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International Clinical Trials

The Ethical Code

Graham Hughes reviews On Moral Grounds: Lessons from the History of Research Ethics, a book by Allen Gaw and Michael H J Burns

The Hippocratic Oath is usually interpreted as one of the first statements of the moral of conduct used by physicians, as translated by Michael North (1). It states in part: “I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone. I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan”.

The strict adherence to the oath can be interpreted as prohibiting any physician from taking part in clinical trials. Nowadays of course, this interpretation is regarded as being over-strict, and the usual guidelines for the conduct of clinical trials are enshrined in the Declaration of Helsinki and its various updates (2). On Moral Grounds confronts this dilemma and looks to moral philosophers such as Immanuel Kant and John Stuart Mill to try to resolve the problem.

In a short introductory chapter the authors lay the philosophical groundwork for carrying out trials, and then move on to discuss a series of examples of what may loosely be described as ‘research’. They start with the example of James Lind and his investigation into the causes and prevention of scurvy, highlighting both the 18th century and the modern day obstacles to the implementation of research findings. A lesser known example follows; that of James Beaumont’s investigation of the digestive processes of one of his patients, who eventually became Beaumont’s servant. Beaumont clearly induced his patient to take part in a series of experiments in a fashion that today would be regarded as unacceptable.

The story then turns to Walter Reed, a US army major who investigated yellow fever in and around 1900. His achievements have been immortalised by the naming of the premier US army hospital in his honour. Reed can be regarded as a pioneer in the obtaining of informed consent (both in English and Spanish), but as the authors point out, his brave and revolutionary approach did not represent a turning point and it was a full 50 years before a similar method was advocated on any widespread scale.

The authors then move on to a discussion of how the Nuremburg code, developed as a consequence of the War Crimes Tribunals, probably came to be the bedrock of “every subsequent ethical code of conduct regarding human experimentation.” Breaching these codes became, and still is, a significant act, and even knowingly allowing experiments to be carried out in contravention of existing ethical standards is almost equally unacceptable. But as the authors point out, whistle-blowing is never popular, nor is it listened to in many cases. Feelings can be hurt, friendships endangered and even careers ruined, and Gaw and Burns give two examples where this did indeed occur. In Chapter 6 they conclude that “the welfare of our patients is what matters and this is what drives those who feel compelled to raise the alarm”. I was looking forward to more modern examples of moral and ethical dilemmas in Chapter 7, but rather to my surprise and disappointment, this slim volume finished there, bar appendices and references.

I would recommend this book to anyone who is interested in the historical development of our current codes of practice; however, I would have liked to have seen some examples drawn from experiences which occurred later than the 1950s.

On Moral Grounds: Lessons from the History of Research Ethics by Allen Gaw and Michael H J Burns is available from SA Press, ISBN 978-0956324221

  • 1. National Library of Medicine, National Institutes of Health,
  • 2. index.html

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