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Informed Consent



  • Ioanna
    02/10/2015 16:18
    4.8.11 part of the GCP guideline: it is written that the patient should receive a copy of the informed consent. I have in mind 2 different approaches: 1. 2 signed originals: one for the patient and one for the investigational site 2. 1 original for the investigational site and 1 (foto)copy of the original given to the patient Could you comment on which approach GCP refers?
  • GCP Committee
    02/10/2015 17:03
    Actually ICH GCP ICH E6 (R2) does state "a copy" and it does not say an original document. "4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects". >> The subject (or LAR) needs "a copy of the signed and dated written informed consent form and any other written information provided to the subjects". As you say that could be by both means you suggest. The photocopy does ensure that the subject has an exact copy of the form which that subject has signed. If a photocopy was not available, then a duplicate of a wet ink signed document would do the same job. >>> The FDA opinion may be useful:- A Guide to Informed Consent - Information Sheet 1988 "A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records. Note that the FDA regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred". >> Institutional Review Boards Frequently Asked Questions - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators 2013 Question - 36. 21 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 subject's signature affixed? Answer - 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. >> Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors1 Draft July 2014 III.E.3:- "The person signing the consent form must receive a copy of the consent form (21 CFR 50.27(a)), and the subject’s case history should contain the signed and dated consent form. Although FDA regulations do not require the subject's copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided".
  • bp
    05/02/2018 09:38
    Related to the above: Would you consider it as a protocol deviation if a copy of the singed consent form was not provided to the subject? And what if the subject, for whatever reason, does not want a copy? If this has been properly documented by the investigator in the medical notes, should that be enough? Many thanks
  • Anon
    05/02/2018 15:25
    It is a deviation from GCP and as all protocols state that the trial will be conducted in accordance with GCP it is also a protocol deviation. A copy must be given to the subject even if they dispose of it immediately. Yes the investigator should document that they gave a copy to the subject and they refused to take it away. Obviously this should be documented immediately (signed & dated contemporaneously) and the problem escalated to the sponsor. If this is a persistent problem at the centre the staff should be re-trained to explain to subjects the need for this. the deviation should not be documented by a note to file just before an audit/inspection!!!
  • Roxana
    10/12/2020 11:17
    If between inform consent signature and first day of IP administration is more 45 days , in this condition the inform consent process need to be restart? Thank you Roxana
  • Juergen Kaetzler
    10/12/2020 14:25
    If the subject is provided with an original ICF rather with a copy of the ICF, I would not consider this as a protocol deviation, even if the protocol states that a copy should be handed out. OK, maybe a formal deviation but how would an inspector address this situation: it is required to hand out a copy of the signed document and the investigator hands out a second signed original? >> Keep in mind that it may be additional workload to the site when a second original is handed out. As far as I know you have to fill out the whole ICF (again), mark all checkboxes (again) and write (again) whether the trial subject has questions and write (again) your answers. Thus, I would recommend to provide a copy to the subject. >> When no copy and no original is provided to the subject, I agree: this is a protocol deviation. >> Regarding the 45 days between obtaining informed consent and first IMP dosage: what does the protocol state? Are the any restrictions on obtaining informed consent and first IMP dosage? Often protocols have time windows for screening assessments and a maximum timeframe thereafter to start IMP... have any trial-specific assessments been performed prior to IMP dosage (e.g. imaging, laboratory, etc.) Of course, after one month I would recommend investigators to ask the subject if he/she is still willing to participate and would let them document this in the source data. Notably: when the Informed Consent changes (e.g. new version), the subject has to be informed and consent has to be obtained with the new version. >> In general, I am not aware that there exists a "maximum" time frame between obtaining informed consent and first study-specific assessment. What do others think?
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