A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

• A. The research must pose no more than minimal risk.
• B. The school must provide written permission.
• C. The participants must be adults.
• D. The study must have direct benefits to participants.

Answer: (A)

The crucial idea here is that IRBs may waive parental permission only if the research involves no more than minimal risk to the children. This low risk level serves as the gatekeeper for allowing consent to be waived, since it protects participants when parental permission isn’t obtained. If the study posed more than minimal risk, a waiver wouldn’t be appropriate. Beyond minimal risk, the IRB also considers that waiving consent must not adversely affect the rights and welfare of the children, and that the study could not practicably be carried out with obtaining parental permission. The school’s involvement or written permission from the school isn’t the requirement that allows a waiver, and the research does not need to offer direct benefits to participants to qualify for a waiver. So the essential requirement that must be met is that the research poses no more than minimal risk.

The crucial idea here is that IRBs may waive parental permission only if the research involves no more than minimal risk to the children. This low risk level serves as the gatekeeper for allowing consent to be waived, since it protects participants when parental permission isn’t obtained. If the study posed more than minimal risk, a waiver wouldn’t be appropriate.

Beyond minimal risk, the IRB also considers that waiving consent must not adversely affect the rights and welfare of the children, and that the study could not practicably be carried out with obtaining parental permission. The school’s involvement or written permission from the school isn’t the requirement that allows a waiver, and the research does not need to offer direct benefits to participants to qualify for a waiver.

So the essential requirement that must be met is that the research poses no more than minimal risk.