and Human Services (HHS)
EXPIRED
BUILDING TRANSLATIONAL RESEARCH IN BEHAVIORAL SCIENCE
RELEASE DATE: February 12, 2002
PA NUMBER: PAR-02-062 (This PA will remain active until reissued,
see NOT-MH-06-105)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission.
Replacement R24 (PAR-06-357), R21 (PAR-06-355), and R01 (PAR-06-356)funding
opportunity announcements have been issued for the submission date of June 1, 2006
and submission dates for AIDS and non-AIDS applications thereafter.
EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for All R24 Applications: July 31, 2006
PARTICIPATING INSTITUTES AND CENTERS (ICs):
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
Application Receipt Dates: April 17, 2002, and standard application
deadlines thereafter.
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
Background
General Objectives
Part A: R21
Part B: R24
Research Topics
o Mechanism(s) of Support
Part A: R21
Part B: R24
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
Page limits for research plan (sections a-d): R21, R24
General Instructions
o Peer Review Process
o Review Criteria
General Review Criteria
Other Review Criteria
Part A: R21
Part B: R24
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute of Mental Health (NIMH) and the National Institute on
Drub Abuse (NIDA) seek to encourage the development of collaborative
partnerships between scientists who study basic behavioral processes and those
who study the etiology, diagnosis, treatment, and prevention of mental and
behavioral disorders (including drug abuse and addiction) and the delivery of
services to those suffering from those disorders. NIMH and NIDA are issuing
this Program Announcement (PA) as part of a major, long-term commitment to (a)
encourage the systematic translation of basic behavioral theory, methods, and
findings into research designed to reduce the burden of mental illness and
behavioral disorders and (b) encourage basic behavioral scientists to seek a
further understanding of behavioral processes through an exploration of how
those processes are altered by mental and behavioral disorders. This PA was
developed in response to a report written by the National Advisory Mental
Health Council"s Behavioral Science Workgroup, entitled "Translating
Behavioral Science into Action," http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm.
This PA contains two mechanisms to support varying types of translational
research partnerships: (1) R21 Exploratory grants for the initiation of
research partnerships, and (2) R24 resource grants for the development of a
translational research capability. For convenience, the sections of this PA
which contain instructions unique to each mechanism are denoted as Parts A and
B, respectively (see Table of Contents, above). Please contact program staff,
as listed below, for information regarding R01 grants in translational research.
Although not formally participating in the PA, the Division of Cancer Control
and Population Sciences within the National Cancer Institute is very
interested in translational research in behavioral science as it relates to
cancer control. This division supports an R21 grant mechanism focused on
pilot projects and feasibility studies enabling investigators to develop
interventions in cancer prevention, screening, or survivorship research
areas. See http://grants.nih.gov/grants/guide/pa-files/PA-02-001.html for a
complete description of this announcement.
RESEARCH OBJECTIVES
Background
NIMH and NIDA have for many decades been primary sponsors of research in the
basic behavioral sciences. This long-term investment in behavioral research
has resulted in the development of a large body of knowledge in such areas as
emotion, motivation, self-concept, personality, cognition, memory, social
cognition and influence, family processes, social networks, and sociocultural
variations (see http://www.nimh.nih.gov/publicat/basbehav.cfm). However, the
theory, methods, knowledge, and insights from the basic behavioral sciences
have not been fully utilized in understanding pressing public health issues in
mental health and drug abuse: the etiology and assessment of disorders, the
development of innovative preventive and treatment interventions, and the
effects of interventions and services for diverse types of people in disparate
social, economic, cultural, and environmental contexts.
In 1999, the NIMH Director and the National Advisory Mental Health Council
convened the Behavioral Science Workgroup to explore ways to increase the
impact of behavioral science research on public mental health issues. The
Workgroup was comprised of experts in social, cognitive, developmental, and
clinical psychology, psychophysiology, anthropology, sociology, public health,
and biostatistics. In their report, "Translating Behavioral Science into
Action," they highlighted three priority areas of translational behavioral
science research:
o Basic behavioral processes in mental illness
o Functional abilities in mental illness
o Contextual influences on mental illness and its care
Regarding these three areas, the Workgroup wrote: "These priority research
areas are critical starting points for progress in translational science
because they are at the interface of what end-users have identified as
important and what behavioral science researchers regard as areas of
opportunity. They offer the prospect of conducting exciting research,
advancing scientific understanding of behavior-in health and in illness-and
improving the mental health of our Nation."
The workgroup recommended that NIMH "establish and publicize translational
behavioral science research as a priority funding area...and develop a
coherent strategy for its systematic development." With this current PA, NIMH
and NIDA continue a long-term commitment to translational behavioral science
research. Some researchers, working singly or in small groups, have already
accomplished significant research of this nature, to a degree that augurs the
significant potential value of this approach. At the current time, however,
there is a clear need to foster a significant increase in collaborative
efforts among basic and clinical researchers in order to realize the fullest
potential of translational research.
This PA is designed to address the needs of investigators in the formative
stages of the collaborative research process. For investigators who are just
beginning to explore translational research questions, there is the
exploratory R21 grant. For investigators who have initiated some collaborative
partnerships and want to build a translational research capability, there is
the R24 grant. Both the R21 and R24 mechanisms are intended to foster novel
and innovative collaborations that are still in relatively initial stages of
development, accordingly, the intent is to support work that has not yet
amassed substantial preliminary data. Priority for R21 and R24 applications
will be given to these relatively new collaborative arrangements. Each of
these mechanisms will be discussed below.
Investigators who have a specific translational research question, and
sufficient pilot data to warrant an R01 research project grant or
investigator-initiated Collaborative R01, may wish to consider PA-02-061,
"Translational Research Grants in Behavioral Science,"
(http://grants.nih.gov/grants/guide/pa-files/PA-02-061.html).
General Characteristics
Regardless of mechanism, all applications to this PA must demonstrate that a
research partnership between basic behavioral scientists and clinical and/or
services researchers exists or will be developed and nurtured. For purposes
of this PA, a basic scientist is defined as one who has demonstrable expertise
in one or more lines of basic research, and for whom a preponderance of his or
her research effort (typically, 50% or more) has involved non-clinical
populations, as measured by publications, grant support, presentations, or
other scholarly work. The minimum collaborative arrangement would thus
involve two investigators, although larger groups of actual and potential
collaborators are encouraged. While the emphasis in this PA is on behavioral
science, collaborations that include relevant biological measures as
integrative components are also encouraged, particularly from disciplines such
as behavioral neuroscience and psychophysiology in which such integration is
implicit. Research teams are to be conceptualized by the nature of the
translational research goals and need not be limited by geographical or
department boundaries. Collaborations among different institutions are
encouraged in view of the typical distinctions between basic sciences and
clinical/services settings. However, the applicants must show how
communication will occur across these boundaries so that fully developed
collaborative research partnerships can occur.
Part A: R21 Exploratory Grants
The primary purpose of the exploratory R21 mechanism is to provide an avenue
for basic and clinical investigators to initiate and explore the potential of
research collaborations. The R21 will be awarded as a single grant to a group
of investigators. The minimum number of investigators for this mechanism is
two (one each basic and clinical), while there is no cap on the maximum number
of investigators, the application needs to discuss how the contributions of
each member will be integrated in the enterprise. The activities of an R21
grant could include discussions of the clinical research problems to be
addressed, the ways in which the basic research being conducted by the group
members (as well as other relevant basic areas) could be applied to the
clinical issues, critical evaluations of relevant research literatures, visits
among the various laboratories and clinics to familiarize members with each
others" work in detail, possible modifications to paradigms and methods that
might be necessary for use with patient populations, determination of other
expertise that might need to be added to the group, new statistical approaches
or methodologies that may need to be developed, priorities for instantiating a
translational research program, and design and execution of small, preliminary
studies to demonstrate feasibility or obtain pilot data. A primary outcome of
the activities of this mechanism should be the specification of a
translational research agenda. This research program should comprise clinical
research studies that clearly reflect the integral contributions of the basic
science areas, and, where relevant, basic research studies to address critical
gaps in the literature or methodological questions important to the clinical
issues. These exploratory grants will have the following characteristics:
o The purpose of this mechanism is to foster initial development of
collaborative work, accordingly, investigators need not demonstrate any
history of prior collaboration. However, those factors in the investigators"
background and/or institutional circumstances that would facilitate success in
collaboration should be clearly delineated.
o The application must contain a cogent description of one or more specific
topics in basic behavioral science, the clinical/services domains to which the
basic science is to be applied, and a compelling justification for the
potential of the research collaboration with respect to the translation of one
or more basic science areas into clinical research.
o Relevant areas of basic behavioral science can include models of behavior,
cognition, social functioning, etc., specific paradigms developed for the
investigation of basic behavioral processes, and statistical models or
methods. In all cases, however, a strong knowledge base should already be
available that is germane to the translational effort.
o The application should provide a clear plan for the development of the
collaboration. Such efforts could include travel among sites for informal
meetings, workshops and small conferences, consultants, and analyses of extant
data sets, using new methodologies or approaches. The purpose of these
activities will be to refine conceptual frameworks for organizing
translational research and to identify which specific research questions show
greatest promise for advancement.
o R21 grants may also include pilot studies, with subjects drawn from
clinical, high-risk, and/or non-clinical populations, in order to demonstrate
feasibility of certain aspects of the research approaches and develop further
translational research projects.
o R21 grants may provide for salary support for faculty, research assistants,
and other professional staff involved with the project.
o Each exploratory grant should present a description of the anticipated
longer-term goals of the collaboration as it develops. Such goals might
variously include an application for a resource development grant (R24), an
R01-based research collaboration, or a larger center mechanism.
Part B: R24 Grants for Translational Research Development
The primary purpose of these larger R24 resource-related grants is to provide
support for enhancing the capability to conduct translational research. As
such, it is expected that the primary components of these projects will
involve activities designed to foster the development of appropriate resources
that support the initial implementation of research capabilities and
feasibility studies. Resources may be both physical (e.g., a laboratory at a
clinical site where paradigms derived from basic science can be used with
patient subjects) and/or scientific (e.g., development of needed
methodologies, paradigms, assessment instruments, etc.). These developmental
activities will have the following characteristics:
o The principal investigator must have demonstrated the capability to
organize, administer, and direct collaborative, interdisciplinary research
activities, and show a minimum time commitment of 20 percent. Other
investigators must also allot a percentage of effort that is commensurate with
their role in the project.
o A development project is expected to include a group of investigators who
integrate ideas from diverse scientific and disciplinary realms. While it is
not necessary that all members of the project have independent research
funding, investigators are expected to demonstrate a strong record of
scientific productivity and innovation.
o The investigators are expected to develop a specific set of hypotheses
related to translational research that define the mission of the project. The
project should address relevant theoretical and empirical literature in both
the basic and clinical/services areas to be studied, and identify the goals of
the translational research effort.
o The project may develop methodological and/or statistical capabilities in a
range of areas. Such methodologies could be developed initially in basic
research areas, and then applied to issues in clinical or services research.
o The project may include plans for the common reduction, management, and
analysis of data across multiple activities and sites. Such work would be
directed toward facilitation of comparing multiple data sets, and allowing
direct comparisons of databases from clinical and non-clinical populations.
o As part of the developmental activity, seed money and start-up funds may be
requested to support new, innovative pilot projects that reflect: (1) research
that is needed to facilitate the development of basic behavioral science to
prime its relevance to applied research, and (2) research in clinical and/or
services domains that incorporates the theories and/or methods of basic
behavioral science.
o Resource development projects are encouraged to include opportunities for
young investigators to be mentored in one or more areas of specialization,
with emphasis on the application of basic research principles to clinical or
services issues. Projects are encouraged to make maximum use of the variety
of mechanisms available to foster the development of scientists with expertise
in translational research (e.g., minority supplements, mentored K awards).
o The goal of a project of this type is to support the development of a
significant potential for conducting innovative translational behavioral
science research. Accordingly, the project should clearly describe the scope
and goals of intended future work, including scientific goals and anticipated
mechanisms of support (e.g., Collaborative R01 submissions, centers) that are
anticipated to emerge from the developmental process. Plans for future work
should include a description of anticipated research
apprenticeship opportunities.
Research Topics
The following are examples of broad research topics that might be the focus of
translational research. This list is not meant to be comprehensive, nor are
the examples meant to be exclusive of other topics.
o Research pertaining to the factors that maintain the engagement of patients
with treatments for mental disorders, including drug abuse or addiction,
whether psychosocial or pharmacologic
o Studies of cognitive, attentional, and/or emotional processes in attention-
deficit/hyperactivity disorder
o Research devoted to an understanding of the nature of specific functional
deficits in mental or drug abuse disorders (e.g., deficits in attention,
memory, emotion-regulation, social interactions and relationships), and
development of targeted interventions for rehabilitation and relapse prevention
o Research regarding neurocognitive and emotional functioning related to
severely disabling mental disorders or drug abuse, such as schizophrenia,
bipolar illness, depression, and addiction
o Studies of cultural factors involved in the diagnosis, prevention,
treatment, and delivery of services in mental disorders, including drug abuse
and addiction
o Research regarding behavioral and neurodevelopmental factors in disorders
characterized by impaired affiliative behavior and social functioning such as
autism and schizophrenia
o Studies of decision making as it affects the behavior of patients and
providers in mental health or drug abuse services settings
MECHANISMS OF SUPPORT
Part A: R21 Exploratory Grants
This application will use the National Institutes of Health (NIH) Exploratory
Grant (R21) award mechanism. As an applicant, you will be solely responsible
for planning, directing, and executing the proposed project. The total
project period for an application submitted for the R21 mechanism in response
to this PA may not exceed 3 years. Applicants must clearly specify in the
application which mechanism is being requested.
For the R21 grant, an applicant may request a project period of up to 3 years
and a budget for direct costs of up to $125,000 per year, this award is
nonrenewable. Direct costs of up to $150,000 per year may be requested to
allow for facilities and administrative (F&A) costs on consortium arrangements.
This mechanism uses just-in-time concepts. It also uses the modular
budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm).
You are required to use the modular format for the R21 mechanism.
Part B: R24 Grants for Translational Research Development
This application will use the National Institutes of Health (NIH) Resource-
related Research Project Grant (R24) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project. The total project period for an application submitted for
the R24 mechanism in response to this PA may not exceed 3 years. Applicants
must clearly specify in the application which mechanism is being requested.
The R24 mechanism is used to support research projects that will enhance the
capability of resources to serve biomedical research. An applicant may request
a project period of up to 3 years and a budget for direct costs of up to
$225,000 per year, excluding F&A costs on consortium arrangements, this award
is also nonrenewable, and is not transferable to another institution.
Applicants may request up to an additional $75,000 per year for such items as
per-patient costs in services settings or neuroimaging charges, these
additional funds must be strongly justified, and not used simply to augment
the scope of the project. Regardless of budget amount, this mechanism uses
the traditional, non-modular budget format.
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 only
o Faith-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
Any research project which involves a Phase I or Phase II Clinical Trial must
include provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures, each project is
further required to include a Data and Safety Monitoring Plan. See the
Federal Citations section, below, for further information and references.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Bruce N. Cuthbert, Ph.D.
Adult Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6184, MSC 9625
Bethesda, MD 20892-9625
Telephone: (301) 443-3728
FAX: (301) 443-4611
Email: bcuthber@mail.nih.gov
Lisa Onken, Ph.D.
Behavioral Treatment Development Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4241, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2235
FAX: (301) 443-6814
Email: lo10n@nih.gov
Herbert Weingartner, Ph.D.
Translational Research Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1321
FAX: (301) 594-6043
Email: herbw@nih.gov
o Direct your questions about peer review issues to:
Michael Kozak, Ph.D.
Chief, Extramural Review Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD 20892-9608
Telephone: (301) 443-1340
FAX: (301) 594-0702
Email: mkozak@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3119, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@nida.nih.gov
SUBMITTING AN APPLICATION
Page limits for the research plan (sections a-d):
R21 Exploratory Grants: 15 pages
R24 Grants for Translational Research Development: 25 pages
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All R21 applications
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.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three 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)
At the time of submission, two additional copies of the application must be
sent to:
Jean G. Noronha, Ph.D.
NIMH Referral Liaison
National Institute of Mental Health
6001 Executive Blvd, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@nih.gov
APPLICATION PROCESSING: Applications must be received by or mailed before the
receipt dates indicated on the first page. 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
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened by NIMH in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o 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
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 your 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 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 and to the type of application, i.e., R21 or R24? Do you acknowledge
potential problem areas and consider alternative tactics?
(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
principal investigator and to that of other researchers (if any)?
(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, where
relevant to the proposed work.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
Given the requirement for explicit collaborations between basic and clinical
researchers, and the differences among the two mechanisms, the following
review criteria are also to be used in evaluating applications submitted
under this PA.
SIGNIFICANCE: What is the application"s overall judged potential to
contribute to substantive progress in clinical research through the
application of the behavioral science area(s)? This potential will depend on
three factors, to which approximately equal weighting should be given: the
quality of the basic research that is being translated, the strength of the
clinical research team and their ability to implement the basic research, and
the appropriateness of the basic science area and paradigms to the clinical
research problem. An important aspect concerns the experience of the basic
research team with the approach that is being developed, and the experience
of the clinical investigators with the clinical population and problem that
is to be investigated.
INNOVATION: What is the potential of the research to foster significant
advances in understanding, developing new interventions, or providing
services for the disorder(s) being investigated?
APPROACH: The type of mechanism should be considered in evaluating the
approach, as follows:
Part A: R21 Exploratory Grants
o The R21 exploratory grant essentially involves a group of investigators
convening to discuss possible areas of translational research. This
mechanism does not require any pilot data, nor any extensive research plans,
evaluation primarily involves the likelihood of how successful the
collaboration might be, given the background and prior work of the
investigators, plans for the work that is proposed, and the promise of the
basic science area for the clinical research.
Part B: R24 Grants for Translational Research Development
o The resource development R24 will typically involve development of both
laboratory resources and scientific capabilities, accordingly, the R24 also
does not require extensive pilot work, and the experiments that are proposed
are to be of a large-scale pilot nature. It is not necessary for the
investigators to have worked out in full all of the details of the
procedures this is the point of the application, however, it should appear
likely that these procedural and/or paradigmatic aspects can be worked out,
and that the subsequent full-fledged experiments would make a
substantial contribution.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
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: http://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
(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 PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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 No. 93.242 (NIMH) and 93.279 (NIDA), 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
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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