In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance.
Recognizing the growing significance of mobile devices within the industry, ACRO has urged FDA to consider this role in the informed consent process. “The Agency has missed an opportunity to not only examine more thoroughly various alternative, electronic methods of obtaining informed consent, but also to examine how new technologies could simultaneously resolve some of the understandability and comprehension concerns,” ACRO explains.
ACRO has also suggested that FDA include more in-depth information regarding the use of central IRBs in the final guidance.
Dana Farber’s most pressing concern addresses FDA’s requirement for full disclosure of alternative treatments. The institute provides a number of reasons why FDA should reconsider this position, including additional length and constant updates to research consent forms.
The time period to submit comments to FDA has since expired, and the release of a final guidance is expected soon.
For more information, check out Zachary Brennan’s article on outsourcing-pharma.com.