Which is a criterion for granting a waiver of informed consent?

• A. The study has more than minimal risk
• B. The waiver will not adversely affect rights or welfare of subjects
• C. The subjects are not human
• D. The research has not been approved by IRB

Answer: (B)

Granting a waiver of informed consent rests on meeting criteria that protect participants while allowing certain minimal-risk research to proceed without written consent. The key idea here is that the waiver will not adversely affect the rights or welfare of the subjects. If a study is designed so that participants’ rights and well-being aren’t compromised by not obtaining consent, a waiver can be considered. In addition, the research must involve no more than minimal risk and could not practicably be carried out without the waiver, and when appropriate, participants should be informed after participation. The other options don’t fit: waivers aren’t allowed for studies that exceed minimal risk; subjects must be humans for consent rules to apply; and an IRB must approve the research with the waiver—if it hasn’t been reviewed and approved, a waiver isn’t granted.