FDA Plans New Regulations on Informed Consent Waivers, IRB Approval and IND Reporting
A final FDA rule allowing IRBs to waive or alter certain informed consent requirements for minimal-risk clinical trials is expected this December, according to the agency’s spring regulatory agenda.
The FDA’s plan, which provides only broad target dates, also lists five new proposed rules for clinical research, including one on cooperative research that would require U.S. institutions participating in multisite trials to use a single IRB for approval of any research conducted in the U.S. This rule was expected to be released in June, but still has not been published.
This month, the agency plans to release two proposed rules: one on annual IND reporting that would add a new requirement to submit a development safety update report to the FDA; and one intended to harmonize FDA human subject protection rules with the requirements of the Common Rule. A proposed rule on clinical holds of medical device trials is planned for September.
A proposed rule altering IND regulations for initiating and conducting clinical trials is expected in April 2021. The proposed rule, which would require additional documentation and reporting from investigators, is intended to help reduce study misconduct, enhance protection of subjects and ensure the reliability and integrity of clinical trial data, the FDA says.
To read the FDA regulatory agenda, click here: https://bit.ly/2W2NgfX.