Acceptable risk in biomedical research. A legal analysis of the requirement that biomedical research shall not involve risks and burdens disproportionate to its potential benefits

The topic of this jurisprudential doctoral thesis is the legal requirement of proportionality between risks, burdens, and potential benefits in interventional biomedical research on human beings. An initial investigation of biomedical research law, revealed that surprisingly little appeared to be known about this old and obviously central professional, ethical, and legal requirement. Although more information about the requirement was found later on, the legal requirement of proportionality in European biomedical research law appeared largely unexplored in legal theory, in European Convention (ECHR) law and Community (EU) law. The purpose of this thesis is to contribute to enhanced knowledge about the requirement’s normative content in the first two jurisdictions, and, consequently, also in national law of European countries. Hopefully, this clarification of the law may improve assessments of proportionality in practice, and consequently improve the respect for and protection of research participants’ individual interests, welfare (including health), and human dignity.