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The
Pediatric Clinical Research Center at Children's National Medical
Center provides the following frequently asked questions (FAQs)
and answers.
Answers
Q.
What type of projects utilize the Pediatric Clinical Research Center?
A. Projects utilizing the research center may be either investigator-initiated
or industry-sponsored. Investigators from many Children's Hospital
departments and Georgetown University utilize the services of the
Pediatric Clinical Research Center.
Projects may be carried out on the clinical research unit, scatter
beds, or utilize the services of the Core Laboratories (including
the Bioanalytical Core, the Genetic Core or the Behavioral Instrumentation
and Phenotyping Core), biostatistical services, bionutrition services
or informatics.
Q.
What are scatter beds and how can I use them for my research project?
A. A scatter bed is a term used to describe the use of an inpatient
bed that is not located on the PCRC for research purposes. Typically,
these beds are located on the Neonatal Intensive Care Unit or Pediatric
Intensive Care Unit because research subjects would be hospitalized
there for medical reasons. Also, because of their special needs,
the environment of the Pediatric Clinical Research Center would
be unsuitable. For scatter beds, the Pediatric Clinical Research
Center can provide support for ancillary costs (costs of research
tests) and limited nursing support for studies.
Q. What support can I expect to get from the Pediatric Clinical
Research Center for my project?
A. It would be ideal for all studies utilizing the Pediatric Clinical
Research Center to have external support from the National Institutes
of Health (or other Public Health Service funding agency) or foundations
awarding funds through peer review (American Heart Association,
Cystic Fibrosis Foundation, Muscular Dystrophy Association etc.)
Although, significant numbers of studies have external funding,
some do not. The Pediatric Clinical Research Center serves as a
site where pilot work can be performed with the goal to submit these
projects for external funding. Many junior faculty members utilize
the Pediatric Clinical Research Center for the development of pilot
work. Established faculty may use it to develop different directions
for their research activities.
Q. Are pilot projects supported by the PCRC?
A. Submission of a protocol as a pilot study is acceptable under
appropriate circumstances. However, such a protocol application
should describe how the information from the pilot study would be
used in subsequent proposals. The investigators may choose to elaborate
on a tentative plan for study size, request resource for a pilot
study, and then submit these preliminary research results to request
the resources necessary to complete the study. Pilot studies often
receive a lower priority; however, those pilot studies that are
likely to lead to meritorious extramural funded protocols or K23
type grant application are given higher priority
Q. How do I get approval for use of the PCRC?
A. All protocols must be approved by the Institutional Review Board
(IRB) at Children's National Medical Center prior to activation
on the research unit. At the time of IRB submission or after that
approval has been obtained, the PCRC GAC application should be completed
and submitted to the PCRC administrative office. The GCRC Scientific
Advisory Committee reviews new projects on a monthly basis. After
the committee review, modifications may be required prior to use
of the Pediatric Clinical Research Center. Once final approval is
obtained, the investigator will meet with the nursing staff who
will coordinate and facilitate the activation of the project on
the unit. Please read the protocol activation section for more information.
Q. How do I obtain submission materials for the General Clinical
Research Center's Scientific Advisory Committee (GAC)?
A. The application materials are available online or by contacting
the Administrative Director, Kerstin Hildebrandt e-mail: khildebr@cncm.org
Q. What happens if the PCRC budget is insufficient to cover the
costs of all projects utilizing it?
A. Each project is given a priority score on the basis of scientific
merit and PCRC need by the GCRC Scientific Advisory Committee reviews
it. Use of limited resources will be determined by these priority
score as outlined in the NIH/NCRR guidelines.
Q. What if I have a project that needs to be started before the
Scientific Advisory Committee has a chance to review it?
A. If you have an institutional review board approved project and
you plan to apply to the Pediatric Clinical Research Center for
utilization, you may under limited circumstances receive administrative
approval to start your study prior to full review by the Scientific
Advisory Committee.
This would only be considered if awaiting final approval by the
GCRC committee would mean missing a rare or special research opportunity.
It should also be understood that the protocol might need to be
modified if required by the committee prior to final approval. For
questions regarding the administrative approval process, contact
Kerstin Hildebrandt at Tel. 202 884-3584.
Q. Do I have to have funding from a grant to use the General
Clinical Research Center?
A. It is not necessary to have external funding for the project
that will use the General Clinical Research Center. Although it
is ideal to have National Institutes of Health or Public Health
Service funding for projects, many investigators have foundation
funding or institutional research support and a limited number do
not have funding. For the unfunded projects, it is understood that
the Pediatric Clinical Research Center is a resource to obtain pilot
results that may lead to future funded research utilizing the center.
Q. How is medical coverage provided for subjects on the PCRC?
A. Each protocol on the PCRC needs to have a physician assigned
as principal investigator or co-investigator for the study. He or
she is directly responsible for the daily medical care of patients
admitted for inpatient or outpatient visits to the PCRC under the
protocols.
The investigator and/or his/her designated associate(s) is responsible
for the physician orders, admission history and physical examination,
a daily progress note, and a discharge summary for each patient
admitted for an overnight stay at the PCRC or scatter bed. This
function may be assigned to a fellow or resident on the investigator's
service, with the investigator serving in a supervisory capacity.
The investigator's team is responsible for day, night and weekends
coverage of patients admitted to the PCRC for inpatient stays or
outpatient visits. The research center nurses must have access to
investigators through pagers or phone numbers at all times. The
Program Directors are available for calls in case of an emergency.
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