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The General Clinical Research Centers (GCRCs) are a national network
of 78 centers that provide optimal settings for medical investigators
to conduct safe, controlled, state-of-the-art, in-patient and out-patient
studies of both children and adults. GCRCs also provide infrastructure
and resources that support several career
development opportunities.
Investigators who have research project funding from NIH and other
peer-reviewed sources may use GCRCs. To request access to a GCRC
facility, eligible investigators should initially contact a GCRC
program director, listed in the Clinical
Research Resources Directory. Because the GCRCs support
a full spectrum of patient-oriented scientific inquiry, researchers
who use these centers can benefit from collaborative, multidisciplinary
research opportunities. To ensure research diversity at the GCRCs,
no single group of investigators at a center may utilize more than
33 percent of the resources.
The individuality of each GCRC is determined by the research strengths and needs
of its host institution. GCRC resources include highly trained research personnel,
a core laboratory, a bioinformatics system, and a metabolic kitchen. The GCRC
research staff--nurses, dietitians, biostatisticians, skilled technicians, and
administrative personnel--help investigators by facilitating the day-to-day research
process and assisting the research patients in a supportive and efficient environment.
Federal regulations and policies protect subjects in clinical research
protocols, ensuring that their safety is given the highest priority.
These regulations complement the policies of academic institutions
that host the GCRCs. Proper performance of research consent and
oversight procedures makes demands on the time of already-busy clinician
researchers. To address these demands, the NCRR has created a Research
Subject Advocate position within each GCRC. The purpose of this
position is to assure that all steps are taken to maximize patient
safety as detailed in the protocols approved by the Institutional
Review Board (IRB).
A GCRC grant supports the components essential to clinical research: operating
expenditures, hospitalization and ancillary laboratory costs, and salaries of
key personnel including nurses, research bionutritionists, administrators, core
laboratory staff, biostatisticians, and computer personnel. Funds for renovation
and equipment also may be provided.
Confidentiality Notice: Certificates of Confidentiality (CoC) are issued by the
National Institutes of Health (NIH) to protect the privacy of research subjects
by preventing investigators and institutions from being compelled to release information
that could be used to identify individuals who are participating in a research
project. A CoC, issued to the institution or university where that research is
being conducted, allows the investigator–and others who have access to research
records–to refuse to disclose identifying information in any civil, criminal,
administrative, legislative, or other proceeding, whether at the Federal, state,
or local level. The availability of such a document frequently helps an investigator
to accrue participants into a protocol that addresses issues that are of a particularly
sensitive nature.
Usually, a request for a CoC is addressed to the NIH Institute that is funding
the clinical study. However, in cases where the investigator does not receive
financial support from a categorical Institute and the protocol is being performed
within a GCRC, the investigator should request assistance from the CoC contact
at the National Heart, Lung and Blood Institute. Investigators are encouraged
to read the information provided through the above-cited link.
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