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( March 15, 2007 - This PA has been replaced by PA-07-329 (R01),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) 710-0267,
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.
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NIH Funding Opportunities and Notices
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