So, let’s start off with informed consent in the clinical trial context. Paradigmatic examples involve the passage of a document from the investigator to the subject who may or may not be a patient as well. This latter participant may be a patient of the investigator or not. They might not even be ill as is the case in many Phase 1 studies. Unlike clinical treatment there are other stakeholders closely involved in oversight. The Institutional Review Board with jurisdiction oversees and approves the document. There is typically a sponsor for the study which may be a pharmaceutical company. They may have written the original consent form.
See how this is unlike the clinical scenario. Typically, there is no document except that I can meet my financial obligation and a privacy agreement about sharing my information. It is only when I have a procedure that I am receiving a document that resembles the research document.
The goals of the primary stakeholders (investigator/subject) are more varied than in the clinical situation. In the clinical context the patient’s goal to receive relief from symptoms or prevention of symptoms and the physician seeks the same end. In the research context it is more complicated. There is a research question to be answered. This is a goal of the investigator and the sponsor. It might also be a goal of the public. Sometimes the furtherance of the knowledge gained is a goal of the subject and sometimes not.
The history of informed consent in clinical research has a different history than that in clinical trials. Maltreatment of human beings are the worst-case scenarios for either one. Informed consent serves as a protection against such maltreatment. The ethical goal of protecting patient or subject autonomy remains the same across both types of interactions and paradigms. The other goals may differ to an extent that we change how we proceed. Our behaviors, expectations, and perceptions of the situation may be entirely different as a result.
It is my hypothesis that differences in stakeholders and goals might be substantial enough to make the paradigms quite different. As you might know the informed consent paradigm failed in clinical practice and it led to shared decision-making. It is easy to see why. The flow of information was only going one way and that made making good decisions simply lucky.
The flow of information is one way in the research case as well. Yet because of the goals of research, it is not clear to me that the shift to shared decision-making will be the same, different, or not necessary.
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