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The IRB also applies this FDA guidance to non-FDA-regulated research.

When you plan to obtain consent remotely, i.e. over the telephone or using audio- or video-conferencing or another web-based platform, your protocol needs to describe the process that will be used (e.g. how and when you will send the consent to the subject, where/how the consent discussion will take place, etc.)

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Please refer to Policy 303 for specific information about telehealth requirements (which includes the informed consent process) in the Intramural Research Program.Before consent can be obtained using a remote process, i.e. over the telephone or using audio- or video-conferencing or another web-based platform, that process must be described in the protocol and approved by the IRB.  

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