RELEASE DATE:  April 3, 2002

PA NUMBER:  PAR-02-092 

Update: The following update relating to this announcement has been issued: 

December 12, 2008 - This PA has been reissued as (PAR-09-048)

LETTER OF INTENT RECEIPT DATE:  Four weeks before the submission date

EXPIRATION DATE:  JUNE 2, 2005, unless reissued

National Institute of General Medical Sciences (NIGMS) 


o Purpose of this PA
o Research Objectives
o Mechanism(s) 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


The National Institute of General Medical Sciences (NIGMS) is 
announcing new guidelines for academic Research Centers in Trauma, 
Burn, and Perioperative Injury, which will supersede all previous 
announcements.  The goals for this centers program are to provide 
support to:

o Improve understanding of the biological processes invoked after 
traumatic or burn injury at all levels, including molecular and 
cellular, physiological, and multilevel integration of homeostatic loss 
and recovery

o Foster translational research, bringing basic scientific observations 
and principles into the clinical arena and using clinical observations 
to generate or validate mechanistic hypotheses 

o Foster interactions and communications within institutions and 
throughout the trauma community by outreach efforts that promote 
trauma, burn, and perioperative research at the institutional level.

Each Research Center must include patient-oriented research, be 
multidisciplinary in nature, and serve as a focal point, within the 
institution, for research on trauma, burn, and perioperative injury. We 
encourage the involvement of scientific expertise and approaches that 
have not usually been associated with this research.  To facilitate 
communication throughout the community of trauma, burn, and 
perioperative injury, the Research Centers will become part of a 
network of researchers and institutions that will meet annually.



Injury is the leading cause of death for Americans under the age of 44 
years.  The years of potential life lost due to trauma are significant.  
Based on recent data from the National Center for Health Statistics 
(see, trauma related to accidents 
results in the death of more than 93,000 individuals per year in the 
United States and, as a cause of death, ranks fifth after heart 
disease, cancer, stroke, and lung disease.  Taking into account the 
potential years of life lost, the estimated cost of each trauma-related 
death in the United States is 2.4 times more than that of cancer and 
cardiovascular disease combined.  Based on the best available data, 
trauma will equal or surpass communicable diseases in 2020 as the 
number one cause of disability-adjusted life years worldwide.  Besides 
mortality, the social and economic impact of morbidity after injury 
also constitutes a significant public health issue.  Trauma victims not 
killed by the initial injury may have prolonged and complicated 
recovery periods.  In addition, surgical interventions for other 
disease conditions constitute controlled injuries and have 
perioperative complications which are also a significant problem.  

Advances in understanding the basic physiological responses to injury 
have yielded improved strategies of care, but, for a multitude of 
clinical problems, the scientific understanding needed to create 
effective new treatments is still lacking.  For example, scientists 
have developed some means to prevent early death after injury (such as 
aggressive fluid resuscitation after a severe burn), but victims then 
face various life-threatening complications well after the initial 
injury.  Research suggests that molecular, cellular, and systemic 
events occurring shortly after a traumatic event may be protective AND 
precipitate programmed potential responses that cause complications 
much later.  Ideally, appropriate therapeutic interventions shortly 
after injury would not only keep a patient alive, but also enhance 
repair and restoration.  

The future of clinical care for victims of traumatic or burn injury, 
including treatment of the inevitable ensuing shock, depends on having 
a fundamental understanding of the physiological responses that occur 
at the molecular, cellular, tissue, organ, and systemic levels.  
Scientific advances have occurred rapidly, to provide new insights into 
biological processes, and investigators interested in trauma are now at 
an opportune time to apply newly available expertise and technology 
(e.g., genomics, proteomics, quantitative analytical approaches, and 
high-throughput testing) to clinical problems.  Simultaneously, 
scientists who understand the clinical issues faced by injured patients 
can offer specific direction for laboratory investigations.  

The body"s response to injury is a complex systemic process that is 
difficult to address, particularly in narrowly defined individual 
research projects.  Moreover, funding mechanisms for independent 
individual investigators (the R01 award, for example) necessarily limit 
the scope of their research projects, making the gathering of an 
adequate and appropriate diversity of expertise and insight often 
impossible.  Studies of injured humans are difficult because of 
medical, scientific, and ethical reasons, but they are still possible 
and necessary.  The multi-component research center grant mechanism 
offers investigators the opportunity to enhance the scientific effort 
from multiple perspectives and to allocate and leverage resources 
efficiently, thus allowing optimal research progress. 

Scope of Research  

The appropriate scope of research for the proposed Research Centers 
broadly covers the mechanisms of immediate and/or long-term adaptive 
and maladaptive physiological responses to injury (which is defined as 
blunt, penetrating, surgical, or burn injury and including hemorrhage 
occurring due to tissue damage). This research includes, but is not 
limited to: 

o Whole organism, organ, tissue, cellular, and molecular responses 
(adaptive, compensatory, or dysfunctional), including shock (e.g., 
hypovolemic, cardiogenic, or septic)

o Mechanisms of cellular and organ failure (alterations in cellular 
bioenergetics, necrosis, apoptosis, single organ failure, and acute 
respiratory distress syndrome or multiple organ dysfunction syndrome)

o Resuscitation strategies and mechanisms

o Post-injury alterations of metabolic patterns and nutritional 

o Normal or pathophysiological changes after injury and factors or 
therapies influencing stabilization and recovery

o Alterations in host-defense mechanisms (innate and adaptive immune 
mechanisms, systemic inflammatory response syndrome, compensatory anti-
inflammatory response syndrome)

o Wound healing, tissue repair and regeneration, or tissue engineering 
related to repair of traumatic injuries

o Behavioral antecedents or consequences of trauma or burn injury as 
related to physiological responses, including effects of allostasis and 
allostatic load

o Individual, age-related, gender-specific, or population-specific 
responses to trauma, burn, or perioperative injury 

The time frame suitable for research is from immediately post-injury 
through ultimate resolution (recovery or death).  Research topics 
derived from issues faced by critically ill patients in intensive care 
units may be responsive to this PA.  We will not consider applications 
responsive to the PA and will not accept them if they focus solely on 
traumatic brain injury or spinal cord injury or on topics related to 
epidemiology, prevention of injury, social or behavioral factors that 
may increase the probability of injury, psychological trauma, long-term 
rehabilitation strategies, or delivery of health care.  Projects may 
include research on the nervous system"s involvement in the systemic 
response to injury or specific subprojects on brain, spinal cord, or 
nerve injury if the overall focus fits within the topics listed above 
and most of the other research proposed does not center on the nervous 

The public health issues related to trauma are far-reaching. We 
encourage you to leverage the scientific endeavor and infrastructure 
created by this centers program to seek additional funding from other 
appropriate Federal agencies or private sources for related activities, 
such as the application of research findings to patient care and public 
outreach and education activities.  We will view your ability to obtain 
institutional and other support for these activities as enhancing the 
chances for success of your Research Center.


This PA will use the National Institutes of Health (NIH) Specialized 
Center Grant (P50) award. As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed 
project. Your total project period may not exceed 5 years, and 
competing renewals are possible.

You may request a budget for your Research Center in FY 2002 of up to 
$1.1 million in direct costs per year for continuing operations (e.g., 
personnel, supplies, travel and other expenses), for a total direct 
cost of $5.5 million for 5 years.  If you request a budget for less 
than 5 years, you should prorate this limit and adjust for inflation.  
The limits for direct costs for Research Centers that would be 
initially funded in the following fiscal years are thus:

FY 2002      $5,500,000
FY 2003       5,650,000
FY 3004       5,800,000
FY 2005       5,950,000
FY 2006       6,100,000

You may request up to $200,000 in direct costs per year, above these 
limits, specifically to support a Human Subjects Core that will serve 
the entire Research Center (see "HUMAN SUBJECTS CORE" below).  With 
prior approval from NIGMS, you may also request funds in excess of the 
limits to acquire large equipment in the first year of your award.  We 
anticipate that the size of awards will vary because the nature and 
scope of the research programs proposed in each application will be 

You may find the program project (P01) mechanism more suited to the 
scale or scope of your effort, if so, you should consult NIGMS staff 
and a previous PA (PA-01-116), which is available at  Please 
note that both human-based studies and translational research may be 
supported by the P01 funding mechanism.


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 


Any individuals with the skills, knowledge, and resources necessary to 
carry out the proposed research are 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.   


Research Centers must have a minimum of three, and generally no more 
than six, subprojects and may include core facilities if appropriate.  
In addition, each Research Center must have an Administrative Core and 
other components, as detailed below.  The actual structure of your 
Research Center will depend on the resources, expertise, and scientific 
and administrative goals of your organization. 

Your application should demonstrate significant and substantive synergy 
between projects.  Reviewers will consider your application meritorious 
if it shows that the sum of your Research Center"s components is 
greater than the individual parts.  Also, reagents, information, and 
ideas should flow between subprojects. Some of your proposed 
subprojects may have limited synergy with the rest of the Research 
Center, but otherwise demonstrate mutual benefits that justify their 
inclusion.  The principal investigator and each project leader must 
demonstrate in your application that the research would be conducted 
much more effectively within a Research Center than as an individual 
research grant.  We expect the participating scientists who lead the 
individual projects to be independent investigators.  We do not intend 
Research Centers to be a vehicle for departmental support or for 
research support of a single senior investigator and several 
postdoctoral and research associates.  

We anticipate that Research Centers will be multidisciplinary and will 
draw on a variety of resources.  You must demonstrate in your 
application and in practice that your Center is well planned and 
carefully organized. The Director is responsible for ensuring that 
scientific goals are met and for developing and managing a decision-
making structure and process that allow for the allocation of resources 
to meet these goals.  The scientifically and managerially complex 
projects that characterize Research Centers will require substantial 
effort from the Director to achieve success.  Therefore, we are 
requiring that the Director devote a minimum of 20% effort to 
leadership and implementation of the Research Center.  In your 
application, you should clearly delineate the administrative structure 
of your Center and include designation of a co-principal investigator 
or an assistant principal investigator. 

You also should describe any core facilities or shared resources that 
are needed, as well as their management and service to the research 
projects.  The purpose of cores is to supply cost-effective and uniform 
laboratory practices to separate subprojects or to provide the means 
for applying state-of-the-art technology to the research topics being 
addressed. You should explain how different components of your 
organization, including key personnel, will interact, why they are 
essential to accomplishment of the research, and how the combined 
resources create capabilities that are more than the sum of the parts. 
If any components are physically separated from others (i.e., in 
different departments or institutions), you need to indicate in your 
application how you will facilitate interactions across the components. 

Except for requiring that your Center includes a minimum of three 
subprojects, we do not specify a particular organizational structure in 
this PA.  Instead, you should develop a structure that would best 
accomplish your goals and objectives. Please note, however, that the 
effectiveness of your organizational structure is a criterion for the 
review of your application and that we will monitor effectiveness after 
an award is made. 

You should present a time line for the project in your application. 
This time line should outline how you expect to meet the project"s 
goals within the time frame you request for the award. The time line 
will also help investigators and NIGMS and our advisors to evaluate 
progress toward your project"s goals. We encourage you to present 
explicit, quantitative milestones for projects, as you deem 

TRANSLATIONAL RESEARCH: An important goal for the Research Centers 
program is to foster two-way transfer of information, knowledge, and 
experience between basic science investigations and clinical studies 
and practice.  Each Research Center must involve both laboratory and 
clinical research efforts. You may consider each subproject as 
translational research (i.e., it contains both laboratory and patient-
oriented research), or you may propose a mix of separate laboratory, 
clinical, and translational subprojects.  We anticipate that successful 
applications will propose a mix of scientists from different 
backgrounds and disciplines.  We do not, however, specifically mandate 
a particular proportion of investigators or research projects, but 
require that your application include human-based research.  If you 
only propose research on animal models, we will not consider your 
application to be responsive to this PA, but we could consider it 
appropriate for a program project (P01) award. Animal models are 
significantly advanced, powerful, and more controllable than research 
with humans, and studies using these models can offer crucial expertise 
and/or technology, as well as depth of understanding, in addressing 
issues related to trauma. Subprojects that deal exclusively with in 
vitro systems or animal models are appropriate if the information to be 
derived is relevant and applicable to the overall intent of the 
Research Center.

ADMINISTRATIVE CORE:  Your application must include an Administrative 
Core with a clearly articulated management plan.  Although each 
Research Center will be unique, we encourage you to include certain 
features in the definable structure.  Examples of these features 
include, but are not limited to:

o Oversight of financial considerations and all pertinent issues 
related to animal care and usage, safety, responsible conduct of 
science, Institutional Review Boards, and inclusion of human subjects 
(which you may address in the Human Subjects Core, if included in your 

o Scientific management, including monitoring of the progress of 
subprojects and cores, mechanisms to foster interactions, and means to 
assure dissemination of research results

o Administration of a home page (see "HOME PAGE" below), including 
expertise to maintain and update your home page regularly 

o Institutional development (as "INSTITUTIONAL DEVELOPMENT ACTIVITIES" 
below), including coordination of efforts, management of resources, 
handling and referral of inquiries, follow-up activities, and 
monitoring of progress 

o Evaluation of the success of proposed and implemented institutional 
outreach activities

o Communication with NIGMS and other funded Research Centers (directly 
or through NIGMS)

o Provision of ready access to statistical expertise routinely and as 

o Travel requirements (including attendance at the annual meeting of 
Research Center Directors and NIH staff).

If any archival or database activities are included in your 
application, you must submit additional detail about these activities.  
We are very interested in ensuring that information about new methods, 
technologies, and computer software and data relevant to clinical 
practice that is developed through this program become readily 
available to the research community for further research and 
development.  We expect that this sharing will eventually lead to 
information and products that improve the health of the public. You 
should develop and propose specific plans for sharing data, materials, 
and software generated by your Research Center (see the recent NIH 
guidance on this at ( We 
strongly suggest that if relevant you describe in your application a 
plan for rapid deposition of data into established public databases, 
which have the capability for collecting and disseminating the data 
that will be collected by the Research Centers (see "PUBLIC ACCESS TO 

The initial review group will comment on your proposed plan for sharing 
and release of data, although they will not include their evaluation as 
part of the priority score. NIH staff also will consider the adequacy 
of your plan as one of the criteria for award. After negotiation with 
you, as needed, your proposed plan for sharing will become a condition 
of your award. When evaluating a non-competitive renewal application 
(i.e., the yearly progress report), we will consider the material you 
provide on the effectiveness of your release of data, materials, and 
software developed as part of any database or archival activities.

You should allocate sufficient funds in your requested budget to cover 
the expenses of the activities you propose for your core.

focus of activities that enhance trauma-related efforts at your 
institution.  This focus may help to create the infrastructure needed 
to address the full spectrum of trauma-related issues.  Ideally, your 
Research Center should promote a greater understanding of the 
scientific issues concerning the body"s response to injury, beyond the 
specific research projects funded.  Your Center should include 
activities that are designed to engage other segments of the research 
and clinical communities at your institution and to foster a cohesive 
institutional approach to the basic and clinical science of 
physiological responses to injury. Expertise, knowledge, technology, 
and approaches offered by disciplines not initially involved with your 
Center may add exciting and important breadth and depth to ongoing 
research efforts.  In your application, you must describe the 
institutional development activities that would foster interaction and 
communication during your award. Include how the particular activities 
will augment your Research Center and facilitate progress toward your 
goals.  Most of your activities will likely be in your Administrative 
Core.  Reviewers will evaluate and comment directly on the efforts you 
propose.  Examples of possible activities include, but are not limited 

o A regular seminar series on trauma research that may be advertised 
and presented innovatively to attract a broad audience, or joint 
seminars with other departments

o A web page that describes activities and research opportunities 
within your Research Center (see "HOME PAGE" below)

o An open house or research day designed to attract and interest other 
faculty and/or students and to offer information on possible research 
topics and specific needs

o Programs designed to attract undergraduate, graduate, and medical 
students, residents, or postdoctoral fellows to course work related to 
trauma or to actual research activities within your Research Center

o A program for placing residents or postdoctoral fellows, who are 
interested in the research offered in your Center, into basic science 
laboratories on campus, to expose them to different ideas and 

o Providing access for other scientists to ideas, models, reagents, or 
experimental systems available within your Research Center

o Linkage of your Research Center to trauma-related activities funded 
by other Federal agencies or private organizations

o Support of joint meetings with basic science departments.

Although the activities you propose will be peer reviewed and are an 
important component of our funding decision, we recognize that your 
efforts may change during the course of an award.  You should discuss 
any significant modifications with NIGMS staff before implementing 
them, and you should describe them thoroughly in your annual progress 
report.  Funds may be used for any of the activities listed above.  For 
example, funds may support salary and research expenses for an 
individual in your Research Center to receive extensive training in a 
laboratory outside the Center, or to bring an individual who has unique 
expertise into your Research Center.  In either case, the actual 
research performed must be an integral part of the research proposed 
for a subproject or core activity.  In this way, funds can be used to 
bridge the activities of your Research Center to potentially valuable 
new collaborations with experienced and qualified investigators and 
thereby foster development and expansion of the science conducted in 
your Center.  However, funds for institutional development activities 
may NOT be used to support pilot projects by new or established 

HUMAN SUBJECTS CORE (OPTIONAL):  To meet the goal for translational 
research, you may wish to consolidate acquisition and management of 
human subjects within a separate Human Subjects Core, rather than 
keeping all aspects of these studies with the relevant subproject.  
Establishing a Human Subjects Core may be effective if a significant 
portion of your Research Center will focus on the study of injured, 
burned, or critically ill patients (by studies of isolated cell and 
tissue samples or physiological assessments of individuals and 
appropriate controls).  The Human Subjects Core should have 
responsibility, for example, for development and implementation of 
standard operating procedures, recruitment and obtaining consent of 
subjects, collection and distribution of samples, keeping of all 
records, and coordination with subprojects.  You should specify a 
particular individual who will directly supervise the core"s functions 
and activities.  You may request up to $200,000 in direct costs per 
year above the limits specified in the section on "MECHANISM OF 
SUPPORT" (see above) for personnel such as research nurses or data 
managers and for necessary supplies, patient care, consultant fees, and 
other pertinent expenses.   Furthermore, if opportunities arise for 
multi-institutional research studies involving injured humans, the 
Human Subjects Core may serve as a focal point and/or resource for 
recruitment, accrual, and coordination of patients and/or samples.

receive a Research Center award, you should plan on attending an annual 
meeting of NIGMS staff and other Research Center personnel. The goals 
for this meeting will be to share scientific information, assess 
progress, solve problems, identify new research opportunities, and 
establish priorities for enhancing the translation of advances to and 
from your Center.  We will hold the meeting on or near the NIH campus.  
You should include travel funds in your requested budget, to cover 
travel expenses for the Research Center Director and one other 
participant, other individuals may attend, but their costs must be paid 
by their institutions. 

HOME PAGE:  Each Research Center must maintain an individualized home 
page that describes its scope of research, lists investigators, contact 
information, and training opportunities, and relates other special 
details.  We will reference and link your site to a home page for 
Research Centers on Trauma, Burn, and Perioperative Injury, which will 
be included on the NIGMS home page.  In your application, you must 
convince reviewers that you have the necessary expertise to develop and 
maintain a home page. Reviewers will not consider the actual contents 
of your page during the review process.


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: 

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
Building 45, Room 2AS.43C
Bethesda, MD 20892-6200
Telephone: (301) 594-5560
FAX: (301) 480-2802

o Direct your questions about peer review issues to:
Helen R. Sunshine, Ph.D.
Office of Scientific Review  
National Institute of General Medical Sciences
Building 45, Room 1AS.13F  
Bethesda, MD 20892-6200  
Telephone: (301) 594-2881 
FAX: (301) 480-8506 

o Direct your questions about financial or grants management matters 

Mr. Joe Ellis  
National Institute of General Medical Sciences 
Building 45, Room 2AN.3C 
Bethesda, MD 20892-6200  
Telephone: (301) 594-5510 
FAX: (301) 480-1969 


Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at  Application deadlines are also 
indicated in the PHS 398 application kit.

Four weeks prior to submitting your application, prospective applicants 
are asked to submit a letter of intent that includes the following 

o Descriptive title of the proposed grant application.
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this 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 NIGMS staff to estimate the potential review 
workload and plan the review.
The letter of intent should be sent to:

Scott Somers, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
Building 45, Room 2AS.43C
Bethesda, MD 20892-6200
Telephone: (301) 594-5560
FAX: (301) 480-2802

YEAR: Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIH staff member 
within one of NIH institutes or centers who has agreed to accept 
assignment of the application.   

Applicants requesting more than $500,000 must carry out the following 

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 

grant applications should be structured as a series of separate, but 
interrelated, project proposals.  Use the following format:

OVERALL PROPOSAL:  An introductory section must contain justification 
for the Research Center and must describe the goals that are better met 
using this mechanism than other possibilities. You should identify 
clearly in the abstract, and more fully in the research plan, the 
specific biological questions to be explored and any new approaches and 
collaborations in place at the Center.  Describe fully the synergy to 
be achieved by establishing multi-disciplinary teams and novel 
collaborations.  This section should include: the face page, an 
abstract for the entire Center, a list of participating personnel and 
institutional affiliations, a biosketch, including other recent 
research support, for the Director of the Center, and the composite 
budget for the entire Center.  The narrative for the general overview 
should include a description of the global vision, objectives, and 
strategy for the entire Center, a brief description of individual 
research projects and cores, including information on the relationship 
of each project and core to the Center and the unique benefits to be 
achieved by funding the work as a composite research program, including 
the synergy between separate components, a general progress report that 
includes a brief recent history of research conducted by the 
investigators and significant accomplishments of the Center (if 
applicable), a statement of any special institutional arrangements 
pertinent to the viability of the Research Center, and a brief 
description of the scientific leadership and overall management plan 
for the Center.  The narrative for the introduction may not exceed 10 

ADMINISTRATIVE CORE:  The section on the Administrative Core should 
contain a cover page, an abstract, a list of pertinent personnel and 
institutional affiliations, a detailed budget with justification,  
biosketches indicating other recent research support, an administrative 
and management plan that details the strategies and policies to be 
developed to assure that the Center functions optimally, a description 
of all institutional development activities, and details on the 
development and management of the Center"s home page.  This narrative 
may not exceed 10 pages.

COMPONENT PROJECTS AND CORES:  You should present each subproject as an 
independent or, if appropriate, an interdependent research effort, 
prepared using the format for individual research grant (R01) 
applications.  This format includes a cover page (with subproject 
title), an abstract, a list of pertinent personnel and institutional 
affiliations, a detailed budget with justification, biosketches 
indicating other recent research support, a detailed description of the 
research to be conducted, and appropriate justification and 
documentation for the use of human subjects or animals (if applicable).  
For each subproject, you should detail the special benefits of being 
associated with the Research Center, including potential synergistic 
efforts.  The page limits for presenting each subproject are the same 
as for R01 applications (as specified in the PHS 398 form for sections 
a-d of the Research Plan).  

You should present core facilities, including the Human Subjects Core 
(if applicable), also in the format used for individual research 
projects.  Provide the same information noted above, except for the 
following two points.  First, instead of relating specific aims, the 
narrative should describe general and specific functions of each core 
facility within the overall Center and, in particular, the 
contributions of each core and the benefits of the core to other 
aspects of the Center.  You should also provide specific details on 
technical and experimental aspects of the core"s functions.  Second, 
the narrative may not exceed 10 pages per core.

Please note that you are not required to submit the maximum number of 
pages for any section. Rather, we encourage you to submit a concise and 
articulate application.
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)

The title and number of the PA must be typed on line 2 of the face page 
of the application form and the YES box must be marked. 

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at  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.

Upon receipt of your application, the CSR will review it for 
completeness, and NIGMS will review it for responsiveness to the PA.  
If your application is incomplete or non-responsive, it will be 
returned to you without further consideration. 


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group, convened by the Office of Scientific Review of NIGMS and in 
accordance with the standard NIH peer review procedures 
(, will evaluate applications for 
scientific and technical merit. 

As part of the initial merit review, all applications will:

o Receive a written critique
o Be discussed and assigned a priority score
o Receive a second level review by the National Advisory General 
Medical Sciences Council 

You should not assume that review of your application will include a 
site visit or an interview of the principal investigator.  Your 
application must be complete as submitted.

Reviewers will give priority scores only to the entire Research Center 
and individual subprojects.  Reviewers will not give priority scores to 
research cores or to the Administrative Core, which includes 
institutional development activities and (if applicable) the Human 
Subjects Core.  However, they will provide an evaluation for each core 
based on the review criteria defined below.


The goals of NIH-supported research are to advance understanding of 
biological systems, improve the control of disease, and enhance health. 
In the written comments, reviewers will be asked to discuss the 
following aspects of the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals:

o Significance
o Approach
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning your application"s (the entire Research Center 
and individual components) overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in 
all categories to be judged likely to have major scientific impact and 
thus deserve a high priority score.  For example, you may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.


SIGNIFICANCE:  Will the results of the Research Center have an impact 
on the understanding of physiological response to injury?  If the aims 
of your application are achieved, how do they advance scientific and 
clinical knowledge? What will be the effect of these studies on the 
concepts or methods that drive this field?  Will potential benefits 
extend beyond the injury research community?
APPROACH:  What are the advantages to you of the Research Center 
mechanism compared with support for multiple separate independent 
research grants (R01s)?  Will the Research Center be able to perform 
translational research?  Will the Research Center foster significant 
synergy among the components (i.e., be greater than the sum of its 

INNOVATION:  Will your Research Center challenge existing paradigms or 
develop new methodologies, technologies, or practices?

INVESTIGATOR (PROGRAM DIRECTOR): Is there adequate evidence that your 
Program Director has the ability to lead and coordinate activities and 
to develop and implement the management plan, as required for the 
project"s success?

ENVIRONMENT: Is the degree of institutional commitment, including 
support for any needed expansion of facilities, improvement of 
infrastructure, and relief from other academic duties when necessary, 
clearly indicated?

management plan and adequate evidence of an effective management 
structure? Is the plan for deployment of equipment and human resources 
sufficient to attain research aims and overall Center goals? What is 
the quality of the plans for making critical decisions or choices about 
overall research direction during a project?  Where appropriate, are 
the approaches that are being used or being developed cost-effective?  
Does your proposed core and plan contain the elements required to 
assure monitoring and oversight of financial, scientific, and 
administrative aspects of the Research Center?  Are shared resources 
readily available to all qualified participants?  Are resources 

The reviewers cannot delete an Administrative Core, but may recommend 
budget changes. 

INSTITUTIONAL DEVELOPMENT ACTIVITIES: Are your plans for bridging the 
Research Center to your institution described adequately?  Are your 
proposed activities innovative and/or likely to enhance the scientific 
productivity of your Research Center and augment or create a larger, 
cohesive effort focused on the science of physiological response to 
injury?  Do you have the capability within the Research Center, to 
evaluate the effectiveness of these activities? 

The reviewers cannot remove institutional development activities from 
your application, but may recommend alterations in your budget to 
reflect their judgment of the value and likely success of your proposed 


SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  What will be the effect of these studies on the concepts or 
methods that drive this field?

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of 
the project?  Do you acknowledge potential problem areas and consider 
alternative tactics?

INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 

INVESTIGATOR: Are you appropriately trained and well suited to carry 
out this work?  Is the work proposed appropriate to your experience 
level as the principal investigator and to that of other researchers 
(if any)?

ENVIRONMENT:  Does the scientific environment in which your work will 
be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

Does your proposal have significant and substantial interactions with 
other aspects of the Research Center?  Does your component depend on 
other components, and visa versa?  If your component does not have 
substantial interactions with the rest of the Research Center, are 
there definite benefits for including it in the Research Center 
(besides access to core facilities or resources)? 

PROTECTIONS:  Is the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the 
project proposed in the application, adequate? 

INCLUSION:  Are the 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, adequately developed and 
described?  Plans for the recruitment and retention of subjects will 
also be evaluated. (See Inclusion Criteria included in the section on 

BUDGET:  Is the proposed budget and the requested period of support in 
relation to the proposed research reasonable and justified?


HUMAN SUBJECTS CORE (if included):  Is this core needed and essential 
to achieve the overall scientific goals proposed?  Is there adequate 
oversight?  Are resources allocated appropriately?  This core will be 
evaluated and given a priority score based upon the criteria listed 

proposed plan to share data and/or activities adequate?  The activities 
you propose will be commented on by the reviewers, but their opinions 
will not be factored into the priority score for the pertinent 
subproject, core, or overall Research Center. 


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 Appropriateness of the plan for sharing data, materials, and 
o Availability of funds
o Relevance to program priorities  

Evidence of institutional support for the Research Center may also be 
important when making final funding decisions.


components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  

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 is a result 
of the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(, a 
complete copy of the updated Guidelines are available at
001.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 

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, 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at and at  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see   It is the responsibility of the applicant to 
provide 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. 

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

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.

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 connect to an Internet 

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

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.859, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourages 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

H H S Department of Health
and Human Services

  N I H National Institutes of Health (NIH)
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Bethesda, Maryland 20892