Subject 's informed consent: Importance for the patient and research, position in the legal regulation: Subject's informed consent

Abstract

Informed consent (IC) is a process in which subjects voluntarily confirm their willingness to participate in the research after being thoroughly informed about all the aspects relevant to the decision to participate. The paper aims to point out the essential elements of IC intended for a patient involved in research and to present novelties in the legislation that will affect the nature of information concerning the subject and the process of obtaining consent. The fundamental goal of the IC content is to understandably present to the potential participant all the relevant data related to the nature of the procedures they would be involved in, the risks and benefits; alternative possibilities; and to assess their understanding of all presented information. The process is more complex when it concerns vulnerable patient populations, that is, people whose willingness to participate can be influenced by expectations or benefits from research or by fear of the reactions of superiors if they refuse. This is particularly important in the case of involving persons who cannot consent independently by themselves for any reason. In such a case, a clear justification for their inclusion should be provided, as well as a detailed description of obtaining consent from parents, relatives, or guardians, i.e., legal representatives. Good knowledge of the international regulations related to the research involving the human population and respect for all ethical standards related to them is necessary as significant differences in the legislation exist among states and regions.