Dear members
Thank you very much for the discussions over the last two weeks. I would like to
ask you what do you think about including in addition to the original protocol
of the sponsor, an adendum detailing such information as:
- Who will be study team members in the local site
- Where and how are the participants to be recruited
- Description of the population targeted and their vulnerabilities, if
applicable
- Description of the study site
In other words, a summary of the protocol pertaining to the local site in what
concern the specific details only.

Also, would you like to see a copy of the sponsor's approval and that of other
IRBs of the protocol?

As for the topic of relying of one IRB on the review of another one, I could
sense that the members agree that this is an idea to consider, but in the
future, and not for the time being.

The material transfer agreement was mentioned during the discussions, and the
field is open to discuss it now!

I have another related question to raise that might appear naive, but we need to
think about it deeper:
Why do we fear the transfer of samples from one country to the other?

Hoping to hear from all of you, best wishes for a happy weekend,

Isabelle