Changes to federal rule governing human research aims for expedited review
Scientists and innovators hope proposed changes to the federal rule regarding the ethics, oversight and transparency of research involving human subjects will expedite the clinical review process.
They, along with officials from HHS and 15 other agencies, will attend a town hall meeting in Washington this week to discuss proposed updates that include clearer consent rules for the reuse of stored blood or tissue in new research unrelated to their original study purpose.
The agencies began overhauling the regulations in response to the more sophisticated ways biospecimens can be analyzed, as well as in response to the collection of digital health records.
Industry leaders say changes to the so-called Common Rule, established in 1991, are long overdue.
In particular, they advocate speeding up the clinical-review process and ensuring institutional review boards can take on multisite, international research projects, said Arthur Caplan, director of the division of medical ethics at New York University’s School of Medicine.
The Common Rule changes are subject to a 90-day comment period before being finalized. Comments must be received by Dec. 7 to be considered.
The call for clearer guidelines comes as the White House launches its ambitious Precision Medicine Initiative, which aims to involve as many as 1 million medical volunteer subjects to help innovate medical treatments specific to individuals.