FDA tackles informed consent concerns with new guidance
- FDA has issued draft guidance on informed consent to help institutional review boards (IRBs), clinical investigators and sponsors understand the various issues surrounding informed consent.
- One area that is addressed is simultaneous patient participation in more than one clinical trial and repeated enrollment in a single clinical trial. FDA strongly discourages this.
- Although the general guidelines for informed consent have not changed significantly, much of the guidance is new.
The new informed consent guidance is extensive and touches on many topics, including review of patient records, using children as subjects, informed consent from individuals with physical disabilities, informed consent from individuals with low literacy or numeracy and more. For instance, FDA specifies in the new guidance that individuals with low literacy levels should receive oral presentation of the content in the informed consent form.
More information can be found here. Comments on this guidance are due by Sept 15.