Results of the analysis of biomedical research ethics in Europe and the USA are discussed in the paper that has recently been published in Science. One of the co-authors of the work is Dr Dorota Krekora-Zając from the Faculty of Law and Administration, the University of Warsaw.

“Modern biomedical research is conducted jointly by scientists from various European and non-European countries, which is why comparative law research showing the differences between individual legal systems is so important. They enable scientists conducting research to better prepare their research and often constitute an impulse for individual countries to harmonize legal regulations,” Dr Dorota Krekora-Zając says.

The authors of the paper investigated three related issues: whether biomedical research ethics review considers the societal and long-term implications of the research, whether bodies charged with performing research ethics reviews are appropriate to consider these issues, and the feasibility and likely support for embedding multidisciplinary researchers with scientists to study societal and long-term implications.

In the context of biomedical research involving human subjects, the review of research proposals by ethics committees in virtually every country is traditionally focused on informed consent and other protections for individuals participating in research. However, the substantial societal implications of modern biomedical research and the globalisation of scientific inquiry make it important to understand whether research ethics review in each country addresses both individual and societal issues.

In the majority of the countries that underwent the research, ethics committees could evaluate the social impact of a biomedical study. Such a possibility, however, was not determined in the American committees.

“Knowledge of the practices internationally can promote understanding and can suggest possible innovations for specific countries,” explains Dr Krekora-Zając, “The article concerns current regulatory policies in selected European countries and the USA and ends with de lege ferenda conclusions”.

The publication is an element of the broader research by Dr Dorota Krekora-Zając, the UW Faculty of Law and Administration, on legal aspects of conducting biomedical research and biobanking, including changes in the Polish law regulations regarding the competences of bioethics committees.