|Informed consent||Participant signs explicit informed consent form.||Most ethically rigorous.|
Ability to recontact participant.63,64
|Requires more time, effort, and infrastructure.|
Generally yields lower number of participants.
|Waiver of consent||IRB grants waiver of consent. Language may be inserted into permission to treat form with opt-in/opt-out check box.||Ability to accrue large numbers of specimens, particularly under opt-out model.||Individual cannot be recontacted.|
IRB indicates institutional review board.