Testing a drug during labour: the experiences of women who participated ina clinical trial

Interviews were conducted with 104 patients who had participated in medical research involving pharmaceutical drugs. All patients were asked about the amount of information they had been given prior to being invited to partic ipate, and about their understanding of, and satisfaction with, that inform ation. Patients were also invited to comment on their reasons for having ag reed to take part in medical research. Each had participated in one of 14 d ifferent drug studies. One of these studies involved a drug that was being used for the first time during labour When analysing these data, it became apparent to the author that responses from some of those involved in the la bour drug study were different from those of patients who had participated in the other studies. This paper compares the views of the 26 patients in t he labour study with those of the 78 other patients. The women in the labou r trial were generally less satisfied than patients in the comparative samp le with the information which they had been given, and reported lower level s of understanding of that information. They had asked fewer questions abou t their study and reported lower levels of satisfaction with the answers th ey had received to those questions. This raises concerns as to whether the consent to participation given by women in the labour trial was in all case s fully informed. This in turn suggests the possibility of a gender bias in fulfilling ethical obligations in medical research.