Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Subjects date of consent

  1. #1

    Subjects date of consent

    Subject took away the PIL and has signed the consent form at home, several days prior to the Investigator. I haven't seen this before. Is this OK?
    From the RQA website: If the subject signs the consent form at home and not in the presence ofthe investigator (or suitably qualified & delegated designee), theinvestigator cannot verify who actually gave consent and the circumstancesunder which consent was obtained. If a consent form has already been signed at home,the subject can simply re-sign & date the form in the presence of theinvestigator (or suitably qualified & delegated designee) and then theinvestigator signs & dates the form during the same interview.
    The CRA reports that the MPA (Swedish regs) and IEC both say its OK that the subject has signed before the Investigator.
    Your thoughts?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    110
    The RQA full response gives more detail:- "GCP COMMITTEE RESPONSE –
    Ensuring that genuine informed consent is gained from a subject is the responsibility of the clinical investigator. As one guidance document states:- “Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation (CIOMS 2002).”
    ICH GCP 4.8 requires that: - “In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirements and should adhere to GCP and to the ethical principles ....….” ICH GCP 4.8.8 requires that the subject personally sign and date the consent form and it is also signed by “the person who conducted the informed consent discussion”. It does not stipulate exactly when these signatures should be made.

    It is clear that obtaining & maintaining genuine consent is a process, not a single act of signing a consent form. As such, there are many aspects involved in the assurance of this process.

    The investigator is key to determining that the consent process is correctly carried out and that all safeguards are adhered to.
    The investigator assures himself/herself (and signs & dates to confirm this) that consent is obtained correctly.
    The subject freely gives consent:-
    • without undue influence from others (relatives, friends, colleagues, their family doctor, the investigator & staff, etc);
    • has the opportunity (in addition to the prior interview, when information was given) to ask more questions before, during and after signing of the consent form;
    • has ample time to consider all the information and to consult with others (if needed);
    • and that the investigator satisfies himself that this is the same subject who the investigator had given the information to and that the investigator now intends to enrol into the study.
    Investigators (or suitably qualified, trained & delegated designees) can not assure themselves of all of this, unless they are present when the subject gives consent.

    If the subject signs the consent form at home and not in the presence of the investigator (or suitably qualified & delegated designee), the investigator can not verify who actually gave consent and the circumstances under which consent was obtained.

    If a consent form has already been signed at home, the subject can simply re-sign & date the form in the presence of the investigator (or suitably qualified & delegated designee) and then the investigator signs & dates the form during the same interview. Of course all of this happens before any study related activities are started.
    The investigator should refuse to endorse the consent form of anyone they feel has not given genuine informed consent.

    There are special emergency circumstances where, in the USA, the FDA has issued guidance (FDA Information Sheets Guidance for Institutional Review Boards and Clinical Investigators Frequently Asked Questions 1998, question 35) on how an investigator can gain consent via fax from the Legally Acceptable Representative (LAR). These are very special circumstances and require a procedure that is approved by an IRB/IEC in advance."

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •