WOMEN, GENDER DIFFERENCES AND DRUG ABUSE   

RELEASE DATE:  June 16, 2003

PA NUMBER: PA-03-139 
( March 15, 2007 - This PA has been replaced by  PA-07-329 (R01),
PA-07-331(R21) and PA-07-330 (R03) 

See NOT-DA-06-015 for NIDA’s Intent to Reissue PA-03-139.

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 Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
Replacement R03 (PA-06-332) and R21 (PA-06-331) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: June 30, 2006

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279

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 OF THIS PA

This PA encourages gender-based drug abuse research that explores the 
mechanisms, origins, and consequences of drug abuse, and that develops and 
assesses gender-based prevention and treatment interventions and services.  
It also encourages the study of female-specific issues in all areas of drug 
abuse.  

RESEARCH OBJECTIVES

Background and Significance

Historically, in drug abuse research, as in other fields of public health 
research, subjects have largely been male.  Findings emerging in the past few 
years, however, clearly are establishing the importance of studying issues 
specific to women and studying male-female differences in all areas of drug 
abuse research.  From basic studies on genetics and neurotransmitters to 
studies on etiology and interventions, evidence for the importance of 
analyzing data separately for males and females is emerging. 

Accumulating epidemiological and clinical research indicates that the 
predictors and progression to drug abuse and dependence are often gender-
specific or are gender-sensitive.  Depression, conduct disorder, physical and 
sexual abuse, prenatal drug exposure and family dysfunction are among the 
variables differentially predictive of drug use, abuse, and dependence in 
males and females.  In some cases, predictors are stronger for either males 
or females, i.e., gender-sensitive.  In other cases, predictors apply only to 
males or to females, i.e., they are gender-specific.  The implications of 
gender-based differences in risk factors for prevention and treatment 
interventions are largely unexplored; however, these differences raise the 
possibility that interventions that are designed to target gender-sensitive 
and gender-specific risk factors and that are guided by well-established 
gender differences in psychosocial and cognitive development could improve 
outcomes for both males and females.  

Animal and human laboratory research has shown that males and females often 
differ in their biological responses to drugs.  Animal studies, for example, 
have found male-female differences in the motor-activating effects of 
stimulants, speed in acquisition of drug self-administration, the amount of 
drug self-administered, the percentage of subjects that acquire self-
administration, motivation for self-administration, and the tendency to 
relapse following drug cessation.   Human and animal pharmacokinetic studies 
often report male and female differences, as do studies of adverse effects of 
abused drugs.  Both human and animal studies have established that the 
menstrual/estrous cycle is a determinant of drug action, both pharmacokinetic 
and behavioral.  Despite the important progress made in laboratory-based 
gender research, the work is just beginning and many questions remain un-
addressed.

Numerous male-female differences in nicotine have been reported, including 
differences in the use patterns and dependence susceptibility, cessation 
rates and relapse rates, effectiveness of nicotine replacement therapies and 
other pharmacotherapies, control of smoking by non-nicotine factors, and the 
genetics of nicotine addiction including the genetic basis of nicotine 
metabolism.  Indeed, research on gender differences in nicotine dependence 
appears to exceed that of other drugs of abuse and thus may serve to guide 
research on other abused drugs.  Nevertheless, many gaps remain in our 
understanding of gender differences in the nature of nicotine addiction and 
its prevention and treatment, including issues specific to females such as 
the menstrual cycle and weight control issues.  

According to the Centers for Disease Control and Prevention, among HIV cases 
that progress to a diagnosis of AIDS, drug abuse is associated with a greater 
percentage of cases among women than among men.  Nearly half (41 percent) of 
all women diagnosed with AIDS are injecting drug users (IDUs), whereas among 
men 22 percent of AIDS cases are IDUs.  An additional 16 percent of women 
with AIDS, compared with one percent of men with AIDS, report having sex with 
users who inject drugs.  Thus, in all, drug abuse is over twice as likely to 
be directly or indirectly associated with AIDS in women (57 percent) as in 
men (23 percent). Additionally, current research suggests that gender-related 
differences exist in some fundamental aspects of the HIV/AIDS disease 
process; for example, an HIV-infected woman with half the amount of virus 
circulating in the bloodstream as an infected man will progress to a 
diagnosis of AIDS in about the same time. There is also evidence that HIV 
risk reduction interventions may impact men and women differently.  Although 
drug abuse plays a greater role in HIV in women than in men, major gaps 
remain in knowledge regarding gender differences in the role of drug abuse in 
HIV/AIDS and the unique needs of women.

Gender differences are emerging in various aspects of treatment research 
including treatment entry characteristics, treatment and services needs, 
barriers to treatment, treatment engagement and retention, treatment 
outcomes, and relapse.  Such research points to the need to address the 
possibility that treatment for both males and females could be improved by 
the development of gender-based approaches.

The extant literature on gender differences in drug abuse strongly suggests 
that males and females are likely to differ in many aspects of drug abuse yet 
to be explored and that in the long run, identifying and understanding such 
differences can improve our understanding of the nature and etiology of drug 
abuse and have implications for tailoring prevention and treatment 
interventions to maximize outcomes for both males and females.  Although 
progress has been made in knowledge of gender differences in drug abuse and 
issues unique to women, noteworthy gaps remain.  Often, studies fail to 
include gender analyses, and only a small proportion of animal research 
includes female subjects or analysis of data by gender.  Thus, in all areas 
of drug abuse, research is needed that examines gender differences and issues 
specific to females.

In referring to differences between males and females, distinctions are often 
made in the use of the terms 'sex-difference' and 'gender-difference.'  In 
this program announcement, for brevity and because it is often not known a 
priori whether a difference is sex-based or gender-based, the term 'gender-
difference' will be used to refer to both types of differences.  
Additionally, researchers are encouraged to recognize that a gender 
difference is often a proxy for an unidentified independent variable (or 
variables) and that finding a gender difference often should be regarded as a 
first step in a search for such variables.

Areas of Research Interest

Research of interest includes, but is not limited to, the following:  

I.  Mechanisms and Origins:  Gender differences in the basic behavioral, 
biological, and genetic mechanisms underlying drug abuse and dependence; and 
preclinical, clinical, and epidemiological studies of gender differences in 
the determinants of initiation, progression, and maintenance of drug use and 
dependence.

o  Studies of the genetic basis of sex differences in drug abuse and 
dependence using a variety of methodologies, including, but not limited to, 
the following:  statistical or epidemiological studies to ascertain 
heritability; identification of genetic variants through linkage, linkage 
disequilibrium, or association studies; studies of candidate genes using 
knockout or over-expression technologies in model organisms; gene expression 
studies.
o  Gender differences in the biological substrates of drug abuse, including 
molecular, cellular, neurochemical, neuromodulatory, neuroendocrine.
o  Gender differences in the pharmacokinetics and pharmacodynamics of abused 
drugs.
o  Gender differences in the role of hormonal (e.g., menstrual and estrous 
cycle, stress hormones), psychosocial, and cognitive factors in modulating 
drug effects and drug use. 
o  Gender differences in the developmental-organizing and activating 
influences of sex steroids on brain and behavior and interactions with 
neurotransmitter systems and the HPA axis.
o  Gender differences in the effects of stress on the response to drugs of 
abuse.
o  Gender differences in the abuse liability of drugs.
o  Gender differences in vulnerability to drug initiation, acquisition, 
escalation, dependence, and relapse.  
o  Laboratory behavioral studies of male-female differences in the role of 
tolerance, sensitization, habituation, drug discrimination, behavioral 
alternatives, impulsivity, delay discounting, stress, learning, memory, and 
cognition in the development and maintenance of drug abuse.
o  Field studies of gender differences in the antecedents and pathways to 
drug abuse and dependence, including study of psychosocial and environmental 
risk and protective factors associated with initiation, progression, and 
maintenance of drug use.
o  Gender differences in the role of psychiatric disorders (e.g. depression, 
PTSD, anxiety, eating disorders, borderline personality disorder, and 
antisocial personality) in the development and maintenance of drug abuse.
o  Gender differences in the roles played by the timing of puberty, the 
transition to puberty (e.g., onset of menarche), adolescent physique 
characteristics, and body image distortion in the onset and progression of 
drug abuse.
o  Family studies of gender differences in the intergenerational transmission 
of drug abuse.
o  Gender differences in the impact of violence, victimization, and stress on 
psychosocial development and functioning as it relates to the development and 
maintenance of drug abuse and dependence.
o  Gender differences in opportunity to use drugs, access to drugs, patterns 
of drugs of use and abuse, and factors affecting these differences. 

II. Consequences and Impact:  Laboratory (both human and animal), field, and 
clinical research aimed at (1) identifying gender differences in the 
consequences of drug use, abuse, and addiction following acute use, chronic 
use, as well as residual effects following prolonged abstinence, and (2) 
examining drug-related consequences that are unique to females.

o  Gender-specific differences in the effects of abused drugs on the nervous 
system, endocrine system, immune system, cardiovascular system, and other 
physiological systems.
o  Laboratory-based studies of gender differences in the behavioral effects 
of abused drugs ranging from effects on sensation, perception, and unlearned 
behavior (e.g., affiliative, reproductive, defensive, aggressive, ingestive) 
to effects on learning, conditioning, and cognition.  Studies of the 
biological substrates of these gender differences.
o  Gender differences in the perception of pain and in efficacy of both 
pharmacological and non-pharmacological pain treatments.
o  Gender differences in the acquisition and transmission of infection among 
drug users, and its clinical course and consequences.
o  Gender-specific medical consequences associated with drug abuse.
o  Gender differences in the precipitation and/or exacerbation of  
psychiatric disorders following drug use/abuse.
o  Gender differences in the effects of drug abuse on the response to stress.
o  The effects of drugs of abuse on the menstrual/estrous cycle as well as 
effects in the postmenopausal female.
o  The impact of drug abuse during pregnancy on medical conditions, both 
physiological and psychological, in the mother.
o  Gender differences in offspring prenatally exposed to abused drugs.
o  Gender difference in the effect of drug use on the development and 
maintenance of interpersonal relationships, e.g. empathy, conflict, 
hostility, attachment, friendships, marriage.
o  Gender differences in the effect of drugs on attainment of age-appropriate 
developmental levels, both physiologically and psychologically.
o  Gender differences in the impact of abused drugs on aggressive, hostile 
and violent behavior including child abuse, sexual assault, victimization, 
elder abuse, and school and workplace violence.
o  The effects of drugs of abuse on maternal and paternal functioning (e.g., 
maternal/paternal infant and child bonding, child abuse and neglect, role 
modeling behaviors) and differential impact on male and female offspring.
o  Gender differences in the socioeconomic and legal consequences of drug 
abuse, including the effects on education, employment, poverty, homelessness, 
gang activities, drug trafficking and distribution systems, and family 
functioning; (e.g., disruption, dislocation, violence, divorce and child 
custody.)

III.  Prevention and Prevention Services: The application of gender-specific 
theories and empirical findings on the origins, pathways, and risk and 
protective factors related to drug use, progression/transition, and 
maintenance, to the design, development, and testing of gender-based 
prevention strategies and interventions to determine efficacy and 
effectiveness.

o  In universal, selective and indicated prevention programs shown to be 
effective, conduct gender analysis and identify the intervention features 
and/or components that account for gender differences in outcomes.
o  Develop developmentally-appropriate gender-based universal, selective and 
indicated prevention strategies that are guided by etiologic research 
findings on gender differences in risk and protective factors and by gender 
differences in psychosocial and cognitive development.
o  In family-based prevention strategies, examine the effect of gender 
congruence between the participating parent and child on prevention outcomes.
o  Develop gender-based screening and assessment tools aimed at the 
identification of both risk and protective factors for use at the individual, 
family and community levels and in health care settings. 
o  Develop interventions that consider the role of childhood and adulthood 
violence and victimization in perpetuating drug abuse in females with 
attention to environmental, psychosocial and cultural factors that keep women 
in the cycle of violence.
o  Conduct prevention studies on the role of effective gender-specific 
communication in media and interpersonal interventions.
o  Assess the effectiveness of gender-specific prevention services and the 
factors that affect their availability, adoption, adaptation, sustainability, 
cost benefit, and cost effectiveness. 

IV.  Treatment and Treatment Services: The development and testing of 
theoretically-based drug treatment approaches (including behavioral treatment 
and pharmacotherapies) that address gender-specific issues, and the 
examination of gender-specific issues related to the effective and efficient 
delivery of drug abuse treatment services. 

o  Assess the differential effectiveness of current drug abuse treatments in 
males and females.
o  Develop and evaluate gender-based behavioral therapies and 
pharmacotherapies, alone and in combination in a variety of treatment 
settings, including traditional community-based drug treatment programs, 
criminal and juvenile justice settings, and primary care settings such as 
office-based practices and primary care clinics.
o  Develop and test alternative or complementary therapies for drug abusers 
(e.g. biofeedback, acupuncture, herbal therapies) and compare their 
effectiveness in males and females.
o  Examine gender differences in therapies that target comorbid 
psychopathology.
o  Examine the role of gender in pharmacogenetic studies.
o  Examine the efficacy and effectiveness of gender-based approaches for 
treatment and relapse prevention, e.g., same-sex vs. mixed-sex treatment 
approaches, same-sex vs. opposite-sex therapist.
o  Examine gender-based treatment approaches and delivery of services for 
individuals having experienced violence and victimization and for those 
individuals with co-occurring drug abuse and mental disorders (e.g. 
depression, eating disorders, PTSD), and/or physical disorders (e.g. STD, 
HIV/AIDS, HCV).
o  Develop and test family-oriented treatment approaches that are gender-
specific with respect to both parents and children.
o  Develop and test treatment approaches aimed at the role of partner drug 
use and drug treatment status in treatment outcomes.
o  Identify gender-specific needs for and use of services ancillary to drug 
abuse treatment (e.g., childcare, transportation, housing, skills training, 
assertiveness training, and vocational training) and their differential 
impact on males and females with respect to access, utilization, retention, 
outcomes and cost-benefit.
o  Identify effective pharmacotherapy for females of all ages including 
adolescence and pre-, peri- and postmenopausal women with consideration for 
issues such as developmental status, use of contraceptives, and use of 
hormone therapy.  
o  Determine best treatment practices for the use of pharmacotherapy in the 
treatment of pregnant women and mothers who breastfeed, in terms of both the 
mother's health and the infant's.
o  Identify gender-based factors affecting drug abuse treatment access, 
treatment entry, readiness for treatment, retention in treatment, compliance 
with treatment, and treatment outcomes; and develop gender-based strategies 
to reduce or eliminate gender disparities. 
o  Identify organizational, management, and treatment financing practices 
that impede or facilitate access, utilization, retention and outcomes for 
female clients and assess the structure and role of organization in the 
development of linkages to other relevant treatment services (e.g., medical 
services, prenatal clinics, psychiatric services) to ensure retention and 
continuity of care for females, including pregnant and postpartum females.
o  Develop or enhance and evaluate gender-based instruments for matching 
drug-abusing clients to appropriate services, and for identifying, diagnosing 
and assessing substance abusers in a variety of treatment settings especially 
primary care settings.

V.  HIV/AIDS and Related Infectious Diseases: Develop and evaluate gender-
specific interventions directed at preventing and treating HIV/AIDS and 
related infectious diseases among drug using populations at every age level. 

o  Examine gender differences in the viral, immunologic, genetic, and drug 
use factors that may influence susceptibility, recovery and persistence, and 
progression of viral diseases associated with drug use.
o  Examine gender differences in factors influencing long-term therapeutic 
effectiveness, development of viral resistance, disease progression, and 
medical outcomes.
o  Examine gender differences in the interactions/effects of antiretrovirals 
when used in combination with drugs of abuse and/or medication to treat drug 
abuse and/or medication to treat co-occurring disorders. 
o  Develop gender-based strategies, including behavioral and cognitive 
approaches, to improve access, utilization and adherence to HIV/AIDS 
medication regimens for drug-abusing populations both in and out of 
treatment.
o  Develop gender-based strategies to improve clinical care and outcome with 
respect to antiretroviral therapy, including interventions to improve the 
clinical management of individuals on multiple medical therapies for HIV and 
associated infectious diseases.
o  Develop valid, reliable HIV/STD risk-of-exposure screening instruments 
with gender and age-group-specific, empirically-based normative data.
o  Examine gender differences in the behavioral dynamics and drug use-related 
processes associated with the acquisition and transmission of HIV and other 
infectious diseases, including factors that influence transitions from non-
injection to injection drug use and their implications for the development of 
prevention interventions.
o  Develop gender-based interventions to prevent HIV and other infectious 
diseases, including research that explores the dynamics of social networks 
and the identification of factors that sustain positive behavioral changes.
o  Develop community-level intervention strategies aimed at preventing 
HIV/AIDS in women whose drug and sex practices put them at high risk of HIV 
infection.

CROSS-CUTTING ISSUES 

In addition to the above areas of research on gender differences and issues 
unique to women, several research considerations and topic areas apply to 
many areas of research.  They include, but are not limited to, the following:
o  Research that addresses and compares stages of the life cycle, from 
infancy, childhood, adolescence, adulthood, to late adulthood.   
o  Research that examines the role of race, ethnicity, culture, and SES in 
drug abuse.
o  Research that examines health disparity issues in drug abuse and 
associated infectious diseases.
o  Research on women in hidden and underserved populations, e.g., 
incarcerated, lesbians, transgender individuals, homeless, victims of 
violence, sex workers, migrant workers, school dropouts, truants, runaways, 
street youth, latchkey children.  
o  Research on all drugs of abuse, including the nonmedical use of 
prescription drugs, over-the-counter drugs with abuse potential, nicotine, 
club drugs, and polydrug use. 
o  Use of a wide range of methodological approaches including longitudinal 
studies, secondary analyses of current data sets, descriptive and 
ethnographic studies, use of and development of novel measurement tools, and 
interdisciplinary approaches.
o  Research that addresses gender-specific recruitment and retention issues.  

MECHANISMS OF SUPPORT 

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

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.  Otherwise follow the 
instructions for non-modular research grant applications.  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_1.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:

o Direct your questions about scientific/research issues to:

Cora Lee Wetherington, Ph.D.
Women & Gender Research Coordinator
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:   301-435-1319
FAX:   301-594-6043
Email:  wetherington@nih.gov

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

Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 3131
Bethesda, Maryland  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
E-mail:  GF6S@NIH.GOV

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

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

2) Obtain agreement from NIDA staff that NIDA will accept your application 
for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and NIDA 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 received by or 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 National Advisory Council on Drug Abuse. 

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.

SIGNIFICANCE:  Does this study address an important problem? If the aims of 
your 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 to that of 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 support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and 
priority score:

PROTECTION 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections 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 

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. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice
-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended
_10_2001.htm.  The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language governing 
NIH-defined Phase III clinical trials consistent with the new PHS Form 398; 
and updated roles and responsibilities of NIH staff and the extramural 
community.  The policy continues to require for all NIH-defined Phase III 
clinical trials that: a) all applications or proposals and/or protocols must 
provide a description of plans to conduct analyses, as appropriate, to address 
differences by sex/gender and/or racial/ethnic groups, including subgroups if 
applicable; and b) investigators must report annual accrual and progress in 
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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 www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

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://stemcells.nih.gov/index.asp 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. 

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  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 
(http://www.hhs.gov/ocr/) 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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 No. 93.279, 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)(or 
other authorizations) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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