Thread by @GidMK

After the whole Surgisphere debacle, I think there's one thing that has been ignored/forgotten a bit

Both of these studies were published ⚠️without ethics approval⚠️

Now, that may seem like a small point - every hospital system looks at data all the time, so why does it matter?

Thing is, this is a HUGE issue that @TheLancet and @NEJM have yet to explain

The absolute minimum of any research project is ethics approval FOR A REASON

Without any independent oversight, we get things like the Tuskegee experiment cdc.gov/tuskegee/timel…

It is a pretty enormous breach of ethical oversight that any study purporting to not need ethics was ever published (even if they are now retracted)

Yes, there is some research that is deemed exempt from ethics approval, but this is usually governed by large independent committees from the places in question

For example, some Scandinavian countries waive ethics for deidentified registry data, but through a government program

And the issues don't stop at published research. There are half a dozen preprints out there that claim that the researchers didn't have any ethical oversight during the process ~and didn't ask for it~

That is a HUGE RED FLAG

Bottom line - researchers should not be the ones who decide whether their own actions are ethical

That articles are being published saying that the researchers don't think they needed ethics is a massive problem