and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows 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) 710-0267,
Email: [email protected].
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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