07/02/2014

Changes to the Declaration of Helsinki /DoH...the interpretations of the 2013 changes related to IC are being debated related to who can obtain consent; can this be delegated vs. required to include or IC signed off by the PI?

DoH: "After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed."

This seems to support consent by appropriate delegate. Is there a difference in interpretation US and OUS? Would IRBs/ECs require language in CIP/protocols to support this and other IC requirements in the DoH? Thoughts?

You can also attend this live sesson to discuss this and other DoH changes related to ICF: http://www.lifesciencetraininginstitute.com/doc/monitoring-informed-consent-ic-frequently-asked-questions-0001