After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects. The guidance begins by reiterating the basic process for obtaining consent, beyond written documentation. FDA explains the obligation for regulators to provide potential subjects with adequate information, in an appropriate medium for comprehension, sufficient opportunity for questions and consideration, and continual communication of relevant information throughout the progression of the clinical investigation.
The guidance continues with a few updates to the original guide from 1998. One section of the draft guidance addresses clinical trials with non-English speaking participants, requiring all information to be communicated in language and terms the subject can comprehend. Additional sections of the document cover the inclusion of children in clinical trials and working with patients with mental disabilities or impairments.
To read the full draft guidance, click here. To read the full article by Alexander Gaffney of raps.org, click here. Need assistance with writing an informed consent form? Pearl’s medical writers are happy to help – contact us at info@pearlirb.com.