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How will prospective participants be identified
for the project?
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What screening method(s) are used to determine
the first stage of eligibility and who implements the screening process?
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Once a prospective subject is identified, what
step-by-step procedures will be implemented to provide information to the
subject prior to obtaining a signature on the informed consent document?
Who introduces the research study to the prospective subjects? Who implements
the informed consent process in depth?
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Where (in what setting) is the informed consent
process implemented?
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Do you require the prospective subject to have
another person (friend or family member) present during the presentation
of the information?
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Is the prospective subject given a copy of the
consent form to read prior to the discussion of the project? Is it presented
in person or mailed to the potential subject?
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What is the time interval between the presentation
of the research study information and the actual signing of the consent
form?
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Who addresses/answers questions presented by
the subject or subject’s family?
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What methods do you use to determine that the
subject truly understands the project; especially the risks involved?
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Is the principal investigator usually/typically
present for the informed consent process?
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Who is authorized to sign the consent form?
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What other method of documentation is used to
record the informed consent process, in addition the executed consent form?