Of course patients need to agree. It's actually even simpler. When you recruit patients into a study they sign an agreement that is broad and usually includes data sharing terms. Properly anonymized, of course.
Said agreements have previously gone through ethics committees which tend to be extremely strict. They are rarely changed afterwards, since this requires agreement of patients, which is impractical to obtain in all but tiny studies.
The only exception I can think of is Scandinavia. They have national registries where all census information, plus electronic health records, is available to researchers by default, unless you explicitly opt out. Their philosophy is that this is a negligible reduction in privacy, in exchange for medical progress. I must note said records are not publicly open, you need to apply for access.
As a consequence, Sweden and Denmark have some of the best epidemiological research in the world and they've been able to spot pretty odd correlations (e.g. ibuprofen and male infertility).
A broad agreement will most likely NOT make it past the institution review board. Any experiment with human subjects has strict rules around consent and data sharing agreements. The legal exposure is huge.
Broad meaning sequencing data (e.g. RNA) from tissues will be made available in public repositories, and accessible via application to committee.
I have had helped draft at least 6 studies with materials coming from our own clinical trials and deposited all data myself. Went through institution review boards without an issue, just like many other equivalent studies.
Perhaps your experience is different because of location? I'm referring to EU.
> Perhaps your experience is different because of location?
AFAIK this is also possible in the US. Probably more hoops to jump through? I don't know anything about the EU. (But also this discussion is basically totally unrelated to the original article or this thread.)
Said agreements have previously gone through ethics committees which tend to be extremely strict. They are rarely changed afterwards, since this requires agreement of patients, which is impractical to obtain in all but tiny studies.
The only exception I can think of is Scandinavia. They have national registries where all census information, plus electronic health records, is available to researchers by default, unless you explicitly opt out. Their philosophy is that this is a negligible reduction in privacy, in exchange for medical progress. I must note said records are not publicly open, you need to apply for access.
As a consequence, Sweden and Denmark have some of the best epidemiological research in the world and they've been able to spot pretty odd correlations (e.g. ibuprofen and male infertility).