Ethics 1: The development of research ethics guidelines.
In 1932, the Tuskegee Clinic in the United States began possibly its most infamous research study on human beings. This ‘blind’ study aimed to collect data on the side effects of syphilis in African-American men. None of the participants enrolled in the study were told what the research was. Penicillin was discovered in 1928, in the UK, and was widely available for use by 1942. However, despite the availability of a treatment for syphilis, this study continued into the 1970s, when the study was leaked to the press and this article appeared in the New York Times:
During the 40 year period of the Tuskegee study, the research practices carried out globally produced more and more examples of disregard for human dignity and humanity in the name of research. WWII saw huge numbers of prisoners in German Nazi camps subjected to torturous experiments against their will. To aid with the trial of those involved, the Nuremberg Code for research on human subjects was adopted in 1947, and was developed alongside the Nuremberg trials, during which the scientists and doctors acting under the Nazi government were convicted of war crimes, charged with conducting medical experiments on both prisoners of war and civilian prisoners captured during WWII, and all, again, without consent, and with the knowledge of harm to the individual.
Outside of Europe, during WWII, The Japanese UNIT 731 experimented using Chinese, Russian, and Korean prisoners between 1939 and 1945 to develop chemical agents and provide live guinea pigs for disease research. The individuals involved in the unit were never brought to trial. Closer to home for many of us, the UK’s research facility at Porton Down in Wiltshire, where the Ministry of Defence carried out research on the effects of chemical agents. The military recruited ‘volunteers’, and individuals were paid large sums to undergo experiments. Ronald Maddison was exposed to Sarin (more commonly known as anthrax), he died along with others after being lied to about what they were being asked to do.
Ronald Maddison Lillias (Ronald’s sister)
Whilst all this historical background may point to the exercise of torture and instrumental use of less powerful groups in society rather than what we would today describe as research, these incidents prompted a global response in the form of research guidelines. In 1964, The Helsinki Declaration was signed, which outlined ethical principles for research on human subjects, and states: “The health of my patient will be my first consideration”. This set of ethical principles, often regarded as a cornerstone in the development of research ethics, sets out that the individual and their welfare will take precedence over any research aims. The individual must be informed and consent freely to participate in any research, and never be used as a means to an end or reduced to simple biological matter.
Growing amounts of attention are being paid to ethics of research and research conduct. The UK has not adopted any legal framework governing research. The UK does, however, have a legal framework for the management of any data collected in the process of research; it also has a statutory framework governing research using animals. The development of ethical principles or codes governing research in the UK is often born out of professional bodies which govern the different branches of research which is taking place, such as the GMC, the NIHR, the ESRC, and the BPS. These principles and codes have developed as research in these areas has grown, suggesting they are reactive rather than proactive, emerging as the need arises.
The principles of ethics governing research have become precisely that, principled. Lists of maxims (or principles) are easy to teach and follow and so this ‘checklist approach’ has tended to dominate. Often research ethics is not taught, if it is taught, it is through e-learning packages or online resources which have little ability to test or cement learned knowledge. Tradition in the UK suggests to us that lists of justice based maxims are the way to think about research practice, because they are measurable and easily translatable. For example, here is a common list of principles presently used in human research:
D Do no harm
E Equality (justice)
The list is easy to recite, mark, learn and digest. These principles sought to guard against the replaying of the examples listed here and to some extent they have done so. But questions remain: is the list complete? Is there a need to update these principles?
The principles are examined further in my next blog piece, from different perspectives.
The Helsinki declaration in full:
Some other links to more resources:
Nazi lead research