To date, FDA requires all subjects to provide their informed consent before participating in any clinical trial, except when there are life-threatening situations or emergency research conditions.

On November 2018, FDA proposed a new rule that will allow investigators to request a waiver of the informed consent from the IRB for minimal risk clinical studies. However, in order for IRBs to waive informed consent requirements, they will need to determine and document the following four criteria:

  • The research involves no more than minimal risk to the subjects,
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • The research could not practicably be carried out without the waivers or alterations; and
  • Whenever appropriate, the subjects will be provided with additional patient information after participation.

The new informed consent rule may become effective in January 2019.

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