Clinical Research Skills Development
Core Specialized Centers of Clinically
Oriented Research (SCCOR)
National Heart, Lung, and Blood
Institute National Institutes of Health
February 2002
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 and junior faculty members.
Investigators 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:
- A summary of the types of skills that would be
developed and a description of proposed project-specific activities;
- 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;
- 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;
- A plan for coordinating the activities of
participating senior investigators;
- A plan for monitoring the progress of the new
clinical investigators;
- 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.
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