THE IMPACT OF CHILD PSYCHOPATHOLOGY AND CHILDHOOD INTERVENTIONS ON SUBSEQUENT
DRUG ABUSE
RELEASE DATE: October 15, 2002
RFA: DA-03-007
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
LETTER OF INTENT RECEIPT DATE: November 22, 2002
APPLICATION RECEIPT DATE: December 23, 2002
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
This RFA by the National Institute on Drug Abuse (NIDA) and the National
Institute of Mental Health (NIMH) solicits research applications to study:
1) the relationship between psychopathologic and behavioral conditions in
childhood and the risk for later drug use disorders, and 2) the impact of
childhood mental health interventions on modifying the risk for later drug
use disorders.
Although a growing body of research has demonstrated associations between
certain psychiatric conditions and substance use disorders (SUDs), the
following important questions remain to be addressed: 1) Which children are
at greater risk for SUD by virtue of their conditions? 2) What shared or
unique characteristics or contextual factors constitute the risk for
psychopathology and SUD? 3) Are there effective interventions for such
conditions or service delivery changes that can prevent or reduce the risk
for later SUD? 4) Do some interventions unintentionally increase
vulnerability to later SUD? 5) How do findings regarding interventions and
outcomes alter understanding of the etiologic processes of drug abuse?
The goal of this announcement is to stimulate both new studies and the
addition of drug abuse-related measures to ongoing studies to address the
above questions. The ultimate purpose of this work is to provide knowledge
that will inform and improve preventive and health services interventions
with populations at high risk for SUDs.
RESEARCH OBJECTIVES
Background
Cross-sectional studies of adolescents and adults in both clinical and
general populations have found high rates of co-occurrence between SUDs and
psychiatric disorders, particularly the conduct/antisocial disorders and the
mood disorders. Far fewer longitudinal studies have examined the temporal
order or causal relationships, including potentially common pathways, for
specific psychiatric disorders and SUDs. Thus, the nature of the
relationships among psychiatric and drug use disorders is unclear,
particularly given that some drugs have disinhibiting and depressive effects
that can mimic or unmask psychiatric disorders. Even when a psychiatric
disorder is shown to predate an SUD, a causal relationship is not
automatically established nor should it be assumed: the childhood psychiatric
condition could be a marker of risk due to common risk factors. Research is
needed to clarify common (shared) and unique risk and protective factors and
pathways for psychopathology and SUDs and to understand how these factors
contribute to adverse outcomes through childhood and adolescence.
Because of limited current knowledge about the relationships between
psychiatric and substance use disorders and their onsets, there is little
data on whether interventions for childhood psychiatric disorders can alter
initiation of drug use or SUD trajectories. Thus, understanding the
relationships between precursor disorders, characteristics, and conditions
and SUD outcomes has important prevention and treatment implications. It is
known that individuals in the general population differ in level of risk for
substance use and SUD. Identifying those at risk, and the nature of the
risk, can facilitate development of prevention interventions targeted to
specific risk groups. Once comorbid psychiatric and substance use disorders
have developed, understanding the relationship between the disorders can also
be used to develop more specific intervention strategies for various
subgroups at risk for relapse of both disorders. Research is needed to
develop interventions that are sensitive to shared risk factors and that may
be capable of reducing multiple adverse outcomes.
Studies are needed to address questions such as the following:
o Which childhood psychiatric and behavioral conditions render individuals at
greater risk for SUD? Research has identified relationships between a number
of mental health disorders and SUD. One of the strongest relationships to
emerge thus far is that between childhood conduct disorder and adolescent
SUD. Data are mixed or lacking for other major disorders, including
attention deficit hyperactivity disorder, depression, bipolar disorder,
anxiety disorders, and eating disorders. It appears likely that some
subgroups of children with these disorders are at increased risk, but the
degree of risk, and moderating factors, are not known at this time. Further
research is needed to better understand the relationships between different
forms of psychopathology and later SUD and to clarify their temporal and
potentially causal nature.
o How do childhood disorders or conditions render individuals vulnerable to
later drug use problems and disorders? What aspects of the disorder
contribute to risk? Even when a childhood condition is shown to constitute a
risk factor for SUD, we need to understand how the condition affects
vulnerability, which in turn has important implications for intervention.
Many individual, developmental, familial, social, and environmental factors
may interact so that multiple pathways can lead to similar SUD outcomes. On
an individual level, research is needed to look beyond symptoms and consider
features and subthreshold constellations that may characterize vulnerable
subgroups and underlie risks common to several disorders. This type of
inquiry can identify targets for intervention. Examples of such explanatory
features include executive cognitive dysfunction, affect dysregulation,
difficult temperament, and social skills deficits. Some underlying features
may have a psychophysiological substrate that merits study. Another
individual attribute, gender, can interact with psychopathology to alter
risk; for example, certain disorders less prevalent in one gender appear to
confer increased risk for SUD (e.g., conduct disorder in girls, the so-called
gender paradox). Given gender differences in rates of childhood behavioral
conditions and traumatic experiences, and in responses to family functioning,
applicants are encouraged to evaluate gender differences in the association
and interaction between these circumstances, psychopathology, and subsequent
drug use patterns. Furthermore, psychopathologic conditions need to be
considered in their developmental context, with attention to the interplay
between individual and environmental characteristics and transactional
course. Drug use itself can be considered as a developmental influence on
the life-course trajectory, and not simply as an adverse outcome; for
example, research has shown associations between substance use in adolescence
and reduced autonomy, positive action, and competence in young adulthood.
o What role do family factors play in child psychopathology and subsequent
SUD? Family history of SUD is a powerful predictor of SUD outcomes in
offspring. Characteristics of the family and the family environment that may
be associated with the child's psychopathology and SUD include genetic
mechanisms, parental SUD, and parental psychopathology, and the interaction
of these. Parental and parenting behavior such as extreme conflict,
violence, divorce, and physical or sexual abuse or neglect may influence the
child's risk for SUD. Some of these factors can affect access to or
effectiveness of treatment and preventive interventions. Research is needed
to determine the causal, mediating, and moderating nature of relationships
between family factors, child psychopathology, and substance use disorders.
Stressful environments and traumatic events may also increase risk for
vulnerable individuals, and socioeconomic status and ethnicity may have
moderating effects on risk. When these types of familial and environmental
variables are ignored, there is a risk of attributing later SUD simply to the
presenting psychopathology, when the childhood condition actually represents
a marker or mediator for other risk factors. Thus, this area of research
lends itself to multilevel conceptualization and analysis.
o Are there effective interventions for childhood psychiatric and subclinical
conditions that can prevent or reduce the risk for later SUD? For example,
does early mental health treatment reduce the risk for later SUD? Several
effective behavioral, pharmacologic, parent and family interventions for a
variety of disorders merit consideration for a possible preventative role.
Furthermore, it may be possible to modify some established childhood
treatments specifically to prevent later SUD.
o Do some interventions unintentionally increase vulnerability to later SUD?
For example, while some studies on treating childhood ADHD indicate that
stimulant medication may reduce risk for later SUD, others raise doubts about
this. Other studies have found that interventions that aggregate conduct
disordered adolescents may engender more conduct problems, including
substance use. Further research is needed on possible iatrogenic effects of
interventions for child psychopathology.
o How do findings regarding interventions and outcomes alter etiologic models
of SUD? It is hoped that research resulting from this announcement will help
inform preventive interventions, so that they can be refined and targeted to
specific risk groups. However, reciprocal research is also strongly
encouraged: that is, findings from preventive interventions should be used to
validate or question etiologic models and help distinguish risk markers from
causal risk factors. For example, if an effective intervention for a known
precursor disorder is delivered and SUD outcomes are not reduced, this may
suggest that that childhood psychiatric disorder is not part of the causal
chain for SUD or that the aspect of the disorder addressed by the
intervention is not critically linked to SUD.
In May of 2000, NIDA, in conjunction with NIMH, held a meeting on Assessing
the Impact of Childhood Interventions on Subsequent Drug Abuse. Experts
discussed basic background information for embarking on this area of
research, exemplar approaches, methodological challenges, and ethical and
logistical issues. Written materials from this meeting are available at
http://www.drugabuse.gov/Meetings/Childhood/, which may be helpful in
preparing applications in response to this announcement. Researchers who
have not previously undertaken drug abuse research, as well as experienced
drug abuse researchers, are encouraged to apply, and consultation with NIDA
and NIMH staff is very welcomed.
Applicants are urged to consider a number of methodological challenges in
this area of research, including the choice of precursor and outcome
variables, instruments, and informants; sampling biases; gender differences;
the validity of self report and reporting bias; and inclusion of key
variables, particularly family history of SUD and of psychiatric disorder.
Consonant with the research literature, it is helpful to distinguish
substance use initiation and lower levels of use from higher levels of use
and the SUDs throughout the study (background, hypotheses, measures,
analyses, reporting). Depending on the proposed study approach, careful
consideration needs to be given to power analyses, particularly for low
prevalence disorders or conditions, and for interactions between variables,
e.g. gender and psychopathology. Both categorical and dimensional approaches
to psychopathology are encouraged; while a particular disorder may constitute
a clear risk factor (categorical approach), sometimes it is the severity of
impairment associated with disorder, rather than simple presence of a
disorder, that is associated with increased risk for SUD (dimensional
approach).
Possible approaches
Examples of research approaches responsive to this program announcement
include, but are not limited to, the following:
o The addition of appropriate precursor or outcome measures to ongoing
longitudinal studies, including genetic epidemiologic studies, using
community-based or clinical samples, to illuminate the temporal ordering and
nature of the relationships between child psychopathologic conditions and SUD
o Secondary data analyses and meta-analyses of existing longitudinal data
sets that include child psychopathologic and SUD data, to explore temporal
and etiologic relationships among the disorders
o Follow up and recapture studies of mental health treatment and prevention
samples, to study whether childhood interventions targeted at psychiatric and
behavioral disorders and their symptoms altered drug abuse and other
behavioral outcomes in adolescence
o Studies of electrophysiologic or other biobehavior markers of potential
vulnerability to both child psychopathologic or subdiagnostic conditions and
SUD, to better identify high risk children and possible foci for intervention
o Addition and evaluation of an SUD assessment or prevention component to
current clinical and prevention trials of interventions addressing child or
adolescent psychiatric disorders
o Studies of possible iatrogenic adverse effects as well as positive or
protective effects of childhood interventions on subsequent SUD and other
behavioral and developmental outcomes
o Research that uses data from intervention studies to propose and test
etiologic models for adolescent SUD and other outcomes in adolescence,
incorporating childhood psychopathology precursors
MECHANISMS OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research project
(R01), small grant (R03) and the exploratory/developmental (R21) award
mechanisms. 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 July 2003.
The total project period for an R01 application submitted in response to this
RFA may not exceed 5 years. For R21 applications, the project period cannot
exceed 3 years and $100,000 in direct costs in each of those years. For R03
applications, the project period cannot exceed 2 years and $50,000 in direct
costs in each of those years, and the application research plan (items a-d)
cannot exceed 10 pages.
This RFA uses just-in-time concepts. It also uses the modular budgeting
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format.
FUNDS AVAILABLE
NIDA intends to commit approximately $2.0 million in FY 2003 to fund 8 to 10
new and/or competitive continuation grants in response to this RFA. NIMH
intends to commit approximately $1.0 million in FY 2003 to fund 4 to 5 new
and/or competitive continuation grants in response to this RFA. 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 and NIMH 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 (Foreign applicants are not eligible for the small
grant (R03) mechanism)
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 inquiries regarding scientific/research issues to:
Naimah Weinberg, M.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-6637
Fax: (301) 443-2636
Email: nw46w@nih.gov
Farris Tuma, Sc.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 5197, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-5944
Fax: (301) 480-4415
Email: ftuma@nih.gov
o Direct your questions about peer review matters to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
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.
Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, Maryland 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6849
E-mail: gfleming@mail.nih.gov
Brian Albertini
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-0004
FAX: (301) 443-6885
Email: albertinib2@mail.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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
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). 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.
It is expected that most of the applications responding to this announcement
will fall under the modular grant format.
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:
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 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:
Director
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by 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.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDA and NIMH.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by NIDA or NIMH in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Drug
Abuse and/or the National Advisory Mental Health Council.
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? 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:
o PROTECTIONS: The adequacy of the proposed protection for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 22, 2002
Application Receipt Date: December 23, 2002
Peer Review Date: February/March 2003
Council Review: May 2003
Earliest Anticipated Start Date: July 2003
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
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
"NIH 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.
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
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.279 (NIDA) and 93.242 (NIMH) 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.