and Human Services (HHS)
EXPIRED
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: [email protected]
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: [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, MSC 5475
Bethesda, MD 20892
Phone: 301-594-0519
Fax: 301-480-3621
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 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 [email protected]
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: [email protected]
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: [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 20892-9551
Phone: 301-402-1746
Fax: 301-443-6814
E-mail: [email protected]
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: [email protected]
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: [email protected]
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: [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, MSC 5475
Bethesda, MD 20892
Phone: 301-594-9102
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
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: [email protected]
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: [email protected]
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: [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 20892-9541
Phone: 301-443-6710
Fax: 301-594-6847
E-mail: [email protected]
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: [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 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: [email protected]
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) 710-0267, Email: [email protected] .
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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