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Bruyère Research Institute

FAQ

Determining Board of Record

The Board of Record refers to the REB that initially reviews the research project. If the Principal Investigator is a Bruyère Researcher, then the Bruyère REB is usually the BOR. If you are recruiting Bruyère patients, the Bruyère must be the BOR, and you must use our BREB form.


Is my project full-board or expedited?

The REB office will assess the risks associated with your project, and you will be informed if your project requires full-board review. For all clinical trials, full-board review is required. For lower risk projects, an expedited review may be possible.

 

How long will the review process take?

For low-risk (expedited) projects, the process usually takes approximately one month, if you have submitted all the required documents. 


For high-risk (full-board) projects, the process is approximately 2 months, depending on the submission of researcher responses, and the submission of documents.


If I’m a student, does that make me the Primary Investigator or Responsible Site Investigator? 

If you are a student, and are leading a project, then you will be the Primary Investigator, with your supervisor listed as the Responsible Site Investigator.


Does a case study require ethics approval? 

Generally, no, a case study does not require ethics approval. However, you must contact the Privacy Office to ensure you have received the necessary approvals, regardless of your patient(s) signing a consent form.

 

What if my student has left, but I still want to keep the project open?

You may renew the project, explaining that recruitment and data collection is not currently active, but will be once you find another student to take over the project.

 

If I’m recruiting both French and English participants, do I have to submit my documents to the REB in both languages?

Yes, you do need to submit all documents that the participant will read in both languages. However, due to translation costs, you may submit documents in English, and once you have received REB requested changes/feedback, go ahead and have them translated. After everything has been translated, please submit all documents to the REB for project approval. Please note, the REB cannot give ethical approval until all documents have been submitted for review.

 

Do acknowledgement requests require an amendment/addendum form?

No, a cover letter is sufficient for an acknowledgement request.

 

Will provincial research ethics training be accepted in lieu of the TCPS 2 certificate?

No, the REB requires the TCPS 2 certificate (issued within the last 5 years) for all researchers and staff.

 

What is the difference between an amendment, an addendum and an acknowledgement request?

An amendment refers to any changes or revisions to your already approved, ongoing research study. They are usually minor, and are within the original scope of the study. They may include changes to the consent forms, information letters, and recruitment and data collection tools, etc. Most amendments require updates to the ethics application, along with any pertaining documents. If your amendment proposes significant changes to the research, such as a new study that pertains to the original study, you must submit a new ethics application.

An addendum is described as an addition to the already approved, ongoing research study. These are very minor changes, and are usually administrative in nature, encompassing the addition of new staff, thank you letters or memos to research participants, etc. You must fill out the Amendment/Addendum Form for all requests.

An acknowledgement request refers to reporting, or informing the REB of something, as opposed to requesting an approval. For example: study closures, safety reporting, signing authority, deviations, SAE’s, incidental findings, new information reports, and/or past reporting, etc.  Please refer to the various reporting forms prior to submitting to the REB. For acknowledgement requests that do not require a form, please submit a cover letter.