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  4. Consent form formatting hint — don’t split signature blocks

Consent form formatting hint — don’t split signature blocks

When the IRB reviews written consent forms, we try to keep in mind formatting issues that make it easier for study teams to ensure the forms are completed correctly. If you send us a consent form that has signature components split across pages (e.g. the subject signature on one page, and the subject signature date on the next page, or the person obtaining consent signature lines all by themselves on a page), you’ll likely get a contingency to reformat the document so the signature blocs are all on the same page. We’ve noticed that splitting the lines across pages is kind of an invitation to have part of a signature bloc overlooked. Signature lines that aren’t completed lead to compliance problems and call into doubt the validity of the consent process and documentation. Researchers have a lot going on when they’re doing consent processes, and making the signature lines as easy as possible to complete is one way to help make the process go smoothly.

Posted by Edith Paal on August 1, 2018

Filed Under: Research News

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