Unethical research

Case number:
98-10

Case text (Anonymised)

We have received a study in which patients with healed duodenal ulcers were randomly allocated to treatment with either placebo or ranitidine. Patients were also categorised as to whether they were type A or type B personality; the hypotheses being tested was that patients who were type A might be more likely to relapse. Patients did not have their H pylori status determined.

Subjects were withdrawn from the study if their duodenal ulcer relapsed.

The question is whether it is ethical to treat such patients with ranitidine or placebo rather than with H pylori eradication treatment. A gastroenterologist has advised me that he does not think it is.

The paper makes no mention of ethics committee approval or informed consent. I have rejected the paper on methodological grounds but have also written to the authors asking them to provide information on the ethical aspects of the study.

What should I do if the authors do not respond? What should I do if they respond with an unconvincing explanation-and it’s hard to see how they could respond with a convincing one?

Advice: 

The employers were notifed, as was the relevant medical association of that country, and the International Human Rights Commission. So far, only the Commission has replied, saying that it would investigate the issue.

Year: