Acceptable risk and the requirement of proportionality
Acceptable risk and the requirement of proportionality in European law
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.
Prosjektet er fullført og avhandling ble levert i juni 2009. Disputas 16. februar 2010.
The topic of this thesis is the requirement of proportionality in European biomedical research law. This requirement is a legal norm which requires that biomedical research shall not involve risks and burdens disproportionate to its potential benefits.
Legal basis of the requirement of proportionality
“European biomedical research law”, or simply “the legal framework”, refers to applicable law in the field of biomedical research on human beings in Europe, and encompasses both “Convention law” and “Community law”.
“Convention law” refers to the legal framework under the auspices of the Council of Europe (CoE) established in 1949. The CoE has 47 member states. The main legal instruments concerning biomedical research are the Convention on Biomedicine and Human Rights of 1997 (the Oviedo Convention), and its Additional Protocol on Biomedical Research of 2005 (the Additional Protocol). Both instruments can be said to be based in and elaborating on the European Convention on Human Rights (ECHR) of 1952. The Oviedo Convention was the first international legally binding instrument concerning biomedical research. The Additional Protocol specifies the Convention’s provisions concerning biomedical research, and is therefore the instrument of prime interest here. The Additional Protocol is accompanied by an Explanatory Report drawn up under the responsibility of the Secretary General of the Council of Europe.
“Community law” refers to the legal framework under the auspices of the European Union (EU), as developed from the 1950s into an economic and political union of 27 member states. Community law also applies to the European Economic Area (EEA), which includes Norway, Island, and Liechtenstein. The main legal instruments concerning biomedical research are the Clinical Trials Directive of 2001, and the Commission’s supplementing directive on good clinical practice (the GCP Directive) of 2005.
Since most European countries are members of the Council of Europe and the European Union, they are directly or indirectly legally bound by at least one of these instruments. Those countries are legally obliged to implement the instruments into national law. Since a requirement of proportionality can be derived from any of these instruments, it is safe to say that the requirement of proportionality is a legally binding norm in Europe, both at the European level and at the national level in most countries.
With regard to Convention law, Article 6 (1) of the Additional Protocol contains the following formulation of the requirement of proportionality:
“Research shall not involve risks and burdens to the human being disproportionate to its potential benefits.”
Article 3 (2) (a) of the Clinical Trials Directive contains the corresponding provision in Community law, which states:
“A clinical trial may be undertaken only if, in particular: (a) the foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.”
Both provisions are supplemented and specified in subsequent provisions.
Acceptable risk and the requirement of proportionality
What does the requirement that biomedical research shall not involve risks and burdens to the human being disproportionate to its potential benefits mean?
The overarching objective of this legal thesis is to clarify the requirement of proportionality as it currently stands in European law. Central research questions are:
• What risks, burdens and benefits are relevant in the assessment of proportionality?
• Are other factors, circumstances or interests relevant, and, if so, how and to what degree?
• What is the requirement’s relationship to the requirement of a valid consent from the individual participant, and his or hers right to self-determination?
• How are relevant factors to be weighed in order to assess whether there is a proportionate relationship or not?
• What is the threshold(s) prescribed by the requirement of proportionality that any interventional biomedical research projects on human beings must pass in order to be lawful? In other words, what degree of risks and burdens are acceptable in human experimentation in Europe today?
The answers are pursued through systematic analysis and interpretation of the requirement in accordance with legal method. The results are thus based on relevant and recognised sources of law. Secondary aims are to place the requirement in a historical as well as contemporary context, and to clarify central concepts. Additionally, a three year semi-structured semi-participating observational study of a REC has been undertaken to gain knowledge about to what extent and how the requirement of proportionality is applied and observed in practice, by researchers as well as REC.
I have published one book and 11 other publications during the period. I have held approx. 20 external presentations. I also teach classes at DMF.
Kommentarer til helseforskningsloven.
I: Norsk Lovkommentar. Publisert som del i oppslagsverk i bokform og som betalingstjeneste på internett. Gyldendal Rettsdata, 2008.
I: Rapport fra Bioteknologinemndas åpne møte, Oslo (under publisering).