What is commonly referred to as a "passive consent" or opt-out consent procedure is allowable if it meets the conditions for a waiver or alteration of informed consent. The passive parental consent procedure is commonly used in school settings where the following conditions are met:
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- The research could not practicably be carried out without the waiver or alteration (i.e., it would not be possible to do this research with active signed parent/guardian permission)
- If the research involves using identifiable private information or identifiable biospecimens, the research could not be carried out without using such information or biospecimens in an identifiable format (i.e., it would not be possible to do this research without obtaining identifiable information and/or biospecimens)
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation
- Subject selection is based on classroom membership and not exclusionary.
The investigator must provide the parent(s) with a written document containing all the required elements of informed consent that gives parents the opportunity and sufficient time to opt-out of providing permission. The protocol application should explain how the written document will be distributed to parents/guardians (e.g. the letter will be mailed/emailed by the school, the letter will be distributed at parent-teacher conferences, etc.). The letter must be sent to parents/guardians at least two weeks before research activities begin and may not be sent home with the child.
Some school districts require active parental consent regardless of whether IRB waiver of documentation of consent is appropriate, so it is a good idea for the researcher to check in with the participating school district(s) prior to the development of a passive consent process.