The medical care of patients admitted to the VCU GCRC is the primary responsibility of the physician investigator. The investigator must provide house staff coverage in case of an emergency.
Once VCU GCRC
approval is granted, investigators are required to contact the
Nurse Manager, Lou Usry, (804-828-9229 or 804-828-9101) to schedule
a staff in-service meeting prior to the start of the research.
The nursing, dietary, and laboratory staff should have sufficient
advance notice concerning the investigator's requirements for
patient care and conduct of the study. The Nurse Manager appoints
a study nurse as a liaison to work with the investigator to schedule
admissions and to plan flow sheets. Nursing staff must have physician
orders prior to initiating clinical procedures. Advance personal
communication with the proper VCU GCRC personnel ensures optimal
conduct of each research study. Additionally, it is important
to schedule admissions as early as possible so that the VCU GCRC
can provide proper staffing during times of heavy utilization.
Patient Recruitment
The investigator
is responsible for recruiting patients and securing their consent.
A written informed consent must be obtained from the study subject
and kept on file in the hospital chart. These informed consents
satisfy NIH and OPRR guidelines for human subject research.
Informed Consent
A patient eligible for admission to the VCU GCRC unit must have a problem relevant to approved research projects or be a "normal" volunteer subject. All subjects must give their written voluntary consent. The investigator has the primary responsibility to have the Research Consent Form completed on or before the day of admission. Should a volunteer be under legal age of consent, permission of parents or legal guardian must be obtained.
The Research
Consent Form gives permission for the patient's participation
as a volunteer in a research study. The patient's consent should
be given with an adequate understanding of the planned procedure
or study to which he/she is to be subjected. This must include
any necessary appreciation of the hazards or inconveniences that
may reasonably be expected. The signed Research Consent Form is
not meant to relieve the hospital or the physician of any of their
medico-legal responsibility. The purpose of the written consent
is to assure complete understanding between the patient and the
investigator, regarding the purpose and condition of the hospitalization
or patient visit. Once completed, the Research Consent Form will
be placed permanently in the patient's medical record. Each VCU
GCRC admission must contain a signed Research Consent Form.
Patient Admissions
The only criteria for admission is a subjects' suitability for participation in a research project and a willingness to become involved in the study as documented by a signed and witnessed Research Consent Form.
Scheduling of admissions is arranged by the investigator with the VCU GCRC Nurse Manager. Investigators are urged to schedule admissions as early as possible. This allows efficient use of the VCU GCRC and its facilities by permitting prediction of workload. The investigator is responsible for notifying the patient of the admission date and providing necessary instructions to the patient. Transportation expenses cannot be covered by the VCU GCRC. The investigator is also responsible for notifying the VCU GCRC Administrative Director or the VCU GCRC Nurse Manager of any change in the patient's research status (i.e. from A to B, C, D). See Patient Types.
All inpatients will be admitted to the VCU GCRC through the regular MCV Hospital Admitting Office on the first floor of Main Hospital. The admitting procedures will be the same as for patients admitted to other floors of the Hospital. Outpatients will be registered directly at the VCU GCRC.
The investigator
must provide the following information on all inpatients and outpatients
at the time of admission: full name, hospital number, gender,
race, date of birth, social security number, and address.
Patient
Care
All details of the care of VCU GCRC patients are the direct responsibility of the investigator, who writes or oversees admission work-ups, progress notes, and any other medical aspects of the project in compliance with MCV Hospitals' standards. Although these duties may be delegated to other members of the investigative team, primary responsibility remains with the investigator. All physicians designated to write orders or admit patients must be clearly listed on the project protocol. The hospital record is to be kept in the same detail and with the same standards of excellence as that of any other patient. All patients admitted directly to the unit must have a complete working History and Physical in the record, and patients transferred from other services to the VCU GCRC must have the appropriate transfer notes in the records.
When a patient is discharged from or transferred to another service, the investigator is responsible for the discharge summary and for signing the record. In addition to the usual information concerning the patient, the discharge summary must include the purpose of the study, the reasons for the inclusion of the particular patient, the procedures and investigations performed, the results of the study, if available, and any future plans which involve the patient.
Twenty-four
hour, seven-day-a-week coverage for the clinical care of the patient
must be provided by the investigator or his/her designee and the
nursing staff must know whom to call at all times for the purpose
of patient care.
Progress Reports
Annually, investigators
are expected to provide a listing of all presentations and publications
relating wholly or partially to their VCU GCRC research. Information
on grant and contract funding (federal and non-federal) and highlights
of their scientific research findings from the projects utilizing
the VCU GCRC resources are collected by the VCU GCRC and submitted
to the NIH for review. Publications, abstracts or presentations
of research which utilize resources in any way must be asterisked.
These will be included in the VCU GCRC Annual Report.
Competitive Renewal
The VCU GCRC
grant is reviewed every 5 years for competitive renewal. After
the VCU GCRC grant has been submitted, a team of peer review scientists
and additional NIH personnel make a site visit to the VCU GCRC.
On the day of the site visit, investigators who are major users
of the VCU GCRC will be asked to make a presentation before the
review committee. Many months of planning go into a site visit,
and investigators are notified well in advance of any presentation
the y may be requested to make. Written protocols outlining the
current and proposed utilization will be requested for the competitive
renewal grant application.
GCRC Publications
When publishing
any article, abstract or chapter, even partially based on a GCRC
Protocol, NIH requires that a citation be given acknowledging
that the investigation was SUPPORTED IN PART BY CLINICAL RESEARCH
CENTER GRANT MO1-RR00065, NCRR, NIH. PART BY CLINICAL RESEARCH
CENTER GRANT MO1-RR00065, NCRR,
Patient
Types
Category A:
Category A study subjects on the VCU GCRC are hospitalized or brought in for outpatient visits only for the purpose of research. The VCU GCRC will assume responsibility for most hospitalization and/or outpatient costs for these subjects and for many laboratory tests as well. Because of our limited budget for ancillary tests, prior agreement with the VCU GCRC Administrative Director must be made in advance to ensure coverage.
Category B:
Category B or research/service patients are individuals who require hospitalization or outpatient visits for diagnosis and treatment according to established standards of care. While admission to the VCU GCRC is to allow participation in one or more ongoing research projects, the costs of routine medical care for Category B patients are not charged to the VCU GCRC, but rather are billed for and collected by the Hospital. All costs for research-only procedures are handled as with Category A subjects.
Category D:
Category D subjects are individuals participating in research protocols that have been developed and initiated by for-profit operations (industry-sponsored research). All charges for Category D studies including patient care and ancillary costs must be paid by the sponsoring company through the responsible investigator. At present, the NIH policy is that no more than 15% of the utilization of the VCU GCRC should be industry-sponsored protocols. The rationing of these beds is a critical responsibility of the VCU GCRC Research Advisory Committee who have indicated that industry-sponsored protocols can only utilize the VCU GCRC if the investigators are actively performing A or B protocols.
Combined Categories (i.e. Category A/B or Category A/D):
The NIH recognizes that not all protocols will fall neatly into one category, and it is often necessary to assign subjects to combined categories. In such instances, the VCU GCRC administration will work with each investigator to assure that an appropriate cost assignment is established for all study-related charges generated during conduct of the research protocol.
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