Summary

Important Points to Remember

• Consent must be an ongoing, interactive process.
• The informed consent process provides the subject with ongoing explanations that will help them make educated decisions about whether to begin or continue participating in the research.
• Create an informed consent process.
• Obtain IRB approval of the informed consent prior to implementing.
• Informed consent may be delegated by the PI only to qualified key personnel.
• Assess subject’s comprehension during informed consent discussions.
• Documentation of the consent process is good research practice.
• The consent document requires IRB review & stamp of approval at the time of continuing review and whenever the document is revised.
• The expiration date on each consent document must be verified prior to presenting to a potential subject.