Research Ethics Approvals

Initial Approval

Researchers are not permitted to contact prospective subjects or to initiate any research related procedures until the Certificate of Initial Ethical Approval and the Letter of Authorization to Conduct Research for their particular research study has been issued by the Research Ethics Co-ordinator to the principal investigator/contact person for that study.  The Certificate of Initial Approval is issued for a ONE year term only. 

Amendments to Previously Approved Research

Amendments to previously approved research must be submitted for approval by the Fraser Health Research Ethics Board and issued a Certificate of Approval for Amendment of a Previously Approved Study approved before any change to the research protocol/consent forms or any other change is implemented.  The approval of any amendments within that one year term also expires on the expiry date of the initial certificate of approval.

Visit our Forms and Guidance Notes page for an application form.

Annual Renewal

Ongoing studies must be renewed annually if they meet one or more of the following criteria:

• data (including follow up data after subject recruitment is closed) is still being collected directly from subjects, or;
• data is still being collected from secondary sources, for example, medical records, linked datasets, or;
• tissue samples are still being withdrawn from a tissue bank or acquired from another research group for studies which analyze human tissue.

Annual renewal is NOT required for studies that have completed the data collection phase and are only conducting the analysis of the data and/or tissue. 

Researchers are not permitted to recruit new subjects until the certificate of annual approval has been issued to the researcher. 

Researchers must submit the Request for Annual Renewal form to the Department of Evaluation and Research Services at least four weeks before the one year expiry date of the Certificate of Initial Approval or subsequent annual renewal certificate. 

The approval of any amendments within the one year period of the renewal certificate also expires on the expiry date of the certificate of annual renewal. 

The renewal certificate is issued for a one year term only from the date of the approval by either the Full Board or Delegated Review. 

Failure to comply with this requirement can result in the suspension or termination of the approval of the research and a report of noncompliance made to the funding agency and/or Health Canada as applicable. 

Visit our Forms and Guidance Notes page for an application form.

Study Completion

Once the study is completed, i.e. all data collection is finished or the study close-out visit has been conducted for clinical trials, researchers must complete the Close Out Form for clinical trials or non-clinical trials and submit to our Research Ethics Co-ordinator for acknowledgement by our Research Ethics Board.

Records Retention

Clinical Trials
Clincal trial researchers must retain all research-related records for a period of 25 years under the Health Canada regulations for drug, device and natural health products.

Non-Clinical Trials
Fraser Health requires that researchers retain all research-related records for a period of 5 years