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Compliance In Focus
Posted by Natalie Jarmusik on Thu, Mar 19, 2015

The Declaration of Helsinki - 1964

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently The Declaration of Helsinki   1964released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2015 calendar year.

The Nuremberg Code of 1947 marks one of the great advances in clinical research history for human subjects protection, prior to which there was no generally agreed upon code of conduct governing the ethics of research involving human subjects. The development of the Nuremberg Code post-WWII set a firm foundation for human subjects protection and impressed upon society the necessity of holding clinical research to the highest ethical standard.  However, in 1964 in Helsinki, Finland, the World Medical Association (WMA) sought to combine the ten principles previously outlined in the Nuremberg Code (noted below) with the Declaration of Geneva, a statement that clarifies a physician’s ethical responsibilities. 

The ten principles from the Nuremberg Code included the following:

  1. Voluntary Consent is essential.
  2. The results must be for the greater good of society.
  3. Should be based on previous animal experimentation.
  4. Should be conducted by avoiding physical/mental suffering and injury.
  5. No experiments should be conducted if it is believed to cause death/disability.
  6. Risks should never exceed the benefits.
  7. Adequate facilities should be used to protect subjects.
  8. Conducted only by qualified scientists.
  9. Subject should always be at liberty to stop at any time.
  10. Scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur.

Learn more about how history has shaped clinical research practices.

The Declaration of Helsinki also marked the arrival of “clinical research,” a field that was previously referred to as ‘Human Experimentation’ in the Nuremberg Code. Furthermore, it introduced a caveat to the consideration of the process for informed consent as an ‘essential’ portion of research, as stated in the Nuremberg Code; according to the Declaration of Helsinki, physicians would be asked to obtain consent ‘if at all possible’ and could be allowed to omit a traditional informed consent form when a legally authorized representative is available.

Since 1964, the Declaration of Helsinki has undergone seven revisions and two clarifications; however one item remains the same:  the Declaration is morally binding for physicians, an obligation that overrides any national or local laws or regulations, should the Declaration require a higher standard of protection of human subjects.

The WMA has continuously sought to improve the manner in which human subjects remain protected throughout the course of a clinical study.  Can you think of any other ways participants in a clinical trial might benefit from these principles? Leave your thoughts below!

Photo Credit: pni

            The History of Clinical Research        

Topics: Good Clinical Practice, Institute of Medicine, Tuskegee Syphilis Study, Ketek Trial


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