skwb
Joined 9 years ago
Joined 9 years ago
I can only hope that projects like these help build better lenses for the future.
At the *very* least you should be following the administrative rules act (requiring you to solicit 45 days for comments by effected parties) before making such a dramatic change in policy.
Courts absolutely love striking down EOs (of both Dems and Reps Admins) when they should have been following the administrative rules act.
I really get irked a lot by seeing (overly obvious) ai generated images being used for stock photos. One of the reasons my wife and I still subscribe to a couple of newspapers is that the photography helps bring to life the story being told. Why where these photos taken and how do they impact the story. You don't get that same visceral emotional reaction with low quality cartoon images.
That said, there's plenty of buying and selling of radiological images for industry development on the second hand market. Now where the line of "research" vs. "industrial" work is, well that's something I would leave to legal council. But as you said any sort of "altering" of clinical outcomes is a clear IRB is required zone like DL based recon.
I admit it sounds pedantic, but I'm not discussing IRB *exemptions* that are sometimes required by an institution nor am I discussing BAAs. I was specifically talking about the specific IRB applications (which I've submitted and signed before) that the blog author was talking about. Yes, HIPAA and other state and local regulations also govern what you can and cannot do with the data, but that's not what I argued.
Sorta off topic but the FDA doesn't care so much about SAR unless you're directly programming the MR machine's pulse sequence. If you're just doing quantification of some brain structure for monitoring a biomarker, they're primarily concerned if your product 1) matches an existing prerequisite and 2) functionality that your product achieves performance that you say it does. That is why the marketing around most of the early DL / AI based radiology startups were focused on language for "study prioritization" rather than more specific claims.
The point I'm trying to make is that the blog is so narrowly defined that it doesn't match the reality of clinical research.
IRBs are only REALLY required when you are intervening in patient care or pose some theoretical risk to a human.
Some institutions still want you to submit approval for institutional data, but as a non-lawyer it seems that's much more of a CYA policy.
The critical part imho will be allowing for enough independence in research, and that the time isn't just wasted filling in remedial RAs pushing pipettes around. Real safeguards will be needed, likely overseen by the PI and committee.
I genuinely hope it works and helps industry "figure out" that R&D is more than just simply productizing over the next quarter.