Clinical Research Networks and
Multicenter Clinical Studies
Clinical Research Skills Development
Core
National Heart, Lung, and Blood
Institute National Institutes of Health
February 2002
Clinical research networks and multicenter clinical
studies typically include among their research staffs new and relatively
inexperienced clinical investigators. The NHLBI recognizes that their
progression to established investigators can be enabled by opportunities to be
exposed to and develop additional research skills. Because they complete
several different protocols in a relatively short period of time, clinical
research networks can provide experiences in many phases of clinical trials and
aspects of patient-oriented research. Large multicenter clinical studies can
enable skills development in such areas as epidemiology, database development,
and clinical trial design. In addition, both clinical research networks and
multicenter clinical studies allow new investigators to interact with leading
clinical investigators, receive mentoring in clinical investigation, and
participate in multi-institutional research experiences.
The NHLBI is interested in ensuring that the full
potential of clinical research networks and multicenter clinical studies to
foster the clinical research careers of new investigators is realized. It is,
therefore, inviting applicants for new or competing renewal clinical research
networks and multicenter clinical studies (whether institute- or
investigator-initiated) 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. For competing renewal
applications, this amount is in addition to the increase ordinarily allowed by
the NHLBI, i.e., 10 percent above the recommended amount for the last
noncompeting project period. Such a Clinical Research Skills Development Core
is not required, and its absence will not disadvantage an applicant. If
proposed, the quality of the Core will be evaluated as a separate part of the
initial peer review process, the evaluation being based on the specific
components outlined below. The priority score on the Core will have no effect
on the overall score of an application.
The Clinical Research Skills Development Core will
enable newly trained clinical personnel to be exposed to and gain experience in
important aspects of human subjects research, including clinical trial design,
protocol development and management, bioethics, design and conduct of ancillary
research projects, biostatistics, epidemiology, and manuscript preparation. In
addition to developing the research skills of new clinical investigators, the
Cores must ensure that the 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.
If a Clinical Research Skill 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 multidisciplinary developmental activities and
appropriate mentoring, active involvement by the Principal Investigator and
other senior investigators within the applicant center 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 the specific developmental activities proposed;
- A detailed discussion of how the mentoring and
professional development of each selected new investigator are to be achieved,
including progression to more independent status;
- The credentials and track record of the Clinical
Research Skills Developmental Core Leader, the Principal Investigator, and
other senior staff;
- A plan for coordinating activities of new
investigators with the network or multicenter study protocols and committee
functions;
- A plan for monitoring the progress of new
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
- 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, clinical
enrichment activities such as special lectures, visiting investigators, 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 clinical research network or multicenter study.
Since the Core is intended to serve new clinical
investigators who occupy positions and receive salary support from the clinical
network or multicenter study, salary support for the new investigators is
neither needed nor allowable as a Core cost. All new clinical investigators
supported by the clinical network or multicenter study 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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