While Singapore will see a new regulatory regime for research as the Human Biomedical Research Act (HBRA) comes into force, the US has undergone one of the most major revisions to its own ‘Common Rule’ regulating research in decades. Interestingly, the new Common Rule overall relaxes restrictions on various aspects of research in the US. In this post I’ll briefly summarise some of the big takeaways, and draw some comparisons to the HBRA.
Softening in the face of Public Comment
The previous draft of the revised Common Rule had several provisions that did not make it into the final draft due to strong public backlash during the comment period. Most prominently: the draft would have required broad consent for research on de-identified biological samples. Researchers reacted very negatively, stating that this would significantly interfere with important biomedical research without providing significant additional protection to participants (as the main risks are informational). Patient groups were in agreement, concerned that innovative treatments would be delayed due to excessive bureaucratic regulation. The requirement was scrapped, and broad consent is now only required for research on identifiable samples.