________________________________
From: Curtiss, Sandy
Sent: Thursday, January 18, 2018 2:36 PM
To: Glasser, Matthew
Subject: RE: [HCP-Users] Any issues with informed consent forms for CONNECTOM
scanners
Hi Matt,
I know the answer for WU but other IRBs may make other decisions. We did not
need any special statements in the informed consents for studies using our
Connectom scanner because our IRB made the decision that even though there are
non-FDA approved aspects (the SC-72 gradient insert and the MB pulse
sequences), the scanner is a Nonsignificant Risk Device. If he has further
questions, Dorian can contact me at
[email protected]<mailto:[email protected]>.
Sandy
From: Glasser, Matthew
Sent: Thursday, January 18, 2018 2:26 PM
To: Curtiss, Sandy
Subject: Fw: [HCP-Users] Any issues with informed consent forms for CONNECTOM
scanners
Hi Sandy,
This question seems like one you might know the answer to.
Matt.
________________________________
From:
[email protected]<mailto:[email protected]>
<[email protected]<mailto:[email protected]>>
on behalf of Dorian P. <[email protected]<mailto:[email protected]>>
Sent: Thursday, January 18, 2018 2:23 PM
To: [email protected]<mailto:[email protected]>
Subject: [HCP-Users] Any issues with informed consent forms for CONNECTOM
scanners
Dear HCP community and developers,
In preparing for an upcoming study, one of my collaborators has asked whether
the CONNECTOM scanners require any special statements in the informed consent
form. The reason behind this is that, from what we understand, CONNECTOM
scanners are not standard clinical scanners with CE certification (or other
equivalent certification in USA). Being uncertified, the subject will be put in
a machine that has not passed certain tests from the authorities. Not sure what
those tests are or what is certified in an CE certification, but the logic
makes sense.
I wanted to ask whether anybody has encountered this issue before for those of
you who have used CONNECTOM scanners or other out-of-series scanners before. I
realize this is a highly specialized question not directly pertaining to the
HCP user community, but I am hoping that someone may have tips on the issue.
Thank you.
Dorian
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