Is passive or opt-out consent allowable?

Passive or Opt-out consent is not generally considered legally valid consent and requires the IRB to grant a waiver of informed consent or documentation of consent. Passive consent should not be used when participants will be recorded or provided with significant compensation or incentives.  

From the hhs.gov informed consent FAQ:  If the IRB has approved this alteration of the consent process and has waived the need for documentation of consent, then such procedures are permissible under the regulations. By sending back a completed survey the recipient has implied that he or she consents to participate but has not signed an informed consent document. Although some might call this “implied informed consent,” OHRP would consider this to be a permissible informed consent process if the IRB has approved the informed consent alteration and waived the requirement for documentation of informed consent.  

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

Last updated: 8/31/2023