ANIMAL MODELS OF ADOLESCENT DRUG ABUSE: INTEGRATIVE STUDIES OF BRAIN
AND BEHAVIORAL DEVELOPMENT
RELEASE DATE: October 31, 2003
RFA Number: RFA-DA-04-011
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
LETTER OF INTENT RECEIPT DATE: February 17, 2004
APPLICATION RECEIPT DATE: March 17, 2004
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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
There is a growing concern that adolescence marks a period
characterized by enhanced vulnerability to the effects of drugs of
abuse and the emergence of substance abuse disorders. Recent studies
in both animals and humans have demonstrated that a dramatic period in
neural development coincides with the unique behavioral changes
associated with adolescence. These studies have given us a framework
for understanding how the adolescent brain develops and how these
alterations affect changes in behavior. The National Institute on Drug
Abuse (NIDA) is interested in determining: i) whether, and, if so, how
change in the adolescent brain is associated with increased drug
taking, and ii) how this dynamic substrate might be altered by drugs of
abuse. NIDA seeks to stimulate research that uses an integration of
neurobiological and behavioral approaches to study adolescent brain
development. Thus applicants are expected to use animal models and an
integrated approach to focus on the development of regions of the brain
that are:
i) involved in drug-taking behavior, and/or ii) altered by acute or
chronic exposure to drugs of abuse. The goal of this RFA is to promote
the advancement of innovative projects that incorporate
multidisciplinary approaches to understand how physical transformations
in the adolescent brain are related to the behavioral changes
associated with drug abuse. Some of the physical changes that are of
interest include structural and functional changes in neurons and glia,
and alterations in brain circuitry. Some of the behavioral changes
that are of interest include: learning, memory, risk taking, cognitive
function, impulsivity, motivation and emotion. The results of these
studies should provide novel insight into the causes and effects of
adolescent drug use.
RESEARCH OBJECTIVES
Background
Adolescence is marked by the physical changes that occur during
puberty, but the changes in behavior typically associated with this
developmental period occur over a longer and less definitive period.
These behavioral changes are poorly understood, but they can have
dramatic effects on developmental trajectories and outcomes. Many
forms of risk taking and sensation seeking behaviors (including drug
taking) begin during adolescence, and these behaviors can lead to a
multitude of health-related problems, including increased rates of
automobile accidents, suicide, drug abuse and exposure to HIV and
hepatitis C. Additionally, adolescent drug taking could potentially
alter subsequent brain maturation, leading to changes in adult
behaviors.
Until recently, brain development was thought to be largely complete
after the first few years of childhood. Thus, animal models
(especially those using rodents and nonhuman primates) relied
extensively on studies of mature organisms to understand basic
neurobiological processes and behavioral phenomena. As such,
evaluation of the possible causes and consequences of substance abuse
in younger, and perhaps more vulnerable, populations have been guided
by the assumption that the adolescent brain is no different from that
of the adult. However, recent studies in both humans and animals have
demonstrated that the brain continues to develop during adolescence and
that this period of neurodevelopment is characterized by dramatic
changes in brain growth and connectivity. These structural changes
coincide with dramatic shifts in a variety of behavioral and cognitive
processes. A complex interplay of genetic and environmental variables
is clearly involved in adolescent development. However, our
understanding of the relationship between these factors is changing,
primarily due to the recent research indicating that adolescence is a
unique developmental period.
Some of the unique aspects of adolescent brain structure and function
are becoming clear. Human imaging studies have shown that a robust
amount of brain growth occurs during the early teen years (in the form
of axonal branching), and that this period is followed by a dramatic
phase of pruning. These changes occur in many regions of the brain
(including the cortex, basal ganglia, and cerebellum) but they do not
occur simultaneously: different brain regions develop during different
phases. Coincident with this growth, many important regions of the
brain (e.g. the corpus callosum and the cerebellum) become better
myelinated, again with distinct kinetics. Thus, a number of circuits
in the adolescent brain are established and refined in a complex and
dynamic manner.
Similar changes are observed in a variety of animals. Studies using a
number of both mammalian and non-mammalian models have identified
adolescent developmental periods, and this work has provided a
foundation for using many animal species to study this process. As in
human adolescents, these brain changes are associated with changes in
complex social behaviors. From this work, we are beginning to identify
the conserved changes in brain structure and regulation that coincide
with the unique patterns of emotion and cognition seen during
adolescent development.
The influence of these structural and functional changes has not been
fully integrated into our understanding of the cognitive, social, and
emotional processes that characterize human adolescent development.
One limitation of human investigations is the inability to test many
hypotheses concerning causation. This limitation has led to a debate
over the role of neurodevelopment in behavior. For example, does
exuberant axonal growth and pruning in the prefrontal cortex (PFC)
permit more abstract cognitive processing, or do the neurological
changes simply result from this cognitive maturation?
With respect to NIDA’s mission, there is a need to examine brain
development during adolescence in the context of understanding the
vulnerability to: i) acquire drug abuse behaviors, ii) escalate to
uncontrollable use, iii) abstain from drug taking, and iv) relapse
after addiction. Furthermore, this dynamic neurobiological substrate,
the adolescent brain, may be differentially altered with exposure to
drugs of abuse. To that end, understanding any and all of the
consequences of this alteration on normal social, emotional and
behavioral maturation is a critical public health issue. Two
fundamental questions are: i) Do specific brain changes play a role in
generating vulnerability to drug taking? and ii) Does drug exposure
change subsequent brain development? The tools to study this important
phase of development are now at hand.
Objectives and Scope
Animal models provide an excellent opportunity to manipulate the adolescent
brain. Whereas some aspects of adolescent development are likely to be
unique to humans (e.g., the degree of prefrontal cortex growth), many
animals undergo similar processes in many, if not all, regions of the brain.
Numerous studies demonstrate that adolescence is surprisingly conserved
during mammalian development. As such, many aspects of adolescent
development can be studied in rodents and nonhuman primates. Non-mammalian
animal models with well-defined neurobiological and behavioral transitions
are also likely to generate important and unique insights. The
neurobiological, molecular, and genetic methods that have been used to
uncover animal brain development provide us with powerful tools to
understand how adolescent neurodevelopment is linked causally to changes in
behavior. Given the evolutionary conservation of many of these processes,
this information should generate insight into understanding human adolescent
development.
NIDA seeks to promote relevant animal research integrating the use of basic
neurobiology with behavioral studies. The goals are to: i) establish
neurobiological models for understanding the causes and consequences of
adolescent behavior associated with drug taking, and ii) identify
neurobiological correlates of behaviors associated with, or produced by,
drugs of abuse.
The best approaches will be those that illuminate the causes and
consequences of changes in adolescent brain development, and provide models
for understanding behavioral vulnerabilities to, and effects of, drugs of
abuse. Two critical themes in this area of investigation should be: i)
which events are causal? and ii) to what extent are these influences on
the behavior driven by internal (e.g., molecular mechanisms, genetics, or
neurotransmitter system interactions) or external (e.g. environmental,
rearing, social, context) factors? Emphasis should be placed on
understanding the relationship between changes in behavior and changes in
brain chemistry and architecture.
Some fundamental areas of interest representing a merger of
neurobiological and behavioral approaches are listed below (these are
provided as examples and this list is not intended to cover the full
range of projects of interest):
o Understand the temporal and spatial changes in neuroanatomy associated
with adolescent maturation, as well as the behavioral consequences of these
changes. Particularly important changes include alterations in dendritic
growth and branching in the prefrontal cortex (as well as other cortical
areas), amygdala basal ganglia, and cerebellum. The changes include, but
are not limited to, specific changes in axonal branching, pruning and
myelination. Both histological and molecular gene expression studies will
be needed to define these changes. One key area of interest is to: i)
determine how and when distinct regions of the brain associated with
cognitive processes (e.g. inhibition) and subcortical motivational circuits
become functionally connected, and ii) link key developmental changes in
behavior with these events. These changes could be studied using na ve
animals, or animals treated with specific drugs of abuse.
o Define the relationship between anatomical and behavioral changes with
variations in hormone levels. The interplay between the
hypothalamus/pituitary/adrenal (HPA) axis and the developing brain is of
particular interest. Studies comparing and contrasting gender differences
are encouraged in these and all other studies.
o Identify the effects of environmental, behavioral and contextual
influences on neurodevelopmental processes. In particular, NIDA is
interested in determining if arousal, emotion and stress alter aspects of
neural development that lead to increases in drug abuse or addiction. Such
studies could identify the neurological substrates for drug-seeking
behaviors that affect the central processes of learning, memory, cognition,
and/or motivation.
o Analyze changes in neurogenesis and apoptosis that occur during
adolescence, and identify the behavioral consequences of these changes
(especially those that have implications for drug taking). Determination of
the role of drug use in altering these processes is encouraged, but not
required. Identification of any unique aspects of adolescent neurogenesis
or apoptosis is of particular importance.
o Characterize the neurobiological effects of drug exposure during
adolescence on the development of behaviors, emotions and cognitions that
have been demonstrated to be important for understanding drug abuse and
addiction.
o Compare the behavioral and neurobiological features of drug taking (i.e.,
initiation, maintenance, escalation, extinction, and relapse) in adolescent
and adult animals. One important question is: how do chronic
neuroadaptations of dependence, tolerance and sensitization differ between
adolescent and adult animals? Furthermore, research could determine: i) how
features of drug exposure (e.g., rate, schedules, context, etc.) or drug
history affects the development of escalated drug intake, and ii) if the
course of behavioral changes in vulnerability is different in adolescent and
adult animals. Related and integrated neurobiological substrate questions
could target events at the cellular or molecular level. Those that have been
demonstrated to be significant for important transitions in animal models of
drug abuse behavior with adult animals could be used to verify and compare
their significance in adolescent models of drug abuse.
o Identify critical periods during adolescent brain development for drug
effects on cognitive, emotional or social behaviors. These periods should
be linked to changes in rates of acquisition and continuation of drug
taking. These behavioral changes should be tied to specific neurological
changes during these critical periods.
o Examine the behavioral consequences of neuroadaptations to repeated drug
administration in adolescent animals. Potential questions include: Are
these neuroadapatations and the ensuing behavioral changes different from
those that have been characterized in adults? and What are the types of
neuroadaptations that lead to rapid progression of excessive, uncontrollable
intake? Behavioral changes of interest include those indicating shifting
central motivational processes, and responses to natural rewards,
alterations in species-specific behavioral patterns, narrowing of behavioral
repertoire, and changes in drug responsivity or sensitivity.
Some of the tools available to answer these questions include the
following (these are provided as examples and this list is not intended
to cover the full range of projects of interest):
o Pharmacological tools to probe the neurotransmitter substrates of
behavior, motivation and cognition, as well as to assess drug responsivity
or sensitivity.
o Animal behavioral models of motivation for drug and natural rewards,
(including, but not limited to, i.v. drug self-administration) and
conditioned place preference. Especially encouraged is the use of choice
procedures that provide alternative reinforcers or behaviors, and paradigms
that allow for the development of dynamic behavioral typographies (e.g.,
sensitization, escalation, changing behavioral repertoires, etc.).
o Genetic tools to determine the role of individual gene products in
directing adolescent development and behavior. While this work is perhaps
most obviously performed using mice (i.e., mutants and transgenics), recent
advances such as RNAi should allow researchers using a variety of animal
models to understand the roles of individual gene products in particular
brain regions.
o Approaches and candidates adapted from embryonic and early perinatal
research. Such approaches have defined a variety of candidate molecules that
regulate earlier neural development (e.g. the Wnt, BMP, GDNF, and FGF
ligands). Recent research suggests that these molecules are also likely to
function during adolescence. As such, they are prime candidates to begin to
understand the molecular basis of adolescent brain development.
o Comparative approaches that exploit species-specific differences in life
histories and behavioral development during the adolescent period. For
example, species differences or specialization in social interaction, pair-
bonding and mating, territoriality, aggression, and communication behaviors
may be useful for identifying the neurobiological basis of behaviors that
are relevant for understanding the development of drug abuse and addiction.
MECHANISMS OF SUPPORT
This RFA will use the NIH research project (R01) and the
exploratory/development (R21) award mechanisms
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). 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 this
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 30, 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
budgeting 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 budget format.
Otherwise follow the instructions for non-modular budget 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
NIDA intends to commit approximately $1.5 million in FY 2004 to fund 4-
8 new and/or competitive continuation grants in response to this RFA.
An applicant may request for the R01 a project period of up to 5 years.
For the R21, the project period is 2 years and up to $275,000 in direct
costs for the two-year period. 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 NIDA provide support for this program,
awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious
applications. At this time, it is not known if this RFA will be
reissued.
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 institutions/organizations
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.
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 your questions about scientific/research issues to:
Robert Riddle, Ph.D.
Genetics and Molecular Neurobiology Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4258, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-6300
FAX: (301) 594-6043
Email: riddler@nida.nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gf6s@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 NIDA 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:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document 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: 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 three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes Of Health/DHHS
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 and
all copies of the appendix material must be sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (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 assignments 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 unfounded 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 from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIDA. Incomplete applications will not be
reviewed. If the application is not responsive to the RFA, NIH staff
may contact the applicant 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.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIDA in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
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 written critique
o Receive a second level review by the National Advisory Council on
Drug Abuse
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application's overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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.
(1) 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? Does the study address an important
problem consistent with the goals of this RFA?
(2) 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?
(3) 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?
(4) 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)?
(5) 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following item will be considered in the determination of scientific
merit and the priority score:
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 REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a data sharing plan in their
application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score.
(See
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.)
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: February 17, 2004
Application Receipt Date: March 17, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 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
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $500,000
or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing. Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://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, in the project description and elsewhere in the application as
appropriate, 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
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.
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://grants1.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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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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