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Post Approval Activities (PAAs) refer to any activity that happens to an ethics application after the initial approval has been given. Once initial approval for a project is obtained from ORE, researchers can initiate research activities related to the project. The initial approval is valid for one year, after which it must be renewed. If your study approval has expired you will only be able to submit a request for renewal or renew/amend. Please note that only one PAA can be submitted per study at any given time.

For instructions on how to submit a PAA, please see our training videos and quick guides here.

 

Annual Renewal

Per TCPS2 requirements the initial approval is valid for one year, after which it must be renewed. 
An Annual Renewal must be submitted every year before the expiry date listed on the initial approval letter or latest annual renewal approval letter. 
 

Amendment

An amendment is a revision to an approved and ongoing study.

If you are changing any part of the study (e.g. consent forms, procedures, co-investigators, title, funding, surveys, questionnaires, etc.) you must submit an amendment request. Amendments to studies should be changes within the scope of the original study, not new studies that are simply related to the original study. Please include any resulting new documentation.

Amendments to previously approved research studies must be reviewed and approved by the SFU REB before any change to the protocol/study details, consent forms, research instruments or any other change is implemented.

Note for graduate students: The ORE in consultation with the Office of the Dean of Graduate Studies and The Library Thesis Office has determined that the Title of the Thesis submitted to the Library does not have to match the title of the project listed on the Ethics Approval Letter. Therefore, the ORE will no longer be processing amendments for Title Change Requests if the request is solely for the purpose of matching the Thesis Title to the Title of the project listed in the Ethics Approval Letter.

Please note the following when submitting an amendment:

  • Amendments that involve adding procedures that are not considered minimal risk must be referred to the Full Board for review and approval
  • Changes to documents should be clearly marked by using track changes or highlighting on the attached, revised document
  • If the reviewer deems the amendment to be more than a minor amendment, you may be asked to complete a new application

The following questions should be considered when proposing an amendment:

  • Does the amendment affect the risk/benefit ratio?
  • Does the amendment affect recruitment? If so, is a revised recruitment ad or letter attached?
  • Does the amendment affect what the participant is asked to do or confidentiality of the data? If so, is a revised consent form attached?
  • Does the consent form adequately reflect the change in time, risk, or confidentiality?

 

Renew/Amend

If a research project needs to be renewed AND revised, the online system allows for a combined request for an Annual Renewal and Amendment.

Note: If you have less than two weeks left before your study expires please submit a renewal only, as the ORE cannot guarantee that the amendment will be approved before the study approval lapses. Once the renewal has been approved you will be able to submit your amendment. 

 

Close Request

When work on a project concludes, the application must be closed. No active recruiting and/or direct contact with participants can occur once the closure takes effect. It is important to note that for projects that are linked to an undergraduate or graduate thesis, we highly recommend not closing the application until after successful graduation. Similarly, we recommend not closing the application until the results have been published, if applicable. 

Once an application has been closed it cannot be reopened. A new ethics application would need to be submitted if you wish to continue with your research activities.