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Human subjects research

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, which is a law in Sweden (SFS 1994:1219). See also the 2nd Chapter of the Instrument of Government ('Regeringsform') which states amongst other things that every "citizen shall in accordance with the law be protected against invasions of his privacy by means of automatic computation of personal data" and that "every citizen is protected against bodily invasive procedures from the state" (editorial unofficial translations).

The Charter of Fundamental Rights of the European Union has been prepared within the framework of the EU. It states that everyone has the right to respect for his or her integrity, and that in the fields of medicine and biology, the following must be respected in particular:The free and informed consent of a person, the prohibition of eugenic practices, the prohibition on making the human body and its parts as such a source of financial gain, and the prohibition of the reproductive cloning of human beings.

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 Declaration and the Biomedicine Convention to the Swedish Act on ethical vetting

Explicitly directed at biomedical research involving humans is the Declaration of Helsinki, created by the World Medical Association in 1964 and last updated in 2013. 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.

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 in recent years. It has had a clear influence on the The Act concerning the Ethical Review of Research Involving Humans (SFS 2003:460). The law is applicable to, among other things, research involving the handling of sensitive personal data, research that involves a physical operation on a subject or is performed according to a method that aims to affect the subject physically or psychologically, as well as studies on biological material that is traceable to individual persons. It is fundamental that research be approved only if it can be performed with respect for human worth, and that human rights and basic freedoms be considered at all times during ethical examination. People's welfare is to be given precedence over the needs of society and science. Therefore, consent to participate in research can be withdrawn at any time, with immediate effect.

By a change of the Act effectuated 2008, the definition of research is clarified so that the activities subject to review is defined. Research is now understood to be scientific experimental or theoretical work to gain new knowledge, and developmental work on scientific grounds, but not such work performed at undergraduate level at universities. Also, the definition of handling personal data is redefined. Research involving handling of certain personal data shall from now on be examined regardless of whether research subjects give their informed consent or not. Research that clearly involves a risk of harming subjects, it can be interviews or surveys for example, shall likewise be ethically examined.

Last updated: 2016-02-03

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CODEX, Centre for Research Ethics & Bioethics, BMC, Husarg. 3, Uppsala | Webmaster | About the web site