Consent

The granulomatous inflammation propagates. Two days later, I attended the ethics committee meeting.

I was the member of this committee for slightly more than a year. (Alas, not everyone in the committee has a high ethical standard - they need someone like me to set the minimum.) Although our chairman, a statistician by training, is highly pragmatic and immensely efficient, the meeting almost always overruns; nearly every time there's something that receives, as Bernard Woolley said, a vigorous exchange in opinion.

This time, the focus was on a particular project that requested waiving of written consent, because it was (at least theoretically) possible that the targeted subjects are highly vulnerable and sensitive, and may be driven away if they are being asked to sign a consent black-and-white.

To my surprise, one of our layman member (non-medical one outside the hospital system) was very supportive for the suggestion. He argued, "Provided that the investigator explains satisfactorily to the participant, it doesn't really matter if they do not put down the thing black-and-white - particularly if signing a paper would turn away the patients."

Many of us did not agree, "If there's nothing written, the participants could come back and sue the investigator for not explaining the study fully."

"You mean," our lay member appeared incredulous, "The consent is for the protection of the investigator, not the patients ?"

I smiled - he began to comprehend.