RISK FACTORS FOR PSYCHOPATHOLOGY USING EXISTING DATA SETS
RELEASE DATE: December 10, 2002
PA NUMBER: PA-03-044
EXPIRATION DATE: November 2005, unless reissued.
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This is a reissue of PA-99-121.
Under this Program Announcement (PA), the National Institute of Mental Health
(NIMH) and the National Institute on Drug Abuse (NIDA) encourage extensive and
innovative use of existing data sets to study the development of
psychopathology, including drug abuse, in order to guide the development of
prevention and early intervention strategies. The aims of the PA are to mine
the full potential of public use and other extant data sets to increase our
knowledge of risk and protective factors for the development of psychopathology
or resilience in community-based and clinical populations, and to encourage
applications from new investigators to examine these research areas using
state-of-the-art data analytic procedures. Under this PA, NIMH and NIDA
encourage proposals to conduct analyses using mental health and substance abuse
research data that are in public use format or that are privately held by a
principal investigator.
In addition, senior investigators are encouraged to develop coordinated
applications for multi-site secondary analyses of data from research studies
which have employed similar methodologies, assessment measures, and risk and
resilience variables, in order to examine the replicability of findings across
studies, and to evaluate the strength of putative risk factors in the larger,
cross-site data set.
Applicants are encouraged to integrate the intent of recent NIMH and NIDA PAs in
their applications. These include:
o Collaborative R01s for Clinical and Services Studies of Mental Disorders and
AIDS http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html;
o Research on Co-Morbid Mental and other Physical Disorders
(http://grants.nih.gov/grants/guide/pa-files/PA-02-047.html);
o Genetic Epidemiology of Substance Use Disorders
(http://grants.nih.gov/grants/guide/pa-files/PA-02-112.html); and
o Research on the Origins and Pathways to Drug Abuse
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-168.html).
Applicants interested in studying child psychiatric risk factors for drug abuse
are referred to the website http://www.drugabuse.gov/Meetings/Childhood/,
which contains useful materials from a meeting organized and sponsored by NIDA
and NIMH on the subject.
RESEARCH OBJECTIVES
The overarching goal of this PA is to elucidate risk factors and processes for
the development of mental health and substance abuse problems across the life
span in order to guide the development of prevention and early intervention
strategies. The immediate objective is to support focused analytical research
using existing data from clinical or community-based studies. These studies may
have been cross-sectional or longitudinal in scope, and may be available to
researchers as public use data sets, or through negotiations with principal
investigators of privately held data sets. The data sets selected should have
sufficient mental health or substance abuse data to establish a categorical or
dimensional measure of mental disorder or psychopathology for the age range
being studied. Analyses of cultural and ethnic variations in developmental
patterns and processes leading from risk to psychopathology or resilience are
encouraged. Applications for analyses of studies conducted in foreign countries
will be acceptable if there is significant relevance for the U.S. population.
Applications are particularly encouraged for analyses of longitudinal data sets
using state-of-the-art statistical analyses to evaluate the sequencing and
potency of environmental, socio-economic, psychobiological, and other risk and
protective factors in association with the developmental course of
psychopathology and substance abuse. Case-control analyses of risk factors and
processes to examine the development of comorbid substance abuse, mental or
physical health disorders are particularly encouraged. Applicants should
carefully evaluate the sampling design and attrition rates of these studies to
determine the feasibility of using these data sets and the generalizability of
the results of the proposed analyses.
Applications involving cross-sectional data sets should include analyses aimed
at the development of new hypotheses about the etiology of disorders, and/or
their recurrence, and the roles of specific risk and protective factors and
processes. Proposals are encouraged which are innovative in studying the
association of psychopathology with a range of potential risk factors which may
be understudied.
Applicants are encouraged to arrange with Principal Investigators (PIs) of
ongoing or recently completed studies to use their privately held data sets for
analyses. The PI who holds the privately held data set should provide a
statement of commitment to the applicant and the research being proposed, a
statement of anticipated work on the project, and a budget and budget
justification.
Of particular interest are applications for multi-site secondary analysis of
existing data sets in order to examine the replicability of findings across
studies, and to evaluate the strength of putative risk factors in the larger,
cross-site data set. These applications may be submitted by experienced
investigators, such as the principal investigator of a study, to coordinate
analyses of risk factors and models of risk and resilience for psychopathology
across similar data sets, which used comparable methodologies, risk and
protective variables, and assessment measures. The funding Institute will
support costs for collaborative activities and statistical and database support.
Collaborative activities may be funded through small subcontracts, consultant
fees, or by means of collaborative R01 research grants.
Data Analyses: The data analyses proposed should include state-of-the-art
biostatistical strategies suitable for complex sampling designs. These may
include, but are not limited to the following: survival, life table, and hazard
rate analyses; latent class variable and growth curve analyses; logistic
regression; cluster analyses; structural equation modeling; random effects
modeling, and methods for handling non-response and missing data. Where
possible, multilevel analyses should be used to integrate risk factors, and
appropriate analytic strategies should be applied to distinguish among causal
factors, markers, mediators and moderators. Studies of Substance User Disorder
(SUD) as a risk factor or outcome should include family history of SUD when
known, and distinguish among substance initiation, substance use, and substance
use disorders. Applications from new investigators should include consultants
in biostatistical approaches to analyses of complex data sets.
Examples of research topics for analyses of existing data sets and multi-site
secondary analyses include, but are not limited to, the following:
o Analyses of risk and resilience processes and pathways involved in the
development of psychopathology and substance abuse disorders over the life span,
processes which interact with existing symptomatology or disorder that increase
the likelihood of developing subsequent comorbid disorders, and attributable
risk associated with these risk factors and processes;
o Examination of the timing and potency of putative risk processes for the
onset, persistence, and recurrence of disorders and analysis of interactions
between environmental risk and individual traits which may be indicators of
personal vulnerabilities or susceptibilities for psychopathology;
o Analyses of adaptive factors related to positive outcomes for high risk
individuals; analyses of factors and processes that alter negative trajectories;
o Analyses of dimensions of behavioral expression, (i.e., impulse control,
executive function, affect regulation) as they inform understanding of the
development, course, or outcomes of psychopathology and substance abuse;
o Analyses of levels and patterns of symptomatology and impairment, as these
relate to: the nosology of mental disorders; categorical and dimensional
diagnoses of psychopathology; comorbidity of disorders; or the use of services,
with an emphasis on child and adolescent populations and ethnic minority
populations;
o Analyses of family studies to identify biomarkers, endophenotypes, and
subclinical phenotypes associated with mental or addictive disorders;
o Analyses of processes underlying different patterns of co-occurring mental
and physical health symptomatology, substance abuse and risk-taking behaviors,
particularly in adolescents and young adults;
o Analyses using new approaches to examine the role of adolescent
psychopathology (including depression and conduct disorder) on intermittent or
chronic participation in interpersonal violence, suicidality, high risk sexual
behavior, substance abuse, and other problem behaviors;
o Examination of the role of physical health, disability, nutrition, and other
health risk and protective processes and the development of psychopathology over
the life span; analysis of interactions between physical health and
psychopathology;
o Analyses examining the mechanisms underlying long-term effects of abuse,
neglect or other trauma;
o Analyses across data sets of assessment measures and risk and protective
factors for disorders with low base rates in community populations, such as
psychoses or completed suicides;
o Analyses of preventive/intervention trials, to evaluate mechanisms accounting
for variation in response to intervention (including social class disparities);
moderating effects of contextual factors such as neighborhood, classroom
structure, family changes and level of ongoing environmental stress on
psychological processes and mental health symptoms;
o Analyses of preventive interventions to study: intervention impact on sub-
groups such as those at highest risk within universal interventions, or those
with comorbid disorders; intervention impact at key developmental transitions or
socially defined periods; intervention impact on the risk for or protection from
development of other, associated psychopathology;
o Examination of intervention studies to determine: if high-risk groups are
adequately defined and representative of the original high-risk populations in
intervention trials; the trajectories of control groups for continued risk,
onset and course of disorders, factors associated with reduced risk for
disorder, reduced risk for recurrence, and/or factors associated with
trajectories of groups with early normative development and later onset of
disorders;
Existing Data Sets: Applicants are encouraged to collaborate with investigators
holding private data sets to examine risk and protective factors and processes
using new statistical strategies or to link methodologically comparable data
sets in order to re-examine the strength of risk factors in the larger, combined
data set. Additionally, there are several public use data sets that applicants
may wish to consider which may be obtained on the Internet. These data sets
include, but are not limited to, the following:
The National Health and Nutrition Examination Surveys (NHANES)sponsored by the
National Center for Health Statistics (NCHS) http://www.cdc.gov/nchs/nhanes.htm.
Major depression and bipolar illness were assessed in the NHANES-3 for ages
15-39 years. Data are available from previous NHANES: the Hispanic HANES
(HHANES) included the depression module from the Diagnostic Interview Schedule
and the CES-D scale, and some substance use and physical health measures (data
are generalizable to U.S. Mexican Americans, Puerto Ricans, and Cuban
Americans); the NHANES 1 and NHANES 1 Follow-up. Information may be located for
these studies at: http://www.cdc.gov/nchs/search/search.htm.
Child and adult mental health measures were included in NHANES-IV and
availability of the data will be announced on the NHANES home page above.
The 2000 and 2001 National Household Survey on Drug Abuse (NHSDA), Substance
Abuse and Mental Health Services Administration (SAMHSA). Mental health service
utilization was assessed for adolescents and adults. The DISC Predictive
Screener for DSM-4 was included in the 2000 survey only. A measure of serious
mental illness in adults was included in 2001. For further information on this
survey, contact Joan Epstein, Department of Health and Human Services, Substance
Abuse and Mental Health Services Administration, Office of Applied Studies,
(301) 443-1038. Web address: http://www.icpsr.umich.edu/SAMHDA.
The National Longitudinal Study of Adolescent Health (Add Health). The Add
Health is a nationally representative, multi-wave, school-based study of the
health-related behaviors of adolescents, grades 7-12, designed to explore the
causes of these behaviors. The public-use data contains information on Add
Health's sample from Waves 1 and 2; Wave 3 will be released in Spring 2003.
The number of respondents in the data set is approximately 6,500. Complete
information about the study and the public use data set may be found at:
http://www.cpc.unc.edu/projects/addhealth.
The National Comorbidity Survey (NCS). This was a one-wave epidemiological
study of the prevalence and correlates of DSM III-R mental disorders and service
use for individuals ages 15-55 years. Web addresses:
http://www.icpsr.umich.edu:8080/ABSTRACTS/06693.xml?format=ICPSR; and
http://www.hcp.med.harvard.edu/ncs. Data from two ongoing follow-up surveys,
the NCS-2 (a 10-year follow-up of participants in the original NCS) and the NCS-
Replication will be released as public use data sets as soon as possible after
data cleaning is completed. Check the Harvard web site listed above for the
most current information.
The Fast Track multi-site study of the prevention of conduct problems. This is
a randomized, controlled, developmentally-based study using a comprehensive
intervention for the prevention of conduct problems. A public use data set is
under development. For information, contact Kenneth A. Dodge, Ph.D., Director,
Center for Child and Family Policy, Duke University, email dodge@duke.edu.
The National Institute of Mental Health Epidemiologic Catchment Area Study.
This study was a two-wave, five-site community-based survey of mental disorders
in a sample of 20,000 adults ages 18 years and over, using DSM-III diagnostic
criteria. The public use data set and documentation may be purchased from the
National Technical Information Service (NTIS), telephone 1-800-553-6847; web
access http://www.ntis.gov.
The National Vietnam Veterans Readjustment Survey (NVVRS) database. This is a
comprehensive source of information about Vietnam and Vietnam-era veterans
carried out by the Research Triangle Institute and supported by the Department
of Veterans Affairs and the NIMH. It includes modules of the NIMH Diagnostic
Interview Schedule for PTSD, Anxiety, Affective Disorders, Substance Abuse and
Personality Disorder. A subset of the sample was selected for a clinical study
using the Structured Clinical Interview for DSM-III-R. The complete database
for the survey and clinical components is available from the VA Medical Center
in Perry Point, MD. The contact person is Thomas Murtaugh, Ph.D., telephone
(410) 642-1100, FAX (410) 642-1101, E-mail at thomas.murtaugh@med.va.gov.
The 1988 National Maternal and Infant Health Survey (NMIHS) and the 1991
Longitudinal Follow-up (LF), NCHS. Both surveys contain the CES-D for the
mothers, and the LF contains a brief problem behavior index on the children.
Data tapes may be purchased from NTIS. Web address:
http://www.cdc.gov/nchswww/about/major/nmihs/abnmihs.htm
The National Collaborative Perinatal Project (NCPP) sponsored by the National
Institute of Neurological Disorders and Stroke (1959-1974). Data files may be
ordered from the National Archives and Records Administration Center for
Electronic Records, College Park, MD, telephone (301) 837-0470. Web information
may be found at
http://www.archives.gov/research_room/center_for_electronic_records/center_
for_electronic_records.html
The National Longitudinal Survey of Youth, now called the NLSY79 Child and Young
Adult data. In 1994, children age 15 years were given a new instrument.
Children have been interviewed biennially since 1986. The current release is
for data through 2000, released as one dataset, and is available through the
Center for Human Resource Research, Ohio State University, 921 Chatham Lane,
Suite 100, Columbus, Ohio, 43221, telephone: (614) 442-7366 or
E-mail at McClaskie.1@osu.edu. NLS data sets are available for download at
http://www.bls.gov/nls.
The 2001 National Health Interview Survey public use data set is expected to be
available in 2003. This survey included modules from the CIDI for adults for
major depression, panic, and generalized anxiety disorders. A child assessment,
the Strengths and Difficulties Questionnaire Extended version was included in
the 2001 NHIS. The availability of this data set will be announced on the NCHS
Web site at http://www.cdc.gov/nchs/nhis.htm.
The Murray Research Center of Radcliffe College has established an archive of
longitudinal mental health data to provide research opportunities for those
interested in reanalyzing longitudinal data. Web address:
http://www.radcliffe.edu/murray/data/mentalhe.htm.
The Inter-University Consortium for Political and Social Research (CPSR). This
Consortium is located within the Institute for Social Research at the University
of Michigan and provides access to a large archive of computerized social
science data. Web Address: http://www.icpsr.umich.edu.
MECHANISM(S) OF SUPPORT
This PA will use the NIH research project grant (R01) and small grant (R03)
award mechanisms. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project. The total project period for an
R03 application may not exceed two years and funding is limited to $50,000 in
direct costs per year. The R01 should be used for applications in which
additional project time and cost are clearly justifiable. It is recommended
that applicants discuss the appropriate award mechanism for their study with
program staff listed under INQUIRIES.
The Small Grant (R03) application includes special eligibility requirements and
review criteria. The R03 also has a special application format and the
narrative portion of the application is limited to ten pages. Information on
requirements for the NIMH Small Grant may be obtained at
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html
and for the NIDA Small Grant at
http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html.
Applicants should obtain the appropriate program announcement for the grant
mechanism being used and are encouraged to consult with program staff listed
under INQUIRIES about any questions regarding their proposed project and the
goals of this PA.
This PA uses the just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-modular
research grant applications.
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 (R01s and R03s); or foreign (R01s)
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. New investigators are also encouraged to apply.
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 related to mental
health outcomes to:
Karen H. Bourdon, M.A.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6200 MSC 9617
Bethesda, MD 20892-9617
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email: kbourdon@nih.gov
o Direct inquiries about scientific/research issues related to mental health
intervention/prevention to:
Belinda E. Sims, Ph.D.
Division of Services and Interventions Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7149, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: bsims@mail.nih.gov
o Direct inquiries about scientific/research issues related to substance abuse
outcomes to:
Naimah Weinberg, M.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-6637
Email: nw46w@nih.gov
o Direct inquiries regarding financial or grants management matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@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 the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and five signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be 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.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of established
PHS referral guidelines. An appropriate scientific review group convened in
accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council or
board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
your application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria in
assigning your application's overall score, weighting them as appropriate for
each application. Your application does not need to be strong in all categories
to be judged likely to have major scientific impact and thus deserve a high
priority score. For example, you may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims of
your application are achieved, how do they advance scientific knowledge? What
will be the effect of these studies on the concepts or methods that drive this
field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does your project challenge existing
paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application
will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the section
on Federal Citations, below)
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
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
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.
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.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to provide
public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive,
which can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore, we
caution reviewers that their anonymity may be compromised when they directly
access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This PA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.242 and 93.279. Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject
to the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards will be administered under PHS grants policy as
stated in the NIH Grants Policy Statement (October 1, 1998).
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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