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Clinical Research Ethics and the Declaration of Helsinki

People have been experimenting with medicine for thousands of years. While these were initially not evidence-based practices, the natural human instinct to cure the sick has played a huge role in history.




However, while this is certainly a good thing, the goal of "fixing the problem" has sometimes been seen to overshadow the fact that you are treating a person, not just a challenge of symptoms, with devastating effects. The modern story of clinical research ethics shows just how far we have come in preventing this.


While this has been a major part of human history, I want to focus on November 1945. This was the start of a very pivotal time in medical ethics.


World War II had just ended, and 23 physicians working under the Nazi regime were prosecuted in what was known as the Nuremberg Trials. It was uncovered that these highly educated 'professionals' had been performing torturous experiments on people for years. This led to the Declaration of Helsinki, which were the first set of regulations on medical research itself.



United States Army clerks with evidence collected for the Nuremberg trials (Charles W. Alexander)


The Declaration of Helsinki emphasises:

  1. Independent ethical review

  2. Minimal harm

  3. Informed consent

  4. Respect for autonomy

  5. Legal capacity

This resulted in a level of control and decency over experiments. Multiple influential acts and reports were later implemented for medical research, such as Beauchamp & Childress' Four Principles: autonomy, non-maleficence, beneficence and justice.


A baby receiving a vaccine that would have undergone ethical clinical trials


While we have come a very long way in enforcing medical ethics, there is still work to be done. Some concerns are:

  1. Unnecessary restrictions limit scientific freedom

  2. "Hopelessly irresolvable" - the arguments for the perfect ethical solution has been ongoing for 2500 years

  3. It is bureaucratic - regulation can be so complex

  4. Is it political?


Join us at REC 2021 to continue the discussion around medical ethics, including what is being done in research right now and ideas for the future.


Find me on Twitter @rebekah_jwhite. I would like to thank Alexander Chrysanthou and Jon Dawson for inspiring this story with their lecture in bioethics at the University of Southampton.



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