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Study Advertising & IRB Approval

Advertising Definition
FDA Guidance on Media Advertising for Clinical Research

According to the FDA, an Institutional Review Board (IRB) must “…ensure that appropriate safeguards exists to protect the rights and welfare of research subjects;” however, IRB review and approval of “listings of clinical trials on the internet…” are different. When it comes to study advertising on the internet the FDA advised that,

IRB review would provide no additional safeguards and is not required.

When the information provided is limited to “basic trial information, such as: the title; the purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information,” IRB review would provide no additional safeguard and is not required. To view the FDA provided guidance on Media Advertising, click here.

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