FDA does not require a third person to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before it is signed. The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. FDA does not specify who this individual should be. Some sponsors and some IRBs require the clinical investigator to personally conduct the consent interview. However, if someone other than the clinical investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.
