Giving research participants their voice: assessing comprehension in the informed consent process

In 1966, Henry Beecher, one of our research ethics heroes, after uncovering numerous consent violations, found it necessary to write: ”Most codes dealing with human experimentation start out with the bland assumption that consent is ours for the asking. This is a myth. The reality is that informed consent is often exceedingly difficult to obtain in any complete sense... Nevertheless, it remains a goal toward which one must strive for sociological, ethical, and legal reasons” [1]. Now, nearly 50 years later, the language we use when we begin the enrollment process indicates that we have not yet shed this assumption. We tend to say that we are ‘going to consent the patient,’ as though this is something we do to the prospective participant just like drawing blood or administering a vaccination. We assume we will walk out of the encounter with a signed consent form. But how do we ensure that the consent is valid, that the signature on the document represents a truly informed study participant? We are responsible for educating patients about the research, helping them review their options and to be sure that they understand the purpose of the research, the risks and benefits of participation and what is expected of them. If they do not understand those things then their signature on the consent form cannot be considered valid. We are always told that ‘informed consent is a process not a form,’ but many people who are obtaining consent for research have never been trained on how to have an effective consent discussion that results in a valid consent. An effective process needs to include an assessment of understanding. We usually do that by asking two questions: