The Helsinki Declaration of October 2013 versus the 1996 Version

Comparative analysis of Helsinki declaration October 2013 compared to the 1996 version

The Helsinki declaration 2013 compared to the one 1996 states that one of the reasons of biomedical research is to continuously evaluate medical interventions apart from the improvement of diagnosis and prevention of diseases which is also stated in the older version. In addition in the newest declaration the importance of final experimentation on human subjects is mentioned, whereas in the previous edition the experimentation in humans is mentioned only as a part of the final experimental design. Regarding the role of ethical committees and the approval of experimental protocol, there are some implementations in the 2013 declaration which give the ability to the committee to control the whole experimental procedure and the adverse effects during the study. In addition, the fact that changes cannot be made in the protocol during the study is mentioned clearly, this part was not mentioned in the 1995 declaration and the clear explanation of this fact does not leave any free space for different types of behavior. Finally, new considerations regarding the protocol have been added in the newest version of Helsinki declaration in which all the details including ethical aspects and compensation for the subjects should be included in the experimental protocol, which will be under consideration by the ethical committee.

Duties of physicians

In both editions of the Helsinki declaration the role of the physician in protecting the human subject involved in the study is stressed out. However in the 2013 declaration in a more detailed way all the parameters that should be protected by the health care professional are described and those include not on...

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... obtained regardless of being negative or positive should be published openly. Moreover liable for the ethical aspects of the study are not only the physicians but also the editors and the publishers. Increasing the liability in all individuals involved in the implementation and publication of the study decreases the possibility of a study that does not take into account all the ethical aspects will be conducted. Finally the 2013 declaration gives the ethical possibility to the physician to use an unproven method if he believes that this will be for the benefit of the patient and after the informed consent is given.

References

1. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013

2. WMA Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects, October 1996