RELEASE DATE:  April 2, 2003

PA NUMBER:  PA-03-088

March 2, 2006  (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181) 
funding opportunity announcements have been issued for the submission date of 
June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 
activities must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE:  This announcement expires on March 15, 2006, unless re-issued. 

National Institute on Alcohol Abuse and Alcoholism (NIAAA)



o Purpose of the PA 
o Research Objectives 
o Mechanism(s) of Support 
o Eligible Institutions 
o Individuals Eligible to Become Principal Investigators 
o Where to Send Inquiries 
o Submitting an Application 
o Peer Review Process 
o Review Criteria 
o Award Criteria 
o Required Federal Citations 
o References 


The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
research grant applications to develop and assess efficacious behavioral 
and pharmacological treatments for adolescents with alcohol use disorders 
(AUD). NIAAA's adolescent treatment research program has developed rapidly 
since its initiation in 1998. There still remain, however, important 
research issues that need to be addressed. The purpose of this program 
announcement (PA) is to invite applications for adolescent treatment 
research projects that will illuminate and resolve concerns in five areas: 
more effective treatments for adolescent alcohol use disorders (AUD); more 
effective treatments for AUD adolescents with psychiatric comorbidity; 
improved maintenance of recovery through extensive relapse prevention 
interventions; identification of contextual effects on treatment response 
and outcomes; and ways to narrow the gap between efficacy research and 

Three types of research design are encouraged under this PA: (1) pilot 
studies to develop and test research protocols for novel interventions or 
new combinations of existing interventions; (2) randomized clinical trials 
to evaluate the efficacy of either (a) novel interventions or combinations 
of interventions developed in pilot studies or (b) extensions and 
enhancements of existing interventions; and (3) natural history studies to 
assess the impact of understudied influences (e.g., developmental and 
contextual effects) on the long term course of adolescent alcohol use 
disorders and associated problem behaviors.     



Alcohol remains the major drug of choice for America's youth.  Based on 
data collected by SAMHSA's National Household Survey on Drug Abuse (NHSDA) 
in 2001, an estimated 10.1 million youth, ages 12 to 20, had consumed 
alcohol during the previous month.  The NHSDA data further indicate that 
an estimated 6.8 million (19%) of youth these ages had engaged in binge 
drinking and 2.1 million (6%) had engaged in heavy drinking.  Binge 
drinking is defined by the NHSDA as five or more drinks on a single 
occasion within the past 30 days and heavy drinking as five or more binge 
drinking occasions within the past 30 days. Among the nearly 148,000 
adolescents entering substance abuse treatment in 1998, 24% had primary 
alcohol problems and 61% had primary, secondary, or tertiary alcohol 
problems (SAMHSA's Office of Applied Studies' Treatment Episode Data Set 
[TEDS] for 1998) (Stevens & Morral 2002).

Epidemiologic and treatment research on adolescent alcohol problems has 
shown that the earlier the age of alcohol use onset, and the more chronic 
and severe the course of alcohol use, the more likely the manifestation of  
additional concurrent problem behaviors.  These include other drug use, 
antisocial behavioral disorders, other mental health disorders such as 
post traumatic stress syndrome and affective disorders, and social 
dysfunction in school, family, and peer contexts.  These findings indicate 
that the appropriate theoretical matrix for developing efficacious 
treatments for adolescent alcohol use disorders will be a translational 
one that seeks to explain and beneficially influence multiple biological 
and social dimensions that mediate and moderate adolescent health, 
behavior, and social functioning.       

In recognition of the widespread problems associated with adolescent 
alcohol abuse and dependence, and the paucity of effective evidence-based 
interventions to treat them, the NIAAA, in collaboration with SAMHSA's 
Center for Substance Abuse Treatment (CSAT), issued in 1998 a joint 
Request for Applications (RFA) for research on the treatment of adolescent 
alcohol abuse and dependence.  The RFA issued a general call for 
randomized controlled clinical trials to develop and assess 
developmentally appropriate treatments for adolescents with a primary 
diagnosis of alcohol abuse or dependence.  Because the knowledge base was 
so narrow at that time, applicants were encouraged to explore a wide range 
of treatment types and settings, and subtypes of adolescent subjects.  The 
program has succeeded in meeting this goal.  Ten projects have been funded 
that assess the effectiveness of a broad range of therapies (family, 
motivational, cognitive behavioral, and guided self-change) tailored 
specifically for delivery to adolescents with alcohol problems in a 
variety of community settings (schools, homes, clinics, shelters for 
runaways, and juvenile justice systems).  This research grant program will 
be concluded in 2003 with final results available one or two years later. 
In addition, NIAAA is funding an ongoing longitudinal treatment outcome 
study as well as projects to assess the effectiveness of school-based 
substance abuse programs, approaches to adolescent aftercare, brief 
motivational interventions, and three pharmacological trials (fluoxetine 
to treat comorbid depression, buproprion to treat comorbid attention 
deficit hyperactivity disorder, and naltrexone to reduce craving and 
alcohol use).   

Despite this plethora of recent NIAAA adolescent treatment research 
activity, it has become clear that a number of important questions on how 
best to address adolescent treatment needs and how to further improve 
treatment outcomes remain to be answered.  It is the purpose of this PA to 
delineate these current research issues.    

Specific Areas of Interest

Research participants with alcohol use disorders (AUDs) who are recruited 
to projects awarded under this PA may include "diagnostic orphans" 
(Pollack and Martin 1999) in addition to participants who meet DSM IV 
criteria for alcohol abuse or dependence.  Diagnostic orphans meet only 
one or two criteria of alcohol dependence as compared with the three 
criteria required for a diagnosis of alcohol dependence. Diagnostic 
orphans were found by Pollack and Martin to be similar in substance use 
patterns and problems to adolescents with DSM-IV alcohol abuse disorder 
and to have significantly greater substance use and related problems than 
adolescent who were regular drinkers but had no symptoms of alcohol abuse 
or dependence. There is a general expectation that interventions delivered 
to adolescents early in the development of clinically significant alcohol 
problems will be more successful than the same interventions delivered to 
adolescents with more severe and multiple clinical problems.  Diagnostic 
orphans provide an opportunity to assess the validity of this assumption.    

Adolescents recruited into treatment studies may also include those who 
have concurrent drug use and/or psychiatric disorders as long as 
measurement of those conditions and assessment of their relationship to 
the subject's AUD are included in the design.  In such cases, analyses to 
examine differential treatment response of predominant clinical subtypes 
are encouraged (see Babor et al. in Dennis & Babor 2002).  Applicants are 
also encouraged to measure nicotine and marijuana use, using measures 
comparable in nature and detail to the alcohol consumption measures, 
because these are the two most commonly used substances by adolescents 
with primary alcohol disorders.  

Research objectives include, but are not limited to:

1.  Develop More Effective Adolescent Treatment Interventions
Evidence from recently completed clinical trials indicate that treatment 
effects, while showing improvement over earlier studies are still modest 
with respect to long-term outcomes. There is thus a need to continue the 
search for more effective therapies.  This can be achieved, in part, by 
extending and refining promising existing therapies and, in part, by 
identifying and developing new and innovative therapies.  Examples:
- Derive new therapies from promising findings in basic behavioral and 
cognitive research, from interventions found to be effective in changing 
associated problem behaviors, and from theory-driven models in the 
sciences of behavior and human development.
- Develop and test behavioral techniques to improve engagement and 
retention of adolescents in treatment.  Treatment providers consistently 
state that, from their perspective, research that improves retention in 
treatment should be a number one priority.
- Develop and assess techniques to improve adolescent compliance with 
treatment, considered a key determinant of treatment outcomes. 
- Develop and evaluate skills training for adolescents who may benefit 
from training in impulse control, anger management, stress management, or 
problem solving.
- Assess the relative efficacy of AUD interventions for different clinical 
subtypes (see Babor et al. in Dennis & Babor 2002).
- Assess the effects of gender on treatment engagement, response, and 
2.  Develop and Test Treatments for Concurrent Disorders
Adolescents who present for treatment of alcohol abuse and dependence 
include youth who exhibit high levels of psychiatric comorbidity and 
developmental impairment as compared with the general population of 
alcohol-using adolescents.  The next wave of alcohol-focused adolescent 
treatment research needs to identify and develop specific, combined, or 
stepped treatment modalities that are effective in subgroups of 
adolescents who manifest these more severe problem clusters.  This 
subgroup includes adolescents who have concurrent psychiatric comorbidity, 
polydrug use, and/or developmental problems.  Examples of research 
- Design specialized treatments for adolescents with psychiatric disorders 
such as conduct disorder, anxiety, depression, or post-traumatic stress 
disorder (see Clark & Scheid 2002).  In general, pharmacological treatment 
of concurrent disorders is best limited to those adolescents with more 
severe disorders; for example, those who are recalcitrant to behavioral 
interventions or who still manifest symptoms after eight weeks of 
abstinence (ibid.), who experienced onset of symptoms prior to or 
concurrent with AUD onset, or those who have a history of previous 
treatment for the comorbid condition(s).   
- Develop and evaluate treatment components to assess and treat 
developmental problems such as deficits in cognitive or social 
- Design a clinical trial to determine the optimal combination and 
sequencing of behavioral and pharmacological interventions that target 
particular constellations of co-occurring disorders and problem behaviors.  
- Determine the impact of therapies for concurrent disorders in AUD 
adolescents on the developmental trajectory of alcohol and other 
associated behavior problems.
- Identify patterns of gender-based comorbidity and assess the effects of 
gender on treatment engagement, response, and outcomes.  

3.  Develop Interventions for Adolescents Comorbid for Alcohol or Drug 
Disorders and Fetal Alcohol Syndrome (FAS) or Alcohol Related 
Neurodevelopmental Disorder (ARND) Research has demonstrated that in utero 
exposure to maternal alcohol consumption may lead to lifelong impairment 
from FAS or from the more subtle impairments of alcohol related 
neurodevelopmental disorder (ARND).  The organic damage caused by maternal 
drinking is expressed by a range of disabilities.  In adolescence, alcohol 
related effects may be manifested as specific types of learning 
disabilities, impulsive behavior, poor executive functioning, deficits in 
social and communication skills, emotional instability, and psychiatric 
disorders. Fetal alcohol exposure is a risk factor for later development 
of adolescent alcohol disorders as shown in longitudinal follow-ups (e.g., 
Baer et al. 1998). The multiple disabilities of these adolescents may 
complicate treatment and worsen prognosis.  Thus, there is an important 
need for research to determine if specialized interventions are needed to 
increase the likelihood of successful substance abuse treatment outcomes.  
Examples of relevant research include:
- Develop methodology and procedures to screen and identify adolescents in 
the community or in substance abuse treatment settings who may have FAS or 
ARND and who require treatment for substance abuse problems.
- Design and test interventions for adolescents with confirmed 
developmental impairments related to fetal alcohol exposure who need 
treatment for alcohol or other substance abuse problems.

4.  Maintain Recovery Through Relapse Prevention Interventions
Although initiation of abstinence in treatment is common among 
adolescents, sobriety is frequently challenged as soon as they return to 
the pre-treatment environment.  Some adolescent treatment outcome studies 
report that as many as 70 percent of adolescents may still have 
significant substance abuse problems at 12 months after treatment. Thus, 
there appears to be a need to develop long-term programs that integrate 
developmentally appropriate primary and aftercare interventions and, when 
feasible, provide recovering adolescents with prosocial alternatives in 
the post-treatment environment.  See, for example, the assertive 
continuing care model and adolescent community reinforcement approach 
developed and assessed by Godley et al. (2002).  Other examples:  
- For more severely affected AUD adolescents, develop and assess the 
efficacy of long-term care models of relapse prevention that integrate 
theoretically consistent primary treatment and aftercare components.
- Develop and test the efficacy of behavioral aftercare interventions 
tailored to the range of challenges faced by adolescents in recovery; for 
example, compare reinforcement of coping responses that target specific 
types of challenges versus more generalizable coping responses.
- Compare the efficacy of two types of aftercare: (1) guided self-
maintenance and relapse prevention via mail, web site, or computerized 
telephone versus (2) a periodic therapist-delivered interactive aftercare 
intervention, by phone or in person. 
- Design and test environmental aftercare interventions that stimulate 
positive lifestyle change and integrate the adolescent in a prosocial 
community network; for example, test the efficacy of contingency 
management strategies to engage youth in prosocial activities (Godley et 
al. 2002).
- Assess the differential response of three subtypes of AUD adolescents 
(alcohol abusers, alcohol dependent, and diagnostic orphans) to relapse 
prevention interventions of varying types and intensities.
- Develop and evaluate a continuing care, school-based intervention 
program for adolescents with alcohol and drug abuse disorders in the 
maintenance and recovery phases.

5.  Identify Contextual Effects on Treatment Response and Outcomes
There are many factors, independent of treatment, in adolescents' 
environments that can influence their engagement in treatment and its 
long-term effectiveness.  As a research subject, contextual effects 
represent a largely untapped area of potential salient factors that may 
shape adolescent treatment outcomes and post-treatment functioning.  
Constructs such as "neighborhood," "social network," and "social support" 
are well developed and productive research subjects but ones which have 
not yet been applied to treatment of adolescents with alcohol problems.  
Social context factors which are known to predict the future emergence of 
substance abuse problems (e.g., Gil, Vega & Turner 2002) may also serve to 
reinforce alcohol abuse and associated problems when they occur in a post-
treatment environment. Because the post-treatment social environment of 
adolescents can continue to have profound influences on their behavior, it 
will be important to identify those contextual factors which have the 
greatest impact on adolescent treatment outcomes, and ultimately to design 
interventions to positively moderate or mediate these environmental 
influences.   Because much of the research to identify and modify 
contextual effects will be exploratory, most projects will need to be 
designed as pilot studies.  Examples of studies on contextual effects:  
- Identify which, if any, familial attitudes and behaviors and adolescent 
school and delinquency behaviors are associated with successful treatment 
outcomes and whether baseline values for any of these social contextual 
effects improve in response to treatment. See Gil et al. (2002) for 
examples of measures.   
- Develop a treatment intervention designed to reduce the influence of 
social context factors that have strong negative effects on adolescent 
behavior in recovery.  
- Identify social and cultural factors that influence motivation for 
treatment, adherence to treatment, and treatment outcomes. Develop 
interventions that are culturally convergent with such factors and 
determine whether such interventions are more efficacious.
- Develop and test in a pilot study a treatment intervention or adjunct 
designed to augment or enhance hypothesized beneficial sociocultural 
mediators or moderators of treatment outcome.
6.  Enhance Transport of Efficacy Research From Science to Service
Research-based treatments for alcohol abuse and alcoholism have not been 
widely adopted by practitioners.  The very nature of efficacy research, 
based on establishing the internal validity of a particular intervention 
under highly controlled conditions, is such that it often can not be 
directly applied to practice.  The best example of this is the restriction 
of most AUD research to individually-delivered treatments and avoidance of 
the group milieu, in part, because of the uncontrolled influences on 
outcomes that may be introduced by group-level influences.  In practice, 
however, group treatment is one of the major types of substance abuse 
treatment provided, both for therapeutic and cost reasons. There are 
several steps that efficacy researchers can take to make research results 
more immediately intelligible and possibly transportable to practice:
- Develop efficacy studies that compare outcomes of individualized 
evidence-based treatment, such as motivational enhancement therapy (MET), 
with outcomes of treatment based on the translation of MET principles into 
a group format that is developmentally appropriate for adolescents (Foote 
et al.1999; O'Leary et al.2002; Walters, Ogle & Martin 2002).  Take into 
account in the design the potential for an iatrogenic effect of certain 
types of adolescent groups (see Brown and O'Leary in O'Leary et al.2002 
and Poulin, Dishion and Burraston 2001).  
- Design and evaluate efficacy studies to extend knowledge on adolescent 
treatment interventions already adopted by practice.  For example, develop 
a randomized controlled clinical trial to test the efficacy in a primary 
AUD population of: (1) one of the five interventions developed and 
assessed in the CSAT-funded Cannabis Youth Treatment study (CYT) (Dennis & 
Babor 2002) or (2) one of ten exemplary substance abuse treatment models 
identified in a CSAT-funded National Evaluation Study (Stevens & Morral 2002).  
- Develop and evaluate specialized treatment components (for example, 
treatment of depression co-occurring with AUD) that can be more easily 
adopted as adjuncts to treatment-as-usual than can new total treatments 
offered in place of existing ones.
- Identify and operationalize the active ingredients of treatment for the 
different phases of adolescent treatment.  Develop and test transportable 
modules designed to enhance specific active ingredients of treatment 
(e.g., a module to enhance the therapeutic alliance in early treatment as 
a means to increase treatment engagement and retention). 
- Add to the assessment battery alcohol and drug questions from assessment 
instruments familiar to practitioners in order to compare data from 
research and practice settings on drinking behavior at baseline, 6 and 12 
months after treatment.  Examples of two widely used instruments in 
practice are the Global Appraisal of Individual Needs (GAIN) (Dennis 1999) 
and the Teen Addiction Severity Index (the T-ASI; Kaminer 1999).   

For efficacy investigators seeking sources of patients and services 
funding, collaborative opportunities for coordinated NIAAA/CSAT funding 
are available under several SAMHSA/CSAT initiatives such as the Adolescent 
Residential Treatment Program (ART) and the Effective Adolescent Treatment 
Program (EAT).  Further information is  available from the CSAT program 
officer, Randy Muck ( or 301-443-6574).


This PA will use the NIH research project grant (R01) small grant (R03) 
and Exploratory/developmental grant (R21) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.

Applications for R01s may request support for up to 5 years.  Facilities 
and Administrative (F&A) costs will be awarded based on the negotiated 
rate at the time of the award.  

Under the NIAAA Small Grant mechanism (R03) applicants may request either 
$25,000 or $50,000 in direct costs per year for up to two years. These 
awards are not renewable; however, a no-cost extension of up to one year 
may be granted to the grantee institution prior to expiration of the 
project period. Before completion of the R03, investigators are encouraged 
to seek continuing support for research through a research project grant 
(R01). (See Program Announcement PAR-99-098, "NIAAA Small Grant Program,",
for a complete description of the R03 mechanism.) 

NIAAA Exploratory/developmental grants (R21) are limited to 3 years for up 
to $100,000/year for direct costs. (See Program Announcement PA-99-131, 
"NIAAA Exploratory/Developmental Grant Program,",
for a complete description of the R21 mechanism.)

Exploratory/Developmental Grants and Small Grants cannot be renewed: 
however, a no-cost extension of up to one year may be granted prior to 
expiration of the project period.  Investigators are encouraged to seek 
continued support after completing an Exploratory/Developmental Grant 
project or a Small Grant project through a Research Project Grant (R01).

This PA uses just-in-time concepts.  It also uses the modular 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 format.  Otherwise follow the 
instructions for non-modular research grant applications.


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
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 your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Cherry Lowman, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003
For express mail use:
Rockville, MD 20852)
Telephone: (301) 443-0637
Fax: (301) 443-8774

o Direct your questions about financial or grants management matters to:

Judy Fox (formerly Simons)
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003
(For express mail use:
Rockville, MD 20852)
Telephone: (301) 443-2434


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at  
Application deadlines are also indicated in the PHS 398 application kit.

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

YEAR: Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIAAA staff member who 
has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following 

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this policy 
is available in the NIH Guide for Grants and Contracts, October 19, 2001 at

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original 
of the application, including the checklist, and five 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)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant 
withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This 
does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

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


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for 
scientific and technical merit.  

As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to 
have the highest scientific merit, generally the top half of applications 
under review, will be discussed and assigned a priority score
o Receive a second level review by  the National Institute on Alcohol 
Abuse and Alcoholism National Advisory Council.


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 

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.

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?

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?

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?

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)?

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 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS: The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

INCLUSION: The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate 
for the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

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


Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


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:  

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 
a complete copy of the updated Guidelines are available at http://
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.

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 . 

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

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.

The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The Privacy 
Rule is a federal regulation under the Health Insurance Portability and 
Accountability Act (HIPAA) of 1996 that governs the protection of 
individually identifiable health information, and is administered and 
enforced by the DHHS Office for Civil Rights (OCR). Those who must comply 
with the Privacy Rule (classified under the Rule as "covered entities") 
must do so by April 14, 2003  (with the exception of small health plans 
which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
( 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 
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Motivational Interviewing: Preparing People for Change, 2nd edition, New 
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