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An ethics committee is a committee dedicated to the rights and well-being of research subjects and makes decisions regarding whether or not proposed research studies are ethical to permit to go ahead.
The emphasis on ethical research arose out of concern regarding unethical experiments on humans that occurred during the Second World War. This led to the “Nuremberg Code,” which continues to inform current day ethics statements. This includes the ten basic principles that must be observed when performing medical experiments in order to satisfy moral, ethical, and legal concepts (BMJa 1996). The Nuremberg Code was informed the Declaration of Helsinki, which was devised in 1964 in order to meet the needs of the biomedical community (BMJb 1996). This has been revised six times; the most recent version was written in 2008. The Declaration of Helsinki stipulates that research protocols should be reviewed by specially appointed committee independent of the investigator and the sponsor. It also stipulates that research that does not directly benefit the patient is restricted to healthy volunteers or for individuals where the experimental design is not related to their illness. Importantly, it also states that any research that does not have ethical approval should not be accepted for publication. Researchers are now increasingly assessed for Good Clinical Practice as developed by the International Conference on Harmonization (http://www.ich.org/home.html), which was developed from the Declaration of Helsinki.
To protect the rights, safety, dignity, and well-being of research participants
To facilitate and promote ethical research that is of potential benefit to participants, science, and society
A list of national ethics committees specializing in the ethical aspects of the life sciences, biotechnology, agriculture, food safety, and health can be found at: http://ec.europa.eu/research/biosociety/bioethics/bioethics_ethics_en.htm.
Links for key documents relating to ethics committees can be found at the following site: http://www.privireal.org/content/rec/documents.php.
References and Further Reading
- BMJa. (1996). Nuremberg. BMJ, 313, 1448. Retrieved from http://www.bmj.com/content/313/7070/1448.1.full
- BMJb. (1996). Nuremberg: Declaration of Helsinki (1964). BMJ, 313, 1448. Retrieved from http://www.bmj.com/content/313/7070/1448.2.extract.Google Scholar