An informed consent document and the information necessary for a HIPAA authorization can be sent to a potential participant electronically or by mail, and the study team can conduct a consent conversation by telephone, but without expecting the return of a signed document, if the IRB approves
This waiver of the requirement for documentation of informed consent does not mean any requirements or expectations for the consent process are changed. Study teams can try to use waiver of documentation to focus the consent conversation(s) more on an interactive process and less on a document. For a simple phone survey or interview-based study (if not eligible for Exempt determination), and if there is no PHI use/disclosure, this may be convenient and respectful of participants’ autonomy.
However, eIC as explained earlier on this page often makes it practicable to obtain documented consent and authorization even in these situations.