According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical trial. A large component of this protection is ensuring that subject informed consent is obtained prior to their participation in the clinical trial.
Because it is common that clinical trials require potential subjects to have screening samples, such as blood or tissue, obtained to determine whether they meet specific requirements to participate in the trial. The potential subject may in fact participate in study activities prior to ever giving informed consent. This scenario can happen rather easily: A study team member discusses the trial with their patient via phone, the patient expresses interest, they arrive for a regularly scheduled visit with their doctor, consent may be obtained, and a requisite sample is obtained and processed, and eligibility for participation in the study is confirmed (or not). In many cases, the sample(s) collected at the screening visit would be a routine part of their clinic visit, such as a Complete Blood Count (CBC).
But what if the Protocol requires the patient to be fasting prior to obtaining a study-specific sample, i.e., a fasting lipid panel? This requires protocol instructions to be provided to the potential participant prior to giving consent. This can easily happen if the study team discusses the trial with their patient via phone, the patient expresses interest, and they are instructed to fast before they arrive for their regularly scheduled visit. The fasting patient comes to clinic, informed consent is secured, and the sample is obtained. Whereas this may seem harmless – the patient still signed the consent form prior to the sample – that verbal instruction to fast is a study procedure, which means the team just initiated a study-specific procedure prior to receiving informed consent from the patient. A seemingly harmless instruction must now be duly documented and reported. I’ve seen evidence of this scenario quite a few times during audits, and the team is always surprised that it’s a finding.
A simple way around this specific situation and how it should be avoided – implement a Quality procedure that requires the potential subject to provide informed consent prior to any study-specific procedures, which includes any instructions required to prepare them for a study-specific procedure.
Alternatively, a partial waiver of consent may be obtained from the IRB to allow the instruction to fast to be given prior to the subject signing the consent. This option should be explored with your IRB to ensure that no ‘surprise’ deviations occur during the course of a study.
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