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 http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.

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 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
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.

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: 
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
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: 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 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 
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.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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