Summary

Important Points to Remember

• Create an informed consent process.
• Informed consent is an ongoing process.
• Incorporate local requirements in the informed consent document.
• Ensure readability of the informed consent.
• Obtain IRB approval of the informed consent prior to distributing to research subjects.
• Conduct informed consent according to your “informed consent process”.
• Assess the research subject’s comprehension during informed consent discussions.
• Implement special protections in the consent process and document when working with vulnerable populations.
• Informed consent may be delegated by the principal investigator only to qualified key personnel.
• Documentation of the completion of the informed consent process is a good clinical practice.
• The informed consent document requires IRB review and 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 participant.