Gaining ethical approval: A necessity or an optional extra?

Abstract

Hazel HcHaffie PhD, RN, RM, Research Fellow, Medical Ethics, Edinburgh, Department of Medicine, Royal Infirmary, Lauriston Place, Edinburgh EH3 9YW, UK Recently, both public and professional attention has been drawn to the matter of informed consent and respect for the individual. For example, the UK daily newspapers reported extensively the case of Mrs Jackie Bartley. She officially complained about the actions of an eminent Harley Street gynaecologist who, during the course of an agreed hysterectomy, removed her ovaries without first consulting her (All main UK newspapers September 1997). Another dissatisfied patient catalogued an appalling set of side effects which resulted from her involvement in experimental radiotherapy for late-stage cervical carcinoma, the risks of which she claimed had never been explained to her (Anonymous 1997). The British Medical Journal (BMJ) ran a series of articles and letters debating the ethics around a Scottish study where patients who had suffered a stroke were randomised, without their consent, to receive or not to receive support from a stroke family care worker (Dennis et al 1997). Both public and professional interest was captured by a number of trials carried out using pregnant women in developing countries. Babies were exposed to the risk of contracting HIV infection since their mothers were not given antiretroviral drugs (Lurie & Wolfe 1997). The perceived injustices of applying a standard to patients in the developing world which falls short of that set for the countries sponsoring the research, i.e. that participants should not be exposed unnecessarily to risks, have been hotly debated (Angell 1997, Lurie & Wolfe 1997, Varmus & Satcher 1997). These cases have attracted considerable attention. But in a small way many well-intentioned people infringe the rights of others by failing to ensure that they are properly protected or adequately informed. So important an i s sue is this, that the question has been raised: Should journals publish papers which report studies which have not obtained ethical approval, or to which participants have not given fully informed consent? The BMJ has recently devoted a large percentage of one issue to the debate (Doyal 1997, Smith 1997, Tobias 1997). The Editor of the New England Journal of Medicine openly discussed the dilemmas its editorial committee faced (Angell 1997). For the issues are not black and white. The fundamental guiding principle, as stated in the Declaration of Helsinki, is that when it comes to research on human beings, 'the interest of science and society should never take precedence over considerations related to the well-being of the subject' (Declaration of Helsinki 1992). Nevertheless, the basic principles of respect for autonomy, beneficence and justice may sometimes be in conflict (Varmus & Stacher 1997). In seeking a commentary on the paper by Whelan and Lupton (1998) published in this edition of Midwifery, the Editor is wisely drawing attention to the issues for midwives. The article raises some interesting questions. The aim of the study is an important one: to find out what promotes or discourages breast feeding amongst women with low incomes. Clinicians, managers and researchers worked together to identify a relevant problem and maximise the chances of the findings being utilised to improve the service offered to women and babies. So far so good. For the purpose of the study 1029 women delivered at a particular District General Hospital over a five-month period were screened to select those who fitted certain criteria. Community midwives identified women who had breast fed their babies, and who were receiving state benefits or were unemployed. Warning bells start to ring. Who gave them permission to scrutinise such personal information for research purposes? Should this search have been allowed? Accessing notes for the sole intention of providing a caring and appropriate service is one thing; using information for any other purpose is questionable and may be entirely improper (Dimond 1990, McHaffie 1996). Did the women themselves know they were potential recruits and that their files were being examined for purposes other than clinical care? A researcher checked all the postnatal notes to ensure no eligible women had been missed. What right had she to do so? Did she have a clinical supervisor who formally accepted professional