Medical research
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. The growth of
ethics codes eventually led to the creation of research
ethics committees in many European countries.
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 the WHO, The Council for International Organizations of Medical Sciences (CIOMS) has issued International Ethical Guidelines for Biomedical Research Involving Human Subjects (first issued in the 80's), 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.
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". ICH's regulations concerning security, efficiency and inspection can be found here and EMEA's collection of documents here. The EU regulations are collected in The Rules Governing Medicinal Products in the European Union.
Specific areas
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. 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 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.
Exceptions?
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 documents with Ethical considerations in HIV research. CIOMS has issued a report on Drug development research in resource-limited countries.
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 some 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. Many European countries lack regulation of this.
Last updated: 2010-01-03
