Informed consent, judicial review and the uncertainties of ethnographic research in sensitive NHS settings

This c'tale from the field' describes events affecting a study of an NHS 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. Judicial review involves the legal scrutiny of administrative decisions to decide whether they are lawful. The LHB's request raised ethical issues about whether the terms of research ethics committee approval had been respected and the position of subjects protected, but also issues concerning the university's and researchers' obligations. Various constraints arose from the Data Protection Act 1998, contractual obligations to the Department of Health as funder, and risks to the university and researcher arising from the impending court proceedings. The case describes how possible release of data was negotiated with the various stakeholders, the process via which subjects were asked to permit release, the position of the university administration and its legal advisors, and how data were eventually passed to the LHB. The chapter discusses the dilemmas that emerged, and how pressures from stakeholders make it very difficult for researchers to formulate a principled position not to release data. Lessons learned and possible solutions discussed, including whether risks need to be communicated more clearly to subjects and what steps can be taken to avoid holding compromising data