Special Lecture: "Studying Informed Consent"
Event date: 10 November 2006
Speakers: Professor Jeremy Sugarman (Harvey M. Meyerhoff Professor of Bioethics and Medicine, Deputy Director for Medicine of the Phoebe R. Berman Bioethics Institute, and Professor of Health Policy and Management at the Johns Hopkins University)
Venue: University of Oxford
Abstract: Informed consent is viewed as a key protection for research participants. Nevertheless, evidence suggests that the informed consent process for research warrants improvement in multiple domains. While it is possible to suggest myriad ways of improving the process, innovations should be tested rigorously to ensure that they are effective and do not in fact do more harm than good. We developed a method to measure the quality of informed consent in the setting of actual clinical research. Then we developed an explicit self-monitoring ‘check-list’ used by the person obtaining informed consent in effort to improve the process, and tested its effectiveness in a nationwide randomized trial in the United States. The rationale for this intervention assumes that persons obtaining informed consent have sufficient knowledge, interest and ability to obtain meaningful informed consent, but that in the context of a busy clinical environment the process or parts of the process may be treated superficially. Thus, we hypothesized that the use of an explicit approach to self-monitoring will focus the attention of the person obtaining consent, and prompt them to attend to each aspect of the informed consent process in greater detail and thereby improve the quality of informed consent. Such an approach is desirable because it doesn’t rely upon additional technology and would not need to be revised for every research project. This talk will describe the emerging results from this research effort and their implications for informed consent.