New informed consent proposal from FDA

WASHINGTON - The FDA last week announced a proposal to amend informed consent regulations to standardize policies on emergency research, and to clarify when such research requires informed consent.The proposed regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject prior to initiation of an experimental treatment.

The exception would apply to a limited circumstance involving persons who need emergency medical intervention but do not have legally authorized persons available to represent them and cannot provide legally effective informed consent. ...