Amendments to Previously Approved Research

 

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.

How to Request an Amendment

To request an amendment to a previously approved study, send an email to dore@sfu.ca citing your study number in square brackets in the subject line (e.g. [2008s0679]) and attach your Amendment Request Form and revised documents in PDF format. Be sure to highlight the sections in the revised document(s) showing where the change(s) occur and include a current version date in the footer of the document.

Note 1: Graduate Students, Post-Doctoral Fellows and SFU staff must have their Supervisor approve the amendment submission, and indicate this on the amendment request form, before the ORE/SFU REB will review the amendment.

Note 2: If the Associate DORE or DORE deems the amendment to be more than a minor amendment, you may be asked to complete a new application.

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;
  • Any changes to documents should be clearly explained and highlighted on the attached, revised document;
  • Where the amendment is limited to an 'administrative change' (e.g. changes in granting status, staff personnel, contact person, etc.), please include an explicit statement to the effect that the research procedures (including recruitment, consent, etc.) have not been changed in any way; and
  • Briefly explain the rationale behind any changes in the protocol.

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

 

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