4 ms·

What the law says does not really matter. What matters in the perception of what it says. In the case of medicine, all clinical trials need to go through "Ethic

by IMTDb 6y ago

What the law says does not really matter. What matters in the perception of what it says. In the case of medicine, all clinical trials need to go through "Ethics committee". And ethics committees overwhelmingly consider that GDPR and co also applies to medical studies. So your study protocol absolutely has to take it into account. It's not like you can really argue with them - or get ready for months/years of delays. At the end of the day, their job is to protect the institution, so it's less dangerous for them to refuse a valid study than to accept an invalid one. The European union included various narrow and strangely worded "exemptions" from the law, but the damage is done: "Better safe than sorry, just apply GDPR to all data collections".

lm28469 6y ago
But... that's valid for every single law then... Every company have an official GDPR contact person, who is trained for their industry, for this very purpose, it's not rocket science. I debunked this in literally 15 seconds on the official gdpr website. How is GDPR different than the other hundred thousands laws regulating medical companies ? GDPR isn't the first law they have to worry about, it's probably not even remotely close to the most complex regulations applied to medical research. They're used to deal with very convoluted texts of law, I'm sure they can figure a list of 5 bullet points... > but the damage is done: "Better safe than sorry, just apply GDPR to all data collections". I don't even understand your logic to be honest, do you think any high level person working in a medical research company in Europe would have this line of thought ? If it's the case I hope everyone in charge of that specific organisation gets replaced real quick. You're telling me your "Ethics committee" is OK with injecting experimental drugs to people who can potentially ask them to delete all contact information (thus endangering them in case side effects are discovered) but they would not be OK with getting familiar with the law ? I have a hard time seeing how that works
- IMTDb 6y ago
  My comment is not related to medical studies performed by pharmaceutical companies - which are indeed probably very well covered by legal experts - but by students/professionals working in university hospitals. Think PhD students. The ethics committees of these hospitals have far less access to trained legal professionals. Especially if you factor in the amount of studies that re submitted. The combination of "little time" + "lots of studies submitted" + "no real expertise", leads to very shallow analysis of each individual study protocol. They basically run some kind of checklist that all studies have to pass before being validated. And because there is no time to review each study in depth, the tendency is to say "regardless of what the law says, we'll just cover the hospital potential liability by refusing any study that does not include strong privacy protection". No one has the time or expertise to say "I believe it's ont of those case where the law does not apply, and I am willing to undersign that study protocol". In the hospital where my wife works, getting your study refused by the ethics committee leads to at least 3 month of delay in the study, since the commitee gathers once per quarter. PhD grants are given on a year-by-year basis, so getting 3 month of delay on your first target can sometimes be a death sentence.
  - lm28469 6y ago
    > but by students/professionals working in university hospitals. Yeah but then it doesn't matter because these student wouldn't come up with a covid vaccine in the first place. The GP comment is about the fact that covid vaccines are (supposedly ?) delayed by gdpr, which is non sense

by IMTDb 6y ago

lm28469 6y ago

But... that's valid for every single law then... Every company have an official GDPR contact person, who is trained for their industry, for this very purpose, it's not rocket science. I debunked this in literally 15 seconds on the official gdpr website. How is GDPR different than the other hundred thousands laws regulating medical companies ? GDPR isn't the first law they have to worry about, it's probably not even remotely close to the most complex regulations applied to medical research. They're used to deal with very convoluted texts of law, I'm sure they can figure a list of 5 bullet points... > but the damage is done: "Better safe than sorry, just apply GDPR to all data collections". I don't even understand your logic to be honest, do you think any high level person working in a medical research company in Europe would have this line of thought ? If it's the case I hope everyone in charge of that specific organisation gets replaced real quick. You're telling me your "Ethics committee" is OK with injecting experimental drugs to people who can potentially ask them to delete all contact information (thus endangering them in case side effects are discovered) but they would not be OK with getting familiar with the law ? I have a hard time seeing how that works

IMTDb 6y ago
My comment is not related to medical studies performed by pharmaceutical companies - which are indeed probably very well covered by legal experts - but by students/professionals working in university hospitals. Think PhD students. The ethics committees of these hospitals have far less access to trained legal professionals. Especially if you factor in the amount of studies that re submitted. The combination of "little time" + "lots of studies submitted" + "no real expertise", leads to very shallow analysis of each individual study protocol. They basically run some kind of checklist that all studies have to pass before being validated. And because there is no time to review each study in depth, the tendency is to say "regardless of what the law says, we'll just cover the hospital potential liability by refusing any study that does not include strong privacy protection". No one has the time or expertise to say "I believe it's ont of those case where the law does not apply, and I am willing to undersign that study protocol". In the hospital where my wife works, getting your study refused by the ethics committee leads to at least 3 month of delay in the study, since the commitee gathers once per quarter. PhD grants are given on a year-by-year basis, so getting 3 month of delay on your first target can sometimes be a death sentence.
- lm28469 6y ago
  > but by students/professionals working in university hospitals. Yeah but then it doesn't matter because these student wouldn't come up with a covid vaccine in the first place. The GP comment is about the fact that covid vaccines are (supposedly ?) delayed by gdpr, which is non sense