Dear Manbir,
I'm not sure if it is exactly what you need for your ethical committee
but here is an example .. a translation of what "we" usually have in the
French consents (at least this is what I wrote)
> Dear Colleagues
>
> Our IRB has asked for language to be inserted in the consent form and
> description of a fMRI/DTI research project that would include a
> section on "incidental findings" Our research involves acquisition of
> fMRI and DTI data and we also acquire a SPGR whole-brain and T1 images
> for co-registration but no other "clinical" images. Does anyone have
> experience as to what would be the appropriate language covering
> "incidental findings" to use in this situation for IRB approval?
> Thanks. Manbir Singh
" No health hazard is expected from the MRI except intracranial clips
or other metallic objects or cardiac prosthesis, which are
contraindicated for this exam. Because MRI has a good anatomical
resolution, it can reveal brain abnormalities or injuries. In such
cases, the MD responsibles for the exam *must and will inform you*
directly or via your familiy MD, even if this abnormalities or injuries
are mild "
of course it goes with another paper (before scanning) describing all
things you must not have inside your body .. I don't know, it seems that
some metallic implants or others are dangerous for subjects an worst ..
it gives bad fMRI data !! :-P
Best
- Cyril
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