Scientific research has been carried out since the beginning of medicine. Doctors experimented with new substances and procedures to treat patients. For years, research was carried out without respect for patients' rights and without any legal regulations - this was changed by the ethical code formulated in 1947, the so-called Nuremberg Code. It was in this piece of legislation that the requirement for 'informed consent', which the patient must give for any medical action proposed by the doctor, appeared.
The Code contained rules on the permissibility of experiments on human beings. Among other things, it emphasised the need for consent, freely and voluntarily given, and fully informed by the person undergoing the research and experimentation. Even then, the patient had the possibility to withdraw consent at any time. Unfortunately, the standards contained in this Code were insufficient and there was a need to modify them.
A comprehensive and universally applicable document became the World Medical Association (WMA) Declaration of Helsinki Ethical Principles for the Conduct of Medical Research Involving Human Subjects, adopted by the 18th General Assembly of the World Medical Association (WMA) in Helsinki in June 1964, where informed and voluntary consent by the adult patient was also emphasised. The Declaration also made a distinction between a clinical (diagnostic or therapeutic) experiment conducted for the direct benefit of the researcher and a scientific (non-medical) research experiment whose purpose is to advance medical knowledge.
The declaration regulates the subject of the study itself, which must have a scientific basis. A study protocol approved by an independent ethics committee is required to initiate a trial. The Declaration of Helsinki also regulates the rights and responsibilities of the patient, the investigator and the sponsor. The trial participant should be informed about the purpose, method, risks and potential benefits of participating in the trial.
In order for the patient to enter the study as a participant, he/she must give written consent (informed, without pressure, after discussing the pros and cons with the researcher and consulting relatives). The investigator is required to be suitably qualified and experienced. Both the investigator and the sponsor are fully responsible for the safety of the patient in the study. Although the Declaration of Helsinki is not a universally binding regulation or standard for the conduct of clinical trials, it is widely recognised as a fundamental document setting out the principles for conducting research involving human subjects. For the first time, a code of ethics has been formulated by the medical research community representing physicians from all over the world, requiring all physician-researchers to adhere to certain standards of conduct with respect to research involving human subjects, even when there is no relevant legislation in a particular country or when that legislation is more liberal than the Declaration of Helsinki.
Clinical trials in the European Union are primarily regulated by Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC and Implementing Regulation (EU) 2017/556 of 24 March 2017 on detailed arrangements for good clinical practice inspection procedures under Regulation (EU) No 536/2014 of the European Parliament and of the Council, In Poland, the Act of 9 March 2023 on clinical trials on medicinal products for human use. Clinical trials are also partly regulated by: the Act of 6 September 2001. Pharmaceutical Law, Act of 7 April 2022 on medical devices.
The regulations set out the principles and detailed guidelines of good clinical practice for investigational medicinal products for human use, as well as the requirements for approval of the manufacture and importation of such products. Today, research is conducted in accordance with GCP (Good Clinical Practice), which is an international ethical and scientific standard for planning, conducting, documenting and announcing the results of clinical trials involving human subjects, developed by the International Conference on Harmonisation (ICH).
Good clinical practice is a set of detailed ethical and research quality requirements relating to the planning, conduct, execution, monitoring, auditing, recording, analysis and reporting of clinical trials, ensuring the protection of the rights, safety and well-being of participants, and the reliability and robustness of the data obtained in clinical trials. Following this standard is a guarantee of the reliability and accuracy of the data obtained, as well as of the reported results and respect for the rights of the subjects. Regulation 536/2014 states that the rights, safety, dignity and well-being of participants should be protected in a clinical trial and that the data obtained should be reliable and resilient.
The Regulation also defines informed consent of a trial participant. The concept of informed consent is the independent and voluntary expression by a subject of his or her willingness to participate in a specific clinical trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate, or, in the case of minors and incapacitated subjects, the authorisation or consent of their legally appointed representatives to be included in the clinical trial.
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