If the subject requests the original signed informed consent document can the site retain a photocopy?

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If the subject requests the original signed informed consent document can the site retain a photocopy?

April 26, 2017DOCUMENT informed consent original photocopy requests signed site Subject

1 Answer

If a site enrolls a subject who cannot read and understand English, does the informed consent document need to be translated into the subject’s native language?
If the subject requests the original signed informed consent document can the site retain a photocopy?
Must each research site submit an informed consent document (ICD)?

score 0 · Answer 1 · 2009-12-04T05:03:49+00:00

No. Per MCW/FH IRB Standard Operating Procedures, the original signed informed consent document must be retained with the study files and a copy given to the subject or the subject’s legally authorized representative who signed the consent form.

If the subject requests the original signed informed consent document can the site retain a photocopy?

1 Answer

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