NATIONAL EYE INSTITUTE
Chyren Hunter, Ph.D.
National Eye Institute, NIH
6120 Executive Blvd., MSC 7164
Executive Plaza South, Suite 350
Bethesda, MD 20892-7164
Phone: 301-451-2020
Fax: 301-402-0528
E-mail: [email protected]
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: [email protected]
NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM
Thomas Gentry, Ph.D.
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard MSC 7003, Suite 302
Bethesda, MD 20892-7003
Phone: 301-443-6009
Fax: 301-480-2358
E-mail: [email protected]
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Christopher E. Taylor, ScD
Bacterial Diseases Program Officer
Respiratory Diseases Branch
Division of Microbiology & Infectious Diseases
NIAID
6700-B Rockledge Drive
Bethesda, MD, 20852-7630
Phone: 301-496-5305
Fax: 301-496-8030
E-mail: [email protected]
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Deborah N. Ader, Ph.D.
Behavior and Prevention Research Program Director
One Democracy Plaza, Suite 800
Bethesda, MD 20892-4872
Telephone: 301-594-5032
Fax: 301-480-4543
E-mail: [email protected]
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPOMENT
V. Jeffery Evans Ph.D., J.D.
Director of Intergenerational Research
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Phone: 301-496-1176
Fax: 301-496-0962
E-mail: [email protected]
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
Patricia S. Bryant, Ph.D
Director, Behavioral and Social Sciences Research Program
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: [email protected]
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Frank A. Hamilton,M.D., MPH
Director, GI Motility Program
Division of Digestive Diseases and Nutrition
NIDDK
6707 Democracy Boulevard, Democracy 2
Bethesda, Maryland 20892-5450
Phone: 301-594-8877
Fax: 301-480-8300
E-mail: [email protected]
NATIONAL INSITUTE OF MENTAL HEALTH
Mary Ellen Oliveri, Ph.D.
Chief, Behavioral Science Research Branch
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9651
Bethesda, MD 20892
Phone: 301-443-3942
Fax: 301-443-9876
E-mail: [email protected]
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
Emmeline Edwards, Ph.D.
Systems and Cognitive Neuroscience Program
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard R2109
Bethesda, MD 20892-9521
Phone: 301-496-9964
Fax: 301-402-2060
E-mail: [email protected]
NATIONAL INSTITUTE ON AGING
Richard Suzman, Ph.D.
Associate Director
Behavioral and Social Research (BSR)
Gateway Building, Suite 533
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-3131
Fax: 301-402-0051
E-mail: [email protected]
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 20897
Phone: 301-402-1746
Fax: 301-443-6814
E-mail: [email protected]
o Direct your questions about PEER REVIEW ISSUES to:
Michael Micklin, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3178 MSC 7848
Bethesda, MD 20814-9692
Phone: 301-435-1258
Fax: 301-480-3962
o Direct your questions about FINANCIAL OR GRANTS MANAGEMENT MATTERS
to:
FORGARTY INTERNATIONAL CENTER
Bruce Butrum
Fogarty International Center
National Institutes of Health
31 Center Drive
Bethesda, MD 20892-2220
Phone: 301-496-1670
Fax: 301-594-1211
E-mail: [email protected]
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: [email protected]
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
Bethesda, MD 20892
Phone: 301-594-9102
E-mail: [email protected]
NATIONAL EYE INSTITUTE
William W. Darby
Grants Management Officer
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD 20892
Phone: 301-451-2020
Fax: 301-496-9997
E-mail: [email protected]
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
E-mail: [email protected]
NATIONAL INSTITUTE OF ALCOHOL ABUSE AND ALCOHOLISM
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 executive Blvd. (MSC-7003)
Bethesda, MD 20892-7003
Phone: 301-443-2434
E-mail: [email protected]
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Lesia A. Norwood
Grants Management Officer
Grants Management Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Disease
6700-B Rockledge Drive, Room 2117, MSC 7614
Phone: 301-402-7146
Fax: 301-480-3780
E-mail: [email protected]
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Michael Morse
Deputy Grants Management Officer
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Phone: 301-594-3506
Fax: 301-480-5450
E-Mail: [email protected]
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPOMENT
Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17K, MSC 7510
Bethesda, MD 20892-7510
Phone: 301-496-5482
Fax: 301-480-4782
E-mail: [email protected]
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
Mary E Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4808
Fax: 301-480-8303
E-mail: [email protected]
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Mr. Donald Ellis
Grants Management Branch. NIDDK
6707 Democracy Boulevard, Room 743
Bethesda, Maryland 20892-5450
Phone: 301-594-8849
Fax: 301-480-3504
E-mail: [email protected]
NATIONAL INSTITUTE OF MENTAL HEALTH
Diana S. Trunnell
Assistant Chief, Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6120, MSC 9605
Bethesda, MD 20892-9605
Phone: 301-443-2805
Fax: 301-443-6885
E-mail: [email protected]
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
Rita Sisco
Grants Management Officer
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard R3265
Bethesda, MD 20892
Phone: (301) 496-7488
Fax: (301) 402-0219
E-mail: [email protected]
NATIONAL INSTITUTE ON AGING
Linda Whipp
Grants and Contracts Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-1472
Fax: 301-402-3672
Email: [email protected]
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
Phone: (301) 443-6710
Fax: (301) 594-6849
E-mail: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
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 NIH staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by June 16, 2003. The letter of
intent should be sent 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: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at 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].
SUPPLEMENTAL INSTRUCTIONS
Applications for the R21 must be prepared according to Modular Grant
instructions. The modular grant concept establishes specific modules in
which direct costs may be requested as well as a maximum level for
requested budgets. Only limited budgetary information is required under
this approach. The just-in-time concept allows applicants to submit
certain information only when there is a possibility for an award. It
is anticipated that these changes will reduce the administrative burden
for the applicants, reviewers and Institute staff. The research grant
application form PHS 398 (rev. 5/01) is to be used in applying for
these grants, with the modifications noted below.
For responses to this RFA, Modular Grant applications will request
direct costs in $25,000 modules, up to a maximum Direct Cost request of
$300,000 per year for a maximum of three years. The Direct Costs must
be requested in accordance with the program guidelines and the
modifications made to the standard PHS 398 application instructions
described below.
In lieu of the preprinted Table of Contents outline on Form Page 3 of
PHS 398, a table of contents should be prepared listing all of the
major sections described below and paginated to enable reviewers to
find specific information readily. The Table of Contents should contain
the types of information suggested below in three sections: Section I
- General Information, Section II - Research Plan, and Section III -
Appendix. The following guidelines will provide directions and
descriptions for preparing each section. Major areas to be listed and
paginated in the Table of Contents appear in capital letters.
SECTION I. GENERAL INFORMATION
A. FACE PAGE
This is page 1; number succeeding pages consecutively.
Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments to a maximum of $300,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the
initial budget period.
Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support (up to three years).
The RFA title ("Mind-body Interactions and Health: Developmental
Infrastructure Program") and number (OB-03-005) must be typed on line 2
of the face page and the YES box must be marked.
B. DESCRIPTION AND PERSONNEL
Abstract of Research Plan. On page 2, describe briefly the objectives
of the proposed developmental grant and the proposed infrastructure
components. The abstract should fit in the space provided.
List key scientific and technical personnel participating in the grant.
Use continuation pages as necessary, numbering consecutively.
C. TABLE OF CONTENTS
Prepare the Table of Contents as noted above. The major areas to be
listed are enumerated in these instructions.
D. BUDGET ESTIMATES
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form
Page 4 of the PHS 398. It is not required and will not be accepted with
the application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete
the categorical budget table on Form Page 5 of the PHS 398. It is not
required and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget
Narrative page. (See
http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form Page.
Provide an estimate of direct costs associated with each proposed
infrastructure component. Provide requested information on personnel
separately for each infrastructure component.
o Under PERSONNEL, list all project personnel, including their names,
percent of effort, and roles on the project. Describe the specific
functions of key scientific and technical personnel, consultants,
collaborators, and support staff. No individual salary information
should be provided. However, the applicant should use the NIH
appropriation language salary cap and the NIH policy for graduate
student compensation in developing the budget request.
o For CONSORTIUM/CONTRACTUAL COSTS, provide an estimate of total costs
(direct plus F & A) for each year, each rounded to the nearest $1,000.
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and
the role on the project.
Indicate whether the collaborating institution is foreign or domestic.
The total cost for a consortium/contractual arrangement is included in
the overall requested modular direct cost amount. Include the Letter of
Intent to establish a consortium.
o Provide an additional narrative budget justification for any
variation in the number of modules requested.
o Budget estimates must include travel costs for attending an ANNUAL
MEETING of project directors and key staff at the NIH in Bethesda,
Maryland. Budget at least for two persons to attend a two-day meeting
once per year.
E. BIOGRAPHICAL SKETCH
The Biographical Sketch provides information used by reviewers in the
assessment of each individual's qualifications for a specific role in
the proposed project, as well as to evaluate the overall qualifications
of the research team. A biographical sketch is required for all key
scientific and technical personnel, following the instructions below.
List key scientific personnel first, beginning with the Principal
Investigator, and following in alphabetical order. Then list all
technical personnel involved in infrastructure components of the
application in alphabetical order. No more than four pages may be used
for each person. A sample biographical sketch may be viewed at:
http://grants.nih.gov/grants/funding/modular/modular.htm. Note that
this information is essential in demonstrating that the applicant
institution meets eligibility requirements for a R21 award. (See
ELIGIBLE INSTITUTIONS, above.)
o Complete the educational block at the top of the form page.
o List position(s) and any honors.
o Provide information, including overall goals and responsibilities,
on research projects ongoing or completed during the last three years.
o List selected peer-reviewed publications, with full citations.
F. OTHER SUPPORT
Not required for modular grant application.
G. SUMMARY TABLE OF RESEARCH SUPPORT
Applicants should present a summary table of the levels of
infrastructure and research support received by the unit, by source.
This table should show, for the applicant unit as a whole, the total
funds supporting research and infrastructure in the unit for the most
recent budget year available. Show sources of funds in major categories
(e.g., NIH P30, R03, or R01 grants, NSF, Foundations, parent
institution, etc.). This table should be presented in a format of the
example available at
http://obssr.od.nih.gov/RFA_PAs/MBFY04/Research_Support_Table.htm.
H. RESOURCES AND ENVIRONMENT
Complete the RESOURCES section on Form Page 8 for the overall unit.
Briefly describe the features of the institutional environment that are
or would be relevant to the effective implementation of the proposed
program. As appropriate, describe available resources, such as clinical
and laboratory facilities, participating and affiliated units, patient
populations, geographical distribution of space and personnel, and
consultative resources. Use continuation pages as needed.
CHECKLIST: This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate
the type of agreement and the date. All appropriate exclusions must be
applied in the calculation of the F&A costs for the initial budget
period and all future budget years.
The applicant should provide the name and phone number of the
individual to contact concerning fiscal and administrative issues if
additional information is necessary following the initial review.
SECTION II - RESEARCH PLAN
Include a detailed Table of Contents with pagination (numeric only) at
the beginning of Section II. Identify each section by title, and assign
each a capital letter (A, B, C, etc.) that reflects the order in which
they are presented in the application research plan.
Page limitations: The length of the sections devoted to the overall
description of the program, progress report, research activity, and
proposed infrastructure components must not exceed those specified
below. Applicants should be concise.
Assurances and Collaborative Agreements. Any arrangements for
collaborative and cooperative endeavors or subcontracting should be
highlighted in the appropriate section below. Letters of Intent to
Collaborate and Letters of Agreement from consultants should be
referenced here and included at the end of the appropriate component.
A. PROGRAM OVERVIEW
Summarize the central scientific objectives and themes of the unit.
Highlight significant, unique, and/or cross-cutting areas of research.
Describe the impact the unit has had on the field with reference to
major recent contributions by active researchers in the program, large-
scale projects that exhibit positive externalities in the field,
creation of interdisciplinary collaborations, training and mentoring of
new scientists, scientific leadership of program personnel, and
translational activities to improve clinical practice, public
intervention programs, and public policy formulation. Summarize the
vision of program researchers for the unit's future scientific advances
and contributions.
Describe the configuration and governance of the unit and provide an
organizational chart. Include information on administrative position of
the unit within the larger institution, the authority of the Director,
and the use of advisory or user committees. Outline the principles and
procedures the unit uses to determine membership in or affiliation with
the unit and to allocate resources and grant access to core services.
If the unit employs more than one category of membership or
affiliation, explain the privileges and responsibilities associated
with each. Describe how the NIH support would leverage and interact
with all other forms of support contributing to the research activities
of the program.
Describe strategies the unit employs for advancing the quality and
innovation of its mind-body and health research program over the short
and long run. Describe how the unit fosters the development of an
intellectual community that bridges investigators from different
disciplines and different projects and promotes innovation in mind-body
and health research. Describe how the unit develops and implements its
goals. Describe how the unit assures the development and success of
junior scientists.
Summarize the key features of the proposed developmental program and
explain how each element will advance the quality, productivity, and
innovation of the unit's research activities.
Do not exceed 10 pages for this section.
B. PROGRESS REPORT
Not required.
C. SCIENTIFIC OBJECTIVES AND THEMES
Describe the themes of the unit's research program and its central
scientific objectives for advancing research on these themes. For each
highlighted theme:
Discuss the scientific and practical significance of the research
theme: how can advances in this area contribute to substantive
knowledge, scientific methods, or public well-being?
Describe how current and recent research activity in the unit has
contributed to the theme: what scientific accomplishments have program
scientists achieved and how have they affected mind-body and health
research? Highlight activities that have produced significant
innovation and/or interdisciplinary collaboration.
Describe the vision of program scientists for advancing research on
this theme. What are the important questions to be answered? What
challenges must scientists overcome to answer them? What specific
objectives will guide the work of program scientists in this area?
What strategies will program scientists adopt to meet the challenges
and objectives relating to this theme? Include discussion of how the
proposed infrastructure components will advance research in this area.
Do not exceed 15 pages for this section.
D. RESEARCH ACTIVITY OF PROGRAM SCIENTISTS
Briefly summarize the recent and current research activity of each
active program scientist with respect to each of the five points listed
below. Use one page per active researcher. Describe the Principal
Investigator's research activity first and that of all other
researchers subsequently in alphabetical order.
1. Summarize the most important scientific accomplishments of the
researcher during the 36 months prior to the receipt date for this RFA
(i.e., July 2000 July 2003). Discuss these accomplishments with
respect to their significance, innovation, and actual or potential
impact on mind-body and health research.
2. Identify externally funded research projects in which the researcher
participated as key personnel during the 36 months prior to the receipt
date for this RFA, the amount, source, and period of funding, and the
role and time commitment of the individual on the project. Information
provided in the BIOGRAPHICAL SKETCH may be referenced as appropriate to
avoid repetition.
3. Briefly summarize relevant working papers and future research plans
(e.g., pending and planned research grant applications).
4. Describe how the researcher contributes to the unit's research
program: how his or her expertise, disciplinary training, substantive
interests, technical skills help to advance the central scientific
objectives and themes of the unit. Identify recent, active, or planned
collaborations involving this researcher.
5. Describe how the researcher uses (or would use) the proposed cores
or activities.
E. COMPONENT DESCRIPTIONS
Describe proposed components in the order listed below. If more than
one component is proposed under a given category, assign letters to
distinguish the components (e.g., 1.a; 2.c). For each component,
provide the name of the Director and describe procedures used to assure
cost-efficiency and high quality administrative and research
activities.
Do not exceed five pages in describing each component (core or
activity), excepted as noted below. If any component is described as a
collaborative activity (i.e., involving partnership with another
institution), applicants may use one additional page to describe how
each partner will contribute (e.g., in terms of administration,
staffing, and other resources); how each partner will benefit (e.g., in
terms of access to services or research productivity); and how
decision-making will be shared.
1. Research Support Activities - Describe the objectives,
administrative organization (use organizational chart), staffing
(including a Core Director and any professional or technical personnel
and their duties, space and physical resources, current and projected
services, eligibility for and allocation of services, and cost-sharing
arrangements. Briefly describe current or planned research activities
that will utilize the core services.
Explain how the proposed research support activities and organizational
structures will contribute to advancing the central scientific
objectives and themes of the research program and how the activities
will foster innovation in the program's research. Describe strategies
for assuring that research support services effectively respond to and
anticipate the evolving needs of science conducted in the unit. Justify
the core in terms of scientific impact and cost-effectiveness. Explain
what the proposed services will provide over and above research support
that the applicant's institution already provides and why they are
essential to meet the needs and goals of the research program.
2. Developmental Activities - Describe the objectives and
administrative organization of each type of developmental activity and
organizational structure. Describe the impact of the activity on mind-
body and health research within the unit. In describing a seed-grant
program, include information on the pilot or small research projects
selected for implementation in the first year (maximum one-page per
project). Then provide details on program procedures and policies
(maximum five pages), including review procedures; priorities for
allocating funds; requirements for leveraging funds or preparing
research proposals to extend or continue the project; size of awards;
length of award periods; number of awards permitted to an individual
researcher; mentorship arrangements; and cost-sharing arrangements with
the parent institution.
Faculty development may include salary and/or research support for new
faculty. Describe the probable use of faculty development funds and the
ways in which the plan will advance the unit's research objectives.
SECTION III: APPENDIX
Follow the standard guidelines for an appendix:
http://grants.nih.gov/grants/funding/phs398/instructions2/
p1_specific_instructions.htm#8_Appendix. Do not use the appendix
to circumvent page limitations. The appendix will not be duplicated
with the application and will be sent only to certain members
of the SRG who will serve as the primary reviewers of
the application.
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 (Mind-Body Interactions and Health:
Developmental Infrastructure Program) and number (OB-03-005) 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 by July 16,
2003. If an application is received after that date, it will be
returned to the applicant without review.
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. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the Office of Behavioral and Social Sciences
Research (OBSSR). Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the CSR 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 the National Advisory Council or
Board of the NIH Institute or Center to which it is assigned.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
health-related biological, behavioral, and social systems, improve the
control of disease, and enhance health. In the written comments,
reviewers will be asked to discuss the following aspects of each project
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of the criteria
listed below will be addressed and considered in assigning the score for
a research project, weighting them as appropriate for each project. Note
that the project 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.
A. OVERALL PROGRAM
One PRIMARY CRITERION will be used to evaluate the overall scientific
merit of an application for a Developmental Award (R21): The potential
future contributions of the applicant program to mind-body and health
research.
Reviewers will base their assessment of potential on such factors as the
current level and trajectory of research productivity, innovation,
quality and significance; the significance of the applicant
institution's central scientific objectives and themes and the plan for
advancing them; the program's plan for encouraging synergy and
interaction among mind-body and health researchers; and the applicant
institution's success in contributing to the development of junior
investigators.
Three SECONDARY CRITERIA will also be used to assess the overall
scientific merit of applications:
a) Quality and potential impact of proposed infrastructure program:
Reviewers will examine the overall quality, scientific merit, and
innovation of the activities to be supported. Reviewers will consider
the likelihood, based on existing capabilities and proposed activities,
that the proposed program will develop the resources and mechanisms
required to build a substantial interdisciplinary portfolio of mind-body
and health research and facilitate significant new contributions to the
field.
b) Research competence of key personnel: Reviewers will consider the
capability and scientific credentials of the Principal Investigator to
direct the program and maintain high standards of research
collaboration; the specific technical qualifications of core directors;
and the scientific accomplishments of all participating investigators.
c) Institutional commitment and environment: Reviewers will assess the
nature and level of resource commitment from the institution in which
the center is housed and any cooperating institutions, taking into
account the institutional context. Reviewers also will consider the
academic and physical environment as it bears on research opportunities,
space, equipment, and the potential for interaction with scientists from
various departments, institutions or disciplines.
B. EXPLORATORY/DEVELOPMENTAL RESEARCH COMPONENTS:
Individual elements of the proposed program will be evaluated separately
based on the criteria below.
1. Research Support Activities
o Potential or actual contribution of the proposed activity to
advancing research within the applicant unit, by: enhancing the
productivity of the existing scientific program; fostering new
scientific advances; facilitating interactions across disciplines and
substantive areas of study; and/or advancing theoretical or technical
approaches.
o Appropriateness to the size and characteristics of the applicant
institution's existing research program and the central scientific
objectives and themes of the program.
o Qualifications, experience, and commitment to the program of the
investigators responsible for the cores or activities and their ability
to devote the required time and effort to the program.
o Cost-effectiveness of services or activities and appropriateness of
cost-sharing arrangements with the institution, relevant departments,
and other external infrastructure support programs.
2. Developmental Activities
o Potential of the proposed activity to advance research within the
applicant unit by stimulating innovation in mind-body and health
research and/or fostering the development of junior scientists.
o Appropriateness to the size and characteristics of the applicant
institution's existing research program and the central scientific
objectives and themes of the program.
o Qualifications, experience, and commitment to the program of the
investigators responsible for the activities and their ability to devote
the required time and effort to the program.
o Cost-effectiveness of services or activities and appropriateness of
cost-sharing arrangements with the institution, relevant departments,
and other external infrastructure support programs.
o For pilot research programs, the appropriateness and quality of
procedures and policies for administering the program, such as
guidelines for reviewing applications, priorities for allocating funds,
requirements for leveraging funds, and size and length of awards, and
the quality for the projects selected for implementation in the first
year.
3. Consortia:
Applications proposing to undertake any infrastructure activity in
cooperation with another institution will be evaluated for the value
added by the involvement of other institutions and the appropriateness
and adequacy of plans for the sharing of rights and responsibilities
among proposed partners with respect to the funding, administration, and
use of shared resources.
C. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See
Inclusion Criteria included in the section on Federal Citations, below)
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: June 16, 2003
Application Receipt Date: July 16, 2003
Peer Review Date: October/November 2003
Council Review: January/February 2004
Earliest Anticipated Start Date: April 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
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(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.
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 No. 93.989 (FIC), 93.213 (NCCAM), 93.395
and 93.393 (NCI), 93.867 (NEI), 93.837 (NHLBI), 93.866 (NIA), 93.273
(NIAAA), 93.856 (NIAID), 93.846 (NIAMS), 93.279 (NIDA), 93.121 (NIDCR),
93.848 (NIDDK), 93.242 (NIMH), and 93.853 (NINDS). This program is not
subject to the intergovernmental review requirements of Executive Order
12372 or Health Systems Agency review. Awards are made under
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and administered under NIH grants
policies described at http://grants.nih.gov/grants/policy/policy.htm
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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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