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

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Sample Protocol Language for Remote and Electronic Consent Processes and Documentation 

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Guideline for Conducting Consent During COVID-19 Outbreak 

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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."

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