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Informed Consent: For COVID-Affected Studies, A Handwritten Document May Suffice

 
• By Sue Sutter

Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol and texting or emailing a photo of the signed document to the investigator, US FDA says in latest guidance update.

hand holding pen with a blank note paper over blackboard background
In the age of COVID, a blank piece of paper may be used by some trial participants in lieu of a printed informed consent document. • Source: Shutterstock

In yet another demonstration of the remarkable flexibility the US Food and Drug Administration is showing in the age of COVID-19, the agency is allowing potential clinical trial participants, under certain circumstances, to reflect their informed consent by signing a handwritten document.

In a 2 July update to the guidance on conducting medical product trials during the public health emergency, the...

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