Medicine is the field surrounded by the most provisions and regulations. It was also in this area that research ethics first gained a foothold - for information, see the summary on Research Involving Humans. Some of the fundamental documents linked to from the summary are the Nuremberg code, the Declaration of Helsinki and 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 (this convention has led to Sweden's etikprövningslagen - law on ethical review - see below for details). The growth of ethics codes eventually led to the creation of regional research ethics committees, which assembled voluntarily and were generally not supported in Swedish law or statute.
Swedish and EU standards
On 1 January 2004, the The Act concerning the Ethical Review of Research Involving Humans came into effect. The act is applicable to, among other things, research involving the treatment of sensitive personal information, research involving a physical operation on the subject or that is performed using a method aiming to affect the subject physically or psychologically, and studies on biological material that is traceable to specific people. Fundamental is that the research can be approved only if it can be performed with respect for human dignity and if human rights and fundamental freedoms are at all times considered. A person's welfare is to be given higher priority than the needs of the community and science. It is therefore that safeguards are in place, such as a subject's right to withdraw consent to participate in research, effective immediately.
According to the law, applications for the ethical review of research are to be reviewed by regional committees, which comprise authorities. There is even to be a central committee for ethical review of research, which also plays a supervisory role. If a committee is not unanimous on the results of an ethical review, it must hand the issue over to the central committee for a decision. A regional committee's rejection can be appealed to the central committee, but the central committee's decision in the matter of ethical review can not be appealed. It is a punishable offense to perform research covered by this law without approval.
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.
There are many particular rules and guidelines for pharmaceutical research, see this research ethics summary. The EU has issued Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This was followed by Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. According to this directive, all clinical trials shall be "guided by ethical principles in all their aspects".
Major international guidelines
Together with the Helsinki Declaration, "Good Clinical Practice" and "International Ethical Guidelines for Biomedical Research Involving Human Subjects" are the most important and most used international rule compilations for medical research. Together with WHO, The Council for International Organizations of Medical Sciences (CIOMS) has issued International Ethical Guidelines for Biomedical Research Involving Human Subjects, focussed on questions concerning security and informed consent. The document attempts to implement the Helsinki Declaration's principles while considering important differences between the world's countries. It includes special provisions on research involving vulnerable groups or women.
Then, at the 1996 International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use (ICH), a more technical and specific set of guidelines was created, going under the name Good Clinical Practice. This document addresses virtually all aspects of experimental work, with special focus on the procedure for application to ethics committees. It is applicable in the US and Japan as well as in the EU. To help European research ethics committees, the European Forum for Good Clinical Practice has produced guidelines and recommendations for GCP. Good Clinical Practice can be found in a somewhat different form from WHO - these guidelines' use is more dependent on which country they are to be used in, and they affiliate themselves explicitly with the Helsinki Declaration and CIOMS guidelines, whereas ICH's GCP does not. WHO has also issued a complementary Handbook for Good Clinical Research Practice.
ICH's regulations concerning security, efficiency and inspection can be found here and the European Medicines Agency's collection of documents here. The EU regulations are collected in The Rules Governing Medicinal Products in the European Union.
There are a number of rules and guidelines that address more specific areas and questions. Specific summaries are in place in CODEX, for example concerning stem cell research and biobanks. For more information on research for and on children, click here. Nursing research has its own Etiska riktlinjer för omvårdnadsforskning i Norden. In Sweden, measures to conduct research on fertilized human eggs are regulated by a specific law (The Genetic Integrity Act). The World Medical Association has a large collection of statements on various questions, as has the Standing Committee of European Doctors.
Regarding epidemiological studies, the Council for International Organizations of Medical Sciences has issued International Guidelines for Ethical Review of Epidemiological Studies. Furthermore, we have Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research and Guidelines for Good Pharmacoepidemiology Practices from the International Society for Pharmacoepidemiology, as well as a Good Epidemiological Practice from International Epidemiological Association.
In 1989 the Swedish Samarbetskommittén för folkhälsoforskning issued proposed ethical guidelines for public health research. The Swedish Medical Research Council then followed with Ethical guidelines for epidemiological research in 1994.
In the area of psychiatry, there are Ethical Guidelines from the European Association for Psychotherapy and the Council of Europe's Committee of Ministers' Recommendation 1235 (1994) on psychiatry and human rights. The latter has more recently been supplemented with The Council of Europe's Steering Committee on Bioethics (CDBI), which has issued a White Paper on the protection of the human rights and dignity of people suffering from mental disorder, especially those placed as involuntary patients in a psychiatric establishment.
Certain research is by nature difficult to perform according to the standards set by the CIOMS guidelines and GCP. A good example of this is research on HIV and AIDS. The organisation UNAIDS has issued outlines with Ethical considerations in HIV research.
Recognizing the need to be able to try new drugs, devices and procedures on patients who are unconscious or otherwise unable to communicate, the U.S. federal government (Exception...) in 1996 approved "emergency research consent waivers" that allow ethical review boards at hospitals and other health centers to authorize medical research without consent in such situations. A special research safety oversight committee is set up for each experiment, and extensive efforts are made to alert people in the community that they or family members might later take part in such a study. Family members have a chance to opt out of treatment. Sweden lacks a regulation of this.
Last updated: 2013-04-04