Monday, September 19, 2011

FDA and OHRP Release Joint Draft Guidance on Exculpatory Language in Informed Consent

On September 7, 2011, the Office for Human Research Protections and the Food and Drug Administration published a joint draft guidance in the Federal Register entitled “Guidance on Exculpatory Language in Informed Consent.” Comments and suggestions regarding the draft document are requested by November 7, 2011. The guidance provides examples of acceptable and non-acceptable (exculpatory) language including the issues of research-related injury and the use of biospecimens for research.

The link to the Federal Register announcement is below:

The links to the Draft Guidance from OHRP and the FDA are below:

No comments:

Post a Comment