Law360, New York ( August 19, 2014, 2:10 PM EDT) -- The U.S. Food and Drug Administration's newly issued draft guidance, "Informed Consent Information Sheet,"[1] provides helpful nuance and specificity to the agency's relatively sparse-informed consent regulations.[2] At the same time, the draft guidance's repeatedly expressed concern that subjects not be "overwhelmed" by too much information is in tension with several recommendations that effectively expand sponsor disclosure obligations. The draft guidance suggests that sponsors — including pharmaceutical and medical device companies — of clinical trials reconsider their approach to informed consent. While providing helpful clarity on several aspects of the Part 50 regulations, the draft guidance creates some additional ambiguity for sponsors, which in turn may increase the risk that consent documents will be considered inadequate by institutional review boards, the FDA and/or courts. Sponsors should carefully review the draft guidance to determine the feasibility and potential consequences of these new recommendations....