The US Food and Drug Administration (FDA) on Tuesday announced it has finalized 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The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. (RELATED: FDA Revises Policies on Obtaining Informed Consent in Clinical Trials, Regulatory Focus 15 July 2014).
The agency announced that it is engaging in separate efforts to harmonize this guidance with the 2018 Common Rule on federally funded clinical trials, and this guidance may be updated to incorporate these changes (RELATED: FDA seeks to harmonize human subject protections with revised Common Rule, Regulatory Focus 27 September 2022).
The document provides general guidance for informed consent, 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.
