The Trump administration is expected to look favorably upon changes to a rule that protects human subjects in clinical trials after a 60-day freeze on rules introduced by the Obama administration is lifted.
The Common Rule regulates the treatment of human research subjects. In 2015, the Obama administration proposed allowing researchers to use biospecimens obtained during medical procedures without written consent from patients. The final rule was issued Jan. 18, just a few days before President Donald Trump took office.
The Obama administration was responding to new ways biospecimens can be analyzed, as well as the emergence of digital health records.
The initial proposed changes in 2015 received backlash from the medical community because of a provision requiring researchers to receive consent during every step of research. Opponents argued this would slow down the work of researchers and greatly increase administrative burdens.
The Obama administration addressed these concerns in the final rule, which stripped the requirement that consent be obtained in order to conduct research. But the changes received negative feedback from patient advocacy groups worried the rules threaten patient privacy.
Experts believe the Trump administration will enforce the final Common Rule because it is business-friendly. But the administration also could send the final rule back for further public comment.
The 21st Century Cures Act, which passed with bipartisan support and was signed into law by President Barack Obama in December, requires that newly created work groups study the Common Rule. That provision likely won't be a priority for the new administration since the primary focus is on repeal of the Affordable Care Act.
If the Common Rule changes are approved, the revisions would take effect starting next year.
