Signatures
At a recent presentation I was asked about whether a witness' signature is required on consent forms. The requirements on signatures are so confusing, I actually misspoke myself. That prompted me to go back to the regulations and check what they actually say about signatures on consent forms. Each of the regulations (45 CFR 46, 21 CFR 50 and ICH E6) has different requirements for signatures. Here is a summary:
46.117(a) requires that the subject sign the consent form.
50.27(a) requires that the subject sign and date the consent form.
ICH 4.8.8 requires that the subjects and "the person who conducted the informed consent discussion" sign and date the consent form.
For oral presentations, all three require a witness to be present. 46.117(b)(2) and 50.27(b)(2) requires the subject to sign the short form. The witness signs both the short form and the summary of the information presented (usually the consent form) and the "person actually obtaining the consent" signs the summary. ICH 4.8.9 requires that the subject, if capable, and the witness sign and date the consent form. Only ICH explains what the witness is attesting to: "By signing the consent form, the witness attests that the information in theconsent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative."
Now, the question is "Which one applies?" and the answer is "It depends". 45 CFR 46 applies to most federally funded research, 21 CFR 50 applies to research regulated by the FDA. Both regulations apply when either 1) federally-funded research involves an FDA-regulated product or 2) an institution has chosen to apply 45 CFR 46 to all of its research in its FWA. ICH is only guidance, not regulation. However, most industry-sponsored clinical trials are being conducted in compliance with ICH since the industry wants to market its products internationally.
In general, when deciding which regulations to apply, it is best to apply the most stringent. With regard to signatures on consent forms, ICH is most stringent and requires both the subject and the person obtaining consent to sign and date the consent form. For oral presentations, the FDA is the most stringent, requiring the subject and the witness to sign a "short form" and the witness and person obtaining the consent to sign the consent form.
posted by Jeffrey Cohen @ 4/17/2006 08:07:00 AM
1 comments
1 Comments:
In its 3-27-2006 Warning Letter to Dr. Brown, http://www.fda.gov/foi/warning_letters/g5785d.htm, FDA said: The IRB-approved consent form required the signature of a witness yet the informed consent forms did not have the signature of the person who witnessed the signing of the consent form. The informed consent forms were signed on 6/11/03 and 3/29/04 but witnessed on 7/10/03 and 1/4/04.
This could be a simple date problem. If the witness was present during the discussion of the study and can attest to the subject's agreement to become enrolled in the study, then the witness may have signed the forms at a later date. If so, the IRB's requirement for a "witness" was met. I doubt that the IRB would be happy with a witness who showed up only to see the subject sign and date the consent form even if the dates matched.
There may be other information that I am not aware of; however, there is no regulatory requirement that the witness "see the subject sign the consent form". ICH explains what the witness should see. I think that FDA's citation in this instance was inappropriate. Generally FDA is correct but not always. A clear example involved the failed attempt to disqualify Dr. Singleton, http://www.fda.gov/foi/clinicaldis/singleton.html
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