RELEASE DATE:  October 31, 2003

RFA Number:  RFA-DA-04-009

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 

National Institute on Drug Abuse (NIDA) 


APPLICATION RECEIPT DATE:        February 20, 2004


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


The National Institute on Drug Abuse (NIDA) invites applications in the area of 
behavioral, cognitive and social cognitive research that have the potential to 
address issues related to drug abuse and addiction during adolescence. The 
objective of this RFA is to stimulate research that has the potential to advance 
our understanding of the causes, consequences, prevention and treatment of 
adolescent drug abuse and addiction.  Research is encouraged that is model-
driven, and either (1) explores and delineates basic processes, particularly 
judgment and decision-making processes, related to drug abuse vulnerability 
during adolescence, or (2) directly studies drug abuse and the effects of drugs 
on particular aspects of adolescent cognitive function, particularly judgment 
and decision-making.  The research does not need to be conducted in drug-abusing 
populations or involve administration of drugs, but investigators must provide a 
clear statement indicating how the proposed research would advance the 
understanding of drug use and addiction in adolescence.  Cognitive science 
research that involves adolescent clinical populations is appropriate under this 
RFA.  The research relevant to this announcement involves human subjects; for 
information about neuroscience research involving adolescent animal studies, 
contact Dr. Robert Riddle, 301-402-3155.



Accumulating evidence raises the concern that adolescence is a period of 
heightened vulnerability to the addictive properties of legal and illegal 
substances.  Epidemiological data collected over the past two decades show that 
adolescents and young adults generally exhibit higher rates of experimental use 
and substance use disorders (SUDs) than older adults and that adult SUDs 
typically have onsets in adolescence or young adulthood.  For example, 
approximately three-fourths of adult tobacco users in the U.S. begin smoking 
between the ages 11 and 17 and 60 percent before age 14.  Fifty percent of 
illicit drug abuse in adults with SUDs begins between the ages of 15 and 18 and 
initiation is rare after the age of 20.  Furthermore, earlier onset of substance 
use predicts greater addiction severity and morbidity.  Moreover, 
epidemiological data indicate that there are both independent and interactive 
effects of gender and age in the prevalence and developmental onset of SUDs.   
Similarly, clinical evidence confirms that adolescence is a period of particular 
vulnerability.  For example, adolescents demonstrate a more precipitous progress 
of illicit drug use than adults; and, despite smoking fewer cigarettes than 
adults, adolescents show higher rates of dependence at similar levels of use.  
More than a third of high school students who have ever tried smoking eventually 
become daily smokers and about 3,000 additional teenagers begin smoking each 
day.  It has been reported that two-thirds of adolescent smokers report 
experiencing withdrawal symptoms during attempts to quit or reduce their 
smoking.  Thus, nicotine effects during adolescence can be critical in 
determining the tenacity of addiction throughout the remainder of life.  

Although many studies have shown that family and sociocultural factors (e.g., 
parental drug use, school engagement, parental concern and monitoring, stress, 
religiosity, peer group deviancy), are associated with drug availability and 
experimentation, these factors alone do not account fully for adolescent drug 
use initiation and progression to addiction.  Indeed, it is reasonable to 
suppose that individual, cognitive, and neurobiological characteristics interact 
with social conditions and experiences in producing trajectories that lead to 
some individuals progressing from experimentation to addiction while others do 
not.  Learning, motivation, judgment and decision-making processes, and their 
underlying neurobiological substrates, for example, are likely to influence 
vulnerability to drug abuse and addiction.  As the epidemiological data suggest, 
some decisions and choices made during the adolescent years can set the stage 
for subsequent SUDs.   

In order to be successful in preventing and treating SUDs, then, it is important 
to understand the mechanisms underlying adolescent judgment, decision-making and 
risk perception.  Recent theorizing, for example, proposes that risk perception 
and decision-making are dependent on two information-processing systems:  i) 
Analytical, normative decision-making is consciously controlled, effortful, 
accessible and deliberate.  This system is rule-governed and flexible.  ii) 
Heuristic decision making, by contrast, is preconscious, rapid, inaccessible and 
effortless:  This latter system relies on an assortment of judgmental 
heuristics.  It is slow to learn and it is sensitive to emotional state.  The 
two systems are interdependent, but contextual variables and age determine which 
will be predominant in a given situation.  

Much of the interest in adolescents’ perception of risk and vulnerability is 
motivated by the desire to understand why youth engage in potentially self-
injurious behaviors, such as drug use.  To date, research in this area indicates 
that adolescents appear to be quite inaccurate in estimating risk.  Studies 
further suggest that adolescents who engage in risky behaviors recognize that 
their behaviors entail risk, but that they may view the risks as less 
significant than do those who do not engage in the risky behavior.  Thus, it is 
important to test hypotheses concerning differential adolescent risk perceptions 
and decision-making processes and to determine how such processes may be 
influenced systematically by cognitive, affective, contextual and/or social 
variables (e.g., peer influence).  Basic findings regarding adolescent judgment 
and decision-making processes may prove useful for developing or tailoring 
existing preventive intervention curricula in order to more effectively teach 
adolescents to recognize and challenge common misconceptions about tobacco, 
alcohol and other drug use.
Moreover, adolescent neurodevelopment involves changes in brain organization and 
function that may predispose to drug abuse and addiction.  Adolescence has been 
characterized neurobiologically as reflecting relatively greater influence of 
excitatory motivational substrates against a background of immature inhibitory 
substrates.  Greater drives for novel experiences and heightened sensation-
seeking, coupled with an immature inhibitory control system, could predispose 
individuals to impulsive actions and risky behaviors, including experimentation 
with and abuse of addictive drugs.  Further, drugs of abuse appear to have 
specific influences on areas mediating inhibitory control and, therefore, drug 
abuse in adolescence may affect normal development of these systems.  Similarly, 
psychiatric illnesses commonly comorbid with SUDs often involve impulse control 
dysfunction putatively reflecting chronically deficient inhibitory and/or 
hyperactive excitatory neural mechanisms.  

Thus, adolescent substance use disorder may reflect, in part, a cognitive 
neurodevelopmental dysfunction.  As such, research (including treatment 
research) targeting adolescents and young adults may benefit all age groups with 
SUDs.  Research is needed to further characterize specific components of 
cognitive, motivational and social cognitive processing underlying adolescent 
neurodevelopment.  In addition, research is needed to explore the influence of 
practices in child and adolescent psychopharmacology on the development of 
motivational neurocircuitry and risk for SUDs.  More research is needed also to 
test the association between impulsivity, decision-making and risk for SUDs 
across clinical contexts and comorbid psychiatric disorders such as obsessive- 
compulsive disorder and attention deficit hyperactivity disorder.  It remains to 
be determined whether adolescent vulnerability to SUDs reflects behavioral or 
cognitive precursors of adult psychiatric symptoms that confer greater risk for 
SUDs and/or represent a greater risk across all adolescent subgroups.  
Longitudinal studies, particularly those employing objective behavioral and 
cognitive measures of impulsivity and decision-making will be of significant 
value in understanding addiction vulnerability across age groups in normative 
and psychiatrically comorbid adolescents.

Conceptual Basis and Rationale:

This RFA underscores NIDA’s appreciation that basic behavioral, cognitive and 
social cognitive methods, models, and approaches should provide new directions 
and innovative ideas for understanding fundamental problems associated with drug 
abuse and addiction vulnerability during the adolescent period.  Research on the 
development and function of processes such as inhibition, emotion, incentive 
motivation, judgment, decision-making, risk-taking, and automated cognition are 
examples of research topics that are relevant for delineating the conditions 
that contribute to the initiation, maintenance and escalation of drug abuse and 
addiction.  It is likely that new and innovative basic research in these and 
other domains will inform and enhance our understanding of drug addiction and 
its underlying substrates.  At the same time, cognitive science research that 
directly studies adolescent drug abuse and related clinical problems, or studies 
the effects of exposure to drugs of abuse on cognitive processes, can continue 
to make important contributions to understanding this complex problem.  

The goal of this RFA, therefore, is to invite research applications in basic 
behavioral, cognitive and social cognitive research relevant to adolescent drug 
abuse and addiction.  Basic research that uses model-driven experimental 
approaches to problems relevant to issues of drug abuse and addiction (examples 
of such problems are listed below) is encouraged.  Such research would 
capitalize on the rapid advances that have been made concerning the functional 
and neurobiological determinants of both simple and complex behavioral/cognitive 
operations.  In the context of this RFA, model-driven research implies the use 
of an experimental approach intended to test the operation of specific processes 
through systematic use of control conditions to rule out alternative 
interpretations.  Applications that employ either functional or neurobiological 
approaches to the study of cognitive processes are appropriate for this RFA.  
Study designs that can test for gender differences and/or make comparisons 
between adolescents and adults are encouraged.  The research does not need to be 
conducted in drug-abusing populations or involve the administration of drugs, 
but it must have the potential to advance the understanding of the behavioral, 
psychosocial, cognitive or neurobiological processes related to adolescent drug 
abuse.  In such cases, applicants should provide a clear statement as to the 
relevance of the research to drug abuse and addiction.

The following are illustrative examples of the basic science topics that are 
relevant to drug use and addiction in adolescence.   These examples are intended 
as a guide and are not meant to subsume or limit the behavioral, cognitive or 
social cognitive research themes that would be appropriate and welcome under 
this RFA.  Nevertheless, it is expected that these topics would be studied in 
adolescent samples:

o Study of modulation of judgment and decision-making by emotion, motivation and 
social context. (This broadly defined research theme is central to nearly all 
aspects of addiction, as well as to issues of comorbidity with other disorders.) 

o Study the developmental changes of normative decision-making and judgment 
heuristics. Determine how these cognitive processes are influenced by context 
(i.e., framing) and experience. (This research could have important implications 
for the design of interventions that optimize thinking and decisions about drug 
use, thereby reducing vulnerability to addiction.)   

o Relate individual differences in reward sensitivity in adolescents to judgment 
and decision-making.  (This is particularly relevant to vulnerability to drug 
abuse and relapse.)

o Study of affective/emotional development during adolescence and its 
interaction with decision-making and risk-taking.  (This is especially relevant 
to the issue of vulnerability to addiction.)

o Development of mathematical or computational models of cognitive processes, 
especially models of judgment.  (Such models, particularly those that 
incorporate modulation by motivational/emotional states/social context are 
relevant and may provide new insights into many aspects of drug abuse and 

o Basic studies of decision-making processes under conditions of risk, social 
context, uncertainty and high motivational states including arousal.  (Risk-
taking and decision-making are relevant to addiction vulnerability, risky sexual 
behavior and medical consequences of drug use such as exposure to HIV.)

o Basic research on top-down and bottom-up control of attention and allocation 
of cognitive resources.  (This research is likely to be relevant to cue-related 
drug craving and its relation to relapse.)

o Study of inhibitory functions, especially with respect to suppression of 
prepotent or conflicting responses, as well as metacognition.  (Such research 
has wide relevance to issues of drug abuse, addiction, and treatment since 
impaired inhibition is important for understanding relapse.)

o Study of cognitive mechanisms that control the transition to and from 
automatic and controlled information processing, from analytical to heuristic 
processing.  (For example, this type of research is directly relevant to 
understanding drug craving, drug abuse relapse, and treatment.) 

o Basic studies of cognitive mechanisms that play a role in the ability to 
monitor and evaluate ongoing cognitive performance.  (This is particularly 
relevant to many issues concerning executive function and self-regulation.)

o Study of age differences in cue-elicited emotional memory, with an emphasis on 
the adolescent period.  (This is particularly relevant to vulnerability and the 
conditions eliciting drug craving and relapse.)  

o Impact of environmental/social stressors and stress responsivity on cognitive 
processes during the adolescent period.  (This is relevant to a number of issues 
in addiction, particularly to vulnerability and the conditions eliciting drug 
craving and relapse.)  
o Studies of the neurobiological substrates of basic cognitive processes that 
might render adolescents vulnerable to drug abuse and addiction or be directly 
affected by drug abuse.  (This has the potential to identify mechanisms of 
adolescent drug abuse.)


This RFA will use the NIH research project (R01), the small grant (R03) and the 
exploratory/development (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 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  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

NIDA intends to commit approximately $1.5 million in FY 2004 to fund 6 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 R03, the project 
period is 2 years and direct costs up to $50,000 for each of those 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 


You may submit (an) application(s) if your institution has any of the following 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, and 
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


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.   


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:

Paul Schnur, Ph.D.
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) 443-1887
FAX: (301) 594-6043

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

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

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:

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


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 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 in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

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 includes step-by-step 
guidance for preparing modular grants.  Additional information on modular grants 
is available at

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:
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:

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 

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignments within 8 
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.  

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


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 
items will be considered in the determination of scientific merit and the 
priority score:  

subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section on 
Federal Citations, below).

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 in the sections on Federal Citations, below).


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

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.


Letter of Intent Receipt Date:    January 20, 2004 
Application Receipt Date:         February 20, 2004
Peer Review Date:                 June/July 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004


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.

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained.

DATA SAFETY AND MONITORING PLAN:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding 
studies (phase I); efficacy studies (phase II); efficacy, effectiveness and 
comparative trials (phase III).  The establishment of data and safety monitoring 
boards (DSMBs) is required for multi-site clinical trials involving 
interventions that entail potential risk to the participants.  (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998:  

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. 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.

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 
a complete copy of the updated Guidelines are available at   
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.

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
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. 

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

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.

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 
( 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

Researchers funded by NIDA who are conducting research in community outreach 
settings, clinical, hospital settings, or clinical laboratories and have ongoing 
contact with clients at risk for HIV infection, are strongly encouraged to 
provide HIV risk reduction education and counseling.  HIV counseling should 
include offering HIV testing available on-site or by referral to other HIV 
testing service for persons at risk for HIV infection including injecting drug 
users, crack cocaine users, and sexually active drug users and their sexual 
partners.  For more information see

Drug Abuse recognizes the importance of research involving the administration of 
drugs to human subjects and has developed guidelines relevant to such research.   
Potential applicants are encouraged to obtain and review these recommendations 
of Council before submitting an application that will administer compounds to 
human subjects.  The guidelines are available on NIDA's Home Page at under the Funding, or may be obtained by calling 
(301) 443-2755.

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at 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

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 

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