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Declaration of Helsinki

In this series of articles, medical students from across the country will discuss a range of topics from medical ethics to the NHS to public health to medical conditions to clinical governance.

These articles give you a basic overview of the principles; we have attached videos and useful websites to develop a more detailed insight.

The Declaration of Helsinki, developed for the medical community by the World Medical Association (WMA), provides the “Ethical Principles for Medical Research Involving Human Subjects”. The document guides physicians engaged in clinical research and highlights their responsibilities of protecting human participants involved. Although not a legally binding document, it has been codified into the laws that govern medical research in countries across the world and has served as a basis for the development of other international guidelines.

📜History

Before World War II there was no formal international statement of ethical principles to guide research with human participants. This meant that researchers were left to rely on organisational, regional, or national policies or their own personal ethical guidelines.

After World War II, a series of trials in Nuremberg were held to hold members of the Nazi party responsible for a multitude of war crimes. The first of the trials, which became known as the "Doctors' Trial", tried German physicians responsible for conducting unethical medical procedures on humans during the war. It was found that medical researchers in Germany had used involuntary unprotected participants drawn from Nazi Concentration Camps for their inhumane medical research. These atrocities clearly demonstrated the need for reform, and for a re-affirmed set of guidelines regarding both human rights and the rights of patients. As a result the 1947 Nuremberg Code was developed. The Nuremberg Code set out 10 clear research ethics principles for human experimentation.

The Nuremberg code was followed in 1948 by the WMA’s Declaration of Geneva, a document outlining every physician’s ethical duties. As an intended revision of the Hippocratic Oath, it included pledges to focus on the health of the patient and not to use medical knowledge to violate human rights.

Both the Nuremberg code and the Declaration of Geneva influenced the development of the Declaration of Helsinki in June 1964. In a document less than 2,000 words long, the initial declaration focused on clinical research trials. It developed the 10 principles first stated in the Nuremberg Code, and tied them to the ethical duties stated in the Declaration of Geneva.

The declaration has been revised several times, firstly in 1975 and most recently being in 2013.

❌Controversies - The 5th Revision

The fifth revision, which was adopted by the WMA General Assembly in Edinburgh, in 2000, was substantial, and many of the changes made were viewed as controversial in the medical community.

One of the most contested paragraphs derives guidelines for the use of placebo in clinical trials where the new treatment is being tested against the best known medical treatment currently available. The following quote is really important 👇

“In any medical study every patient, including those in the control group, if there is one, should be guaranteed access to the best proven diagnostic and therapeutic method of treatment available.”

American physicians Peter Lurie and Sidney Wolfe raised the issue of ethical acceptability of research in developing countries in their paper on HIV trials. The actual standard of care and therefore the placebo in the context of HIV patients in developing countries is `no treatment'. They argued that providing sick patients with placebos (no treatment) instead of available proven-effective medical treatment could cause harm, especially in cases involving disease transmission, such as the transmission of HIV between a mother and child. The opposing view held that when risk of harm is low and there are no local standards of care (as is often the case in developing countries), placebo-controlled trials are ethically acceptable, especially given their potential benefits for future patients.