4 ms·
Regarding consent, these are for image analysis, not bioinformatics (I can't ID the person from the information). As such this is a standard tissue repository u
by killjoywashere 8y ago
Regarding consent, these are for image analysis, not bioinformatics (I can't ID the person from the information). As such this is a standard tissue repository use case. The courts have held, in cases (UCLA, WashU, and Florida come to mind) that the archive is the property of the institution and the patients have no claim to "remnant tissue". As DNA is considered identifiable, that would be a separate issue, but they're not going after genomics.
- mbreese 8y agoRegardless of if the data is identifiable, the patient would need to be consented for their data to be used for research purposes. This is a pretty standard clause, and I’d be shocked if MSK didn’t have this as part of their standard consent, but it may not have been done for all patients over the years. The patients would not have a right to reclaim the reminant tissue, but they may still have a say in how the data derived from their treatment is used, deidentified or not. Normally this is an IRB issue. I have no idea how you’d go though licensing these data commercially. It’s an ethical minefield. For example, if patients knew their data would be licensed commercially, they may not have agreed to their treatment. And even if it was legal do do this without consent, you’d still want to make sure you had patient consent just to avoid these issues at all. If they didn’t have consent, it’s a huge PR issue, even if not a legal one.
- killjoywashere 8y agoAn IRB can waive the requirement for consent when the data is de-identified and the barrier to gain consent would be onerous. In this case, with 25 million slides, and quite a few of the patients are dead or lost to follow up, I'm fairly confident the IRB would waive the consent requirement.