Summary

To Maintain Informed Consent Compliance

• create an informed consent process
• obtain IRB approval of the informed consent prior to implementing
• only use consent forms with the IRB approval date stamp on the last page
• use the correct consent form (e.g. the consent document receives a new IRB approval stamp whenever the document is revised)
• complete all lines of the consent signature page
• provide the subject with ongoing explanations that will help them make educated decisions about whether to begin or continue participating in the research
• delegate informed consent only to key personnel that are knowledgable and who are listed on your protocol
• assess the subject's understanding during informed consent discussions
• document the consent process
• obtain consent prior to any research procedures
• do not use one form for multiple subjects, only one form per subject
• do not have someone other than the subject sign or date the consent form
• do not pre-sign consent forms, PI or designee may sign and date after the subject and prior to research procedures but should never sign and date before the subject is allowed to read and sign
• do not hand write any additional information on the consent form that you have a subject sign, all changes to the consent form must have prior IRB approval