Medical experiment in the new legal reality.

Introduction and Objective . Medical experimentation is part and parcel of the research work of medical staff and makes the development of medicine possible. Effective as of 1 January 2021, the amendment to the Act on the Medical and Dental Professions has introduced significant changes to the rules of medical experimentation. Some of these changes have raised controversy and generated problems of interpretation. This article aims to demonstrate the breadth of the changes that have been introduced, draw attention to the related doubts and update the knowledge of medical staff on the rationale for the legality of medical experimentation in Poland after 1 January 2021. Review methods . This review has been compiled based on data contained in the Polish Legal Information System “LEX”. It also uses the Online System of Legal Acts and the system of Legal Acts available online at https://isap.sejm.gov.pl/ Brief description of the state of knowledge. The amendment to the Act has caused a great deal of confusion in research, insurance and legal communities. Already at the stage of drafting the law, numerous concerns were raised about the proposed changes. Major concerns were voiced about the introduction of a new type of medical experiment into the law, the qualifications of a person in charge of a medical experiment, the compulsory insurance, as well as changes to the rules of medical experimentation with minor participants and the rules of medical experimentation without the required consent. Summary . The changes to the rules of medical experimentation introduced by the Act on the Medical and Dental Professions are still controversial, and research practice does not always go hand in hand with the solutions adopted. The regulations in force since 1 January 2021 do not meet the expectations of the research, insurance and legal communities and thus require further revisions.