Starting in October 2025, there will be two major application updates: the addition of a new state- Administrative Hold and revisions to the Clinical Post-Approval Activity (PAA) Renewal Coversheet.
New state added for all Applications- Administrative Hold
Administrative hold on ethics approval is a state between approved and suspended. It can be issued in cases where the REB chair or designee have substantial concerns related to an aspect of a research protocol and would like a study/project to be put on hold while the REB and researcher resolve concerns. An administrative hold does not necessarily pause all research activities. The REB must be clear with the researcher what activities are being paused, e.g. all research activities, new recruitment, a specific procedure etc. Upon satisfactory resolution, administrative holds can be lifted by the REB chair or designee.
Renewal updates
Below are a list of new questions being added to the renewal form coversheet. Questions are in draft form and may be revised slightly as we are currently programming the form:
Section 3.3 Participant recruitment
c. Number of participants enrolled in the last 12 months:
c.2. If there has been no participant enrolled in the last 12 months, please explain:
Optional Components:
d. In addition to the main study, does your application include optional components or consent forms (e.g., Optional Biobank, Optional MRI, etc)? Yes/No
d.2. For optional components, how many participants have enrolled at BC sites covered by this research ethics approval?
Total enrolled since start, per component (e.g Optional Biobank: 7; Optional MRI: 10):
Section 5.1 Progress Report
If applicable, please also report on progress of optional components (e.g., Optional Biobank). Clarify if optional components are open to enrollment.
Section 5.4 Related to Biobanking/registry
We are getting more and more biobanks or applications that include biobanking, however the reporting of them is quite lacking. A new section has been added to capture more info.
- Registry or Biobanks (if BC is custodian): List of projects linked to biobank/registry
- Biobanks (if BC is Custodian): Inventory report
- BC is contributing samples to a biobank: report on biospecimen transfer
General update: We have changed “study” where appropriate to “project” or “application” to be inclusive of applications that are solely biobank/registry applications.
Updated copy of the Renewal PAA Coversheet will be posted here once finalized.