Ropes & Gray team analyzes FDA draft guidance on emergency research
Recently, the Food and Drug Administration issued draft guidance on complying with the emergency exception to the general rule requiring the informed consent of human research subjects. The draft guidance aims to clarify the exception, which allows for a waiver of consent in certain instances in which the subject has a life-threatening medical condition. In the BNA's Medical Research Law & Policy Report
, a team of attorneys in Ropes & Gray's Health Care Practice – partner Mark Barnes and associates Clinton D. Hermes and Sharon Rackow Herrick – looks at some of the unresolved issues and concerns raised by the FDA's draft guidance and the underlying regulation. Please click "Download PDF" for the full article.