Much appreciated, thank you. On Thu, Jan 18, 2018 at 3:38 PM, Glasser, Matthew <[email protected]> wrote:
> > > > ------------------------------ > *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]. > > 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] < > [email protected]> on behalf of Dorian P. < > [email protected]> > *Sent:* Thursday, January 18, 2018 2:23 PM > *To:* [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 > > _______________________________________________ > HCP-Users mailing list > [email protected] > http://lists.humanconnectome.org/mailman/listinfo/hcp-users > > _______________________________________________ > HCP-Users mailing list > [email protected] > http://lists.humanconnectome.org/mailman/listinfo/hcp-users > _______________________________________________ HCP-Users mailing list [email protected] http://lists.humanconnectome.org/mailman/listinfo/hcp-users
