Informed Consent, More than Just a Document

Written by: Barbara Postol

We talk a lot about informed consent in ethics. For good reason, it is an important issue. Most people have a general understanding of the notion that in order to consent to any treatment or procedure in a clinical or research setting, one must be “informed.”

This means to have information disclosed, understand the information, not be forced or persuaded into a study or medical procedure and then voluntarily sign a consent form. But consent is two part. Consent is a form, which is complex and thorough, all possible risks (and benefits) are included and much of it is grounded in law. Consent forms are pretty solid in that regard. There are long and exhaustive lists of possible negative outcomes included ranging from nausea and vomiting to even death in a consent, so for patients and participants, there is a good idea of what is going on. But what about the process of consent, in practice, could the informed consent process be better? Like most things, most likely.

How many times does consent seem like a formality, another form to complete at a doctor’s office? Surgery or a research study may devote much more time to the form but it is very important that consent does not become a “formality”. Giving consent is a big deal, a lot of unforeseen things can happen to a patient or a research study participant, so the process itself should be given just as careful attention as is the document. Clinical staff should carefully go through each page, reading it to the patient/participant and ask reflective questions to ensure that there is an understanding. While consent language is written at the best possible tone for the average person to understand, let’s face it, for those without a medical background it can still sound pretty tricky or confusing. Participants should be given ample time to look over the consent form independently and given a copy for their records, too. Special attention may also be given to certain situations where consent could be in a critical or emergency situation, like research studies that recruit participant in emergency departments, or parents with sick children, for example. These are sensitive situations. When situations are emotional or stressful, the utmost care should be given and because often participants take the information from the physician, for example than directly from the consent form itself. Clinical staff who administer informed consent should be extremely well-trained in the process and able to answer questions thoroughly and clearly.