INFORMED CONSENT AND THE THERAPEUTIC MISCONCEPTION

Univ Of Massachusetts Med Sch Worcester, Worcester MA

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Abstract

Research suggests that clinical research subjects often fail to appreciate significant elements of what their informed consent because of the "therapeutic misconception." The therapeutic misconception involves patient/subjects failing to grasp the difference between participating in a clinical research project and receiving ordinary clinical care. We do not know how: 1) prevalent it is, 2) with which personal and situational variables the therapeutic misunderstanding is associated, 3) how seriously this misconception affects other aspects of a decision to participate in research, 4) what its effects are on patients' experience of research participation and 5) how it affects the rate of recruitment to, and dropout from clinical research. This proposal aims to remedy these lacks of knowledge by interviewing in depth 200 subjects from 10 different clinical research projects and then reinterviewing them after they have completed their participation in the project. This will facilitate new approaches to gaining consent and reduce potential sources of public disaffection with clinical research.