Researchers must submit an Amendment when a previously approved research protocol and/or related study documents undergo revisions or modifications.  The changes must be submitted and approved prior to implementation unless the changes are:

• crucial and therefore urgent actions need to be taken for research participant safety
  
• logistical/administrative and do not impact the study design
  

For information on the types of amendments and instructions on the submission processes, please see UBC CREB PAA Guidance Notes - Section IV– Study Amendments.

Note: only one amendment can be submitted at a time per study.

Researchers must submit annual renewals with sufficient details to enable the REB to make an informed judgement about the continued ethical acceptability of the research (TCPS 2 Article 6.14).

Level of review may change depending on the study status, and the extent of any remaining risk to participants are re-considered at the time of annual renewal  (e.g. A clinical trial that was initially reviewed by the full board may be eligible for delegated review depending on the extent of the remaining risk to participants if treatments are complete).

For determining what type of review is required, refer to this Quick Reference Table for Annual Renewal & SAE Reporting & Completion of Study. This table also indicates when a study no longer requires annual renewal and reporting of serious adverse events (SAEs), and when a study can be considered complete (see Study Completion panel below).

For more information and instructions on the submission process, please see UBC CREB PAA Guidance Notes - Section III - Annual Renewals.

Note: amendments and annual renewals cannot be combined. To make changes to the application form, please submit a separate PAA amendment.

R 

‎Researchers have a responsibility to ensure that any new information that may affect participant welfare or consent is shared with the REB (TCPS 2 Article 11.8). 

New information includes (but not limited to):

• Safety data
  
• Protocol deviations (see below)
  
• Unanticipated issues/problems (see below)
  
• Evidence of any new risks
  
• Newly discovered risks
  
• Newly discovered information
• New research findings, including non-trial findings
  
• Study holds/closures/completion
  
• Enrolment holds/closures
  

Should unanticipated issues (including protocol deviations) arise that may increase the level of risk or have other ethical implications that may affect participants' welfare, researchers shall report them to REB in a timely manner (TCPS2 Article 6.15).

Examples of unanticipated issues include:

• unexpected participant reaction to the study intervention
• unavoidable single incidents 

For information on submitting Unanticipated Problems, please see UBC CREB PAA Guidance Notes - Section VII– Submitting Unanticipated Problems.

For information on submitting Protocol Deviations, please see UBC CREB PAA Guidance Notes - Section VIII– Protocol Deviations.

The obligation to report new information ends with the completion of the study (TCPS 2 Article 11.8).

A study may be closed when:

• all data collection procedures as per the approved protocol is complete for studies involving DIRECT human participation*.
• all data/biospecimen acquisition is complete (from charts, other research groups, biobanks, etc.) for studies that do not involve DIRECT human participation**.

^{*Studies with US Federal Government support/funding cannot be considered closed until all participant-related activities and data analysis involving personally identifiable information are complete.}

^{**US-affiliated studies are subject to specific requirements.}

‎For more information on submitting Study Completions, please see UBC CREB PAA Guidance Notes - Section V - Study Completion.