Guidelines Under Which an IRB May Waive the Informed Consent Process
- 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
- Whenever appropriate, the subjects will be provided with additional information after participation
If the informed consent process is waived, the study may need to attain passive consent, a form sent home to parents to be signed and returned only if they do not want their child to participate in a research study. An IRB can determine if this kind of consent is appropriate for the targeted population. The process of passive consent may enable a higher response rate than active consent, which requires that parents document their permission. Passive consent is considered ethically questionable by some researchers since it does not guarantee that the consent form reaches the parents, especially if it is being carried home from school by the child.