The UBC PET imaging facility is used for research purposes only. Studies are not used for diagnosis or treatment, therefore the Principle Investigator (P.I.) and/or designated members of the P.I.’s study team are required to coordinate and personally supervise the scanning process for all PET research studies.
Each P.I. performing a study using the UBC PET imaging equipment is responsible for following the requirements outlined below with respect to the study procedure and subject care during the imaging sessions. These responsibilities can be fulfilled directly by the P.I.; otherwise it is the P.I’s responsibility to designate a Study Coordinator who will ensure that the requirements described below are satisfied.
Responsibilities of the Study Coordinator
Prior to booking subjects to take part in a new PET study, copies of the full ethics application, consent, UBC Research Ethics Board certificate of approval, and Health Canada approval must be provided to the PET technologist. The study cannot proceed without the information contained within these documents. Within three months of beginning a study, the assigned Study Coordinator will be required to attend a radiation safety course offered by UBC hospital. This is a requirement of our radiation safety license. Scanning time is booked with the PET technologists. Since many studies are performed in the centre, scheduling for all PET studies must be confirmed by first speaking with the PET technologist to ascertain available dates and times. No commitments can be made to study subjects without this knowledge. Once study subjects have agreed to participate and have agreed to one of the available times, these details must be communicated back to the PET technologist and entered into the schedule.
As is the case for all research studies, the Study Coordinator will be required to obtain informed consent prior to subject participation. PET imaging alone is considered a research procedure, therefore the Study Coordinator is also required to re-obtain consent on the day of each scanning procedure. This process provides a final opportunity for dialogue in the event the subject has concerns or has reconsidered their participation.
Care of the study subject while he/she is participating in PET imaging is the responsibility of the Study Coordinator. The Study Coordinator must therefore be present for the entirety of the procedure to monitor the subject and respond to any questions or concerns the subject has during the course of the scan. As the conducted clinical research is considered to be of an invasive nature the Study Coordinator is also required to have the assistance of a medical doctor. We ask that the medical doctor be on site (within UBC hospital, and with approval to work at UBCH) and carrying a pager during the PET scan. The medical doctor should be available to provide assistance should a subject experiences any unexpected or unanticipated change in well-being, for example shortness of breath, dizziness, pain, anxiety. This is an absolute requirement for a PET scan to proceed.
A PET technologist will be present during the imaging procedure. The technologist will be responsible for the administration of the PET radiotracers, and functioning of the PET scanner. They may offer assistance, but are not responsible for the care and management of the subject.
Day of the study: For each PET scan the Study Coordinator must arrive with the subject no later than one hour prior to the scheduled time of tracer injection. There is a waiting area available in the adjacent nuclear medicine area. The original signed consent form must be provided to the PET technologist as it will be stored as a record of the procedure. All women will be asked to sign a form confirming they are not pregnant or lactating and those women who are of childbearing age, who have not gone through menopause or had a surgical procedure to prevent pregnancy, will be required to do a urine pregnancy test. The pregnancy test kit will be available in the PET suite. The test will be administered by the Study Coordinator who will document the results on the appropriate form. This form becomes part of the study records along with the consent form.
Approximately 1⁄2 hour prior to injection of the PET tracer, positioning of the study subject will begin. The Study Coordinator will be asked to assist in positioning the subject on the scanning
bed. After the scan begins the Study Coordinator may sit at the observation desk, but is required to monitor the subject over the course of the scan, ensuring their comfort and well being. At the end of the scan the Study Coordinator will assist in getting the subject off the bed, and will be responsible for providing post-scan instructions (e.g. instructions about fluid intake, bathroom use, diet), and making the necessary arrangements for the subject (e.g. snack, reimbursement for parking costs, travel documentation).
The PI will be asked to stop the study if these requirements, aimed at ensuring subject’s safety, are not met.
Please feel free to ask any questions you have after reading this document. If you have not previously conducted a PET scan in this centre please inquire about the opportunity to speak with other users or observe other scans. Relevant contact numbers are listed below.
We look forward to a successful collaboration.