Informed consent is much more than just getting a signature on a form. Whilst the ICF (Informed Consent Form) still plays a vital role, it is only part of an increasingly diverse picture. Recently published draft FDA guidance covers a plethora of these techniques, under the umbrella term “electronic informed consent” (eIC).
The FDA document refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.”
The role of informed consent is enshrined in good clinical practice rules – “freely given informed consent should be obtained from every subject prior to clinical trial participation.”
As explained in the online training course, ICH GCP in English, Patients must be fully informed about the trial, the intervention to which they will be subjected, what they will have to do if they take part in the trial, what benefit they might gain or what harm may come to them, what will happen to them once the trial is over, and what their rights may be to other treatments.
However, it is pretty easy to inform a patient – the more tricky part is that they must understand what they are being told. This may be in the form of updates as the trial progresses rather than just an initial briefing.
Clearly, widening the tools available to include electronic media makes a lot of sense and is already done in a lot of cases. What the FDA guidance does is to answer a lot of the key questions in areas such as:
- Confidentiality
- How and where to conduct eIC
- Paediatric studies
- How to confirm understanding etc
Useful stuff!
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