SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) IN TRANSLATIONAL 
RESEARCH IN ACUTE LUNG INJURY
                                 
RELEASE DATE:  January 23, 2002

RFA:  RFA-HL-02-014

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)

LETTER OF INTENT RECEIPT DATE:  September 11, 2002
APPLICATION RECEIPT DATE:       October 11, 2002 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE

The primary purpose of the Specialized Centers of Clinically Oriented Research 
(SCCOR) programs is to foster multidisciplinary research on clinically 
relevant questions enabling basic science findings to be more rapidly applied 
to clinical problems.  The clinical and basic research supported through this 
RFA will be related to acute lung injury (ALI) and adult respiratory distress 
syndrome (ARDS).  It is expected that results from these SCCOR grants will 
have a positive impact on the prevention, diagnosis, and treatment of ALI 
and ARDS.  

RESEARCH OBJECTIVES

The National Heart, Lung, and Blood Institute (NHLBI) revised the Specialized 
Centers of Research (SCOR) program, based primarily on recommendations from 
the National Heart, Lung, and Blood Advisory Council.  The new program is 
called the Specialized Centers of Clinically Oriented Research (SCCOR) 
program.  The original SCOR program required both basic and clinical research, 
but the preponderance of funded projects were in the basic science arena.  The 
new title and the revisions to the program reflect the Institute's desire to 
capitalize on these basic research advances by encouraging their translation 
to the clinical arena.  The guiding principle of the new SCCOR program is the 
central focus on clinically relevant research, and the key change to achieve 
this goal is the new requirement that at least one-half of funded projects be 
clinical.  The specific requirements of the new SCCOR program are detailed in 
this RFA.  

Acute lung injury (ALI) and its more severe form, the acute respiratory 
distress syndrome  (ARDS), is a sudden, severe lung inflammation that results 
in hypoxemia, loss of lung compliance, and commonly, multi-organ system 
failure.  Mortality from this potentially preventable disease has decreased 
since its initial description, but remains unacceptably high (30 to 40 
percent).  The syndrome has diverse etiologies involving either direct or 
indirect insult to the lung.   

Results of clinical trials evaluating agents that block excessive inflammation 
have proved disappointing.  These include steroids, nitric oxide, antioxidant 
strategies, surfactant replacement, and blockade of cytokines and the 
arachidonic acid cascade.  Similarly, in sepsis, a disease often associated 
with ARDS, several large trials of endotoxin blockade have failed to improve 
outcome.  Two recent positive clinical trials, however, suggest that a single 
intervention can reduce mortality.  The NHLBI-supported ARDS Clinical Trials 
Network showed that a low tidal volume ventilation strategy lowered mortality 
in ALI/ARDS patients and supported the concept of lung injury as a factor 
influencing systemic inflammation and organ dysfunction.  A recent 
industry-sponsored trial of activated protein C in sepsis suggests that agents 
that interfere with the coagulation cascade have promise for reducing 
sepsis-associated ALI/ARDS, and enhance the need to understand the link 
between coagulation and other cell signaling pathways such as inflammation, 
apoptosis and adhesion.   

Despite information about cell and molecular pathways, signaling, and other 
molecules important in the pathogenesis of ALI, little progress is being made 
in translating information about cellular events to effective treatment for 
patients.  In order for further progress to occur, better tools are needed for 
more rapid diagnosis, prognosis, and treatment and this new SCCOR program 
provides the opportunity for the needed translational work.  More information 
is needed to identify subgroups of patients who are at increased risk of 
developing ALI/ARDS and for developing more specific targeted approaches to 
treatment.  Approaches to the molecular study of ALI/ARDS that might be 
valuable, include but are not limited to, studies of epithelial and 
endothelial injury, alterations in innate immunity, and interactions among 
oxidation, inflammation, and coagulation.  Enhanced understanding of 
individual host response to lung injury may provide new approaches to 
determining risk and disease severity.  Studies that explore molecular 
mechanisms and/or gene and protein expression tightly linked with information 
on clinical status and outcome should help to provide mechanistic definitions 
of the disease which should enable development of better diagnostic and 
prognostic approaches and more effective treatments.

Applicants are encouraged to submit projects that applies clinical genomics 
technology to the study of ALI/ARDS, including arrays, chip technologies, 
SNPs, proteomics, and/or genetic family or linkage studies to the study of 
ALI/ARDS.  Approaches that might be valuable include studies of susceptibility 
and genetic predisposition within families of patients who developed ALI/ARDS, 
molecular/genetic studies to explore patient responses to ventilator-induced 
lung injury, or gene and protein array studies to develop new ALI/ARDS 
subgroup definitions or risk categories based on genetic or biochemical 
determinants.  It is anticipated such studies will be useful in providing data 
to make earlier diagnosis and to identify new targets for therapy.    
 
This SCCOR Program will therefore emphasize application of molecular and/or 
genetic studies to clinical issues such as prediction of risk, severity, or 
outcome of ALI/ARDS   In accordance with the new SCCOR guidelines, 
applications must include at least 50 percent clinical projects and may focus 
on any or all phases of the syndrome including initiation, progression, and 
resolution.  Aspects of long term recovery would also be of interest.  

These examples of research topics are intended to provide a perspective of the 
scope of research that would meet the objectives of this program.  
Investigators are encouraged to consider other topics that are relevant to the 
goals of the new Translational Research in Acute Lung Injury SCCOR program.  

Clinical Research Skills Development Core

The newly developed Specialized Centers of Clinically Oriented Research 
(SCCOR) program mechanism requires clinical and basic scientists with a broad 
range of skills to work together on a unified theme.  It, therefore, presents 
a rich environment for young clinical investigators to be exposed to and 
develop additional research skills. The individual centers can be expected to 
include among their research staffs clinical personnel who are newly trained 
and relatively inexperienced in research.  To assist the SCCOR grants in 
enhancing the developmental environment for their new clinical investigators, 
the NHLBI will permit applicants for a new SCCOR to request up to $100,000 in 
direct costs per year for a Clinical Research Skills Development Core.  The 
objective of the Core is to support activities to assist new clinical 
investigators in progressing to more senior status by enhancing their research 
skills.  This support is in addition to the usual cap on the SCCOR mechanism 
that is updated annually.  A Clinical Research Skills Development Core is not 
required, however, and its absence will not disadvantage an applicant. The 
quality of the Clinical Research Skills Development Core, if proposed, will be 
evaluated based on the specific components listed below.  The priority score 
on the Core will have no effect on the overall score of an application.

Developmental opportunities that provide experience with new technologies and 
skills are encouraged for inclusion in the Core.  Innovative strategies should 
be proposed for cross-disciplinary career development to achieve the goal of 
exposing new clinical investigators to additional research techniques and 
opportunities.  Examples include a program of seminars focusing on scientific 
topics that include an integration of basic and clinical studies or an 
"exchange" program wherein clinical investigators spend time in basic science 
labs.  In addition to developing research skills, the Cores must ensure that 
the participating new clinical investigators receive the mentoring they need 
to foster their research careers.  The Clinical Research Skills Development 
Core is intended for staff investigators with limited clinical research 
experience, including fellows, house officers, and junior faculty members.  
Investigators who are recipients of NIH Career Awards or who have had a 
previous K series award are not eligible to participate as new investigators 
under this program.  The Core should also address other skills necessary for a 
successful research career, such as grant writing, ethical conduct of 
research, and clinical trial design.

If a Clinical Research Skills Development Core is proposed, it must be 
directed by an investigator with strong educational and mentoring credentials 
who will devote a minimum of 5 percent effort as its Leader.  To facilitate 
mentoring and multidisciplinary developmental activities, active involvement 
by the principal investigator and other senior investigators within the SCCOR 
is strongly encouraged.

An application for a Clinical Research Skills Development Core will be 
evaluated in terms of its potential effectiveness in developing the skills and 
research capabilities of new clinical investigators as reflected in the 
following required elements of the application:

1.  A summary of the types of skills that would be developed and a description 
of proposed project-specific activities;

2.  A detailed discussion of how mentoring and the professional development of 
the new clinical investigators will be achieved, including their progression 
to more independent status; 

3.  The credentials and track records of the Clinical Research Skills 
Development Core Leader, the Principal Investigator, and other participating 
senior staff in developing new investigators; 

4.  A plan for coordinating the activities of participating senior 
investigators; 

5.  A plan for monitoring the progress of the new clinical investigators; 

6.  A description of existing opportunities within the applicant=s institution 
for supporting investigator development and steps taken to avoid overlap with 
or duplication of these efforts; and 

7.  A detailed development plan for each proposed new investigator (or a 
representative plan and proposals for tailoring it to needs of multiple new 
investigators) including required course work and scientific enrichment 
activities such as special lectures, visiting scientist symposia, seminars, 
and workshops.  

Costs allowable for inclusion within the $100,000 direct costs per year limit 
for the Clinical Research Skills Development Core include salary support for 
the Core Leader and other participating senior investigators and staff, travel 
costs for new investigators, supplies and equipment to be used in support of 
developmental activities, and costs for courses, seminars, workshops, and 
other activities directly related to the development plan.  All costs 
requested in this Core must be justified with respect to developmental 
activities and may not be used to supplement the costs of research proposed in 
the rest of the SCCOR.

Since the Core is intended to serve new clinical investigators who occupy 
positions and receive salary support from the SCCOR grant, salary support for 
the new investigators is neither needed nor allowable as a Core cost.  All new 
clinical investigators supported by the SCCOR grant should be eligible to 
participate in Core-sponsored activities so long as they have not attained 
independent status.  However, attaining independent status should be an 
objective of the Core activities so participating new investigators should be 
encouraged to apply for either a Career Development Award, a patient-oriented 
regular research grant, or any other source of independent research or career 
development support.  Although the participating new investigators will be 
expected to devote essentially full-time effort to research during this 
period, they may devote an appropriate percentage of their time to maintaining 
clinical skills.

MECHANISM OF SUPPORT  

This RFA will use the NIH P50 award mechanism.  As an applicant you will be 
solely responsible for the planning, direction, and execution of the proposed 
project.  This RFA is a one-time solicitation.  The anticipated award date is 
December 1, 2003 (fiscal year 2004).

All applications received in response to the Translational Research in Acute 
Lung Injury SCCOR program will be considered as new applications and must meet 
the requirements for the new SCCOR program. Therefore, applications submitted 
by currently funded Acute Lung Injury SCOR groups must be sufficiently changed 
to meet the objectives of this new program.

Each NHLBI SCCOR program is limited to 10 years of support.  Exceptions to 
this policy will be made only if a thorough evaluation of needs and 
opportunities, conducted by a committee composed of non-federal experts, 
determines that there are extraordinarily important reasons to continue a 
specific SCCOR program.  Under this policy, a given SCCOR grant is awarded for 
a 5-year project period following an open competition.  Only one 5-year 
competing renewal is permitted, for a total of 10 years of support, unless the 
SCCOR program is recommended for extension.  

The NHLBI comprehensive evaluation of the Translational Research in Acute Lung 
Injury program will be conducted during the second project period according to 
the following timetable:

Program Announced:                    FY 2002

Project Period (First Competition):   FY 2004 through FY 2009

Program Reannounced:                  FY 2007

Project Period (Second Competition):  FY 2009 through FY 2014

Letter to Principal Investigators 
  Regarding SCCOR Evaluation Plans:   FY 2010 (mid-way through year 02
  of 2nd project period)

SCCOR Evaluation Meeting:             FY 2011 (late in year 02 of 2nd
  project period)  

The NHLBI does not limit the number of SCCOR applications in a given SCCOR 
program from one institution.  However, each application must have a different 
principal investigator and must be self-contained and independent of the 
other(s).  Institutions envisioning more than one application should discuss 
their plans with the program contact listed under Inquiries.  

FUNDS AVAILABLE

The NHLBI intends to commit approximately $11,250,000 in FY 2004 to fund three 
to five new center grants in response to this RFA.  Applicants may request up 
to $2,500,000 direct costs, not including indirect costs for collaborating 
institutions, in the first year.  An increase of no more than 3 percent may be 
requested in each additional year.  An applicant must request a project period 
of 5 years.   Although the financial plans of the NHLBI provide support for 
this program, awards pursuant to this RFA are contingent upon the availability 
of funds and the receipt of a sufficient number of meritorious applications.

Equipment is included in the budget limitation.  However, requests for 
expensive special equipment that cause an application to exceed this limit may 
be permitted on a case-by-case basis following staff consultation.  Such 
equipment requests require in-depth justification. Final decisions will depend 
on the nature of the justification and the Institute's fiscal situation at the 
time of award.  

Consortium Arrangements  

If a grant application includes research activities that involve institutions 
other than the grantee institution, the application will be considered a 
consortium effort.  Such applications are permitted, but it is imperative that 
the application be prepared so that the programmatic, fiscal, and 
administrative considerations are explained fully.  However, at least 50 
percent of the projects (including at least one clinical project) and 50 
percent of the cores must be located at the applicant institution.  The 
published policy governing consortia is available in the business offices of 
institutions that are eligible to receive Federal grants-in-aid and should be 
consulted before developing the application.  For clarification of the policy, 
contact Mr. Ray Zimmerman, Grants Operations Branch, NHLBI, (301) 435-0171.  
Applicants for SCCOR grants should exercise great care in preserving the 
interactions of the participants and the integration of the consortium 
project(s) with those of the parent institution, because synergism and 
cohesiveness can be diminished when projects are located outside the group at 
the parent institution.  Indirect costs paid as part of a consortium agreement 
are excluded from the limit on the amount of direct costs that can be requested. 
 
ELIGIBLE INSTITUTIONS

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

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic

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.  Women and minority investigators are 
underrepresented in the field of ALI/ARDS research. Participation of women and 
individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities is strongly encouraged.

The principal investigator should be an established research scientist with 
the ability to ensure quality control and the experience to administer both 
clinical and basic research effectively and integrate all components of the 
program.  A minimum time commitment of 25 percent is required for this 
individual.  The principal investigator must be the project leader of one of 
the component research projects. If this project is not recommended by peer 
review, the overall SCCOR application will not be considered further.  If this 
project is judged by peer review to be of low scientific merit, this will 
markedly reduce the overall scientific merit ranking assigned to the 
entire application.    

Project leaders should have significant research experience and must agree to 
commit at least 20 percent effort to each project for which they are 
responsible.  Investigators with minimal research experience, but promising 
credentials, may participate; however, it is expected that most of the project 
leaders will be investigators with significant research experience. 

SPECIAL SCCOR REQUIREMENTS

1.  The overall concept of a SCCOR program focuses on clinical and basic 
scientific issues related to diseases and disorders relevant to the mission of 
the NHLBI.  To be considered responsive to this announcement, all applications 
must include both clinical and basic research and at least 50 percent of the 
projects must be clinical.  For example, if an application has a total of 
three projects, two of the projects must be clinical.  In addition, 
interactions between clinical and basic scientists are expected to strengthen 
the research, enhance the translation of fundamental research findings to the 
clinical setting, and identify new research directions.  Translation of 
findings from basic to clinical studies is an important focus of the 
SCCOR program.  

2.  In order for a project to be considered clinical for the purposes of 
responsiveness to this RFA, the research must fit the definition of clinical 
research in the PHS 398 
(http://grants.nih.gov/grants/funding/phs398/phs398.html, parts 1 and 2, but 
not part 3).  That is, the research must be either patient-oriented research, 
or an epidemiologic or behavioral study.

For patient-oriented research, this is "research conducted with human subjects 
(or material of human origin such as tissues, specimens and cognitive 
phenomena) for which an investigator (or colleague) directly interacts with 
human subjects."  Clinical investigations may include studies of subjects with 
the disease of interest as well as normal healthy subjects.  In studies 
involving the use of human specimens, e.g., blood, bronchoalveolar lavage, or 
biopsy, the investigators must have direct interaction with the subject or 
patient and relate the research results to the patient status or outcome for 
this to be considered a clinical project.  It is intended that the requirement 
for investigator interaction with the study participants will eliminate 
research involving archived tissue.

Human biomedical and behavioral studies of etiology, pathogenesis, prevention 
and prevention strategies, diagnostic approaches, and treatment of diseases, 
disorders or conditions are also responsive.  Small population-based 
epidemiologic studies, where the research can be completed within 5 years, may 
also be proposed.  However, clinical research projects focused on large 
epidemiologic studies or Phase III clinical trials will be considered 
unresponsive to this RFA. 

Clinical research projects, whether on human subjects or human specimens, will 
be subject to the standard NHLBI policies and procedures regarding human 
subjects monitoring.  

3.  The number of clinical projects in each NHLBI SCCOR must be equal to or 
greater than the number of basic science projects, at the time of submission, 
award, and throughout the 5-year project period.  Neither a clinical component 
in a basic science project nor a clinical core fulfills the requirement for a 
clinical project.  Because a SCCOR grant is a 5-year program, an applicant 
should submit a 5-year plan for all the projects. 

4.  Each awarded SCCOR must consist of three or more projects, all of which 
are directly related to the SCCOR program topic.  At least 50 percent of the 
projects and 50 percent of the cores must be located at the applicant 
institution and at least one of the clinical projects must be at the applicant 
institution.  All basic research projects must be related to the overall 
clinical focus of the SCCOR.  Each component project whether clinical or basic 
requires a well- described clinically relevant hypothesis, preliminary data 
and a time-table for conducting the proposed investigations.  

5.  The relationship of each core to each component project should be 
described.  A core must provide services to two or more projects.   

6.  Applicants are encouraged to establish links with existing resources, 
including General Clinical Research Centers, the NHLBI Program in Genomic 
Applications, and NHLBI clinical research networks, as appropriate.  

7.  Each SCCOR must have a well-delineated organizational structure and 
administrative mechanism that foster interactions between investigators, 
accelerate the pace of research, accelerate basic research findings to 
clinical applications, and ensure a productive research effort.  

8.  Applicants should provide a detailed data and safety monitoring plan for 
the clinical research proposed; the monitoring plan will be considered as part 
of the peer review of the application.  This plan should address informed 
consent, recruitment, reporting of adverse events, patient safety, oversight 
of clinical issues in the protocols, storage and analysis of confidential 
data, and dissemination of any research results.  There may be isolated cases 
when the Institute may wish to convene a DSMB to oversee the clinical projects 
in a SCCOR program.  This will be determined after review and selection of the 
SCCOR centers.

9.  Each applicant should request $10,000 in direct costs each year (to be 
included in the budget cap) for SCCOR coordination to enhance opportunities 
for collaboration and communication among participating SCCOR centers.  

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

Andrea L. Harabin, Ph.D. 
Division of Lung Diseases 
National Heart, Lung, and Blood Institute 
2 Rockledge Centre   Suite 10018
Bethesda, MD  20892-7952
Telephone:  (301) 435-0222 
Fax:  (301) 480-3557 
Email:  Harabin@nih.gov

o Direct your questions about peer review issues, send letter of intent and 
two copies of the application to:

Anne P. Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs 
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178, MSC 7924
Bethesda, Maryland  20892-7924 (20817 for express/courier service) 
Telephone:  (301) 435-0270 
Fax:  (301) 480-0730 
Email:  clarka@nhlbi.nih.gov

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

Raymond Zimmerman 
Division of Extramural Affairs 
National Heart, Lung, and Blood Institute 
2 Rockledge Centre,  Room 7154
Bethesda, Maryland  20892-7926 
Telephone:  (301) 435-0171 
FAX:  (301) 480-3310 
E-mail:  rv7g@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 number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to Dr. Anne Clark at the 
address listed under Where to Send Inquiries.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email:  GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:  Because of the size and complexity of a SCCOR, 
prospective applicants are urged to consult with the staff of the Division of 
Lung Diseases early in the preparation of the application (see INQUIRIES 
Section).  Special instructions are needed for preparing a SCCOR application 
and are available from the program contact listed under Where to Send 
Inquiries or at http://www.nhlbi.nih.gov/funding/inits/dldsccor.htm.  To 
provide opportunity for such interactions, the time frame for implementation 
of this program includes an ample interval between the release of this RFA and 
the receipt date for applications.
   
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked. The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed photocopies, in one 
package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to Dr. Anne Clark at the address listed under Where to Send Inquiries.

Appendix material should NOT be included as part of the grant application but 
may be submitted as additional material at the same time reprints are 
requested by the Scientific Review Administrator. 

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

Principal investigators should not send supplementary material without first 
contacting the Scientific Review Administrator (SRA).  The SRA will be 
identified in the letter sent to you indicating that your application has been 
received.  If you do not receive such a letter within 3 weeks after submitting 
the application, contact Dr. Anne Clark listed under Where to Send Inquiries. 

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  Applications 
that are complete and responsive to the RFA will be evaluated for scientific 
and technical merit by an appropriate peer review group convened by the NHLBI, 
Division of Extramural Affairs, in accordance with the review criteria 
stated below.
 
No site visits of reverse site visits will be conducted.
 
As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit will be discussed and assigned a priority score
o Receive a second level review by the National Heart, Lung, and Blood 
Advisory Council.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
Factors to be considered in the evaluation of each application will be similar 
to those used in the review of traditional clinical and basic research grant 
applications and, in addition, will include overall proposed interactions 
between clinical and basic research projects.  Major factors to be considered 
in the evaluation of applications include:    

1.  Scientific merit of the proposed clinical and basic research projects 
including significance, importance, clinical relevance and appropriateness of 
the theme; innovation, originality, and feasibility of the approach; and 
adequacy of the experimental design.  

2.  Leadership, scientific stature, and commitment of the principal 
investigator; competence of the investigators to accomplish the proposed 
research goals and their time commitment to the program; clinical research 
experience among the investigators; and the feasibility and strength of 
consortium arrangements.  

3.  Collaborative interaction between clinical and basic research components, 
the required number of clinical projects, and plans for transfer of potential 
findings from basic to clinical studies.  

4.  Adequacy of the environment for performance of the proposed research 
including clinical populations and/or specimens; laboratory facilities; 
quality of the support cores, proposed instrumentation; quality controls; 
administrative structure; institutional commitment; and, when needed, data 
management systems.   

5.  Adequacy of the data and safety monitoring plan for the clinical 
research proposed.  

Each project will receive a priority score.  Each core (except the Clinical 
Research Skills Development Core) will be Recommended or Not Recommended based 
on whether the core is essential for the proposed research and has the 
capability to fulfill the proposed function.  Reviewers will evaluate the 
number of projects serviced by the core; strengths and weaknesses of the 
proposed approaches, resources, and interactions; whether the investigators 
are qualified for their role(s) in the core; and whether the proposed budget 
for the core is appropriate.  Each application will receive an overall 
priority score based on the review criteria listed above.   

The Clinical Research Skills Development Core will receive a priority score 
based on the review criteria below, but the priority score will not enter into 
the overall priority score.    

Clinical Research Skills Development Core  

The Clinical Research Skills Development Core will be evaluated for its 
effectiveness in developing the skills and clinical research capabilities of 
new investigators.  This will include an evaluation of:   

1.  Credentials and track record of the PI, Clinical Research Skills 
Development Core Project Leader, and other participating senior investigators. 

2.  Methods by which new investigators are to be recruited and selected 
including plans to recruit women and minority individuals.   

3.  Plans for developing the skills of new investigarors; the types of skill 
and technologic development proposed.  

4.  Means by which the new investigators' professional development will be 
achieved.   

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

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data.

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    September 11, 2002
Application Receipt Date:         October 11, 2002
Peer Review Date:                 February, 2003
Council Review:                   May 29-30, 2003
Earliest Anticipated Start Date:  December 1, 2003

AWARD CRITERIA

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

In addition to scientific merit as determined by peer review, a major factor 
guiding the Institute in selecting which applications to fund will be the 
strength of the clinical projects and their integration with the basic science 
projects.  Applications with weak clinical projects will not likely be funded, 
regardless of the overall priority score.  The availability of funds and 
programmatic priorities will also be factored into the decision.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 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:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance with the 
new OMB standards; clarification of language governing NIH-defined Phase III 
clinical trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported by 
the NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects. 
 You will find this policy announcement in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. 
In addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider 
use of data collected under this award.

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance No. 93.838 and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review. 
 Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284)(or other authorizations) 
and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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


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