SAN FRANCISCO — Drug companies here are rallying behind legislation that they say would fix a state consumer privacy law that threatens to jeopardize the integrity of clinical trial results and drive scientists out of California.
The bill, called SB-1121, would prevent patients from accessing and deleting some of their data from clinical trials. The idea is to make sure that clinical trial participants can’t use the consumer privacy law to prohibit their data from being used by researchers, or to find out if, say, they’re receiving an active treatment or a placebo.
This makes little sense.
One of the very fundamental premises in human subject research is the subjects’ option to withdraw at any time and, likewise, to have their data expunged upon withdrawal.
Why would CA want to pass a law that violates the foundations of protecting humans in a research environment? These rules and regulations are there to prevent negative effects on subjects and are part of the premise of weighing potential harm versus potential gain…and the ability to drop out and have your data expunged when you have left the study is an iomportant component in the subjects’ perception of well-being and trust in researchers
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