Program Description
Specialized
Centers of Clinically
Oriented Research (SCCOR)
National Heart, Lung, and Blood
Institute
August 2004
A. INTRODUCTION
The National Heart, Lung, and Blood Institute (NHLBI)
has 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. This program has been described by the Institute
Director, NHLBI in an
editorial in
the January 29, 2002 issue of Circulation. The original SCOR program
required both basic and clinical research, but the preponderance of funded
projects were in the basic science arena. The newly developed SCCOR program
mechanism still requires clinical and basic scientists with a broad range of
skills to work together on a unified theme, but more emphasis is placed on the
clinical research projects. The new title and the revisions to the program
reflect the NHLBIs desire to capitalize on 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 document. Guidance for preparing an application is available on the NHLBI Special Instructions for Specialized Centers of Clinically Oriented Research (SCCOR) Grant Applications and questions and answers about the program can be found on the NHLBI Specialized Centers of Clinically Oriented Research (SCCOR) Frequently Asked Questions Page. NHLBI Links to current and future solicitations for SCCORs can be found on the NHLBI Grants and Contracts Page.
NOTE: This program is not an
investigator-initiated grant mechanism. SCCOR programs specific for certain
research areas will be published as individual RFAs which will appear in the
NIH Guide.
B. PURPOSE
The primary objective of the SCCOR program is to
foster multidisciplinary research on clinically relevant questions enabling
basic science findings to be more rapidly applied to clinical problems. It is
expected that results from these SCCOR grants will have a positive effect on
the prevention, diagnosis, and treatment of the particular disease under
study.
C. SCCOR REQUIREMENTS
- 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. All applications must include both clinical and
basic research and at least 50 percent of the funded 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.
- In order for a project to be considered clinical,
the research must fit the
definition
of clinical research in the PHS 398 (parts 1 and 2, but not part 3). That
is, the research must be either patient-oriented research, or an epidemiologic
or behavioral study.
Patient-oriented research 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 not
include 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 may be proposed. 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 not be
considered.
All clinical research projects, whether on human
subjects or human specimens, will be subject to the standard NHLBI policies and
procedures regarding human subjects monitoring.
- 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. If a project can
be completed in less than 5 years, it should not be included in the
application.
- 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 timetable for conducting the proposed investigations.
- The relationship of each core to each component
project should be described. A core must provide services to two or more
projects.
- 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.
- Each SCCOR must have a well-delineated
organizational structure and administrative mechanism that foster interactions
between investigators, accelerate the pace of research, accelerate translation
of basic research findings to clinical applications, and ensure a productive
research effort.
-
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 application and will be peer reviewed. 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 NHLBI 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.
D. PRINCIPAL INVESTIGATORS
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.
E. 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 they are prepared so that the programmatic, fiscal, and
administrative considerations are explained fully. In addition, 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. Applicants for SCCOR grants should
exercise great care in preserving the interactions of the participants and the
integration of the consortium projects 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.
F. CHANGE OF INSTITUTION
If a project leader in a funded SCCOR program moves to
another institution, the project is not normally allowed to continue under a
consortium relationship with the new institution. Therefore, in such
situations, the SCCOR program director should plan to justify the continuation
of the component project based on its role in the overall program. Furthermore,
a SCCOR program may normally not be transferred administratively to another
institution.
G. 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.
- 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
October
9, 2001 amendment to the NIH Guidelines for Inclusion of Women and
Minorities; a
complete copy of the updated Guidelines are also available. 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.
- REQUIRED EDUCATION ON THE PROTECTION OF HUMAN RESEARCH
PARTICIPANTS: NIH policy requires education on the protection
of human research 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 were published in the NIH Guide
and frequently asked
questions and answers regarding the use of hESC are available and should be
consulted by investigators proposing to use hESC. Only research using hESC
lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding. It is
the responsibility of the applicant to provide the official NIH identifiers for
the hESC lines 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 and should consult
guidance
provided by the NIH.
Data may be collected 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.
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