3 ms·

I can see your point, but almost all clinical research already involves a consent process where the patient is told the benefits and risks of participating; sig

by pak 11y ago

I can see your point, but almost all clinical research already involves a consent process where the patient is told the benefits and risks of participating; signing away a license to a subset of their medical data could simply be included in the consent. There are some regrettable examples of cells and tissue being taken from patient specimens without their knowledge, some of which give birth to entire fields of research, and then it is later unclear whether data that could re-identify the patient's family (like genomic data) can be published [1]. It can be really hard to fully de-identify imaging and molecular data. [1]: http://www.nature.com/news/deal-done-over-hela-cell-line-1.13511 http://www.nature.com/news/deal-done-over-hela-cell-line-1.1...

kendallpark 11y ago
> I can see your point, but almost all clinical research already involves a consent process where the patient is told the benefits and risks of participating; signing away a license to a subset of their medical data could simply be included in the consent. You don't need to get consent if the PHI is de-indentified and the data was obtained through a regular course of treatment (not a study). This is really important because hospitals can publish anonymized case reviews for rare disorders or perform chart reviews on patient outcomes (drug X produced Y outcome in Z patients with [some condition]). I read through a lot of these papers on a daily basis and can't imagine the state of medical literature if consent was needed for publishing this clinical data. Retrospective chart reviews are typically exempt from human subject regulations. More info: http://wichita.kumc.edu/Documents/wichita/researchcompliance/Guidelines%20for%20Retrospective%20Chart%20Reviews.pdf http://wichita.kumc.edu/Documents/wichita/researchcompliance... The cases of unauthorized cell lineages predate HIPAA and other health laws that would make such actions illegal today.

by pak 11y ago

kendallpark 11y ago

> I can see your point, but almost all clinical research already involves a consent process where the patient is told the benefits and risks of participating; signing away a license to a subset of their medical data could simply be included in the consent. You don't need to get consent if the PHI is de-indentified and the data was obtained through a regular course of treatment (not a study). This is really important because hospitals can publish anonymized case reviews for rare disorders or perform chart reviews on patient outcomes (drug X produced Y outcome in Z patients with [some condition]). I read through a lot of these papers on a daily basis and can't imagine the state of medical literature if consent was needed for publishing this clinical data. Retrospective chart reviews are typically exempt from human subject regulations. More info: http://wichita.kumc.edu/Documents/wichita/researchcompliance/Guidelines%20for%20Retrospective%20Chart%20Reviews.pdf http://wichita.kumc.edu/Documents/wichita/researchcompliance... The cases of unauthorized cell lineages predate HIPAA and other health laws that would make such actions illegal today.