What are the consent requirements for phone based research?
The IRB expects that the level of information provided in an oral consent process will be comparable to a written consent document, and would need to see a consent script or a summary indicating how the investigator will describe the research to participants. As with a written consent process, the IRB may also require investigators to include additional elements with oral consent, or may waive some or all the elements of the consent, depending on the characteristics of the research. For example, during phone interviews, where a script with all the formal elements of the informed consent form could be considered arduous and unnecessary, an abbreviated script with the following information may be sufficient: • name and nature of the study, • voluntary nature of the study and the ability to withdraw at any time or to not answer a question, • a note about confidentiality and, • contact information for the PI if requested by the participant. For oral consent, investigators should describe h