(Effective May 27, 2003, Revised Nov 11, 2008, Nov 4, 2009, Feb 6, 2011, Mar 4, 2013)The REB (RISe) Application Form must identify;
- BCCA Principal Investigator (PI) responsible for the study (section 1.1)
- all co-investigators (Section 1.3)
- the lead PI (only one) for each additional participating "BCCA centre" (Section 11)
- Note: Section 4.2B may be used to identify individuals or sites that must appear on the certificates of approval that will otherwise not appear (see below).
BCCA REB certificates will list;
- the BCCA PI responsible for the study (Section 1.1 in RISe)
- the lead PI (only one) for each additional participating "BCCA centre" (Section 11 in RISe)
- any information entered into section 4.2B (in RISe) exactly "as entered" by the applicant on each certificate unless an amendment is submitted by the applicant.
BCCA REBcertificates do NOT list;
- co-investigators (from section 1.3 in RISe)
- study personnel from sections 1.2, 1.4 or 1.5 in RISe.
- If an individual from one of these sections must appear on the certificate, the applicant may enter them in section 4.2B (in RISe) which will appear exactly "as entered" by the applicant on each certificate unless an amendment is submitted.
The consent document(s) must identify;
Permanent changes or a leave of absence of six months or longer of any investigator (including co-investigators) must be reported to the REB. If a PI or co-investigator is'relinquishing their responsibility' for six months or longer an amendment must be submitted to notify the REB of the change (even if there is a "designated coinvestigator with signing authority in RISe"). The consent document should be revised if the study is open to accrual so that subjects yet to be enrolled will be given the revised approved consent. For already enrolled subjects, the timing and mechanism for informing (or not informing) already enrolled subjects about this type of change should be determined by the principal investigator as to what is applicable and reasonable taking into consideration the status of the study and the status of already enrolled subjects. For example, notification may be verbal (in person or by phone and documented in the subject's file) or by mail, or by formal signed reconsent. It may be acceptable to not inform a subject(s) if a rationale is provided. A subject's participation status or health status may change from the time a notification plan is submitted to the REB and as a result notification may require a different approach, which may simply be documented in the subject's file with the rationale or in the overall study documentation if the change will apply to all enrolled subjects. If the investigator or sponsor requires it, a Request for Acknowledgment of the change to the notification plan for already enrolled subjects may be submitted to the REB but it is not required by the REB for this circumstance.
- the lead PI responsible for the study (this should match Section 1.1 in RISe).
- the lead PI (only one) for each additional participating centre (covered by the REB approval)
- the subject's study doctor if different from above
- a 24/7 emergency contact
- a non-emergency contact person other than the PI (i.e. Dept. Head) for concerns about the conduct of the study
- the UBC Research Subject Information Line (noted in the BCCA REB consent template)
- Note: It is NOT a requirement of the BCCA REB to list all co-investigators in the consent document.
Designating Coinvestigators with Signing Authority: Once a study is approved, the PI should immediately designate up to 2 "Coinvestigators with Signing Authority" in RISe from the list of approved coinvestigators. These coinvestigators may submit applications in RISe on behalf of the PI. Only the PI can designate these individuals which can be done quickly in RISe (it does not require submission to the REB) and takes effect as soon as the PI adds their name. Note: If the PI or coinvestigator is relinquishing their responsibility for six months or longer (regardless of whether there is a designated coinvestigator with signing authority in RISe) submission of an amendment to notify the REB is still required, and if applicable, a revised consent document. See instructions to: