Applications packets may be obtained from the GCRC Administrative Office
or you may or you may view/download a packet from our Application Page.
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GCRC Supported Studies
The GCRC is designed to serve primarily as a core service for investigators
who obtain their primary means of support from individual NIH grants.
However, investigator-initiated studies supported all or in part by industry,
investigator-initiated pilot studies designed to obtain preliminary data for a
grant application to industry, and investigator-initiated studies that do not fulfill
the above definitions are also supported. Industry-initiated studies where
the principal investigator is a University of Utah faculty member and multicenter
industry-initiated clinical trials are also supported.
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GCRC Advisory Commttee
The Advisory Committee has the responsibility for the review, approval,
and oversight of all research projects requesting GCRC support. The
chairman of the committee is John R. Hoidal, M.D. The committee meets
monthly to evaluate proposals based upon scientific merit and need for
center resources. Approved research projects are prioritized using these two
factors. The committee is responsible for the designation of the category of
inpatient days and outpatient visits for each research project proposed to
the center as category A, B, or D, including the classification of research
sponsored by industry.
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GCRC Funding Categories
Category A - Research Patients:
These are research patient days or outpatient visits utilized solely for research
purposes. All hospitalization costs associated with category A days or visits
the financial responsibility of the center and/or the investigator, depending
upon the committment of GCRC resources as recommended by the GCRC
Advisory Committee. Persons who are hospitalized for research purposes only,
but whose care is partly supported by non-center funds (e.g., other grants,
industry) may also be classified as category A. This category includes normal
volunteers or controls.
Category B - Research Service Patients:
This category includes patients who require hospitalization for diagnosis or
treatment according to established standards of care, and who are admitted
to the GCRC to participate in a research project. The cost of established
medical care for category B patients can not be assumed by the center.
The patient's insurance carrier is responsible for costs which relate to
non-research charges. The hospital is responsible for all billings and
collections on these patients. The cost of those ancillary services performed
solely for research on category B patients and not related to their routine
medical care may be assumed by the center, and shall not appear on the
patient's bill which is submitted by the hospital to the patient or the insurance
carrier.
Category D - Industry-Initiated Projects:
These are inpatient days or outpatient visits utilized for industry-initiated
studies. All charges are paid directly by the sponsor through the responsible
investigator. Those projects which are designed by organizations will be
considered industry- initiated, and the organization is expected to pay for
the use of the GCRC facilities at the same rates it would pay for any other
hospital beds and ancillary charges. All category D patient charges are to be
paid to the University Hospital from funds provided by the organization. In
some cases, investigators may add additional research aims to the project.
In those cases, the Advisory Committee ascertains the relative resource
needs to be contributed by industry, the GCRC and the investigator's
resources. Investigator-iniated components of drug company sponsored
studies may qualify for Category A funding. Once a category D study is
approved and activated, the center administrator will charge the
appropriate fee to the study's funds in consultation with the responsible
investigator.
Industry-Supported Investigator-Initiated Research
In some cases an organization may provide funds for an
investigator-initiated study. Investigator-initiated projects which are
partially supported by an organization through a grant of unrestricted funds
or by a donation of drugs or devices may be pursued on the GCRC as
category A or category B research, subject to the usual IRB and Advisory
Committee review and approval. Copies of the agreement (including the
budget) signed by the University of Utah Research Administration Financial
office, the principal investigator, and the drug company or other source
must be maintained in the center's administrative files. In addition, copies
of other relevant correspondence, along with the FDA letter assigning an
investigational new drug (IND) number to an experimental drug or device,
are to be maintained in the center's research project files. If approved by
the Advisory Committee, such investigator-initiated projects will be eligible
for full use of center facilities.
In order to determine whether an industry-sponsored study is category
A/category B (investigator-initiated) or category D (industry-initiated) the
following documentation needs to accompany the proposal: 1) all pertinent
communication between the investigator and the industrial source that
resulted in funding; 2) a copy of the agreement (including the budget)
signed by the University of Utah Research Administration Financial office,
the principal investigator, and the drug company or other source; and 3)
any other documentation that will assist the Advisory Committee in
deciding whether the study is category A, category B or category D.
Investigators who receive industry support for projects conducted on the
GCRC must be free to publish or distribute data from such studies without
restriction.
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GCRC Research Costs
Hospitalization Costs
It is the responsibility of the principal investigator to explain to subjects the
hospitalization costs of their participation in the study and the assumption
of the responsibility for those costs by either the GCRC, the investigator's
own funds, third-party payors, or the individual study subject. It is the
investigator's responsibility to make certain that participants understand
that only the research costs for time spent on the GCRC may be paid by the
center, and that the GCRC is not responsible for charges that apply for any
other purpose or period of their hospitalization.
The GCRC may subsidize certain costs related to research protocols. Costs
of an inpatient admission include nursing, room and board, and ancillary
services. Costs of an outpatient visit include visit and procedure charges,
and approved ancillary services.
The cost of occasional, unexpected, temporary use of special facilities, such
as an intensive care unit, may be charged to the GCRC provided that the
care is required by an illness resulting from the research; the care is
provided in a specialized area (intensive care unit, coronary care unit, etc.);
the subject remains on the GCRC census (under the scatter bed
classification) while in the special care unit, and there is no duplication of
payment for care.
Scatter Bed Costs
Some studies require that patients be cared for in areas away from the
discrete GCRC nursing unit. This arrangement is referred to as a
"scatterbed" visit. Currently the GCRC can provide nursing and
research-related ancillary services support for adult or pediatric studies at
Primary Children's Hospital and the University of Utah Hospital.
Ancillary Services
Ancillary services are defined as services routinely available through the
hospital departments for all patients in the hospital (e.g., blood tests, x-rays,
medications, etc.). This definition applies even when these services are
purchased from sources outside the hospital for reasons of economy or
efficiency. Also, services provided either by the laboratory of a GCRC
investigator for that investigator's patients or by a laboratory which is
directed by a GCRC investigator may not be charged to the center, even if
that investigator has a contractual arrangement with the hospital to provide
these services. The center, however, cannot assume the costs of high cost
ancillary services such as CT scans, MRIs, etc., unless approved in advance
by the Advisory Committee.
Professional Fees
Physicians' fees or other professional services (e.g., from anesthesiology,
pathology, or radiology) are not supported by the center for category A
patients or for research-related services on category B patients.
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Investigator Responsibilities
It is the responsibility of the principal investigator to provide the GCRC
staff with necessary subject information, M.D. coverage, IRB Approval,
signed consent form (original for patient chart), and standard orders prior to
each admission or outpatient visit.
Standard Orders
Standard Orders must contain an explicit outline of those aspects of the
research which are to be carried out by the GCRC nursing staff and are
required for each inpatient/outpatient admission. To develop this most
efficiently, investigators are encouraged to work with the delegated GCRC
nurse team assigned to the research project. Specific clinical procedures
and schedules are best planned in collaboration with the nurses who are
familiar with and experienced in the day-to-day implementation of research
projects.
Special Equipment
It is the investigator's responsibility to procure special equipment not
available from the GCRC. The center routinely provides standard clinical
supplies such as syringes, needles, IV solutions, IV tubing, blood tubes and
other means of sample collection. The availability of pumps for infusing
solutions, monitors, and special collection devices or recording equipment
is the investigator's responsibility and should be checked with the Clinical
Nurse Manager before subjects are scheduled for admission.
Scheduling Subjects' Admissions
Investigators with approved projects should contact the Clinical Nurse
Manager between one and six weeks prior to the expected date of inpatient
admission or outpatient visit in order to determine the specific admission date
and time. A study priority rating given by the GCRC Advisory Committee will
determine the utilization of resources in the event that requests exceed
available resources.
Provisions for Medical Care of GCRC Participants
Each investigator is responsible for the care of patients admitted under his
or her project either personally or through designated co-investigators,
fellows, or residents. Arrangements for emergency and night care must be
formalized.
Intercurrent Illnesses
In the event of an intercurrent illness, the subject may be kept under
treatment in the GCRC when the illness is unrelated to the research but is
anticipated to be of short duration. If the intercurrent illness requires
termination of the study or its interruption for a substantial time, other
arrangements for the participant's care should be made.
Medical Records
The hospital medical record is to be kept in the same detail and with the
same standards as that of any other patient admitted to the University
Hospital. This means that subjects admitted directly to the GCRC must
have a full medical history and physical in the record, and that subjects
transferred from other services to the GCRC must have the appropriate
transfer notes. The principal investigator or the designated
physician-in-charge will be responsible for signing out the record when the
subject leaves the center.
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Publications
Publications arising from research projects involving use of center resources
should acknowledge this support by stating:
This investigation was supported by GCRC Grant no. M01-RR00064 from the
National Center for Research Resources.
Two reprints of any publication resulting from studies supported by the GCRC
are requested by February 1 of each year so as to be included in the GCRC
annual report.
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