ITA (Investigational Testing Authorization) for Clinical Feasibility Study

[Squidman]

Hi,
We are looking to conduct a feasibility study that will require an ITA. The study is small enough that we can manage it ourselves. Would this require that we setup an REB internally? TCPS 2 seems to be directed more towards universities and research institutions.
Thanks

 

[Marc]

For those of us"following alone" here:

ITA = ?
REB =?
TCPS = ?

 

[Squidman]

Hi Marc,

Sorry, I left out the key details.

ITA = Investigational Testing Authorization
REB = Research Ethics Board
TCPS = Tri-council Policy Statement

Health Canada seems to require approval from the REB prior to issuing an ITA.

 

[shimonv]

I don't know enough about this topic but a Research Ethics Board is not something you do internally; it's an external unbiased board.

My advise to you is to approach Health Canada directly with more details.
From past experience they are responsive and sensible.


-Shimon

 

[RA Guy]

Ethics approval is always required for any study involving human participants/volunters. If you are doing your study at a clinical site (hospital, clinic, etc..) you will need to submit the site ethics board and have an ITA.

I'm not sure what you mean by "manage it ourselves". Does this mean the study will be performed at your premises? Health Canada does not consider that type of activity to require ITA. You would however still require IRB/REB approval and this can be done through a recognized IRB "for hire".

I attached some slides the HC put out in May on the topis of ITAs. Also suggest you review the current draft guidance that came out a few months ago.

If you can provide more details, I'd be happy to comment further.

RA Guy
.