FDA issues final guidance on obtaining informed consent

The US Food and Drug Administration (FDA) has announced the finalization of guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations.

The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998.

The document provides general guidance for informed consent in both drug and device trials, covering exceptions to informed consent, avoiding coercion and exerting undue influence on subjects, how to make language understandable to the subject or the legally authorized representative, and avoiding the use of exculpatory language on consent forms.

It also discusses the basic elements of informed consent, which addresses describing the clinical investigation, explaining the risk and discomforts as well as the benefits of the treatment to patients, and compensation and medical treatment in the event of an injury.

The guidance, copies of which can be obtained from here, also addresses the roles of IRBs, clinical investigators, sponsors, and the FDA in the informed consent process, followed by a series of frequently asked questions.