a. Any patient participating in an GCRC-approved research protocol may be admitted to the GCRC for research studies. In the event of excess demand for beds, NIH-supported studies have priority over all others, and other peer-reviewed studies funded by non-commercial entities will have second priority.
b. Before any patients can be scheduled for admission to the GCRC on newly approved research protocols, the Principal Investigator or a member of his/her research team must meet with the GCRC nursing staff to discuss details of the protocol relating to nursing care; i.e., the role and expectations for involvement of the GCRC nursing staff in the study, potential side effects of any treatments or medications used in the study, means of contacting investigator(s) if a problem arises. If any nursing staff has questions or requires additional information regarding details of a research protocol, the Principal Investigator is expected to be available for answering those questions. The GCRC nursing staff should be provided with the results of the findings at the conclusion of the research study.
c. Before bed space can be assigned for a study subject, the Principal Investigator must obtain approval for the study from the GCRC Advisory Committee and the IRB. The consent form approved by the IRB must be signed by the research subject (or parents/guardians) on the day of admission to the GCRC.
d. A Protocol Manager is assigned to each protocol before implementation. After a scheduled meeting with the Principal Investigator, Protocol Manager, Unit Director and GCRC staff, the investigator may schedule research subjects by calling the GCRC Administrative Assistant and filling out a reservation form. The investigator will be notified of admission approval within the same day of request. The Principal Investigator must complete and submit a GCRC Patient Admission form. GCRC Patient Admission form must be completed and received by the GCRC Administrative Assistant at least one week prior to the admission. NIH is encouraging GCRC's to recover costs of hospitalization that are unrelated to research from third party payers (i.e., medical insurance carriers or Medicare/Medi-Cal). This is encouraged particularly when the patient derives benefit from the hospitalization. With the permission of the Principal Investigator and with the knowledge and consent of the research subject, third party coverage must be indicated on the attached GCRC Admission form. At the time of admission, detailed insurance coverage information will be obtained, and the patient must be informed in advance that this information will be requested by the GCRC staff. Details of this policy can be clarified by speaking with Helen Williams-Bayne.
e. Accurate estimation of the duration of hospitalization is crucial for smooth operation of the UCLA-GCRC. If the patient's hospitalization must be extended beyond the time indicated on the GCRC Admission form, the Nurse Manager must be notified immediately to request a time extension. Every effort will be made to meet the exigencies of the situation. If cancellation of a scheduled patient becomes necessary, notify the Nurse Manager immediately so the hospital bed may be used for another patient.
f. For all studies that involve investigational drugs, the Principal Investigator must provide the Nursing staff with a written summary of the usual dosage, form, route of administration, strength, actions, side effects, adverse reactions, interactions, and symptoms of toxicity for the investigational drug to be used.
g. All medications for the study must be dispensed from the UCLA Pharmacy. To prevent any errors, it is extremely important that the name of any investigational drug be written in the doctor's order exactly the way it is written on the drug vial or package. In addition, the pharmacy requests that the UCLA Pharmacy Investigational Drug Study (IDS) number be included in the orders for any investigational drug. The IDS number can be obtained from the UCLA Drug Information Center at Extension 59755.
Outpatient Studies
a. Scheduling of all outpatient visits requires 2 weeks advance notice and must be scheduled with the charge nurse Monday through Friday between 8:00 a.m. and 3:00 p.m. by conferring with the Charge Nurse in the GCRC at 27-066 CHS or calling (310) 825-5225.
b. Orders for procedures to be completed during outpatient visits must be written in the patient's chart before procedures may begin.
c. IRB approved consent forms must be signed by the patient, or parent/legal guardian in the case of minor subjects, before any procedures may commence. Outpatient Consent Forms must also be signed by an appropriate witness.