EPIDEMIOLOGY OF DRUG ABUSE
RELEASE DATE: May 3, 2004
PA NUMBER: PA-04-100
December 8, 2006 - The R01 portion of this funding opportunity has been
replaced by PA-07-118, which now uses the electronic SF424 (R&R)
application for February 5, 2007 submission dates and beyond.
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-06-330) and R21 (PA-06-329) 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 R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This program announcement (PA) replaces PA-99-002, Epidemiologic Research on
Drug Abuse, published in the NIH Guide, October 2, 1998; PA-99-113, Drug
Use and Related Adverse Behavioral and Social Consequences, published in the
NIH Guide, June 18, 1999; and PAR-99-168, Research on the Origins and
Pathways to Drug Abuse. This new PA encourages a broad range of
epidemiologic research on drug use, abuse, and dependence. It highlights new
areas for research that emphasize the vital public health role of
epidemiologic research in drug abuse.
The major goal of this PA is to stimulate innovative investigations that
enhance our understanding of: (1) drug use patterns and trends within and
across populations; (2) interplay of social interactions, social environment,
structural context with individual behavioral characteristics and genetic
vulnerability; (3) the phenotypic heterogeneity of drug abuse; (4) causal
mechanisms leading to onset, maintenance, and remittance of drug abuse, as
well as protective mechanisms that reduce the risk of drug abuse; and (5)
drug abuse over the life course, including developmental processes that
influence drug use trajectories and behavioral, health, and social
consequences of drug abuse. In addition, research is encouraged to develop
methodologies to improve the accuracy, efficiency, scope, timeliness, and
analytic yield of drug abuse epidemiologic data. Because of the breadth of
epidemiology research, applications are anticipated to reflect diverse and
multidisciplinary putative approaches and multiple levels of causation. To
take advantage of the strength of specific research fields in an efficient
manner, and to maximize the generalizability of findings, researchers are
encouraged to develop and/or incorporate innovations in epidemiologic study
design. Such designs may include nesting of biological and/or basic
research, contextual analysis, and contemporary longitudinal analyses.
RESEARCH OBJECTIVES
Background
Drug abuse epidemiologic research focuses on understanding the nature,
extent, consequences, and etiology of drug abuse across individuals,
families, age groups, gender, communities, and population groups.
Epidemiologic research plays a critical public health role by providing an
estimate of the magnitude, impact, and risk of drug abuse on a population,
and by laying the foundation for developing strategies to prevent drug abuse,
plan and evaluate drug abuse services, and suggest new areas for basic,
clinical, and treatment research.
The natural history of drug abuse can be observed most validly in
epidemiologic studies and the population-based approach provides specific
advantages over research relying on samples of convenience, such as clinical
samples, by reducing the potential for selection bias in observed
associations while enhancing generalizability. There are, however,
limitations to epidemiologic research. Large sample sizes can pose
difficulties in terms of time and cost to obtain intensive and detailed
measures, particularly over extended periods of time. Also, the
observational nature of much epidemiologic drug abuse research limits
experimental control and manipulation of variables under study. However,
underutilized applications in epidemiologic study design, such as nested case
control studies, enable integration of focused intensive measurement in the
context of epidemiologic research. It is also possible to draw
epidemiologically informative samples, based on specific characteristics, for
recruitment into laboratory-based research. Although collaboration between
laboratory-based and epidemiologic research is becoming more widespread in
other areas of health research, it is less common in the field of drug abuse
research. This PA encourages innovative research that incorporates the
strengths of epidemiologic and laboratory-based designs.
Recent advances in health science research have connected biological and
genetic factors across the spectrum of diseases including drug abuse and
addiction. For diseases with a substantial environmental component, however,
biology and genetics are not sufficient to explain or predict disease
patterns. In order to better understand the epidemiology of drug abuse and
its consequences within and across populations, research is encouraged on the
influence of social and cultural factors on the initiation and progression of
drug use among population groups. Novel conceptualization and measurement of
social and cultural contexts within theoretically grounded research are
important to the advancement of drug abuse research. Increased understanding
of how genetic, biological, social, and contextual phenomena interact to
influence behavior will inform prevention and treatment for individuals at
risk for drug abuse.
Crosscutting Issues
Research indicates that there are significant gender-specific differences in
biological factors in drug abuse, antecedents and consequences of drug abuse,
and responses to prevention and treatment. Investigators should, wherever
germane, include adequate numbers of both male and female subjects in their
studies in order to make meaningful gender comparisons. Researchers are also
encouraged to design studies to explore gender differences in the nature and
extent of drug-using behaviors, in the pathways and determinants of
initiation, progression and maintenance of drug abuse, and the behavioral and
social consequences of drug abuse. For more information on research on this
topic, see the Women, Gender Differences and Drug Abuse PA
http://grants.nih.gov/grants/guide/pa-files/PA-03-139.html.
HIV/AIDS and drug abuse are frequently referred to as twin epidemics, and
whenever possible, it is essential that epidemiologic studies address this
interrelationship. Investigators are encouraged to incorporate appropriate
measures and analyses of factors critical to understanding the transmission
of HIV/AIDS and other sexually transmitted diseases (STDs), Hepatitis (HCV
and HCB), and Tuberculosis (TB), as well as related disparities across
different population groups. The aim is to promote integrated approaches to
understanding and addressing interactions between individuals and
environments that contribute to the continuum of problems related to drug
abuse, including HIV/AIDS. For more information on research on this topic,
see http://hiv.drugabuse.gov and
http://www.drugabuse.gov/MeetSum/HIVworkshop.html.
Research shows that minority groups, particularly Blacks and Hispanics, are
in some instances less likely to use licit or illicit drugs, but that such
groups tend to be over-represented among those who suffer from adverse
health, behavioral, and social consequences related to drug use (e.g.,
HIV/AIDS, premature births, intentional and unintentional injuries, violence,
crime, etc.). Epidemiologic research is clearly needed to inform prevention
and intervention strategies aimed at reducing and eliminating drug-related
health disparities, as well as services research on access, utilization, and
retention of racial and ethnic minority populations in drug abuse treatment.
This announcement therefore encourages research that focuses on identifying
risk factors and consequences that are unique to or more prevalent in
subpopulations in socioeconomically disadvantaged (i.e., low education level,
poverty) and medically underserved rural and urban communities. For more on
NIDA’s interest in this topic, see
http://www.drugabuse.gov/StrategicPlan/HealthStratPlan.html.
Advances in the field of drug abuse epidemiology will require innovations in
statistical, epidemiologic, sociologic, and genetic epidemiologic designs to
meet challenges in the rapidly evolving drug abuse field. This announcement
encourages methodological innovations that address transitions in stages and
trajectories of drug abuse, intergenerational transmission of drug abuse, and
heterogeneous pathways to and consequences of drug abuse. Especially
encouraged are approaches that facilitate: (a) nested case-control and case-
cohort designs that efficiently combine the advantages of epidemiologic
samples with more intensive laboratory-based and biological measures, (b)
innovations in measurement such as real-time measures of drug abuse through
the use of handheld devices, and (c) secondary analyses of existing
epidemiologic data sets that contain high-quality information about drug
abuse. For more information on research using secondary analyses,
particularly research on psychopathology vulnerability for drug abuse, see
the Risk Factors for Psychopathology using Secondary Data Sets PA
http://grants.nih.gov/grants/guide/pa-files/PA-03-044.html.
Major Program Areas
The epidemiologic drug abuse research program is further organized into major
program areas that are described below. It is important to note that the
crosscutting issues of gender, HIV/AIDS, health disparities, and
methodological innovations apply across all of these topics. Examples of the
types of research topics include, but are not limited to, the following:
o Emerging and current trends
o Social epidemiology of drug abuse
o Familial/genetic liability and phenotypic heterogeneity
o Drug abuse psychopathology: comorbidity and vulnerability
o Human development in adolescence and adulthood
o Developmental consequences of drug abuse
o Social and behavioral consequences of street drugs
o Drug markets and behavior economics
Emerging and current trends Research directed at examining drug abuse
trends is particularly important in the contemporary context where a variety
of new substances are available to increasingly diverse populations and in an
expanding range of settings. Changing availability and changing social and
cultural trends influence patterns of use. Research continues to reveal new
drug use trends and issues warranting further exploration such as the high
level of abuse of prescription drugs, patterns of use of drugs in
combination, and the association between non-injection drug use and HIV-risk
behaviors in some contexts. This program of research encourages: (a) studies
that develop more effective and timely ways to identify the nature, extent,
and changes of new trends at an early stage within local, national and
international contexts, and to identify associated health, social and
behavioral consequences; (b) theory-driven research models for understanding
the diffusion of drug trends into new populations including the impact of
cultural factors, social networks, drug distribution mechanisms and media;
(c) exploratory descriptive hypothesis-generating ethnographic studies as
well as analytic studies that examine factors impacting initiation,
continuation, progression and cessation of use of novel drugs; (d) studies
that examine the relation between the use of novel drugs and HIV-risk
behaviors; (e) research into whether users of these new substances experience
substance use disorders; and (f) innovative studies to improve methods for
characterizing drug use behaviors such as, for example, the use of different
substances strategically in combination or in sequence within specified
periods of time.
Social epidemiology of drug abuse Drug abuse research has focused largely
on individual risk factors, while the universe of determinants includes
individual, familial, neighborhood, community, population-specific, and
societal factors. There is urgent need to extend drug abuse research to
incorporate the concept of interactivity (individual susceptibility
interacting with social environment, genetic environment, neighborhood
environment) and cumulative history (how these determinants differentially
impose risk across time, generations, and the life course). This program
specifically encourages: (a) studies that examine the interaction of
individual and social environmental factors on drug use/abuse/dependence; (b)
studies that consider both immediate and cumulative (life-course and trans-
generational) effects of interactions among drug abusing behaviors,
environments, and genes; (c) studies that draw upon current research on the
effects of social environmental factors on health and disease in general; (d)
research that identifies whether and how the environment as culture can be
meaningfully disaggregated into measurable components and tested for effects
on drug abuse; (e) studies that inform the debate on which aspects or
dimensions of the social environment (e.g., society, social institution,
small group, dyad) also should be included, when they should be included, and
how they should be measured; (f) investigations of the collective impact of
neighborhood factors such as residential stability/instability, collective
efficacy, social cohesion or other aspects of locally shared environments on
drug abuse among different groups; and (g) studies of how social and cultural
factors influence or predict drug use/abuse and its consequences.
Familial/genetic liability and phenotypic heterogeneity Numerous genetic
epidemiologic studies confirm that drug abuse "runs" in families, and that
such transmission is due in part to genetic factors. These findings have
been tremendously important, and have set the stage for additional research
to specify drug abuse phenotype(s) and gene-by-environment interactions
inherent to complex disorders such as drug abuse. Indeed, untangling the
complicated pathways from genotypes to phenotypes is one of the biggest
challenges in the drug abuse field. The objective of this program area is to
further explicate the transmissibility of drug abuse phenotypes and to
explicate individual differences, familial processes, and
social/environmental factors that confer and/or protect against the
expression of genetic liability. This program area encourages research on
the following topics: (a) the refinement of drug abuse phenotypes and
nosology to inform prevention, services, and molecular genetic research; (b)
identification of key individual and environmental characteristics that
affect genetic vulnerability and/or the course of drug abuse, including
psychopathological conditions; (c) clarification of gene-environment
interactions for fine-tuning preventive interventions with high-risk
populations; (d) studies that inform the debate on the general liability
versus specificity of genetic risk for drug abuse; (e) genetically-
informative assessments that are nested within epidemiologic-based studies;
(f) development of statistical and analytic approaches to model complex
disorders and traits.
Drug abuse psychopathology: comorbidity and vulnerability Cross-sectional
and longitudinal studies of adolescents and adults in both clinical and
general populations have found high rates of co-occurrence between drug abuse
and psychiatric disorders, particularly the conduct/antisocial disorders and
the mood disorders. Far fewer studies have examined the temporal order or
causal relationships, including potentially common pathways, for specific
psychiatric disorders and drug abuse. Thus, the nature of the association
among psychiatric and drug use disorders remains unclear. Understanding the
relations between precursor and comorbid psychiatric disorders and drug abuse
is the focus of this program and has important prevention and treatment
implications. Specifically, this program of research encourages studies that
focuses on: (a) child psychiatric precursors to drug abuse, with a particular
emphasis on attentional, externalizing, and internalizing disorders; (b) the
impact of mental health interventions on drug abuse risk; (c) moderating and
mediating factors that can inform the association between psychiatric
disorders and drug abuse; (e) temperament and personality, particularly
behavioral disinhibition, as stand-alone etiologic or potential mediating
factors; and (f) dynamic relations between the timing and course of
psychiatric illness and the timing and course of drug abuse, including drug
use initiation, maintenance, escalation, and remittance. Towards this end,
research approaches of particular interest to this program include:
epidemiologic (population-based) cross-sectional and longitudinal studies,
genetic epidemiologic and other studies of familial risk, clinical
prospective and clinical follow-up studies, innovative designs that
characterize the interactions between individual psychiatric and genetic
factors with the environment, nested studies, and secondary data analyses.
For additional information related to psychopathology vulnerability for drug
abuse, see http://www.drugabuse.gov/Meetings/Childhood.
Human development in adolescence and adulthood This program focuses on
three key adolescent developmental issues that have relevance for drug abuse:
timing, transitions, and biologic maturation. The developmental stage when
drugs are introduced has implications for drug abuse, as evidenced by recent
research showing that initiation during early developmental periods is
associated with greater subsequent use. Similarly, developmental transitions
(e.g., pubertal, cognitive, social, and achievement related), and individual
variation in the timing of these, are also likely to influence trajectories
of use. Studies of particular interest under this program include, but are
not limited to, those that assess: (a) how developmental timing and the
timing of drug use act and interact to influence the course of drug using
behavior and related outcomes; (b) the implications of emerging cognitive,
emotional, and social capacities across developmental periods for drug abuse;
(c) the impact of the adoption of stage-specific roles on drug abuse and the
impact of drug abuse on the adoption of such roles; (d) the creation of new
or implementation of existing methodologic approaches that adequately capture
the developmental nature of individual change; (e) real-time assessment
methodologies to capture the capricious and context-dependent nature of drug
using behaviors over developmental periods; and (f) translational research
including epidemiologic studies that incorporate lab-based findings on
adolescent brain development, measures of shifts in emotional and cognitive
processes, and assessments of biological changes associated with puberty.
Developmental consequences of drug abuse This program focuses on the
effects of parental drug abuse and its consequences (e.g., family violence,
child maltreatment) on child development. Parent drug abuse may influence
children’s development through direct and indirect pathways. Direct pathways
include genetic transmission of vulnerability to substance use disorders and
prenatal exposure to drugs. Parent substance abuse can also indirectly
impact development through its effect on children’s environments.
Longitudinal, prospective, and multidisciplinary studies are needed to
investigate the independent and combined contributions of biologic/genetic,
psychosocial, and contextual factors that influence the development of
children. Child populations at heightened risk for drug abuse (e.g., homeless
youth, children in foster care) are of particular interest. This program of
research encourages studies that focus on factors related to parent drug
abuse, as they relate to children’s drug abuse and other developmental
outcomes as well as the processes by which these factors influence child
development. This program of research specifically encourages: (a)
independent and combined effects of parental drug abuse, family violence and
child maltreatment; (b) effects of exposure to lifestyles associated with
illicit drug activities; (c) effects of forced parent-child separations due
to parental drug related illness, death or imprisonment; (d) post-traumatic
stress disorder (PTSD) affecting the child and parental drug abuse, family
violence, and/or child maltreatment; and (e) child characteristics and family
dynamics that contribute to associations between parental drug abuse and
child maltreatment and between parental drug abuse, family violence and/or
child maltreatment and related child outcomes.
Social and behavioral consequences of street drugs This program examines
the range of behavioral and social consequences arising from street-level
drug abuse. Behavioral consequences include educational and occupational
problems, crime and violence, and comorbid conditions (overdose, suicide,
cognitive impairment). Social consequences include drug trafficking and
distribution, gang activities, family disruption, and neighborhood
dysfunction. Little attention has been given to how abuse of particular
drugs and combinations of drugs affects these consequences. Understanding
retail street drug activity and consumption patterns is key to understanding
drug distribution networks and drug price/purity and availability. Data are
available on the frequency of drug use, but better estimates of drug
price/purity, and a better understanding of the quantity of drug used are
sorely needed. Specifically, the street-level drugs program encourages
research on: (a) what, how much, and how often drugs are actually consumed by
drug users; (b) which adulterants, diluents, and contaminants are present in
retail drugs; (c) the patterns of use of different drugs, including teasing
apart patterns of polydrug use; (d) economic analyses to understand issues
such as price/purity, consumption, and cross-elasticities; (e) small-scale
epidemiologic studies could characterize price, demand, and consequences at
the level of a city or other small geographic area; and (f) ethnographic
studies to describe price and availability effects on behavior of those who
use, abuse, or are dependent to explore whether elasticity of demand varies
with severity of drug use.
Drug markets and behavior economics Research increasingly points to the
importance of studying drug abuse as the behavior of individuals in their
environments. While the immediate (proximal) environments of drug abusers
have received considerable research attention, the context of broader and
more distal environmental influences have received less consideration.
Principles of behavior derived from more macro-environmental disciplines,
particularly economics, have great potential for expanding understanding of
the full set of influences on drug abuse. It is important to examine the
intersection of psychological, economic and environmental concepts and
findings and their relevance to drug abuse etiology, continuation, relapse
and hopefully, more effective preventive and treatment interventions. By
applying the research and perspectives of behavioral economics, marketing
research, drug availability market factors, the psychology of decision making
and other related areas, important but understudied pieces of the drug abuse
puzzle will be investigated. The following issues are of particular
interest: (a) nested case control studies within larger epidemiologic studies
that enable laboratory-based behavioral economic analysis of defined
populations; (b) research on the influence of environmental factors on
behavioral economic measures such as delayed discounting functions or
impulsivity and risk taking; and (c) interactions among broad social forces
(e.g., neighborhood quality and socioeconomic status), racial and ethnic
health disparities, and drug abuse trajectories and consequences.
MECHANISMS OF SUPPORT
This PA will use the NIH research grant (R01) award mechanism, NIH small
grant award (R03), and the NIH exploratory/developmental award (R21). The
applicant 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 as
well as the non-modular budgeting formats (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 budget format. Otherwise follow the instructions
for non-modular budget research grant applications. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
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 institutions/organizations
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:
Yonette Thomas, Ph.D.
Division of Epidemiology, Prevention, and Services Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5169, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Telephone: 301-402-1910
Fax: (301) 480-2543
Email: yuthomas@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D.
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming@nida.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. 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.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
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 BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget 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 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 IC staff that IC will accept your application for
consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
at 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 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 unfunded version 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. Appropriate scientific review groups
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 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 written critique
o Receive a second level review by an 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 evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional 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:
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues related
to institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.
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.
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://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, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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.
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.
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).
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.healthypeople.gov/.
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 the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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