Ethical regulations

Looking back in history, we can see that not so long ago, there were no ethical standards that could regulate the process of conducting clinical trials. It was only after the end of World War II that the ethical foundations were established, which gave rise to the development and shaping of what are now international ethical standards for the conduct of clinical trials.

The Nuremberg Code

After World War II, the Nuremberg Trials were held in 1947, during which an Allied Military Tribunal tried doctors in Nazi Germany who had tested new chemicals on humans to study their effects. The trial was followed by the first 10 ethical principles for the conduct of clinical trials, called the Nuremberg Code.

It was decided that informed consent of the participant is a necessary condition before starting a clinical trial involving humans. In addition, any clinical trial should be of benefit to society and have a scientific basis for its initiation, and the benefits must always outweigh the potential risks.

Declaration of Helsinki

The Declaration of Helsinki is a document developed by the World Medical Association in which the basic principles for conducting clinical trials involving human subjects are described. This document was published in June 1964. The content of the declaration was written based on the Nuremberg Code. For the first time, there was a requirement to prepare a detailed study protocol. Moreover, the rules of conducting clinical trials combined with medical care were presented and the basis for presenting and publishing the results of medical experiments was defined.

Currently, when preparing a protocol for a clinical trial, it is worth knowing that it must comply with the set of principles contained in the Declaration of Helsinki.

The Belmont Report

The Belmont Report is a document that provides ethical principles and guidelines for research involving human subjects. It was drafted and published by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research in 1979 in the United States. It describes in detail the boundaries between the practice of medicine and biomedical research. It also contains basic ethical principles for research involving human subjects, including principles of justice, beneficence, and the duty of respect for persons.

Good Clinical Practice

The Good Clinical Practice (GCP) has been prepared by the International Conference on Harmonization (ICH) and contains detailed international standards for the proper conduct of clinical trials, such as how to plan and prepare a clinical trial, how to monitor, document, and report the results obtained in a trial. Moreover, this document contains information about the sponsor, investigator and persons monitoring the trial. The basic documents necessary for each clinical trial are also described: trial protocol, investigator's brochure and others.

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