| Abstract: | The manner in which the informed consent process is structured was explored by means of intensive interviews with 17 experienced psychiatric researchers. Despite differing views on informed consent, investigators displayed a commonality of practice. Most investigators were themselves not usually involved in obtaining consents, relegating the process to lower-level assistants. They did not closely monitor the process and generally were unaware of problems that may have arisen. Most protocols called for repeat contact with patients so that a relationship would develop and information could be provided before obtaining a formal consent. The actual signing of a consent form often reflected a decision that had been made much earlier in the process. These findings have significance for both sides in the dispute over informed consent in research. Those who favor tighter controls over psychiatric research will have to consider the implications of monitoring, without destroying, a prolonged and complicated process. Those who argue for a reliance on investigators' integrity must deal with the apparent lack of involvement most investigators have in the consent process. |
