FOGARTY INTERNATIONAL COLLABORATIVE TRAUMA AND INJURY RESEARCH TRAINING 
PROGRAM (ICTIRT) 

RELEASE DATE:  April 2, 2004

PA Number:  PAR-04-083

EXPIRATION DATE:  August 26, 2006 unless reissued. 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH) 
 (http://www.nih.gov) 
Centers for Disease Control and Prevention (CDC) 
 (http://www.cdc.gov)
World Health Organization (WHO) 
 (http://www.who.int) 
Pan American Health Organization 
 (http://www.paho.org)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

Fogarty International Center (FIC/NIH) 
 (http://www.fic.nih.gov) 
National Heart, Lung and Blood Institute (NHLBI/NIH) 
 (http://www.nhlbi.nih.gov) 
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH) 
 (http://www.nibib.nih.gov) 
National Institute of Nursing Research (NINR/NIH) 
 (http://www.ninr.nih.gov/) 
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH)
 (http://www.niaaa.nih.gov) 
National Institute of Mental Health (NIMH/NIH) 
 (http://www.nimh.nih.gov)
Office of Behavioral and Social Sciences Research (OBSSR/NIH) 
 (http://obssr.od.nih.gov/) 
Office of Research on Women’s Health (ORWH/NIH) 
 (http://www4.od.nih.gov/orwh/)
National Center for Injury Prevention and Control (NCIPC/CDC) 
 (http://www.cdc.gov/ncipc/) 

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  FIC 93.989; NHLBI 
93.837, NIBIB 93.286; NINR 93.361, NIMH 93.242, NIAAA 93.273 

LETTER OF INTENT RECEIPT DATE:  July 25, 2004;  July 25, 2005;  July 
25, 2006  

APPLICATION RECEIPT DATE:  August 25, 2004;  August 25, 2005;  August 
25, 2006
   
THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Training and Training Objectives
o  Mechanism of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
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

The Fogarty International Center (FIC), in partnership with the 
National Heart, Lung and Blood Institute (NHLBI), the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB), the 
National Institute of Nursing Research (NINR), the National Institute 
on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of 
Mental Health (NIMH), the Office of Behavioral and Social Sciences 
Research (OBSSR), the Office of Research on Women’s Health (ORWH), the 
National Center for Injury Prevention and Control (NCIPC), Centers of 
Disease Control and Prevention (CDC), the World Health Organization 
(WHO) and the Pan American Health Organization (PAHO), invites 
applications from nonprofit, private or public, domestic educational 
and research institutions in developed countries to establish research 
training programs that contribute to the capacity of developing country 
investigators and institutions to conduct human trauma and injury 
research relevant to the health needs of the developing country.  
Applications are solicited to create innovative research training 
programs within existing NIH- or CDC-supported scientific 
collaborations between developed and developing country researchers to 
begin to build a critical mass of scientists, health professionals and 
academics with human trauma and injury expertise and a sustainable 
research environment at the collaborating developing country 
institution. 

The International Collaborative Trauma and Injury Research Training 
Programs will honor the memory of Dr. John "Jack" Furman Finklea, whose 
leadership and advice were instrumental in the creation and development 
of CDC's extramural injury control research grants program and a 
closely related FIC program, the International Training and Research in 
Environmental and Occupational Health (ITREOH) Program.  The program 
will enhance and promote equitable international collaborations between 
investigators in the developed world and those in low- and middle-
income nations (see World Bank definition at 
http://www.worldbank.org/data/databytopic/GNIPC.pdf) where a base level 
of institutional infrastructure for the advancement of sustainable 
trauma and injury science is already established.  Each proposed 
program should provide opportunities to generate the combined expertise 
at the developing country institution that could contribute to the 
long-term goal of harnessing new injury knowledge and skills to assess, 
diagnose, prevent or ameliorate acute and long-term morbidity and 
mortality stemming from a health issue with a significant injury 
component.  The burden of disease and the biological, behavioral, and 
psychosocial changes that result from such trauma and injury should 
produce substantial public health cost in that country.  Programs 
should include training in one or more of the following areas:  injury 
statistics and epidemiology, prevention, biological and behavioral 
sciences, clinical injury and trauma care, blood product research, 
rehabilitation programs or low-cost prosthetics, medical imaging such 
as low-cost imaging development, the use of technology to diagnose and 
localize injury, bioengineering methods and technology, mental health 
issues such as traumatic stress disorders (acute and post trauma 
phases), depression, suicide risk, post-trauma injury and nursing care 
issues and medical informatics.  Expertise should be developed 
simultaneously on the ethical, social and legal implications of human 
trauma and injury research in each program, as well as address 
diversity issues on a national or institutional basis.  Consideration 
of gender issues related to trauma is specifically encouraged.  The 
training programs supported will begin to address and reduce the 
growing disparity in injury sciences between those nations that have 
been at the forefront of such research and those with a limited but 
growing capacity in injury science in developing regions of the world. 

RESEARCH TRAINING OBJECTIVES

Background

Trauma and injury encompass one of the leading causes of death and 
disability in the world, with a greater proportion of the burden 
falling in the developing world, where resources, both financial and 
medical, are sorely lacking.  Six of the 15 leading causes of death in 
people 15 – 44 years old in the world are trauma-related.  More than 5 
million deaths per year are caused by trauma, intentional and 
unintentional.  In addition, trauma and injury are major contributors 
to disability.  In 1998, of the estimated 5.8 million people who died 
from injury-related causes, approximately 1.2 million died from road 
traffic accidents and violence, including 948,000 by suicide, 736,000 
from homicide and 588,000 from war.  The remainder died from other 
injuries, including falls, drowning, burns and poisonings.  For every 
person who dies of injuries, several thousand injured persons survive, 
but many suffer life-long health consequences.  The burden of disease 
attributed to injuries is expected to rise in the years ahead.  In 
fact, by the year 2020, it is projected that injuries will be the third 
leading cause of death and disability worldwide.  For people ages five 
to 44, trauma and injury account for at least five of the 15 most 
common causes of disability life years.  The 1999 CDC report “Traumatic 
Brain Injury in the United States:  A Report to Congress” identifies 
traumatic brain injury as the leading cause of death and disability 
among children and young adults.  CDC also notes that worldwide, of all 
types of injury, those to the brain are among the most likely to result 
in death or permanent disability.  In 1998, injuries accounted for 11 
percent of deaths worldwide.   Suicides were 16 percent of these.  

Alcohol is a major contributor to motor vehicle crash deaths and other 
unintentional injury deaths such as falls, drowning, burns, as well as 
intentional injury deaths.  For example, in the United States, 41 
percent of motor vehicle deaths involve a driver or pedestrian who had 
been drinking.  A recent review of published medical examiner studies 
covering a 20-year period in the United States revealed that 38.5 
percent of unintentional non-motor vehicle injury deaths tested 
positive for alcohol, as did 47percent of homicide deaths and 29 
percent of suicide deaths.

Americans suffer trauma while working or traveling abroad.  Road 
traffic accidents are the second leading cause of death for Americans 
abroad, according to statistics culled by the Maryland-based 
Association for Safe International Road Travel (ASIRT), a nonprofit 
organization that tracks road conditions and accidents in 54 countries.

These deaths and disabilities are most common in the poorest countries.  
According to World Health Organization (WHO) estimates, almost 90 
percent of deaths due to injuries take place in poorer countries.  This 
is true for all forms of such trauma including road accidents, war, 
homicides, and suicides.  The WHO Division of Injury has shown that in 
developing countries more than 70 percent of traffic deaths are among 
those who will never be able to afford a car.  Because infectious 
diseases and malnutrition are responsible for 16 million deaths per 
year, the impact of trauma and injury on premature mortality and long-
term disability is often overlooked.

The World Health Organization has deemed April 7, 2004 to be Road 
Safety Day.  On that day around the globe, hundreds of organizations 
will host events to help raise awareness about road traffic injuries, 
their grave consequences and enormous costs to society.  They will also 
contribute to spreading the word that such injuries can be prevented.  
Among its other research training purposes, this present PA is 
contributing to that effort.

The technical definition of an injury is "a bodily lesion at the 
organic level, resulting from acute exposure to energy (mechanical, 
thermal, electrical, chemical or radiant) in amounts that exceed the 
threshold of physiologic tolerance.  In some cases, for example, 
drowning, strangulation or freezing, the injury results from an 
insufficiency of a vital element."  Professionals in the injury field 
divide the causes of injuries into two categories:  "unintentional," 
which includes most injuries resulting from traffic accidents, burns, 
falls, and poisonings; and "intentional," which includes injuries 
resulting from deliberate acts of violence against oneself or others. 

Although injuries affect everyone regardless of age, sex, income or 
geographic region, some populations are more vulnerable than others.  
Data indicate that, for most types of injuries, people die at a higher 
rate in low- and middle-income countries and in the poorest sections of 
developed countries than in high-income countries.  The poor are at 
high risk for injury because they are faced with hazardous situations 
on a daily basis.  For example, pedestrians on unsafe, overcrowded, and 
poorly maintained roads are vulnerable to being hit by cars, buses, or 
other vehicles.  People living in homes lacking safety devices and 
precautions are more vulnerable to the risk of fires and burns.  

While residents in resource-poor settings are at greater risk for 
trauma and injury than those in wealthier regions, it is not possible 
to simply transfer technologies from developed nations to developing 
nations because the context in which injuries occur is different.  For 
example, road traffic injuries (RTI) are the leading cause of injuries 
across the globe.  In developed nations, changes in automobile 
engineering have contributed to a reduction in RTI morbidity and 
mortality.  In contrast, in developing nations, most of the injured do 
not own an automobile, making such technological changes of 
significantly less importance as protective factors.  Instead, other 
approaches such as road safety education become more important, but 
also need to be validated.  Similarly, developing nations face hazards—
such as landmines—that are rarely seen in developed nations.  These 
hazards create unique needs for low-cost technologies for trauma 
patients, e.g., prosthetics developed locally from local materials.

Other differences between developing and developed countries include 
the absence of trained emergency medical services personnel in most 
developing countries that lengthens the critical time period before 
trauma victims are seen by clinicians and contributes to increased 
morbidity.  For example, the mortality rates among seriously injured 
patients in Seattle was 35 percent; in Monterrey, Mexico, 55 percent; 
and in Kumasi, Ghana, 63 percent; with the differences attributed 
primarily to differences in the percent of pre-hospital deaths.  

Among the reasons why trauma and injury are so devastating in the 
developing world are inadequate systems of emergency care at both the 
community and hospital levels and inadequate infrastructure, such as 
paved roads, inequities in access to emergency response systems, as 
well as inequities in access to pre-hospital and hospital emergency 
services between urban and rural areas.  Other factors include 
constrained resources, need for enhanced administrative leadership in 
ministries of health due to poor recognition of the impact of trauma on 
national health, inadequate public education and public communication 
around injury prevention issues.  Compounding the problem is the fact 
that responsibility for injury prevention cuts across many 
administrative domains including public health, criminal justice, and 
road safety, among others.

The burden imposed by trauma and injury is not confined to the physical 
consequences of a single, acute event.  There is risk of significant 
mental health consequences associated with trauma and injury stemming 
from experiences such as child and elder abuse, criminal victimization, 
domestic violence, rape, torture, war, terrorism, natural and 
technological disaster.  In addition to psychiatric disorders such as 
post-traumatic stress disorder and depression, that can last for years, 
increased risk for severe functional impairment and disability creates 
a need for interdisciplinary researchers (e.g., public health, 
psychiatry, psychology, nursing, neuroscientists, biologists, 
prevention researchers, etc) to identify risk and protective factors 
for psychopathology, the development, testing and dissemination of 
innovative resource-modest models for outreach, prevention and 
treatment of trauma related disorders and adverse functioning among 
children, adolescents and adults within the developing country. 

Occupational injury and trauma are also of great importance.  Data from 
the National Traumatic Occupational Fatalities Surveillance System 
(NTOF) indicate that 93,929 civilians in the United States were killed 
on the job from 1980 through 1995.  The average annual fatality rate 
for this period was 5.3 per 100,000 workers.  From 1980 through 1995, 
the number of deaths recorded by NTOF decreased by 28 percent (from 
7,405 to 5,314), and the rate of death decreased by 43 percent (from 
7.46 to 4.25 cases per 100,000 workers).  The Census of Fatal 
Occupational Injuries (CFOI) fatality counts exceeded those of NTOF by 
about 1,000 in the years reported in both surveillance systems (1992–
1995).  Based on CFOI data, the rate of fatal occupational injuries 
declined by 7 percent between 1992 and 1997.  

Of particular interest are industrial accidents as developing countries 
progress toward industrialization, farm injuries, and violent acts.

For this PA, research training can include programs such as those 
related to prevention, treatment at the scene, emergency medical 
facilities and services, diagnostic imaging, post-acute care, and long-
term care including rehabilitation.  Diagnostic procedures especially 
low-cost techniques could be evaluated.  Training may include topics 
such as low-cost surrogate technologies for CT and MRI Scan, 
ventilators, optimal resuscitation fluids, blood substitutes, and 
materials to cover wounds in burn victims, integration of psychosocial 
services with other systems providing assistance to victims.  

Training Objectives

It is expected that each human trauma and injury research-training 
program supported will:

1.  Substantially increase the expertise of trainees from developing 
countries in human injury-related research and thereby strengthen 
sustainable human trauma and injury research within the developing 
country institutions by providing a crucial level of human trauma and 
injury expertise.  The building of capacity in developing countries to 
continue such research and research training for future generations of 
developing country scientists, nurses, and health professionals is a 
major part of this PA;

2.  Simultaneously increase trainee expertise in the legal, ethical and 
social implications of trauma and injury research.  

o   Address the many ethical questions that will arise in both treating 
the victims of trauma and injury who may not be able to give informed 
consent at the time of entry into the study and more generally in 
conducting research in developing countries.  

3.  Expand collaborative human trauma and injury research interactions 
between developed and developing country scientists, nurses, 
bioengineers and imaging researchers, or individuals, and other health 
professionals at the collaborating developing country institution;

4.  Generate data for research-based (evidence-based) decision making 
in injury disease clinical treatment and prevention programs, for 
creating guidelines and procedures for conducting human trauma and 
injury research and for informing national health care policy in the 
collaborating developing country including critical demographic factors 
such as gender; and,

5.  Stress an interdisciplinary approach that integrates behavioral, 
social, and basic human trauma and injury research with clinical 
training and public health priorities.

6.  Where appropriate, the design of research projects should take into 
account potential sex and gender differences that may affect the 
questions asked and the analyses performed.  These might include 
different responses to and impact of health interventions, differences 
in physiology, and different behavioral bases for disease prevention 
strategies.

Examples of research and training priorities include, but are not 
limited to, the application of epidemiologic methods and/or population-
based studies that examine trauma and injury in low- and middle-income 
countries including, for example: 

o  Patterns and trends in morbidity and mortality from different 
sources of trauma, outcome by demographic and gender characteristics;
o  Long-term impact related to rehabilitation needs, disability and 
loss of productivity; 
o  Treatment of injury and trauma in the acute phase at the scene or at 
first healthcare institution;
o  Post trauma physical and psychological rehabilitation including low-
cost prosthetics;
o  Development and testing of preventive interventions to shorten the 
course of psychological problems by early identification and rapid 
intervention
o  Post-trauma emotional rehabilitation to reduce chronicity of 
emotional problems, and prevent complications such as health, work or 
family problems
o  Development and testing of tools, models and algorithms which could 
facilitate assessment, utility and priority for injury services in 
developing countries; and be used in trauma or injury research studies;
o  Formation of interdisciplinary disaster research teams and protocols 
for rapid data collection efforts after trauma and injury in 
conjunction with national, state, and local authorities and 
researchers;
o  Identification of genetic factors that will maximize cerebral 
perfusion in the trauma or injury patient with brain injury;
o  Research to describe the symptoms of acute complications after 
trauma or injury and to identify the influencing factors;
o  Research on the ethical, legal and social implications of performing 
human injury research (as an adjunct to the other research training); 
and
o  Research related to the creation of low-cost diagnostic and 
treatment methods that might facilitate the recognition of specific 
sequelae to trauma and injury, and the development of preventive or 
ameliorative treatment options. 

The design of human trauma and injury research training programs must 
demonstrate that the critical mass of trauma and injury expertise at 
the collaborating developing country institution will increase over 
time (capacity building).  This must include activities, including 
research and a support structure to encourage trainees to return to 
their home countries on completion of training.  In addition, since 
trauma and injury is a multidisciplinary field, in order to build a 
critical mass of trauma and injury expertise at the developing country 
institution it is expected that trainees supported in each program will 
represent diverse academic backgrounds.  Trainees may include pre- and 
post-doctoral behavioral or biomedical scientists, physicians, nurses, 
or individuals from a variety of other academic disciplines.

Training Plan

1.  Applicants should design a training plan that attempts to fill 
specific gaps in human trauma and injury research expertise and 
expertise in the ethical, legal and social implications of this 
research at the collaborating developing country institution.  The end 
result should be a critical mass of scientists, nurses, and health 
professionals who will be able to conduct injury research, understand 
the pathophysiology and prevent or treat injury or the sequelae of 
injury in their country.  Proposals may incorporate a wide range of 
long- or short-term research training opportunities or a mixture of 
training possibilities that can be offered to a wide range of possible 
developing country participants.  

A proposed training plan should include developed country grantee 
institution-based research training.  However, applicants are expected 
to provide support and mentored research training that will be 
conducted at the trainees’ home institution in the developing country 
and overall at least 80 percent of the funding should be spent in the 
developing country or directly for the training of the developing 
country scientists.  This should take place to the greatest extent 
possible in order to promote sustainable and ongoing collaborative 
research once the training is complete.  Applicants are also strongly 
encouraged to include women and developing country ethnic minorities as 
trainees.  

FIC strongly encourages applications from women and individuals from 
underrepresented racial, ethnic and socially disadvantaged groups.  
Where appropriate, the design of projects should take into account 
potential sex and gender differences that may affect the questions 
asked and the analyses performed.  These might include different 
responses to and impacts of health interventions, differences in 
physiology, and different behavioral bases for disease prevention 
strategies

Applicants must address the ability of the trainee recruiting and 
selection process to capture the most qualified individuals and to 
include an adequate representation of men, women and ethnic minorities 
or socially disadvantaged population groups among the developing 
country trainees.

2.Long-term training (usually a minimum of two years) may include 
studies leading to an advanced degree or a mentored post-advanced 
degree experience.  Applicants should describe how the long-term 
training proposed would combine the acquisition of specific expertise 
to successfully answer a hypothesis-based or a technology-development 
driven human injury research question.  This should include the 
opportunity to acquire multidisciplinary knowledge about the 
biomedical, behavioral and public health impact and the related 
ethical, legal and social implications of performing human trauma and 
injury research to the greatest extent possible.  Research training 
opportunity may also include development or improvement of existing 
technology to prevent, diagnose and treat injury or trauma.  Long-term 
training should include academic trauma and injury courses taken at the 
grantee institution, as well as instruction in the responsible conduct 
of research, medical informatics, technical writing and English as a 
second language, if necessary.  

3.  Applicants are expected to develop, promote and facilitate short-
term training opportunities targeted toward the specific injury and 
trauma research needs of their developing country collaborators, which 
will directly enhance their research capabilities.  Short-term training 
may be offered on such topics as clinical or behavioral research 
methods, medical informatics, medical technologies such as tissue 
engineering, radiology, biostatistics, data management and intervention 
trial protocol development or in areas which support research efforts 
such as an institutional review board (IRB) and biosafety procedures, 
proposal writing and research administration skills.  When a short 
training course or workshop is given by one human trauma and injury 
research training program, it is expected that this activity will be 
open to trainees from the other training programs supported by this PA 
to the extent that this is feasible.  Likewise, training materials are 
expected to be shared, especially those developed in or translated into 
languages other than English. 

Types of Training

Training may include any or all of the following:

o  Long-term pre-doctoral training in human trauma, traumatic stress, 
and injury research associated with a human trauma and injury research 
study leading to a masters, Ph.D. or equivalent degree for individuals 
with or without previous research experience in this field.  Research 
training should relate directly to the Principal Investigator’s or co-
investigator’s collaborative research in human trauma and injury at the 
developing country institution and may range from two to five years.
o  Long-term post-advanced degree human trauma, traumatic stress and 
injury research associated with a human trauma and injury research 
study for developing country scientists and health professionals 
including human injury-related clinical training for approximately two 
years duration.
o  Short-term training in either the grantee or developing country 
institution (typically two to four weeks) in specific research methods, 
clinical, field or administrative skills related to human trauma, 
traumatic stress, and injury research associated with human trauma and 
injury research study efforts at the collaborating developing country 
institution for technicians, health care professionals and research 
administrative staff.
o  Short-term training of three to six months duration for individuals 
with advanced degrees or health care professionals conducted in the 
grantee institution in research methods or other skills, in order to 
support specific collaborative human trauma, traumatic stress, and 
injury research efforts at the developing country institution.
o  Advanced research training support (“re-entry” funding), generally 
for one to two years, to enable trainees with advanced degrees or 
health care professionals to continue mentored human trauma, traumatic 
stress, and injury research in their home country or to initiate 
independent human trauma, traumatic stress, and injury research 
projects related to ongoing collaborative research at the developing 
country collaborating institution.  It is expected that such research 
will be certified through the foreign country IRB, the domestic 
institution’s IRB and all such research projects will be reviewed by an 
independent peer review committee convened by the domestic institution.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) international 
research training grant (D43) award mechanism that limits facilities 
and administrative (F&A) costs to eight percent of allowable direct 
costs.  F&A costs up to eight percent can be requested in applications 
which include a subcontract to a foreign institution (see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html.  
The applicant organization must provide the necessary management for 
the transfer of funds and material to the collaborating developing 
country institution.  As an applicant, you will be solely responsible 
for planning, directing, and executing the proposed project.  

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 total project period for an application submitted in response to 
this PA may not exceed five years.  Continued support during this 
period depends on satisfactory performance as judged by:  annual 
progress reports; institution visits; participation in periodic 
meetings of program directors; career progress of trainees; continued 
“parent” research grant funding and the long term development of 
sustainable human trauma and injury research capacity at the 
collaborating developing country institution.  The International 
Collaborative Trauma and Injury Research Training awards will provide 
up to $150,000 per year in direct costs for up to five years of 
support.  

Trainees Stipends

Trainees (developing country graduate students and post-advanced degree 
participants) studying at the developed country grantee institution may 
be paid a stipend comparable to their professional experience similar 
to other equivalent trainees but not exceeding $45,000 per year in 
accordance with the grantee institutional policies while involved in 
long-term training at the grantee institution.  Applicants may wish to 
refer to the NRSA stipend levels described on the web site 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-023.html.  
(NRSA substitute pages, pre- or postdoctoral stipends)

Salary for Developing Country Faculty 

Professional and clerical support staff at the grantee developed 
country institution who provide major program administration or 
extended long-term training or conduct collaborative research with 
trainees at the developing country institution may receive salary and 
fringe benefits.  The total amount of salary and fringe benefits 
requested for all grantee faculty may not exceed $45,000 of direct 
costs per year in the budget request.  The administrative, training or 
teaching responsibilities and time commitment for personnel receiving 
salary should be thoroughly described in the budget justification.  
(Form 398 budget pages, personnel)

Consulting Fees for Developing Country Faculty 

Developing country institution faculty who provide major program 
administration at the developing country institution or participate in 
long-term training of participants at the developing country 
institution and grantee faculty or developing country faculty who teach 
short courses may receive a consulting fee not to exceed $3,000, in 
accordance with their institution’s policies.  No more than $10,000 of 
the direct costs per year may be requested for consultant fees.  The 
administrative, training or teaching responsibilities and time 
commitment for personnel receiving consulting fees should be thoroughly 
described.  (NRSA substitute pages- training related expenses)

Tuition, Fees and Insurance for Trainees

Funds for tuition, academic fees and self-only or family medical 
insurance for developing country trainees at the grantee institution 
may be requested.  Programs are encouraged to seek cost-sharing 
arrangements with the grantee institutions in order to provide reduced 
tuition for long-term trainees and tuition-free short courses.  (NRSA 
substitute pages, tuition, fees, insurance)

Travel for Trainees

o  Funds may be requested for one round trip economy class airfare per 
year (on U.S. carriers to the maximum extent possible) and local ground 
transportation for each long-term developing country trainee to travel 
to the grantee institution or for developing country trainees to 
participate in short courses or to attend scientific conferences.  
Funds may also be requested for developing country trainees and 
developed country grantees to present their results at an annual 
network meeting at the NIH for all grantees.  A mandatory annual 
meeting will occur for representatives of each awarded program.  FIC 
program staff must approve additional travel.  (NRSA substitute pages, 
trainee travel)
o  Funds may be requested for per diem and lodging for developing 
country trainees to participate in short courses or attend scientific 
conferences to present their results.  (NRSA substitute pages, trainee 
travel)

Training related expenses

o  Funds to support developing country participant training or research 
related costs at the grantee developed or developing country sites may 
be requested.  (NRSA substitute pages, training related expenses)

Faculty Travel for Developed Country Staff

o  Funds may be requested for one round trip economy airfare per year 
(on U.S. carriers to the maximum extent possible) for each grantee 
faculty participant providing extended training or participating in 
collaborative research to go to the developing country institution or 
teach short courses at the developing country institution.  FIC staff 
must approve additional travel. (PHS 398 pages, travel)
o  Funds may be requested for per diem and lodging for grantee faculty 
to teach short courses at the developing country institution.  (PHS 398 
pages, travel)
o  Funds should be requested for airfare, per diem and lodging 
comparable to U.S. government rates (see 
http://www.policyworks.gov/org/main/mt/homepage/mtt/perdiem/travel.htm) 
for the Program Director and the primary foreign collaborator to attend 
an annual network meeting in Bethesda, Maryland.  Inclusion of funds 
for trainees and other key personnel to attend these meetings is at the 
request of the applicant and at the discretion of FIC.  (PHS 398 pages, 
travel)

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the 
following characteristics:

o  Non-profit organizations
o  Public or private institutions, such as universities, colleges, 
hospitals, health professional schools and research institutions 
capable of meeting the objectives of the PA
o  Domestic institutions/organizations
o  Faith-based or community-based organizations

Only one application may be submitted from any given institution and an 
institution already having received an award may not apply for a second 
award from this same PA.  However, there may be opportunities in the 
future to apply for competing supplements, depending on availability of 
funds. 

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.

SPECIAL REQUIREMENTS

In order to be eligible, applicants must be the Principal Investigator 
or project director on an NIH, CDC, or Department of Transportation 
Trauma Centers “parent” research grant or training grant with 
appropriate infrastructure and interest related to trauma and injury 
topics, as outlined in the Research Training Objectives Section, with 
at least 18 months of active research support remaining at the time of 
application.  NIH- or CDC-sponsored research project grants (R series) 
or center grants, program project grants or cooperative agreements (P 
and U series) from one of the co-sponsoring NIH Institutes or Centers 
or from the CDC qualify as “parent” research grants.  Equivalent 
research or related institutional research training grants from NIH, 
CDC or other sources may qualify as “parent” research grants if 
approved by the FIC program officer before submission of the 
application.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as Principal Investigators.

The applicant training institution must demonstrate either an ongoing 
collaborative research relationship or high potential for development 
of collaborative research with the human trauma and injury researcher 
named as the primary foreign collaborator from a single foreign 
institution.  The foreign collaborators should be from Africa, Russia 
and Eastern Europe, Asia (except Japan, Singapore, South Korea and 
Taiwan), the Pacific Island region (except Australia and New Zealand), 
the Middle East (except Israel), Latin America and the Caribbean.  The 
primary foreign collaborator must either hold a full-time faculty 
research position or should have a full-time faculty position with a 
strong research commitment.  The individual may be based at a public or 
private university, health professional school (including school of 
public health, dental school, nursing school or medical school) or 
research institution that will allow him or her adequate time and 
provide appropriate facilities and resources to participate in the 
proposed human trauma and injury research training program. 

Training in the Ethical, Legal and Social Implications of Injury 
Research:  Applicants should address specifics related to training in 
the ethical, legal and social implications of trauma and injury 
research.  

Training in Responsible Conduct of Research:  Applicants must include 
plans for training in responsible conduct of research for long-term 
trainees and short-term trainees.  An award will not be made unless a 
description of such training is included.  The description should 
include the topics, format, faculty participation, instructional 
materials and the frequency and duration of the training provided.

Recruitment and Selection Plan:  The applicant institution must include 
a detailed plan describing the recruitment criteria and selection 
procedures for trainees and what criteria will be used to demonstrate 
that trainees will be reintegrated into their institution of origin 
upon return.  Degree candidates must meet all entrance requirements of 
the grantee degree-granting institution. 

If applicable, proposals should describe the mechanism for internal 
peer review of re-entry funding applications by a committee composed of 
grantee and developing country investigators from participating 
institution(s) to support human trauma and injury research projects at 
the developing country institution relevant to an injury-related health 
problem in that country to be conducted by returning trainees.  

Trainee Tracking System:  Applicants should describe their plans to 
track their trainees with respect to the short- and long-term impact of 
both human trauma and injury training and training in the ethical, 
legal and social implications related to trauma and injury research 
studies on their trainees.  Awardees will be required to track and 
document the long-term impact of this training program on: (1) the 
careers of all trainees; (2) the research capacity at the collaborating 
developing country institution from which the trainees originated in 
the developing world; (3) positions trainees assume upon completion of 
training; (4) the contributions of trainees to future international 
human trauma and injury research and intervention trial efforts 
supported either by NIH, CDC, or by other granting institutions.  
Examples of training impact might include data on (1) how training may 
have enabled participants to assume more responsible positions upon 
returning home, (2) how collaborations with former trainees resulted in 
the funding of human trauma, traumatic stress, and injury intervention 
trials or (3) collaborative research projects on which trainees were 
either PIs or co-investigators, or (4) research publications authored 
or co-authored by trainees supported by this program and (5) the impact 
of current and former trainees and training-related research supported 
under this PA on trauma and injury public health programs and policies 
in the foreign country.  The evaluation and impact of training 
resulting from each program will be considered an important criterion 
during   this PA.  The Fogarty International Center is developing a 
centralized trainee tracking system and awardees will be required to 
submit the above data to this system when it becomes live.

Research Involving Human Subjects:  Applicants must inform the FIC 
program staff that approval of research protocols involving human 
subjects has been obtained from U.S. and developing country ethics 
review committees registered under Institutional assurances with the 
Office of Human Research Protection, as well as foreign government 
agencies’ clearances, before research involving human subjects is 
initiated. 

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 three areas:  scientific/research, peer review, and 
financial or grants management issues.

o  Direct your questions about scientific/research issues to:

Aron Primack, M.D., M.A.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
Fax:  (301) 402-0779
Email:  primacka@mail.nih.gov

o  Direct your questions about peer review issues to:  

Hilary D. Sigmon, Ph.D., R.N.
Scientific Review Administrator, RM 5216
International Collaborative Programs, AARR
Division of Biologic Basis of Disease
Center for Scientific Review
6701 Rockledge Drive, Rockledge 2
Bethesda, MD  20892
Telephone:  301-594-6377
Fax:  301-480-2241
Email:  hilary.sigmon@nih.gov 

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

Mr. Bruce Butrum
Grants Management Office
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29-2220
Telephone:  (301) 496-1670
Fax:  (301) 594-1211
Email:  butrumb@mail.nih.gov

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 numbers of the Principal Investigator  
o  Names of other key personnel
o  Name and address of participating institutions
o  Number and title of this PA

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 CSR staff to estimate the potential review 
workload and plan the review.  Further information about this PA can be 
found at http://www.fic.nih.gov.  

The letter of intent should be sent by the date listed on the face 
page.  The letter of intent should be sent to:

Aron Primack, M.D., M.A.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220

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 document 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 form and the YES box must be 
checked.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten 
original of the application, including the Checklist, five signed, 
photocopies, and all appendix materials 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 on or before the 
application receipt date listed in the heading of this PA.  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 PA that is essentially 
the same as one currently pending initial review, unless the applicant 
withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This 
does not preclude the submission of a substantial revision of an 
unfunded version of an application already reviewed, but such 
application must include an Introduction addressing the previous 
critique.

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

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the FIC.  Incomplete and/or nonresponsive 
applications will not be reviewed.  

Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the CSR in accordance with the review criteria 
stated below.  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 the 
applications under review, will be discussed and assigned a priority 
score
o Receive a written critique
o Receive a second level review by an appropriate national advisory 
committee 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 the 
application in order to judge the likelihood that the proposed research 
training 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

Applicants must demonstrate specific relevant research support from NIH 
or CDC (eligible parent grant) or another funding source that will 
serve as the foundation for the research training proposed.  The 
scientific evaluation of each application will include an assessment of 
linkage between the proposed training and human trauma and injury 
research support for the PI and other co-Investigators and developing 
country collaborators.  Evidence of support for initiating the proposed 
human trauma and injury research-training program from the 
collaborating developing country institution and country must be 
submitted with the application.

The application does not need to be strong in all categories to be 
judged likely to have a major scientific or public health 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
1.  The need for the specific human trauma and injury research training 
proposed to fill the identified gaps in human trauma and injury 
research expertise at the collaborating developing country institution.
2.  The expected public health and scientific contributions related to 
the proposed human trauma and injury research training to address major 
health issues in the collaborating developing country.
3.  The potential to achieve independent and sustainable trauma and 
injury research capacity at the developing country institution through 
the proposed training efforts.

APPROACH
1.  The clarity and feasibility of the research training objectives.
2.  Adequacy of the research training plan to achieve the proposed 
research training objectives including:

o  A trainee recruiting, application and selection process that 
captures the most qualified individuals with the appropriate variety of 
professional backgrounds from the developing country who could most 
benefit from the training proposed (the proposed qualifications of 
potential candidates should be well described in terms of academic 
status and previous accomplishments and experience);
o  The process for determining appropriate trainee skill development 
plans, research project participation and mentorship;
o  For proposed long-term research training, the adequacy of the 
training opportunities to provide a breadth of knowledge in either 
academic-based or other studies including the legal, ethical and social 
implications of human trauma and injury research, while providing human 
trauma and injury research training to fill recognized gaps in 
expertise at the collaborating developing country institution;
o  If short courses or non-degree training are proposed, the adequacy 
of the mixture of long- and short-term training opportunities within 
the program as a means to achieve the overall objectives stated;
o  Appropriate assessment and enhancement of background skills through 
training in research-related areas such as those related to research 
safety, technical writing, statistical methods, good clinical practice, 
medical informatics, English as a second language (if necessary), etc; 
o  Process for periodic evaluation of short- and long-term trainee 
progress and mentoring activities;
o  Methods to monitor the long-term impact of the human trauma and 
injury research training experience on the subsequent careers of the 
trainees and on the capacity for human trauma and injury research in 
the collaborating developing country; and
o  Plans to include an adequate representation of women and ethnic 
minorities in the collaborating developing country among the developing 
country trainees.

INNOVATION
1.  Innovation in strategies for trainees to become actively involved 
in human trauma and injury research, clinical or public health 
research, development of ethical, legal and social guidelines and 
procedures for conducting human trauma and injury research or 
intervention trials conducted at the developing country institution.
2.  Innovation in training strategies to produce a critical mass of 
independent human trauma and injury researchers and build a sustainable 
human trauma and injury research training environment at the developing 
country collaborating institution during the course of the program.
3.  Creativity of plans to use modern information technology training 
to facilitate trainee access to electronic information resources, 
distance learning and collaborative interaction.

INVESTIGATORS
1.  Qualifications of the program director to lead and other faculty 
from the grantee and the collaborating developing country institution 
to participate as mentors in the proposed research training program.  
(The human trauma and injury research experience and training 
accomplishments should be included in addition to Biographical Sketches 
and Other Support forms for each faculty participant.)
2.  Qualifications of the program director or other faculty to provide 
research training and, if proposed, mentorship in research on the 
ethical, legal and social implications of performing human trauma and 
injury research in developing countries.
3.  Adequacy of the ongoing collaboration between the grantee and 
developing country investigators and their institutions to provide a 
suitable framework in which the proposed training will occur.
4.  Commitment to building a long-term partnership with the developing 
country institutions to develop a sustainable trauma and injury 
research capacity.

ENVIRONMENT
1.  The adequacy of the teaching and research facilities and other 
resources and the overall training environment at the grantee and 
developing country institutions.
2.  The grantee and developing country institutional commitments to 
international human trauma and injury research and training in the 
ethical, legal and social implications related to the trauma and injury 
research.  (Letters of commitment from appropriate institutional 
officials must be included in the application.)

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research training program.
o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research involving human subjects.  Plans for the recruitment and 
retention of subjects will also be evaluated. 
o  The adequacy of the proposed protection for participants, animals or 
the environment, to the extent they may be adversely affected by the 
project proposed in the application.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children, as appropriate, for the 
scientific goals of the research.  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.  

AWARD CRITERIA

Applications submitted in response to this PA will compete for 
available funds with all other recommended applications.  The following 
will be considered in making funding decisions:

o  The extent to which proposed training programs support and 
complement FIC and other NIH and CDC international human trauma and 
injury research efforts
o  The availability of funds
o  Program balance among critical research and public health training 
areas of emphasis, including the scientific interests of the co-funding 
NIH and CDC partners in this program
o  The geographic distribution among countries included in applications 
under consideration, including the strength of the rationale for a 
given program to be carried out in a specific country

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.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of 
research on hESCs can be found at http://stemcells.nih.gov/index.asp 
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the 
NIH Human Embryonic Stem Cell Registry will be eligible for Federal 
funding (see http://escr.nih.gov).  It is the responsibility of the 
applicant to provide, in the project description and elsewhere in the 
application as appropriate, the official NIH identifier(s) for the hESC 
line(s)to be used in the proposed research.  Applications that do not 
provide this information will be returned without review. 

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 287b) 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 (also cite 
other relevant policies)

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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