FDA Extends Comment Period on Proposed IRB, Informed Consent Rules
In response to requests for more time to weigh in on a pair of long-awaited proposed rules on IRB review and informed consent requirements, the FDA has extended the comment period to Dec. 28.
The proposed rules would line up the FDA’s IRB and informed consent requirements with the Common Rule’s provisions and are intended to cut down on administrative burden for sponsors, investigators and IRBs by making IRB reviews more consistent across government- and privately funded research. They were finally published in October after years of delay (CenterWatch Weekly, Oct. 3).
“The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rules,” an FDA spokesperson told CenterWatch Weekly. “The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.”
Read the notice here: https://bit.ly/3G4QLKr.