Normative framework of informed consent in clinical research in Germany, Poland, and Russia

Abstract

Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.

Informed Consent in Clinical Studies Involving Human Participants: Ethical Insights of Medical Researchers in Germany and Poland

“…It is understandable that clinicians may be hesitant to provide information on the overall study design. There is already a widely acknowledged problem of overburdening patients with information, something that is also recognized in the normative frameworks of the study countries ( 4 ). Informing patients about possible rare side effects may trigger certain effects that can harm them and distort studies, placing physicians in a difficult ethical dilemma concerning the nocebo effect ( 18 ).…”

“…It has been shown that despite shared acceptance of the norms listed in the Declaration of Helsinki, there are substantial differences on how Germany and Poland implement ethical norms related to patient protection in the different national laws ( 4 ). Cross-border clinical studies are becoming increasingly common, with a substantial increase in studies carried out in countries in of Central and Eastern Europe.…”

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…While our focus here is primarily on ethical frameworks within United States and European Union, and it is beyond the present scope to canvas the complexities of consent across all regions and jurisdictions, it is important to note that approaches to informed consent in and across other regions are highly varied. Lacunae in regulatory standards of informed consent and research ethics in some regions underscore a significant need for global harmonization of approaches to informed consent to protect research participants [ 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. Less developed regulatory oversight in some regions has contributed to a trend of “outsourcing” of global clinical trials to jurisdictions where clinical-trial conduct is perceived to be less burdensome, including areas of Eastern Europe, China, India South America, and elsewhere [ 26 , 31 , 32 , 33 , 34 , 35 , 36 ].…”