[yread]

Exactly! As someone working in medical research data sharing I am sometimes stopped from doing things the simple way by our IRB but I much prefer them being there and saying this is ok and this isn't versus just doing it the best way I can only to miss a detail and then be sued/charged with mishandling information.

I don't understand how a medical doctor can write such a simplistic post. Of course your consent forms need to mention that you will access medical data if you look at diagnosis even though they are your patients! You have access to all kinds of data for treating the patient (so called primary use), but you should have the absolute minimal set of attributes for research (secondary use). Who judges whether these attributes are really needed? IRB!

Of course you need to have you paperwork in order. This is not only your paperwork but also the hospital's! If you fuck up the newspapers are gonna carry headlines: doctors in this hospital leaked patients data. Do you think patients will want to come to that hospital?

Of course your investigators need to go through training on research ethics! In fact you should've put them through more training so that they fill in the damn consent forms properly!

Of course you need to separate personally identifiable information from the actual research and encode patient identifiers. Ever heard of publishing your data next to your research? When someone asks for the data from your study and you would forget to scrub it you would leak data. Encoding it and having it in two separate folders in one cabinet makes data sharing simpler. It protects you from making a stupid error.

Of course they can be next to each other in the cabinet. That cabinet is fucking locked! And it's in a hospital next to other private data. The risk is with publishing it!

Of course you need to fill in New Study Application, describe your study design and consent. IRB judges research studies, how would they do it if they didn't have that? You need to describe that stuff when asking for a grant and most studies are funded by grants so for most people it's no extra work.

Of course you need a monitoring plan and study meeting monitoring problems. If you had one you would notice that the newbies were doing a shitty job! Them doing a shitty job is not only bad for you but much more importantly it wastes patient's time! Patient's didn't come to hospital to improve your credentials!

The fact that there is some less than ideal stuff already used doesn't mean that your new study can be shit. That's like being angry about your pull request not getting accepted cause your indentation is all over the place and saying "but your indentation is already inconsistent". If there are style guidelines that's the way to do it. New code needs to follow them. Old stuff might get fixed or not but new stuff should be done according to guidelines.

[DataWorker]

I think you make his point. You work in medical research, all of these hoops to jump through are a real benefit to you. They keep you from being sued and act as moats that protect your livelyhood from external disruption. Do the hoops protect the participants in the research? Of course. But at what cost to the participants and at what cost to less well equipped researchers and at what cost to science itself? It's good that you won't be sued, and your training in filling in the various forms is commendable but maybe there's another side to things you're too inculcated to see clearly.

[euyyn]

> They keep you from being sued [but] at what cost to the participants [...]?

The people suing you would be the participants, because you would have already harmed them. Not getting sued by them is just a derived benefit of the primary goal of protecting them from you. And the protections extend well beyond what a patient might bother suing you for: it's an ethical committee after all.

> at what cost to less well equipped researchers and at what cost to science itself?

Completely secondary considerations, for very good reasons. Nazis weren't the only ones to harm patients; also well-intentioned scientists that thought of the greater good for science itself, and grad students that lacked resources or equipment.