Informed Consent, Judicial Review, and the Uncertainties of Ethnographic Research in Sensitive National Health Service Settings

Abstract

This case describes what happened in a study of a National Health Service panel responsible for deciding whether to fund high-cost drugs when the Local Health Board asked the researchers to release audio-recorded data because of an impending judicial review case. In judicial review, the courts scrutinize the conduct of administrative decisions to determine whether they are lawful. When research access was negotiated, panel members had been told that access to audio recordings of meetings would be limited to the researchers. The Local Health Board’s request raised ethical issues about whether the terms of research ethics committee approval had been respected and the position of subjects protected, and issues concerning the university’s and researchers’ obligations under the Data Protection Act 1998, contractual obligations relating to the requirements of the Department of Health as funder, and risks to the university and researcher arising from legal processes related to the object of study. The case describes how possible release of data was negotiated with the various stakeholders, the process via which specific subjects were asked to permit release, the stance taken by the university administration and its legal advisors, and how data were eventually passed to the Local Health Board. It discusses the dilemmas facing the researchers and, in particular, how pressures from stakeholders make it very difficult for researchers to formulate a principled position that resists release of data. Lessons for future research projects are discussed, including whether risks need to be communicated more clearly to research subjects and what steps can be taken to avoid holding data that may harm them.

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