FDA plans to waive informed consent for some clinical trials
UPDATE: Feb. 22, 2019: FDA said Friday it will reopen the comment period on the proposed rule due to the online comment portal being unable to accept submissions on a portion of the final day of the last comment period.
"The Agency is aware that interested persons attempted to submit comments during the period of time," the Federal Register document states. "Therefore, FDA is reopening the comment period for the proposed rule for 10 days, until March 7, 2019."
FDA is planning to waive the requirement for clinical researchers to obtain informed consent if their studies poses minimal risk to human subjects.
The proposed regulatory changes would give institutional review boards (IRBs) the power to alter or waive the informed consent requirements if certain criteria are met.
FDA put forward the idea as part of its implementation of the 21st Century Cures Act.
U.S. law has required clinical trial sponsors and investigators to obtain informed consent from people before enrolling them in studies since the early 1960s. The provision is designed to ensure people understand what a trial involves before signing up to participate, but it slows progress in certain situations.
The Medical Device Amendments of 1976 addressed one problem by permitting investigators to use experimental products without obtaining informed consent in certain life-threatening situations. However, the amendments failed to address all the situations in which investigators see informed consent as an unnecessary barrier to research.
"Over the years, we've received feedback from sponsors and investigators that they were not able to move forward in conducting important clinical investigations where there would be minimal risk as these trials involved situations where obtaining informed consent wasn't possible," FDA Commissioner Scott Gottlieb said in a statement.
Previously, FDA lacked the power to waive the informed consent requirement in these situations. That changed with the passage of the Cures Act in 2016. To ensure the new flexibility is attached to sufficient safeguards, FDA plans to adopt the Common Rule that has been used to protect subjects in studies run or supported by HHS since the early 1990s.
The original Common Rule set out four criteria a trial must meet before an IRB waives or alters the informed consent requirement. The criteria state the trial must involve minimal risk, could not practicably be performed under normal informed consent rules and that the waiver will not adversely affect the rights and welfare of subjects. Whenever appropriate, researchers should provide subjects with pertinent information after participation.
FDA is proposing to copy the Common Rule requirements into its own regulations. In doing so, FDA plans to overlook a recently-added fifth criterion covering the use of identifiable biospecimens or private information. FDA thinks it is best served by just adopting the four original criteria but is open to receiving comments on the merits of that proposal.
The move was praised by former Obama FDA Commissioner Robert Califf.
The agency is accepting feedback on the proposed rule until Jan. 14.
- FDA FDA In Brief: FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations
- Federal Register Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
- Federal Register Reopening of Comment Period