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Obtaining Consent Using a Remote or Other Alternative Process


Guideline for Protocol Language Regarding Remote and Electronic Consent Processes and Documentation

Guideline for Protocol Language Regarding Remote and Electronic Consent Processes and Documentation.pdf

09/09/2021

205 kB

Sample Protocol Language for Remote and Electronic Consent Processes and Documentation 

Sample Protocol Language for Remote and Electronic Consent Processes and Documentation_508C.docx

09/08/2021

25 kB

Guideline for Conducting Consent During COVID-19 Outbreak 

Guideline for Conducting Informed Consent during the COVID-19 Outbreak.pdf

06/30/2021

146 kB

Other than getting written consent in person, are there alternative methods to obtain written consent? 

The FDA has provided guidance on Alternative Methods of Obtaining Informed Consent (see section E.2). “Methods other than a face-to-face consent interview may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject. For example, the consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail, and the consent interview may then be conducted by telephone when the subject or subject's legally authorized representative can read the consent form during the discussion. After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and return the document to the clinical investigator by facsimile, scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address."

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

When you plan to obtain consent using a remote process, 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.).

In addition, your protocol must describe how you will document consent remotely.  If you are going to use an electronic platform, you need to describe how the signature of both the subject and investigator will be obtained.  Specifically describe whether you plan to use a true electronic signature or whether signature will be obtained using a stylus/mouse.  Describe the electronic platform that will be used, and if it is 21 CFR Part 11 compliant.  Note that if you are obtaining a true electronic signature for a FDA-regulated study, the system MUST be 21 CFR Part 11 compliant and you must also describe the process of how you will verify the identity of the subject prior to obtaining consent.

Please refer to Policy 303 for specific information about telehealth requirements (which includes the informed consent process) in the Intramural Research Program.