Advantages and Disadvantages of Informed Consent Versus Waiver of Consent Models for Biobanking

Informed consentParticipant 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 consentIRB 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.