Wednesday, June 18, 2014

The Informed Consent Process: What needs to be included?

Patients understanding what's going on during a clinical trial is key to the participant.  That is why the informed consent process is critical and each patient participating in the clinical trial must understand what is going on in the trial and why it's taking place.

Forte Research Systems recently looked at four key items that need to be addressed in the informed consent process that should take place no matter what the trial or who the participants are - whether they are children, the mentally challenged, seniors or other demographics.  Everyone should understand these four key things no matter what the trial: what the trial is for and how it's run, the risks and potential benefits of participating in the trial, the responsibilities and confidentiality needed to ensure a smooth trial and that the trial they're participating in is voluntary.  Also, depending on the trial, it's important to communicate the additional information needed to understand the trial critical to the patient.

When you're working with patients, what are some of the information roadblocks that occur with patients when working on the informed consent process?

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