The modern era of medical ethics was set in motion after the Second World War, following the Nuremberg trials in Germany in which Nazi physicians were accused of conducting medical experiments on people without their consent. 

The 1947 Nuremberg Code – also known as the International Code of Medical Ethics – made it clear that the benefits of clinical research must always outweigh the risks and every effort must be made to avoid research participants being harmed. Fifty Years Later: The Significance of the Nuremberg Code.1

Importantly, the Code also stated that people must be free to choose if they want to take part in clinical research – and must be given all the facts needed to allow them to make this decision. They should also be free to withdraw from the research at any time and for any reason. 

Although the Nuremberg Code set the stage for ethics in research, unethical practices continued in the first half of the 20th century – one of the worst examples being a US trial that ran in Tuskegee, Alabama from 1932 to 1972. In this trial the participants – who were African American men – were misled, misinformed and badly mistreated, all in the name of science. 

In 1964, the World Medical Association drafted an international document called the Declaration of Helsinki that stated clearly the need to put humanity above science. Updated many times since, the Declaration of Helsinki set out the basis for laws that govern medical research in countries across the world. WMA Declaration of Helsinki – Ethical Principles For Medical Research Involving Human Subjects.2

In 1982, The Council for International Organizations of Medical Sciences (CIOMS) – an international non-governmental organization founded by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural and Organization (UNESCO) – produced the first version of its International Ethical Guidelines for Biomedical Research Involving Human Subjects, which has been regularly updated since then. International Ethical Guidelines for Health-related Research Involving Humans.3

In 1996, the International Conference on Harmonization published Good Clinical Practice, which has become the universal standard for ethical conduct of clinical trials. ICH guideline E6 on good clinical practice.4

How modern clinical trials are governed

Official regulatory authorities carefully review the reasons for conducting a clinical trial and consider whether it is designed and planned in the best way. They won’t allow a trial to go ahead if they think there is inadequate justification for it or if the trial plan has flaws in it that could cast doubt on the findings. 

Often, clinical trials are also monitored by an independent data and safety monitoring board which keeps a close eye on the trial all the way through. If anything of concern emerges, the trial won’t be permitted to continue or will be put on hold until the issues are resolved. 

Clinical trial sponsors are responsible for ensuring that all the necessary reviews and approvals are in place and that the trial is properly managed, coordinated and financed. They also have a duty to announce the trial in a public database (such as www.clinicaltrials.gov or www.clinicaltrialsregister.eu) before it starts and a duty to publish the trial findings, even if the results are not what was hoped for or expected. 

Go back