CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subjects signature affixed?
No. The regulation does not require the copy of the form given to the subject to be a copy of the document with the subject’s signature, although this is encouraged. It must, however, be a copy of the IRB approved document that was given to the subject to obtain consent [21 CFR 50.27(a) or 21 CFR 50.27(b)(2)]. One purpose of providing the person signing the form with a copy of the consent document is to allow the subject to review the information with others, both before and after making a decision to participate in the study, as well as providing a continuing reference for items such as scheduling of procedures and emergency contacts.
Related Questions
- CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subjects signature affixed?
- Does the consent document being given to the person signing the form need to be the IRB approved stamped consent?
- Is a faxed copy of the signed consent or parental permission form acceptable to document informed consent?
