MAINTENANCE OF LONG TERM BEHAVIORAL CHANGE
RELEASE DATE: January 15, 2003 (see NOT-OB-03-002)
RFA NUMBER: OB-03-003
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov/)
Office of Disease Prevention (ODP)
(http://odp.od.nih.gov/)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Eye Institute (NEI)
(http://www.nei.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 of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.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 Nursing Research (NINR)
(http://www.ninr.nih.gov/)
LETTER OF INTENT RECEIPT DATE: March 11, 2003
APPLICATION RECEIPT DATE: April 11, 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 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 above named organizations invites applications for research projects that
(a) examine biopsychosocial processes and test interventions designed to
achieve long-term health behavior change and (b) a Resource Center to provide
coordination for this set of research projects. Past research has typically
focused on short term behavioral change, yielding little information on how
change, once achieved, is maintained over the long term. This Request for
Applications (RFA) encourages investigators to expand on the current
theoretical base of change processes and intervention models, as well as to
consider new conceptualizations from basic research in the social and
behavioral sciences. Applications must focus on important health-related
behaviors already demonstrated amenable to short-term change, such as tobacco
use, exercise, eating habits, alcohol and drug use, inoculation obtainment,
disease screening, stress reduction, adherence to health care regimens,human
immunodeficiency virus (HIV)or sexually transmitted infection (STI) risk
practices, bullying and abuse of others, sun exposure, and failure to use
safety equipment.
RESEARCH OBJECTIVES
Background
This Request for Applications follows on a 1997 RFA focusing on "Innovative
Approaches to Disease Prevention Through Behavior Change." The goal of the
1997 RFA was to stimulate investigation of innovative strategies designed to
achieve healthy behavior change by focusing on tobacco use, sedentary
lifestyle, poor diet, and alcohol abuse. The RFA solicited intervention
studies aimed at either a comparison of theoretical approaches to behavior
change or assessment of the utility of specific behavior change theory in a
multibehavioral framework.
Although programs funded through that and other NIH efforts have been
successful in achieving change during and immediately following the
intervention phase, little empirical attention has been given to
understanding factors that sustain and support behavior change after risk
practices are identified, appropriate interventions implemented, and initial
outcomes assessed. Indeed, other research indicates that relapse rates for
addictive behaviors such as substance abuse and tobacco use are very high.
For example, most individuals who stop smoking cigarettes relapse within six
months. Adherence to exercise, diet and other health regimens is no better,
despite the fact that initial success rates for various behavior change
programs are very high. Thus long term maintenance of behavior change is as
challenging, if not more so, than the initiation of behavior change. NIH
believes that progress in this area may be accelerated by a more thorough
examination of behavioral change processes that address factors influencing
the initiation, maintenance, and resumption of behavior change at multiple
levels.
In 1998 the National Heart, Lung, and Blood Institute held a conference on
"Maintenance of Behavior Change in Cardiorespiratory Risk Reduction." Cross-
cutting themes and research recommendations that emerged from this conference
included the need for (a) new models of population health behavior change and
maintenance that integrate individual-level with broader environmental and
macro-level policy influences; (b) a fuller model, which views maintenance
more as a process than as a destination; and (c) more theory-based and
interdisciplinary research on the maintenance process and on strategies for
assisting special populations and addressing more than one behavioral risk at
a time. Participants suggested that researchers should focus on
understanding those who are successful at long-term maintenance, and on
developing new approaches that can be used to help those who are not.
The National Research Council 2001 report, "New Horizons in Health: An
Integrative Approach", suggested that behavioral and social interventions
have traditionally emphasized acute change. These interventions assume that
the individual, group, community, or population has an adverse influence on
health that could be corrected by a brief program of change. In its report,
the committee recognized the need for new models of behavior change that
address sustaining change in the face of constantly shifting personal, social
and environmental circumstances ( p.157).
Similarly, the Institute of Medicine (IOM) 2001 report, "Health and Behavior:
The Interplay of Biological, Behavioral, and Societal Influences", noted that
most studies, while demonstrating the ability to alter behavior, either do
not test, or when tested do not demonstrate, sustained behavior change
(p.334). The IOM committee indicated that interventions are most likely to
be effective when they address the context in which behavior occurs. In
their recommendations, they suggested the need to study both longer duration
efforts, and concurrent interventions at the multiple levels that influence
behavior: individual (physiological, psychological), family, social networks,
organization, community, and society.
Research Goals and Topics
This RFA seeks to stimulate studies of biopsychosocial processes and
interventions that target long-term maintenance of behavioral change.
Investigators are encouraged to expand on the current theoretical base of
change theories and intervention models to include relevant areas, such as
motivational interviewing, contingency management, goal setting, social
marketing, and innovation diffusion, as well as to consider new
conceptualizations from basic research in the social and behavioral sciences,
including behavioral extinction, behavioral momentum/choice theory,
behavioral economics, models of decision-making, and goal-directed behaviors.
Applications must focus on important health behaviors previously shown to be
amenable to short-term change, such as such as tobacco use, exercise, eating
habits, alcohol and drug use, immunization, disease screening, stress
reduction, adherence to health care regimens, HIV/STI risk practices,
bullying and abuse of others, sun exposure, or use of safety equipment.
Multi-level (individual, interpersonal, community and/or societal) approaches
to the understanding of behavior and intervention are encouraged, as is an
interdisciplinary perspective. Studies are welcome that expand upon currently
funded projects to ascertain influences on participants' failure to maintain
behavior change following intervention. Also, encouraged are studies that
explore interpersonal or social contexts that may interfere with maintenance
of behavior change. Studies may be observations, experiments, epidemiological
surveys, intervention trials, or examinations of archival data. Cost/benefit
analyses are also encouraged.
The examples listed below are not exhaustive; it is expected that additional
important strategies and topics will be identified by investigators who
respond to this RFA. Studies in these areas can include:
1) Research on factors affecting maintenance of behavior change, including:
Studies of risk and protective factors operating and interacting at
different levels: individual level (isolation, genetics, poverty, lack
of confidence, personality, stage of readiness to change, personal
history of behavior change, coping skills, changing neurobiological
substrates); interpersonal level (caregiving, peer pressure, friends
and partners who smoke or drink, social support); community level
(norms, stigma, community support, enforcement of laws, exposure to
negative cues, neighborhood resources, safety); and/or societal level
(food labels, changing policies, taxes, media, environmental
determinants)
Studies examining whether different neurobiological,
social/psychological, cultural, and other processes are involved in
adopting a new behavior (short term change) versus sustaining a
behavior over time (long term change), including tests of the
underlying assumptions of various maintenance theories
Research examining maintenance of behavior change in persons with
multiple risk behaviors (e.g., comparing long term intervention
response of people who engage in multiple risk or problem behaviors to
those who engage in a single risk behavior; and analyzing possible
transfer of behavior skills from one behavior to another).
Research examining the factors associated with maintenance of behavior
change in those who achieved change themselves versus those who
participated in formal interventions programs; or in those whose
participation is voluntary versus court-mandated.
Investigations of the extent to which social contexts sustain and
support behavior change after behaviors are targeted, an intervention
is implemented, and initial outcomes of intervention are determined.
These factors may include continuation of cues and supports, and
maintenance of reinforcement schedules supporting change. Studies that
ascertain how social environments may be modified to provide greater
reinforcing value or that increase the cost or delay of rewards
associated with targeted health risk behaviors.
Research that explores ways to sustain skills that are newly acquired
or enhanced through intervention but that decay over time due to lack
of opportunity to practice or mastery experiences.
2) Research on intervention, including studies of:
Intervention target: Investigations of various underserved or high-
risk/special need populations across the life-course, with respect to
the effectiveness of different maintenance interventions for different
and potentially vulnerable population groups (e.g., psychiatrically
high-risk populations, ethnic or minority populations; economically
disadvantaged populations; children, adolescents, elderly; injecting
drug users and their sexual partners). Also studies that describe how
people lapse or relapse after behavioral proficiency is demonstrated in
the context of intervention; studies examining the "match" between the
intervention type and delivery style to individual or target population
Intervention type and delivery channel: Studies of factors associated
with intervention success or failure (e.g., therapeutic relationship,
continuous care/ contact; tailored messages; self-help; dual behavior
programs; partner support programs; relapse prevention training;
varying learning contexts; providing retrieval cues; financial
incentives; use of multiple media; pharmacotherapy; program intensity;
integration into lifestyle, consistency of community enforcement
programs)
Intervention setting: Studies of factors associated with the
environment in which the intervention is delivered (e.g.,home,
community centers, community task forces, social institutions such as
schools and law enforcement, mass media) that either enhance or
undermine successful maintenance
Intervention timing, duration, intensity: Studies that compare
initiation and maintenance phases of behavioral change efforts, to
determine how best to structure interventions designed to maintain
behaviors (e.g., is it best to structure interventions so that they are
initially intensive, then decreasing in intensity during maintenance,
or should less intensive interventions be used for longer periods of
time, or intensity maintained at high levels throughout?) Also included
are studies that test the sustainability of various interventions over
time, with and without "reintervening" or the use of "boosters"
following some initial shorter follow-up period. In this regard,
studies that have demonstrated short-term, positive impact are
encouraged to apply for funding to demonstrate longer-term
sustainability. The initial grant in which short-term outcomes were
found does not necessarily have to be NIH funded.
Intervention level: Studies that compare single level interventions
with programs that either intervene or coordinate at more that one
level (individual, family, organizational, community, and/or societal);
studies that capitalize on naturally occurring community or societal
changes as these affect the success of structured interventions in
maintaining changes in behavior; studies that identify how to make
maintenance interventions self-sustaining after research funding ends
Active elements: Research that identifies the mechanisms of action or
active components of behavioral, institutional, and community
interventions that promote the maintenance of behavioral change, and
how these may differ from active elements in interventions successful
in producing acute change effects. These studies may focus on testing
the underlying assumptions of various maintenance theories.
3) Other topics/special issues, including:
Studies that develop, adapt, or assess new technologies for either
studying the natural history of behavior or delivering interventions
designed to maintain behaviors over the long term (e.g., examining
whether internet-based programs can facilitate behavior maintenance or
function in place of direct therapist support)
Interdisciplinary research that links biomedical, behavioral,
sociological, anthropological, and policy perspectives to gain a more
comprehensive understanding of maintenance as a process involving the
interaction of multiple influences (e.g., metabolic, developmental,
socioeconomic, physiological, psychosocial, and cultural influences on
dietary patterns)
Studies that examine the role of different financing factors and
mechanisms (e.g., health plan parity benefits, managed care practices,
other cost control measures, public vs. private insurance) in enhancing
or undermining the effectiveness of behavioral, institutional, and
community interventions designed to promote the maintenance of
behavioral change.
MECHANISM(S) OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research project
(R01) award mechanism. The total project period for an R01 application
submitted in response to this RFA may not exceed 5 years. As an applicant
you will be solely responsible for planning, directing, and executing the
proposed project. The anticipated award date is October 2003.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).
FUNDS AVAILABLE
The co-sponsors intend to commit approximately $6,150,000 in 2003 to fund
between 16-19 awards. The total cost of the Resource Center (see below)is not
to exceed $200,000 annually. Studies of complex intervention trials are not
to exceed $750,000 in annual total cost per individual grant. Studies of
pyschosocial processes are expected to cost significantly less.
Administrative adjustments in project period or amount of support may be
required at the time of the award. Since a variety of approaches would
represent valid responses to this RFA, it is anticipated that there will be a
range of costs among the grants awarded.
The usual NIH policies governing grants administration and management will
apply. Although this program is provided for in the financial plans of the
sponsoring Institutes and Offices, awards pursuant to this RFA are contingent
upon the availability of funds for this purpose and the receipt of a
sufficient number of applications of high scientific merit.
ELIGIBLE INSTITUTIONS
You may submit an application 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
It is anticipated that a successful grant application will contain the
following key elements:
Research Sites
Process studies
Studies of behavior and social processes may involve either the examination
of archival data or the collection of new data. Preference will be given to
studies that are guided by conceptualizations that expand on the current base
of change theories to include relevant areas, such as motivational
interviewing, contingency management, goal setting, social marketing, and
methodology of innovation diffusion. Also receiving preferencial
consideration will be studies that examine new conceptualizations from basic
research in the social and behavioral sciences, including behavioral
extinction, behavioral momentum theory, behavioral economics, models of
decision-making, and goal- directed behaviors. Applicants are expected to
show the relevance of their previous work to the current effort.
Interventions
Interventions should be maintenance effectiveness trials in real world
settings (e.g., home, clinic, workplace, club, church). Community-level
interventions (e.g., studies of community-based regulatory or policy changes)
will also be supported under this initiative. When appropriate, the nature
of the proposed intervention should be specified in terms of, for example,
its intensity, duration, and frequency of contact. Plans for assuring
treatment fidelity and implementation must also be specified. Applications
must explain how the design will handle external factors that can affect
intervention implementation and success. Involvement of a community advisory
panel and/or partnership with a non-academic community or health organization
may be helpful in devising strategies to enhance intervention design,
implementation, outreach, and interpretation of findings. Preference will be
given to those with data demonstrating the efficacy of affecting shorter-term
change on the same study cohort and behavior(s) of interest as the proposed
study.
Resource Center
Applications are also requested for one Resource Center (CC)to interact with
the selected grant Sites and the NIH program administrators on a variety of
topics ranging from seeking and compiling information, to providing technical
assistance, to assisting in cross-site analyses, to disseminating outcomes
via mechanisms such as a website. Because the behaviors, samples, and
objectives may vary considerably across projects, the CC's first task will be
to help the sites assess the potential for cross-study analyses and common
measures. It is likely that commonalities will be found in subgroups of
grantees rather than in the cohort as a whole.
In consultation with the Sites and NIH, the CC will facilitate and coordinate
selection of any common instruments (e.g., compiling the listing of proposed
common measures; reviewing the literature and assessing the advantages and
disadvantages of different measures for common study variables).
Additionally, the CC will be responsible for tracking recruitment and
retention across the different Sites, and advising the Sites on strategies
for enhancing recruitment/retention, especially in minority or ethnic
populations. The CC will work with projects to maximize the potential for
cross-site comparability of data.
While different sites may take the lead on different cross-study projects,
including application for supplemental funding, the CC staff will collect and
store shared data generated by the Sites, and have the option of
participating with other awardees as co-authors in preparing manuscripts that
report results from the common data sets. In addition, the CC will perform a
variety of functions, such as, maintaining a directory of investigators and
co-investigators; arranging all conference calls and meetings, and ad-hoc
meetings of project directors; and facilitating information exchange among
the Sites and NIH, and between the NIH and the general research community.
Along these lines, the Resource Center will be responsible for planning the
agendas and handling the logistics for the semi-annual meetings of the
Research Sites, to be held in the Washington DC area. The CC will post
minutes of the conference calls and meetings on a website that it will
establish and maintain. The CC will post discussions of progress, problems,
and accomplishments of the individual Sites and working groups that are
formed to address topics of common concern (e.g., recruitment and retention,
common measures, social support, common behaviors). The latter role will
also include compiling specific reports and developing and implementing
common formats across Sites for all reports, protocols and descriptions. The
CC will also devise plans for the dissemination of information resulting from
these studies, including the preparation of slides for presentation of study
objectives, methods, and findings. Up to $20,000 per year for cross-site
consultants and small working group sessions should also be budgeted. Two
completely separate applications from different applicant-investigators must
be filed if an institution seeks selection as both a Research Site and the
Resource Center. New Research Sites may be added in subsequent years.
Bi-Annual Meetings and Collaboration
All prospective awardees should describe strategies for the establishment of
collaborative arrangements with other awardees. Applicants must plan for
conference calls four times a year among grantees supported as a result of
the RFA, to discuss new developments, review research progress and
difficulties, coordinate ongoing research and plan future research. In
addition, application budgets must include funds to attend two collaborative
meetings to be held in the Washington DC area, for three investigators from
each site per year. The first collaborative meeting will occur shortly after
grant award, and will focus on research designs, objectives, and possible
collaborative arrangements that might foster increased productivity or
efficiency in addressing the objectives proposed by the applicants. Where
feasible, it will be desirable to achieve some uniformity in measurement of
key behaviors across the different funded sites. Applicants should include a
statement about their willingness to participate in such activities. The
Resource Center will assist grantees with collaborative activities, such as
conference calls, meeting logistics, and the development of common measures
and methods.
Data from any shared data sets will be submitted to the Resource Center on a
regular basis, where it will made available for cross-site analyses and
archived for public use within two years after the end of the initial award
period. The CC, Sites and NIH program representatives will jointly define
rules regarding publication of findings from analysis of the shared data sets.
It is hoped that the spirit of collaboration which spawned this initiative
will carry forward throughout the project and beyond. Toward this end,
researchers are encouraged, after a reasonable period of time for primary
analyses and publication, to make the data collected as a result of this RFA
readily available to future researchers wishing to use this data at their own
research site. This availability may be achieved by either archiving the
data and related documentation at any recognized data archive, placing the
data and documentation on a publicly available file server maintained by the
grantee organization, or supplying the data and documentation at cost upon
request.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
Direct your questions about scientific/research issues to:
Linda Nebeling, PH.D., MPH, RD, FADA ,Chief
Health Promotion Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, EPN 4080
MSC 7335 Bethesda, MD 20892-7335
(Rockville, MD 20852 for express mail)
Telephone: (301) 451-9530
Fax: (301) 480-2087
Email: nebelinl@mail.nih.gov
Maryann Redford, D.D.S, M.P.H.
Division of Extramural Research
National Eye Institute
Building EPS, Room 350
6120 Executive Blvd, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: maryann.redford@nei.nih.gov
Sidney M. Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533/Gateway
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: StahlS@nia.nih.gov
Jan Howard, Ph.D., Chief
Prevention Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
6000 Executive Blvd. Suite 505
Bethesda, MD 20892
Telephone: (301) 443-1678
Fax: (301) 443-8774
E-mail: jhoward@niaaa.nih.gov
Lynne M. Haverkos, MD, MPH
Behavioral Pediatrics and Health Promotion Research Program
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm 4B05, MSC 7510
Bethesda, MD 20892-7510
(Rockville, Md 20852 for Fed Ex or UPS)
Phone: (301) 435-6881
Fax: (301) 480-0230
E-mail: haverkol@mail.nih.gov
Minda R. Lynch, Ph.D.
Behavioral and Cognitive Sciences Research Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Rm. 4282
Bethesda, Maryland 20892
Phone: (301) 435-1322
Fax: (301) 594-6043
E-mail: mlynch1@nida.nih.gov
Robert J. Kuczmarski, Dr. P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673 (MSC 5450)
Bethesda, MD 20892-5450 (for express mail, use 20817)
Telephone: (301) 451-8354
FAX: (301) 480-8300
E-mail: RK191R@NIH.GOV
Andrew D. Forsyth, Ph.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Blvd, MSC 9619
Bethesda, MD 20892
Telephone: (301) 443-8403
FAX: (301) 443-9719
Email: aforsyth@mail.nih.gov
Janice Phillips, PhD, RN, FAAN
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Express Mail Zip Code - 20817)
Telephone: (301) 594-6152
FAX: (301) 480-826o
Email: phillipsj@nih.gov
Direct your questions about peer review issues to:
Michael Micklin, Ph.D.
Risk, Prevention, & Health Behavior Integrated Review Group
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Rm. 3178 MSC 7848
Bethesda, MD 20814-9692
Telephone: (301) 435-1258
Fax: (301) 480-3962
Email: micklinm@csr.nih.gov
Direct your questions about financial or grants management matters to:
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8634
E-mail: crystal.wolfrey@nih.gov
William W. Darby
Grants Management Officer
National Eye Institute
Building EPS, Room 350
6120 Executive Blvd, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 496-9997
Email: wwd@nei.nih.gov
Linda Whipp
Grants and Contracts Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@nia.nih.gov
Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd. Suite 504
Bethesda, MD. 20892-7003
Phone: (301) 443-4704
Fax: (301) 443-3891
Email: jsimons @niaaa.nih.gov
Dianna N. Bailey
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm 8A01, MSC 7510
Bethesda, Md 20892-7510
(Rockville, Md 20852 for Fed Ex or UPS)
Phone: (301) 435-6978
Fax: (301) 480-4783
Email: db405m@nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: gf6s@nih.gov
Teresa Farris Marquette
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 728
Bethesda, MD 20892-5450
Telephone: (301-594-7682)
FAX: (301) 480-3504
E-mail: Marquettet@extra.niddk.nih.gov
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Blvd, MSC 9605
Bethesda, MD 20892
Telephone: (301) 443-2805
Fax: (301) 443-6885
Email: diana_trunnell@nih.gov
Tara Mowery
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Express Mail Zip Code - 20817)
Telephone: (301) 594-5979
Fax: (301) 451-5650
Email: tara_mowery@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Susan D. Solomon, PhD
Senior Advisor
Office for Behavioral and Social Sciences Research
National Institutes of Health
One Center Drive, Room 256
Bethesda, MD 20892
E-mail (preferred): ssolomon@nih.gov
Phone: (301) 496-0979
Fax: (301) 402-1150
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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
https://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
https://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,
number, and type of application: "Site," or "Resource Center," must be typed
on line 2a of the face page of the application form and the YES box must be
checked. The RFA label is also available at:
https://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 the receipt dates
described at https://grants.nih.gov/grants/funding/submissionschedule.htm.
The CSR will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept any
application that is essentially the same as one already reviewed. This does
not preclude the submission of a substantial revision of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR.
Incomplete applications will be returned to the applicant without further
consideration. Applications that are complete will be evaluated for
scientific and technical merit by an appropriate scientific review group
convened by 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 selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council
or board
REVIEW CRITERIA FOR THE RESEARCH SITES
The goals of NIH-supported research are to advance our understanding of
biopsychosocial systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the following
aspects of Research Site applications 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 your application's overall score, weighting them as appropriate
for each application. Your 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, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics? If an intervention is proposed, are the conceptual models well
integrated into the design and testing of the proposed intervention? Will the
intervention take place in a real world setting? Has sufficient detail about
the intervention been provided to understand the intervention processes and
mechanisms of change? Have provisions been made for extended follow-up,
including methods capable of assessing maintenance of change and confounding
variables?
(3) INNOVATION: Does your project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
PI and to that of other researchers (if any)? If an intervention has been
proposed, has there been provision for partnerships between behavior change
experts, intervention specialists, and appropriate health professionals or
community leaders?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
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.
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)
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
REVIEW CRITERIA FOR THE RESOURCE CENTER
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged deserving of a high priority score.
(1) CROSS SITE STUDY COORDINATION: Prior experience of the Principal
Investigator and other key personnel in functioning as a Resource Center in a
multi-site study, including coordination of both substantive and
administrative aspects of multi-site studies
(2) METHODS AND MEASURES: Previous experience in instrument selection and
development
(3) CONTENT: Substantive familiarity with issues related to maintenance of
behavioral change
(4) DISSEMINATION: Experience with communication and dissemination of
information, including the preparation of slides and reports; establishing
and maintaining a multi-site website; facilitating information exchange among
the Sites, the NIH, and the general research community.
(5) BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed set of activities.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: March 11, 2003
Application Receipt Date: April 11, 2003
Peer Review Date: June/July 2003
Council Review: September 2003
Earliest Anticipated Start Date: November 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
o Content area balance
o Practice relevance
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://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
IH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information
Act(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://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 PA
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 Numbers 93.395 (NCI), 93.867(NEI), 93.886 (NIA),
93.273 (NIAAA), 93.865 (NICHD),93.279(NIDA), 93.242 (NIMH), and 93.361(NINR),
and 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 https://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.