Human subjects research

The concept of research ethics developed from many events around the time of WWII that greatly upset both researchers and the general public. Above all, it was the Nazis' cruel and often deadly research on humans that received attention. In light of these events, a personal and public need for research-ethical reflection and rules and recommendations for research was born. Furthermore, both new techniques (e.g., nuclear technology, IT, gene technology) and the revelation of a number of cases of unethical research have brought to the fore such a need. It can even be said that it is quite natural that research aimed at developing knowledge, treatments and medicines to promote human health and development will carry with it a measure of risk. Research on humans is of essential importance in obtaining scientific knowledge and in helping people who live under severe conditions. At the same time, it is imperative that risks and harm be minimized as much as possible. The researcher assumes a responsibility for the humans he or she performs research on, for both their well-being and the information collected about them.

Nuremberg code and human rights

In connection with the Nuremberg trials after WWII, the first official code for medical research was formulated: The Nuremberg Code of 1947. Among other things, the Code established that informed consent is necessary, that research must have positive consequences for the community and that the risks to research subjects must be minimized. It points out that each subject has the right to terminate participation in an experiment at any time, and that the researcher leading such an experiment is to terminate it if it seems probable that a subject is being harmed. Other important declarations and rules that followed in the Nuremberg Code's footsteps are the UN's Universal Declaration of Human Rights from 1948, the Covenant on Civil and Political Rights and Covenant on Economic, Social and Cultural Rights from 1966 and the European Convention for the Protection of Human Rights and Fundamental Freedoms from 1950. The Charter of Fundamental Rights of the European Union has been prepared within the framework of the EU.

It has often been discussed how one should interpret a person's right to life according to the documents discussed above. In a decision from the European Court of Human Rights (case no. 53924/00, verdict 2004-07-08), it is acknowledged that most governments bound to the European Convention on Human Rights have not yet settled the question of when life begins. There is no unanimous European view on this subject, either medical or judicial. Therefore, the Court feels that the question of when life begins should be decided on a national level.

From the Helsinki to the Bioethics Declaration

Explicitly directed at biomedical research involving humans is the Declaration of Helsinki, created by the World Medical Association in 1964 and last updated in 2008. The Declaration still serves as the fundamental document in regard to this type of research. Among other things, it introduced a controversial distinction between therapeutic and non-therapeutic research, something not included in the Nuremberg Code. In its latest version, one of the issues it addresses is the role of poorer countries in research. In the United States, The Belmont report was the starting point for much work in research ethics and it remains influential to this day. The Council of Europe's Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine has played a major role for European national legislation in recent years, not only for those countries that have ratified the Convention. The last major guideline has been the Universal Declaration on Bioethics and Human Rights from UNESCO.

Ethical review by financiers

Naturally, researchers' primary responsibility is always to informants, patients and research subjects. Before a project begins, a researcher is as noted often examined by some kind of ethical review committee or IRB. Furthermore, granting authorities often conduct an ethical trial before financing a project. Within the sixth framework research program of the European Union about 10 % of the grant applications were ethically reviewed. Almost half of the applications regarding biotech research were reviewed. Research activities supported by EC Framework Programmes should take into account the opinions of the European Group on Ethics in Science and New Technologies. In a similar vein, WHO has issued guidelines for research they sponsor.

Last updated: 2010-01-01