07/18/2014

Tomorrow, July 24th, join us for an Informed Consent (IC) discussion that includes the new FDA IC Information Sheet, released last week. Please join us at 1pm EST. Here is the link to find out more or sign-up!

The FDA ICF Guidance released last week (July 15th, 2014) is a timely draft in light of the debate over the interpretation of some of the updates to the Declaration of Helsinki (DoH 2013). Will this further the differences in interpretation of investigator requirements US and OUS, like DoH has in some cases?

The FDA draft has been anticipated and triggering a lot of conversation. The FDA draft informed consent guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. The final guidance will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of Health Affairs, FDA. This Guidance links to many others that are part of the efforts of the agencies to enhance human subject protection and reduce regulatory burden, and is part of the efforts to harmonize the regulatory requirements and guidance for human subject research. efforts. Come discuss this draft and also address many frequent questions about consent.

ALSO, Go to our blog to review more information about informed consent and many more topics. http://clinicalpathwaysresearch.com/blog