DEVELOPMENT OF TOOLS FOR THE ASSESSMENT OF DEPRESSION

RELEASE DATE:  July 31, 2002

RFA:  MH-03-002

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  September 15, 2002
APPLICATION RECEIPT DATE:  October 15, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Mental Health (NIMH) and the National Institute on 
Drug Abuse (NIDA) invite research applications that apply recent advances in 
affective science, basic behavioral science, and measurement theory to the 
development of an instrument or assessment battery to assess depression. The 
instrument must be psychometrically sound, time-efficient, and suitable for 
tracking changes in symptoms and functioning as a repeated measure over time or 
in response to therapeutic intervention.  Functional impairments for which 
treatments would be necessary or beneficial should be defined and assessed in 
the context of any instrument developed. Measurement development should also aim 
to reliably and validly distinguish depression from the many other physical
disorders with overlapping symptoms, for example, fatigue, sleep problems, and 
changes in eating behavior.  Applications emphasizing method development 
proximal to the development of a depression assessment tool will also be 
considered.  Collaborations are expected between scientists examining basic 
behavioral processes, (e.g., emotion, motivation, cognition), researchers 
studying the behavioral biology of mood disorders, clinical investigators 
studying the etiology, course or treatment of depression, and experts in 
contemporary measurement theory.

RESEARCH OBJECTIVES

Background

Depression is a serious mental disorder that ranks as one of the leading causes 
of disability in developed countries.  The core presenting features of 
depression are essentially psychological in nature, i.e., reports of dysphoric 
mood, anhedonia, and feelings of hopelessness and guilt.  Vegetative signs such 
as sleep and eating disturbances are also frequently present.  While proper 
assessment is critical to meet the primary purposes of diagnosis (demonstrating 
presence of pathology, guidance for treatment selection), the assessment of 
depression has long been difficult due to the subjective nature of reports of 
disturbed mood and difficulties in knowing which aspects of particular symptoms 
to emphasize.

Historically, diagnostic measures of depression have utilized two modes:  
patient self-report of symptoms or clinician rating of patient symptoms.  
Measures in each of these traditions have been widely used for multiple purposes 
with broad public health implications, including validation of the utility of 
new medications for treatment and identification of candidates for various 
treatments of depression.  The most widely used instruments in treatment 
development and clinical settings have relied on global indices of depression 
(i.e., one summary score of severity of depression), failing to target or 
provide ratings of specific symptom clusters or dimensions (e.g., sleep 
difficulties, hopelessness, various forms of cognitive bias) which may reflect 
more precise targets for treatment. More precise description of symptom clusters 
derived from empirical advances in the field will likely sharpen the measurement 
of clinical status and increase the clinical and research utility of depression 
assessment tools.

Advances in depression research and treatment development are highly dependent 
on the quality of instruments to measure or classify the pathology and its 
expressed symptomatology. No reliable biological markers or valid behavioral 
tests exist that could help define the exact nature of depression and 
disentangle issues of comorbid pathologies, or co-occurring syndromes or 
clusters of symptomatology. Accordingly, diagnostic and classification systems 
have principally relied upon clinical description and the naming of behavioral 
signs and symptoms to define the syndrome (e.g., sad mood, sleep difficulties 
diminished interest).  Recent advances in understanding the nature of depression, 
its course and treatment, and risk factors for its onset and recurrence invite 
the development of new tools for assessing components of the disorder.  For 
example, the nature and incidence of depression varies across the lifespan, 
negative cognitive styles or negative information processing, when coupled with 
stressful events, place an individual at elevated risk for depression, a 
ruminative coping style is predictive of longer and more severe episodes of 
depression and appears to enhance negative cognitions, stressful life events 
predict the onset of new episodes of depression, hopelessness appears to mediate 
the relation between the cognitive vulnerability-stress interaction and 
depressive episodes, and primary depression has been associated with a variety 
of neuroendocrine, neurochemical, neurophysiological, and neuromorphometric 
abnormalities. Furthermore, the co-occurrence of major depression with other 
disorders (e.g., drug/alcohol abuse/dependence) or symptom clusters (e.g., 
anxiety) tends to be the rule, with "pure" cases of depression presenting in 
exceptional cases. Theoretical and empirical work in recent years has addressed 
the co-occurrence of depression and anxiety and there is growing evidence that 
dimensional factors (e.g., negative and positive affect, physiological arousal) 
may facilitate our definition of the core components of depression.

These recent advances have highlighted a growing realization that depression is 
not a single entity, but rather a heterogeneous complex of disorders.  
Assessment tools need to deal effectively with such heterogeneity for several 
reasons.  First, different forms of depression may respond differentially to 
various treatment modalities, or have a different course.  However, the 
traditional assessment and diagnosis of depression has proved insensitive for 
the identification of likely responders to existing psychosocial and 
psychopharmacological treatments.  Second, the complete mapping of the human 
genome raises the possibility of relating disorder subtypes to specific genetic
vulnerabilities.  Third, advances in techniques to study neuropathophysiological 
processes facilitate the study of associations between clinical phenomena and 
the neural substrates of mood and emotion.  Refined measurement is a 
prerequisite for studies that examine such associations, link genetic diatheses 
to particular forms of disorder, or guide the precise tailoring of future 
therapeutics.

Advancing the field of depression research will require the talents of 
investigators from diverse traditions working together.  In the past decade, 
investigators in the fields of basic behavioral science and cognitive 
neuroscience have made significant advances in understanding fundamentals of 
behavior and brain functioning relevant to mood disorders.  For example, there 
is a well-established literature on the effects of mood on information 
processing in normal subjects and a complementary literature on information 
processing abnormalities observed in depressed individuals.  Simultaneously, 
notable advances have been made in the field of measurement theory and 
psychometrics.  Methodological advances in the field of educational psychology, 
for example, could be particularly informative to investigators developing tools 
for psychopathology assessment.  Also, the use of item response theory would 
allow depression measurement investigators to examine item bias or differential 
item functioning in order to develop a tool best protected against group biases.  
However, there have been limited opportunities for collaboration among 
scientists with expertise in clinical psychopathology, basic behavior and 
cognition, and psychometrics.  Thus, there exists great opportunity and need for 
the interdisciplinary collaboration of scientists in the service of advancing 
the assessment of depression.

Investigators responsive to this RFA will assemble an interdisciplinary team 
(e.g., clinical psychopathology investigators, behavioral scientists, cognitive 
neuroscientists, psychometricians, and statisticians) appropriate for the 
development of a measure or assessment battery for depression in the context of 
recent advances in relevant research areas.  This team will use their 
complementary skills and advanced psychometric techniques, such as item response 
theory, adaptive testing, and computational modelling, to develop an optimal 
measure or set of measures for depression.  Studies responsive to this RFA will 
incorporate recent advances in measurement theory and methods when developing 
the measure and evaluating the instrument"s psychometric characteristics (e.g., 
construct validity, internal consistency, inter-rater reliability, and test-
retest stability), and screening properties (e.g., sensitivity, specificity, and 
predictive power).  The measure must demonstrably be: (1) suitable for tracking 
changes in symptoms and functioning as a repeated measure over time or in 
response to therapeutic intervention, (2) time-efficient, and (3) cost-efficient.

The tools developed should address validated components of depression such as:  
depressed mood, hopelessness, anhedonia, psychomotor retardation, sleep 
disruption, fatigue or loss of energy, diminished ability to think or 
concentrate, disturbed self-image (i.e., feelings of worthlessness or excessive 
guilt) and suicidal ideation. Since the number and type of items that are 
included in a scale will likely obviously influence the total score value, it is 
expected that the research will include efforts to define core components or 
dimensions of depression that are supported by empirical data, and which may be 
useful in assessing severity, guiding treatment decisions, or predicting outcome.  
To the extent that individual differences in the patterning of severity or 
impairment across these different dimensions may provide an avenue for 
addressing the heterogeneity of depression and offering specific targets for 
treatment, strong consideration should be given to the possibility of batteries 
with validated subscales in addition to a single, overall depression score.

Any measure developed needs to be appropriate for both sexes, individuals of 
diverse cultural backgrounds, valid for individuals at various stages of 
development (i.e., children, adults, elderly), and sensitive to individuals with 
various co-morbid medical conditions.  Tools developed must also be suitable for 
use in diverse settings including clinical trials based in academic centers, 
community-based mental health centers, drug/alcohol treatment programs and 
institutions (e.g., jails/prisons).

Applications must feature the types of translational partnerships described in 
the report of the National Advisory Mental Health Council"s Behavioral Science 
Workgroup, "Translating Behavioral Science into Action" 
(http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm).  An example for this particular 
initiative would be a partnership between experts in advanced psychometric 
techniques and clinical psychopathology.

Below are examples of research areas and questions that could advance scientific 
knowledge regarding the description and assessment of depression.  The list is 
not exhaustive, and it is expected that additional important research topics may 
be identified.

o  Development of an instrument or set of measures with one or more subscales 
based upon a theoretical model of depression substantiated by behavioral, 
psychophysiological, cognitive, self-report, and/or biological measures of the 
fundamental "core" components of the disorder

o  Development of a new rating scale to assess proposed core components of 
depression (e.g., mood lability, guilt and worthlessness, and loss of capacity 
to experience pleasure).  The identification of core components should be guided 
by empirical evidence of the validity of such components.

o  Development of an instrument appropriate for children and/or adolescents 
which is sensitive to developmental stages and relies on multiple informants.

o  Development of methods for assessing affect regulation which will inform our 
understanding of the activation and termination of negative affect.

o  Development of one or more procedures to assess cognitive regulation in 
depression, such as measures of attention or memory, which demonstrate disorder-
related biases.

o  Development of instruments/procedures to assess fluctuations in vulnerability 
to depression, such as that resulting from stressful life events, drug/alcohol 
abuse and medical illness.

o  Development of new approaches to conceptualizing and measuring depression 
that incorporate the inherent co-occurrence of various anxiety symptom clusters 
or disorders (somatic anxiety, social anxiety disorder, generalized anxiety 
disorder, etc.)

o  Development of new approaches to conceptualizing and measuring depression in 
the context of co-morbid medical conditions and their treatment (e.g., hepatitis 
C, HIV/AIDS).

o  Development of scales to measure impairment in functioning or quality of life 
in mood disorders.

o Development of new approaches to conceptualizing and measuring depression and 
vulnerability to depression in the context of drug/alcohol abuse/dependence, 
including maintenance use, states of intoxication/withdrawal, and enrollment in 
drug/alcohol treatment.

o Development of new approaches to conceptualizing and measuring the 
relationship of depression to drug/alcohol abuse patterns, (e.g., drugs of 
choice, polydrug use, bingeing, injection use) and drug/alcohol relapse in 
individuals with periods of sobriety.

MECHANISM OF SUPPORT

This RFA will use NIH Research Project Grant (R01) and the Exploratory/ 
Developmental Grant (R21) award mechanisms.  As an applicant you will be solely 
responsible for planning, directing, and executing the proposed project.  This 
RFA is a one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 1, 2003.

This RFA 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.

FUNDS AVAILABLE

The NIMH intends to commit approximately $1,500,000 in FY 2003 to fund 4 to 7 
new and/or competitive continuation grants in response to this RFA.  The NIDA 
intends to commit approximately $500,000 in FY 2003 to fund 2 to 3 new grants in 
response to this RFA.  NIDA"s R21 Exploratory/Developmental announcement can be 
found at 
http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html.  A research project 
grant (R01) may involve either a single Principal Investigator or a group of 
investigators using the Collaborative R01 mechanism, applicants may request a 
project period of up to 5 years, with a budget determined by the work proposed.  
Applicants for the Collaborative R01 Grant are strongly encouraged to 
familiarize themselves with the NIMH announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) and direct questions 
to program staff listed in this announcement.  An applicant may request a 
project period of up to 3 years and a budget for direct costs of up to $125,000 
per year for a Developmental/Exploratory Grant (R21).  For those applications 
that include a subcontractual/consortium arrangement, direct costs of up to 
$150,000 per year may be requested to allow for F&A costs on those consortium 
arrangements.  Because the nature and scope of the proposed research will vary 
from application to application, it is anticipated that the size and duration of 
each award will also vary.  Although the financial plans of the IC(s) provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  At this time, it is not known if this RFA will be reissued.

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 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 inquiries concerning this RFA 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:

Regina T. Dolan-Sewell, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6183, MSC 9625
Bethesda, MD  20892-9625
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  [email protected]

Sander G. Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1801
FAX:  (301) 594-6566
Email:  [email protected]

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

Brian Albertini
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD  20892-9625
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  [email protected]

Gary Fleming, J.D., M.A.
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3119, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  [email protected]

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel 
o  Participating institutions
o  Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Regina T. Dolan-Sewell, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health, NIH
6001 Executive Boulevard, Room 6183, MSC 9625
Bethesda, MD  20892-9625
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email: [email protected]

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: 
[email protected].

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.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the Checklist, and three 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)

At the time of submission, two additional copies of the application must be sent 
to:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9625
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  [email protected]

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial revisions of 
applications already reviewed, but such applications must include an 
Introduction addressing the previous critique.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the participating ICs.  Incomplete applications will be 
returned to the applicant without further consideration.  And, if the 
application is not responsive to the RFA, CSR staff may contact the applicant to 
determine whether to return the application to the applicant or submit it for 
review in competition with unsolicited applications at the next appropriate NIH 
review cycle.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIMH in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will 
be discussed and assigned a priority score
o  Receive a second level review by the National Advisory Mental Health Council 
and 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.

(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:

o 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.

o 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)

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    September 15, 2002
Application Receipt Date:         October 15, 2002
Peer Review Date:                 February 2003
Council Review:                   May 2003
Earliest Anticipated Start Date:  July 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic 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://grants1.nih.gov/grants/guide/notice-files/not98-024.html

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance Nos. 93.242 (NIMH) and 93.279 (NIDA) 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 (cite other relevant policies) and 
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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