> Collecting clinical MRIs to do deep learning doesn't require an IRB
Yes it does, but typically the IRB will waive consent and waive notification for those sorts of studies if the images can be de-identified. There's also HIPAA involved which may or may not require establishing a BAA depending on what's being done if the images can't be de-identified. This is particularly an issue with brain MRI because it is usually trivial to generate an image that can be compared to full-face photographs (i.e. can be compared to drivers license/passport type photos to reestablish identify).
And longer term you're not getting anything even in the door at the FDA without an IRB and you're not selling anything without FDA approval.
Also please note that MRI is a Class II regulated device that deposits energy in subjects/patients so it doesn't qualify for a lot of the exemptions (early last year the FDA granted IRBs the ability to do things like wave full written consent for minimal risk research for FDA-regulated research).
Yes it does, but typically the IRB will waive consent and waive notification for those sorts of studies if the images can be de-identified. There's also HIPAA involved which may or may not require establishing a BAA depending on what's being done if the images can't be de-identified. This is particularly an issue with brain MRI because it is usually trivial to generate an image that can be compared to full-face photographs (i.e. can be compared to drivers license/passport type photos to reestablish identify).
And longer term you're not getting anything even in the door at the FDA without an IRB and you're not selling anything without FDA approval.
Also please note that MRI is a Class II regulated device that deposits energy in subjects/patients so it doesn't qualify for a lot of the exemptions (early last year the FDA granted IRBs the ability to do things like wave full written consent for minimal risk research for FDA-regulated research).