First Epidemiology Class and Consenting Patients

The topic of our epidemiology class this morning was ethics of clinical research. It's very timely for what I've been doing in lab this past week and a half. We spent part of the class going over factors that are necessary to make clinical research ethical. But we spent a lot more time discussing something called the therapeutic misconception. This means that patients, when they sign up to join a clinical trial, often believe that they are signing up for therapeutic care that will benefit them personally as opposed to research where the benefits, if any, are unknown. It is a problem because studies show that many patients do not have a very good understanding of the level of personal risk or benefit they can be exposed to by participating in a clinical trial.

The social worker and I went to consent two patients this afternoon. We didn't even try to consent the first patient because apparently there was some kind of problem and the patient was meeting with the ombudsman. We had to wait for about an hour until the second patient was available. There were two other study coordinators who had already spoken to her. One of them had gotten her to sign up and the other had not. As soon as the social worker started speaking to her, it was obvious that she was not going to be a good candidate for any ethically-run clinical study. She was one of those people who pretends like she knows what is going on even when she doesn't. When the social worker asked her if she had ever heard of the procedure being tested in this clinical trial, she started rambling on about researches (sic) and expressed her concern that the residents might be terrorists since some of them are from other countries! So the social worker told her that probably she should just pass on this trial. The patient agreed, and we left empty-handed and disappointed. But I really think that the social worker absolutely did the correct thing by not enrolling this woman. Even though she didn't understand a thing, she continually tried to pretend that she did.