MENTAL HEALTH CONSEQUENCES OF VIOLENCE AND TRAUMA

RELEASE DATE:  March 12, 2004

PA NUMBER:  PA-04-075 (see NOT-MH-04-005)

This funding opportunity has been reissued as PA-07-312 (R01), PA-07-313 (R03), 
PA-07-314 (R21), PAR-07-315 (R34).  All of these mechanisms now use the electronic 
SF424 (R&R) application.

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. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03, R21 and R34 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03, R21 and R34 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 of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

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

Through this Program Announcement (PA), the National Institute of Mental Health 
(NIMH) seeks to encourage investigator-initiated research to enhance scientific 
understanding about the etiology of psychopathology related to violence and trauma, 
as well as studies to develop and test effective treatments, services, and 
prevention strategies in this area.  The NIMH mission encompasses the conduct and 
support of biomedical and behavioral research, as well as the translation and 
testing of scientifically generated information into clinical applications, 
interventions, and services.  In the last several years, various programs of the 
NIH and NIMH have organized and participated in scientific meetings concerning 
acute reactions to trauma and risk for psychopathology, disaster mental health, 
mass violence (terrorism, bioterrorism), as well as exposure to domestic and 
community violence.  This PA reaffirms the NIMH’s long-standing interest concerning 
mental health research on trauma and victimization and also reflects recent 
suggestions that have emerged from the above-mentioned scientific meetings.

Emerging areas of particular interest to the NIMH concern acute reactions to 
trauma, risk for psychopathology, translation of basic behavioral and neuroscience 
findings on resiliency and risk for intervention development and testing, and 
strategies for effective service provision, particularly where non-specialty 
systems (i.e., primary care) may be required to provide mental health services.  
These areas incorporate research needs regarding interpersonal violence (e.g., 
victims/survivors of child abuse and neglect, violence against women, hate crimes); 
exposure to mass violence/major traumatic events (e.g., terrorism, major accidents, 
combat and war, refugee trauma and relocation, torture, natural and technological 
disaster); exposure to family, school, and community violence; violence in the 
media; and other types of trauma and victimization.  Populations of concern include 
children, youth, adults, the elderly, men and women, and all racial and ethnic 
groups.

A great deal has been learned and applied to improve the mental health of 
traumatically stressed persons.  For instance, research on the course and 
expression of symptoms helped identify risk and protective factors, age-specific 
psychosocial and behavioral responses to traumatic stress, and new intervention 
strategies.  Despite the growth of research on traumatic stress, predicting which 
traumatized individuals will go on to develop mental disorders and serious 
functional impairment remains a challenge.  Other challenges include understanding 
how to maintain and enhance resilience; finding and refining effective treatments 
for all who suffer from often debilitating disorders; and achieving a better 
understanding of the most effective means of organizing, implementing, financing, 
and delivering mental health services, including quality and outcomes of care.  The 
need for focused, systematic research in these areas provides the impetus for this 
PA.

Although not participating in this program announcement, the National Institute of 
Child Health and Human Development (NICHD) shares an interest in this area of 
research.  For specific information on NICHD interests, see 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-096.html and 
http://www.nichd.nih.gov/crmc/cdb/p_cog.htm.

RESEARCH OBJECTIVES

Background

The effects of experiencing traumatic stress, either as a witness or direct victim, 
are a major public health problem in the United States, with consequences of 
potentially severe psychological, behavioral, medical, and social dysfunction, 
including Post Traumatic Stress Disorder (PTSD) and other anxiety disorders, 
depression, and psychotic conditions, as well as injury and death.  Gaps exist in 
the fundamental knowledge of psychosocial implications of traumatic stress, 
particularly with regard to the development of children and adolescents.  It is 
clear that simple models about the direct effects of early exposure to trauma and 
adversity are incomplete.  Early trauma does not equate simply and consistently to 
complex psychopathology.  A variety of research approaches can provide needed 
insights into the nature, cause, and pathogenesis of posttraumatic psychopathology 
including:  assessment and measurement research on violence exposure and its 
consequences, theory-guided research on risk and protective factors, studies of 
mediators and moderators of exposure to various and multiple forms of violence and 
their consequences, and basic research on cognitive processing, arousal, and 
memory, as well as neurobiological, neurophysiological, neuroanatomical, and 
functional consequences of exposure to traumatic stress.  This information in turn 
can inform the further development of theoretically driven interventions and 
services, ultimately making prevention of trauma-related psychopathology a 
pragmatic goal.

Trauma affects a large number of people.  Self-report surveys suggest that millions 
of children are physically abused each year, and hundreds of thousands are victims 
of sexual abuse (National Clearinghouse on Child Abuse and Neglect Information 
http://nccanch.acf.hhs.gov/).  School shootings in Littleton, Colorado and in 
other communities have caught the Nation’s attention and galvanized scientific and 
social concerns.  While lethal violence has actually been decreasing over the last 
decade, levels of non-lethal violence in schools have not been decreasing and are 
of concern.  Each year many children and adolescents sustain injuries from 
violence, they lose friends or family members, or they are adversely affected by 
witnessing a violent or catastrophic event.  Annually, approximately 500,000 
persons report rapes and sexual assaults.  Other forms of physical assaults on 
women by their partners are widespread (Department of Justice 
http://www.usdoj.gov/).  A recent review of disaster studies highlights that 
natural disasters, technological disasters, and mass violence, including terrorism 
in the U.S., other developed countries, and in developing countries, can have 
severe impacts on those affected (Norris, 2001).  Although long-term mental health 
outcome data regarding the terrorist attacks of September, 2001 are not yet 
available, preliminary national data and early findings from studies conducted in 
the most directly impacted communities underscore the capacity of man-made 
disasters to cause clinically significant psychobiological disorders, emotional 
distress, and impairment.  The World Health Organization report on Violence and 
Health (2000) underlines the heavy cost of violence and trauma in health effects, 
in both financial losses from injury and decreased productivity as well as 
psychological and behavioral problems that may extend to permanent physical and 
mental disability.

Research Goals and Topics

Several areas stand out as priorities for future research on the mental health 
consequences of traumatic stress.  Broadly stated, needs include:  basic, clinical, 
and genomic studies of the mental health consequences of traumatic stress and the 
development and testing of interventions to assist victims and survivors.  
Specifically, knowledge is sought regarding methods for measuring various types of 
exposure, the pathological sequelae of various types of traumatic events, gene-
environment interactions that influence risk/susceptibility and resiliency, 
treatment alternatives, and preventive options.

Much can be learned from research involving various types of trauma (e.g., 
interpersonal violence and crime, child abuse and neglect, family violence, and 
community violence) and from basic, pre-clinical, and clinical research  (e.g., 
animal models of stress, as well as human studies of molecular and cellular brain  
function in the context of trauma).  Major areas of interest for the NIMH include 
research assessing acute responses to trauma, risk for long-term adjustment 
problems, translational research to better understand early experiences, emotion 
regulation, and the development of stress-sensitive neurobiological systems and 
their relevance as targets for preventive interventions.  Research in these areas 
will improve the ability to predict who is at greatest risk for developing mental 
disorders and what is the optimal time to intervene and how.  Specific 
developmental areas that require additional exploration include defining critical 
aspects of exposure, taking into account cognitive, emotional, and neurobiological 
limitations in young children.  The examination of potentially modifiable factors 
and processes involved in reactions to trauma, which are indicative of risk and 
resiliency, are also of interest to the NIMH.

The events of September 11, 2001 and the ensuing national reactions to terrorism 
and threat of terrorist attacks highlight a significant long-term goal of 
developing and testing models for organizing and deploying emergency mental health 
response to mass trauma.  Another major area of interest for the NIMH is research 
on the efficacy and transportability of various forms of therapy and counseling 
techniques.  Cognitive restructuring, public education on symptoms and coping 
strategies, supportive counseling, and various types of “exposure” therapy may help 
reduce incidence, duration, and severity of Acute Stress Disorder, Posttraumatic 
Stress Disorder, and Depression in response to a variety of traumatic events.  
Areas ripe for exploration include approaches that seek to enhance coping and self-
efficacy and teach cognitive skills for managing emotional and physiological 
responses.

There is a need to study methods to rapidly deploy available effective 
interventions for large numbers of survivors/victims.  Likewise, there are 
questions about the most appropriate time to intervene and with what type of 
intervention, and whether one type of intervention (or perhaps no intervention) is 
more appropriate immediately following the trauma.  Novel collaborations among 
neuroscientists, behavioral scientists, and clinical scientists in order to develop 
integrative and cutting edge research projects are encouraged.  This approach is 
consistent with the NIMH’s interest in translational research and the formation of 
cross-disciplinary groups of scientists interested in studying the etiology of 
trauma and stress related psychopathology and the implications for assessment and 
treatment.

The topics listed below are additional examples of studies that fall under the 
scope of this program announcement.  The list is not exhaustive; it is expected 
that investigators who respond to this program announcement will identify 
additional important topics.

o  Animal studies of the biological and behavioral effects of unpredictable and 
uncontrollable stress and trauma.

o  Prospective studies of groups of individuals who are at risk due to individual 
characteristics and/or occupational status, to identify risk and protective factors 
for developing a disorder following one or more traumatic events.

o  Mechanistic and descriptive studies of behavioral and biological regulation and 
dysregulation in humans associated with stress and trauma.

o  Clinical studies examining how the severity of trauma is linked to neural 
functioning, processing of memories, and interpretations of trauma (e.g., 
qualitative studies) and functional disability.

o  Interdisciplinary research to better understand biological and behavioral 
parameters important for extinction of negative imagery.

o  Studies of the bi-directional nature of parent-child adaptation to stress and 
trauma.

o  Studies of interactions among psychosocial, contextual, and biological risk; and 
protective factors that increase or decrease risk for and course of psychopathology 
(escalation, persistence, and cessation), including the role of social supports, 
community factors, cultural issues, etc.

o  Research on the contributions of sleep patterns, comorbid disorders including 
substance abuse, and pathophysiological indicators of stress and anxiety, including 
the failure to extinguish negative imagery.

o  Studies of stress responses following a trauma to determine if PTSD symptom 
severity, if PTSD symptom persistence, and/or if efficacy of 
treatment/intervention/services depends on the type of trauma and any gene-
environment interactions that may take place.

o  Studies that examine the neurobiological and functional consequences of exposure 
to violence; and the brain regions/systems that are vulnerable and how these 
regions/systems are further affected by age, pre-trauma, trauma, and post-trauma 
characteristics/factors.  Studies that examine alterations in attentional capacity, 
regulation of affect, stress reactivity, control of motor activity, executive 
functions, linguistic and cognitive capabilities, community and role functioning, 
etc.

o  Theory driven intervention studies that test the efficacy and refinement of 
individual, family, organizational, and/or community-level models; and, methods of 
referral and diagnosis, prevention, treatment, and services.

o  Longitudinal studies that examine the potential value of early interventions for 
trauma-exposed children and adults, for prevention of anxiety, depressive, and 
substance use disorders.

o  Research on combined therapies involving new medications and/or psychosocial 
therapies, and/or other rehabilitation strategies to achieve a rapid onset of 
clinical response, maintain symptom reduction, or maximize community integration 
and functioning.

o  Research on whether particular interventions like those involving prolonged 
exposure are more appropriate after a certain time period has passed since the 
traumatic event, and/or specific symptomatology has developed.

o  Pilot studies to explore combining and sequencing interventions (psychosocial 
and medication) over time.

o  Feasibility studies to assess the efficacy of novel drug candidates alone and in 
combination with psychosocial therapy to reduce clinical symptoms and provide 
prophylactic protection.

o  Studies of the organization, delivery, outcomes, and financing of care in 
nontraditional mental health settings (e.g., school, faith-based, or primary care) 
and systems that become default providers in times of crisis (e.g., after 
disasters, school shootings, and other  types of mass trauma)

o  Studies to identify neurobiological and functional mechanisms underlying 
effective interventions.

o  Studies to identify the decision-making, provider-client interaction, 
organizational, and systems level factors underlying effective service delivery.

o  Intervention studies that explore patient and treatment parameters relevant to 
optimizing interventions for trauma-exposed children and adults.

o  Studies related to the identification and treatment of PTSD in trauma-related 
anxiety and depression among high-risk and vulnerable populations (e.g., 
incarcerated and homeless populations, including juveniles).

MECHANISM(S) OF SUPPORT

This PA will use the NIH Research Project Grant (R01), Exploratory/Developmental 
Grant (R21), Clinical Exploratory/Developmental Grant (R34), 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 R01 application submitted in response to this PA 
may not exceed 5 years.  The Exploratory/Developmental Research Grant (R21) 
provides 2 years of funding with a maximum of $275,000 direct costs for each year 
over the entire budget period; with no single year exceeding $200,000 (see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).  The R34 mechanism 
provides up to $450,000 direct costs for 3 years with no single year exceeding 
$225,000 for research on 1) the development and/or pilot testing of new or adapted 
interventions, 2) pilot testing interventions with demonstrated efficacy in broader 
scale effectiveness trials, or 3) innovative services research directions that 
require preliminary testing or development (see 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html).  The Small Grant 
(R03) provides 2 years of funding with a maximum of $50,000 direct costs for each 
year (see http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html).

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:

Dr. LeShawndra Price
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
Email:  lprice@mail.nih.gov

Dr. Denise Juliano-Bult
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3364
Email:  djuliano@mail.nih.gov

Dr. Susan Brandon
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7218, MSC 9651
Bethesda, MD  20892-9651
Telephone:  (301) 443-9400
Email:  sbrandon@mail.nih.gov

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

Rebecca Claycamp, CRA
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2811
Email:  rclaycam@mail.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) 435-0714, 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 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 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 the 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 mailed on or before the receipt dates 
described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA that is essentially the same 
as one currently pending initial review unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is essentially the same 
as one already reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such application must include an 
Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  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 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 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?

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 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:  Starting with the October 1, 2003 receipt date, 
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.  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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal regulation under 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  Those who 
must comply with the Privacy Rule (classified under the Rule as “covered entities”) 
must do so by April 14, 2003  (with the exception of small health plans which have 
an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr/) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals for 
NIH funding must be self-contained within specified page limitations.  Unless 
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be 
used to provide information necessary to the review because reviewers are under no 
obligation to view the Internet sites.  Furthermore, we caution reviewers that 
their anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This PA is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.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

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