BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM

RELEASE DATE:  February 3, 2003

PA NUMBER: PA-03-066

EXPIRATION DATE:  February 28, 2006, unless reissued.

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTNACE NUMBER:  93.279 and 93.273

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms 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

PURPOSE

The National Institute on Drug Abuse (NIDA) and the National Institute on 
Alcohol Abuse and Alcoholism (NIAAA) are seeking research grant applications 
on the development of behavioral treatments for drug and alcohol abuse and 
dependence.  This program announcement (PA) reaffirms NIDA's and NIAAA's 
continued and ongoing commitment to major programs of research on behavioral 
therapies.  The term "behavioral therapies" is used here in a broad sense and 
includes various forms of psychotherapy, behavior therapy, cognitive therapy, 
family therapy, couples and marital therapy, group therapy, skills training, 
counseling, and other rehabilitative therapies.  Behavioral therapy research 
has been conceptualized, for the purposes of this initiative, to consist of 
three stages.  Stage I, or early therapy development, involves research on 
the development, refinement, and pilot testing of behavioral interventions.  
Stage I includes research on the translation of basic behavioral, cognitive, 
and neuroscience research into novel behavioral therapies.  Stage II involves 
the efficacy testing of therapies that show promise.   Stage III is research 
aimed at determining if and how efficacious behavioral therapies may be 
transported to community settings, including primary care sites.  Stage III 
includes research examining methods of training therapists and counselors to 
administer new behavioral therapies.  All three stages may focus not just on 
the development of efficacious treatments themselves, but also on how and why 
behavioral treatments work. This program announcement replaces in its 
entirety PA-99-107, Behavioral Therapies Development Program, published in 
the NIH Guide, Vol. 22, No. 26, May 25, 1999 at 
http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html.

Applicants interested in the organization, management, and economics of drug 
abuse treatment services, and the effects of these factors on the quality, 
cost, access to, effectiveness, and outcomes of care for drug abuse and 
addictive disorders are referred to the program announcement "Drug Abuse 
Health Services Research"
http://grants.nih.gov/grants/guide/pa-files/PA-01-097.html.

RESEARCH OBJECTIVES

Background and Rationale.  Behavioral therapies are frequently the only 
treatments available to drug-dependent individuals.  Even where medications 
are available, behavioral therapies can be an integral component of 
treatment, and may enhance adherence to medications.  In addition, behavioral 
treatments may be an important alternative for those unable to take 
medication. 

Recognizing the importance of behavioral therapies, NIDA has been supporting 
research in this area through the Behavioral Therapies Development Program 
(BTDP).  The BTDP is intended to promote all of the necessary stages of 
behavioral therapy research so that new and more efficacious behavioral 
therapies are developed as advancements in basic science  (e.g., cognitive 
neuroscience, affective neuroscience and behavioral science) are made, and so 
that efficacious behavioral therapies may be effectively transported to the 
community treatment provider.  It is NIDA's intention to support 
scientifically-sound and clinically-relevant behavioral treatment research 
that will have a meaningful impact on improving the efficacy of drug 
abuse/dependence treatment. 

Research indicates that many behavioral therapies for drug abuse and 
dependence are efficacious. However, no therapy has been shown to be 
completely efficacious for every individual.  For many individuals, 
engagement and retention in treatment and relapse during and following 
treatment remain concerns.  NIDA has undertaken the Behavioral Therapies 
Development Program with the goal of addressing these concerns and 
substantially improving, for each individual, the efficacy of behavioral 
therapies for drug abuse and dependence.

For alcohol abuse and dependence, most of the treatments available in the 
U.S. also have been behavioral in nature. A large number of clinical trials 
conducted over the past 15 years have demonstrated effectiveness for several 
types of behavioral therapies, including cognitive behavioral therapy, 
motivational enhancement therapy, marital family therapy, brief 
interventions, and the community reinforcement approach.

Although progress has been made in a broad range of behavioral interventions 
to treat alcohol abuse and dependence, many alcoholics do not respond 
adequately to currently available behavioral therapies. The purpose of this 
PA is to develop new innovative behavioral therapies or modify existing 
treatments to improve their effectiveness and devise ways to improve the 
engagement, retention, adherence, and outcome of alcoholism treatment across 
various populations of alcohol dependent and abuse subjects. 

NIDA's Behavioral Therapies Development Program delineates three stages of 
behavioral treatment research.  Stage I, the earliest stage of behavioral 
therapy development research, is viewed as an iterative process involving:  
(1) identifying promising clinical, behavioral, affective and cognitive 
scientific findings relevant to behavioral treatment; (2) generating and 
formulating new behavioral treatments or modifying existing treatments; (3) 
operationally defining and standardizing principles and techniques of the 
therapies in manuals; and (4) pilot testing and refining the therapies.  
Stage I also involves testing the theory and/or hypotheses upon which the new 
or modified treatment is based to gain knowledge about moderators, mediators, 
and mechanisms of behavior change.

Stage II research consists of efficacy testing of promising therapies 
identified in Stage I.  Stage II may also involve studies examining the 
components of therapies, studies of the mechanism of action of efficacious 
therapies, studies examining the dose-response of therapies, and studies 
examining individual differences in response to the therapies.  Stage II also 
involves the replication, at other sites, of efficacy studies with positive 
results.

Stage III research is aimed at understanding if and how an efficacious 
therapy may be transported to the community. One question relevant to Stage 
III research is the degree to which a therapy maintains its potency when it 
is administered within community-based treatment programs.  Another question 
relevant to Stage III research is the question of how therapists and
counselors can be trained to administer a new therapy effectively.  Thus, 
Stage III research may involve developing training procedures and techniques 
to help teach therapists and counselors how to utilize new therapies, and 
testing the utility of these procedures and techniques.  In sum, Stage III 
research involves highly controlled research on behavioral treatments in 
community settings, such as randomized clinical trials of efficacious 
treatments, research on how to train therapists to make a treatment able to 
work in the community, and the examination of the mechanism of action of 
treatments and/or training procedures.  Although Stage III involves studying 
the efficacy of behavioral treatments in community settings and how to train 
community therapists to administer efficacious behavioral treatments, 
research on the development or modification of a therapy for use in a 
community setting is considered to be Stage I research. 

It is NIDA's and NIAAA's objective to ensure sufficient emphasis and support 
for all stages of behavioral therapy research, so that scientific knowledge 
can readily be incorporated into newer and more efficacious behavioral 
interventions, and so that therapies can be effectively transported from 
research to the community.  This PA is intended to promote this objective by 
encouraging research grant applications in any one of the three stages of 
behavioral therapy research.

SPECIFIC AREAS OF INTEREST

This PA is intended to support all types of research on behavioral therapies 
for drug and alcohol abuse and addiction.  This includes, but is not limited 
to, behavioral therapy research on:

o Therapies to treat abuse or addiction to understudied drugs including, but 
not limited to, marijuana, methamphetamine, MDMA and other club drugs, 
sedative-hypnotics, prescription drugs, inhalants, and hallucinogens, 
appetite suppressants and other supplements promoted for weight loss or 
physical enhancement, as well as more commonly studied drugs including, but 
not limited to, heroin, cocaine, and nicotine.

o Therapies for smoking cessation, including therapies specifically for youth 
and young adults, that can be utilized alone or in conjunction with nicotine 
replacement therapies and/or medications.

o New and innovative therapies to treat drug and/or alcohol use disorder that 
can be based on promising findings from basic behavioral and cognitive 
research, interventions found effective in changing other problematic 
behaviors, and theory-driven models of behavioral sciences.

o Therapies to treat patients with a comorbid drug abuse and/or alcohol use 
disorders.

o Therapeutic interventions that can be added to enhance an existing 
behavioral therapy.

o Active components/mechanism(s) of action of behavioral therapies.

o Identify and evaluate factors that mediate or moderate treatment efficacy.

o Therapies to be utilized in conjunction with medications, to optimize the 
efficacy of drug/alcohol addiction treatment.  Optimal combinations and 
sequencing of behavioral and pharmacological treatments need to be 
established. 

o Behavioral interventions to increase compliance with medication regimens.

o Therapies to enhance the engagement and retention of patients in treatment.

o Therapies that manage precipitants of relapse. Relapse to drinking or drug 
use is common after treatment. Patients have identified multiple precipitants 
of relapse including stress, social pressure, insomnia, anger, depression, 
anxiety, and environmental cues associated with prior drinking or substance 
use experiences. Behavioral techniques to enable patients to manage these 
precipitants without resorting to drinking or drug use are needed. 

o Therapies for after-care or long-term treatment of drug and alcohol abuse 
and dependence. 

o Behavioral therapies in group settings. Group therapies are the most 
commonly used approach in the treatment of alcohol and drug abuse and 
dependence. Research has been limited in this area, particularly on how group 
therapy compares with individual counseling. Behavioral dynamics and modeling 
of group sessions and evaluation of its effectiveness with subtypes of 
alcoholics or drug addicts in diverse treatment settings need to be 
investigated. Research from social psychology would be informative for 
studying group therapy. 

o HIV and other infectious disease risk-reduction interventions that can be 
implemented in conjunction with other therapeutic interventions.

o Therapies for individuals with co-occurring drug or alcohol abuse and 
dependence and mental or other health disorders, including HIV/AIDS and 
hepatitis.

o Therapies that address the unique needs and perspectives of women, 
minorities, families, couples, specific cultural groups, children, early or 
pre-adolescents, adolescents, the elderly, and persons with disabilities, 
such as the deaf.

o Therapies for use in primary care, criminal and juvenile justice, welfare 
system, workplace settings, and for health care professionals.

o Outreach therapies to out-of-treatment drug users to enhance their 
motivation and facilitate their entry and retention in treatment, including 
outreach approaches in primary care settings.

o Adequate "dosage" of specific types of behavioral therapies for particular 
individuals and determination of minimally effective "dosages".

o Treatments administered or assisted by technological devices and software 
applications such as computers, the Internet, expert systems models, 
telephone, pagers, or hand-held computers. 

o Alternative or complementary interventions as sole treatments or as 
adjunctive strategies to enhance the therapeutic potency of existing drug and 
alcohol abuse treatments.

Stage I, Stage II, and Stage III grant applications are encouraged in these 
and other areas of behavioral therapy research for drug and alcohol abuse and 
addiction.  Applicants are encouraged to include, and if necessary develop, 
measures of mediators of behavior change and mechanism of action of 
behavioral interventions in all three Stages.  If this is not appropriate for 
a particular application, applicants are encouraged to address and justify 
why this will not be done.  Additional information regarding Stages I, II, 
and III is provided below.

Stage I Research.  
Investigators are encouraged to submit applications to develop new or to 
modify existing individual, group or family behavioral therapies for drug and 
alcohol abuse or dependence, and to pre- or pilot-test the therapies.  
Applications are encouraged to develop therapies that have a strong 
theoretical basis or logical rationale and are based on new developments in 
the behavioral and/or cognitive sciences. Applications based on modifications 
of existing efficacious treatments for use in other populations, cultures, or 
settings, especially for groups and settings for which few efficacious 
treatments exist, are encouraged.  Modifications of treatments are encouraged 
to make them easier to administer in community treatment settings while 
retaining a beneficial effect, thus improving the likelihood they will be 
accepted by community practitioners. 

Applicants are encouraged to explicitly describe the theoretical basis for 
the proposed therapy, the scientific basis for the therapy being proposed, 
and the population for whom it is intended.  A general description of the 
nature of the therapy/intervention being proposed and the plans for 
manualization of this therapy/intervention are also encouraged.  If proposing 
a behavioral intervention that is supplemental to a manualized therapy, 
applicants are requested to include a copy of this therapy manual in their 
appendix materials, following the instructions for appendices in the PHS 398 
application kit.  Applicants are also encouraged to propose testing of the 
hypothesized effects of the therapy, and should incorporate, as appropriate, 
the development of measures of these effects in their applications.  Where 
adequate measures do not exist, applicants may propose the development of 
measures of therapist competence and adherence, process measures, and 
instruments measuring the integrity and fidelity of the therapy.

In the development of a new therapy for drug and alcohol dependence, a broad 
range of issues relevant to efficacy and safety are raised.  Since pre- or 
pilot-testing is considered an integral part of the therapy development 
process, applicants are encouraged to describe the nature of any pre- or 
pilot-testing intended.  Depending upon the scientific question being asked, 
a variety of research designs may be appropriate for Stage I research, 
including single case designs, random assignment of clinics to condition, and 
studies involving random assignment of subjects to condition.

Although one goal of a Stage I project is to proceed to Stage II, another 
goal is to obtain scientific knowledge about behavioral processes that lead 
to behavior change.   Therefore, testing of the theories and hypotheses upon 
which the novel behavioral treatment is based is a critical part of Stage I.   
Because the early therapy development process is an inherently exploratory 
process, immediate movement from Stage I to Stage II is not always possible 
or desirable.  For example, an investigator may not be able to conduct a 
pilot study warranting movement to Stage II because of feedback necessitating 
changes in the therapeutic intervention during the pilot.  In this case, 
although the Stage I investigator may not have acquired the pilot data to 
warrant a larger-scale Stage II efficacy study, the Stage I investigation may 
have produced valuable scientific information about behavior change that 
could lead to another successful Stage I study.  Stage I may be 
conceptualized as having multiple phases.  Early Stage I, or "Stage Ia" can 
be viewed as the most exploratory part of the Stage I process, in which the 
critical therapy development groundwork is laid.  Late Stage I or "Stage Ib," 
although still exploratory, can be viewed as the phase of Stage I in which a 
pilot study is conducted that determines effect size, and is compelling 
enough to warrant progression to Stage II.  Where scientifically warranted, 
it is acceptable to submit competing continuation applications of Stage I 
research when further development is indicated.

Stage II Research.  
Stage II research establishes the efficacy of behavioral therapies or therapy 
components shown to be promising in Stage I.  Stage II research examines if 
therapies work, but also examines why therapies work, and for whom therapies 
work.  Such research may examine any type of behavioral therapy for drug and 
alcohol abuse or addiction, including behavioral therapies that are used in 
conjunction with medications.

Proceeding to Stage II presumes that promising pilot data exist.  That is, 
when proposing a Stage II study, investigators are encouraged to provide 
evidence that the new therapy shows promise in some way (such as in terms of 
a reduction in drug and/or alcohol use, dropout rate, or psychiatric 
symptoms).  If evidence of promise does not exist, or such evidence is not 
strong enough to warrant progression to Stage II, applicants are encouraged 
to reconsider a Stage II submission.  That is, they are encouraged to 
consider either ceasing the therapy development work or submitting a Stage I 
application.   Investigators who believe that significant modification of the 
therapy is needed before it can be tested in another population are referred 
to the section of this PA entitled, "Stage I Research."

As in Stage I, in Stage II research designs are determined by the research 
questions.  In general, Stage II research asks if a therapy is efficacious, 
but also asks for whom the therapy is efficacious, and under what conditions 
and in what amount.  The most common research design for Stage II research is 
the randomized, controlled clinical trial.  However, there may be 
circumstances in which other types of research designs may be appropriate and 
scientifically justifiable.  Knowing the effective components of a therapy 
can greatly aid in improving the quality of that therapy.  Research designs 
used to determine the effective components or combination of components in 
drug and alcohol dependence behavioral therapies are encouraged.  It is 
recognized that for many research questions asked in the behavioral therapy 
field, no perfect research design may exist.  Where there is more than one 
way to answer a proposed research question, investigators are urged to state 
their theoretical, ethical, and practical reasons for choosing one control 
group or one research design over another.

Progression to Stage III may occur when a behavioral therapy has been proven 
to be efficacious for a particular population of individuals.   It should 
also be noted that information gathered in Stage II (or in Stage III) may 
lead an investigator back to Stage I.  This may occur when a therapy is shown 
to be efficacious for a substantial majority of the population, but for some 
individuals it is ineffective, and the investigator believes a new therapy 
can be developed for these individuals through modification of the existing 
therapy, based upon information gathered in the Stage II study.

Stage III Research.  
Where a behavioral therapy has been shown to be efficacious in Stage II 
research, investigators may propose to carry out a study to address the 
therapy's transportability to a community treatment setting.  Stage III 
research addresses not only if a therapy can be transported, but also how and 
for whom a therapy may be transported to the community.  Thus, Stage III 
research may sometimes be used to address issues of generalizability to 
different settings and patient populations more broadly representative of 
those in the community.  Such research may test the acceptability of the 
therapy to patients, counselors, and therapists in the community.  Stage III 
research is expected to maintain the integrity of the efficacious treatment 
examined during Stage II trials. Stage III research may also address 
questions about the amount or dosage of therapy required and the type and 
amount of training for clinical practitioners to deliver the behavioral 
treatment.  One of many potential Stage III research paradigms is a 
randomized clinical trial conducted in a community setting.  However, such a 
randomized clinical trial cannot be conducted adequately unless therapists 
are trained to competently administer the therapy.  This raises the research 
question of how to train previously trained therapists and counselors to 
effectively utilize new therapies.  Hence, Stage III also consists of another 
research area:  the training of therapists.  This includes research on the 
development of procedures and techniques to train therapists to administer 
new therapies.  Conceptually, such research is analogous to a Stage I 
research, in the sense that a new behavioral intervention is under 
development.  In this case, however, the new behavioral intervention is not a 
behavioral therapy, but a procedure or technique to help therapists 
administer new therapies.  The investigator might, for example, develop the 
training procedure, pilot the procedure in the community clinic, refine the 
procedure, and ultimately test the training procedure in comparison with 
another training procedure and/or a "training as usual" condition (analogous 
to Stage II).  Research on the refinement or modification of therapy to 
facilitate implementation in the community setting is considered Stage I 
research.  

HIV Considerations.  
It should be noted that if a subject is identified as being at risk for HIV 
acquisition and/or transmission, HIV testing and counseling should be offered 
to the subject in accordance with current guidelines.  Wherever possible and 
appropriate, investigators are encouraged to collect data on the effect of 
their behavioral therapy on AIDS risk behaviors, including data on the route 
of drug administration and sexual behaviors that may place individuals at 
risk for HIV transmission.  Also, as appropriate, investigators should offer 
risk-reduction counseling and collect data on the effect of their therapy on 
the acquisition/transmission of HIV/AIDS and other infectious diseases, such 
as Hepatitis C, associated with drug use.

MECHANISMS OF SUPPORT 

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

The total project period for an R01 application submitted in response to this 
PA 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.  Applicants are strongly encouraged to read the 
R21 and R03 announcements, which specify the goals and guidelines for each 
program at http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html and 
http://grants.nih.gov/grants/guide/pa-files/PA-03-039.html.

This PA 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.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_l.htm.

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

Direct your questions about scientific/research issues to:

Lisa Onken, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., MSC 9551
Bethesda, Maryland 20892-9551
Telephone:  301-443-2235
Fax:  301-443-8694
E-mail:  Lisa_Onken@nih.gov

Raye Litten, Ph.D.
Division of Clinical and Prevention Research 
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
Willco Building, Suite 505
6000 Executive Blvd., MSC-7003
Bethesda, MD 20892-7003 
Telephone:  301-443-0636
Fax:  301-443-8774 
Email:  rlitten@willco.niaaa.nih.gov 

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/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
E-mail:  GF6S@NIH.GOV

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone:  301-443-4704
Email:  jsimons@niaaa.nih.gov

For any of the above addresses use Rockville, MD 20852 instead of Bethesda, 
MD, for express or courier services.

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.

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

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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

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

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

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 mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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.

PEER REVIEW PROCESS

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 
(http://www.csr.nih.gov/refrev.htm) 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 appropriate national advisory council 
or board

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

PROTECTIONS OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
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.)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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.)

ADDITIONAL CONSIDERATIONS

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

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phases 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 "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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide 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. 

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  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 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
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 http://www.nida.nih.gov under the Funding, or may be
obtained by calling (301) 443-2755.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/, and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under 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.  All awards are subject to the terms 
and conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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