The declaration of Helsinki: The cornerstone of research ethics

The modern era of oncology is dominated by data arising from cancer clinical trials. Research ethics guidelines are needed to help investigators to protect the rights and welfare of human participants involved in research, to promote the adherence to the ethical and scientific principles underlying research and to allay public concerns about the responsible conduct of medical research. Three fundamental ethical principles underlying research that involves humans are respect for persons, beneficence and justice. The Declaration of Helsinki (DoH), developed by the World Medical Association (1964), is the most widely accepted code of research ethics. The DoH has been revised five times, the last time by the 52nd WMA General Assembly in Edinburg, Scotland (October, 2000). The distinction between therapeutic ("clinical") and non-therapeutic research, the standards of care ethically required when research is combined with medical care and the ethics of placebo-controlled trials were three major points of discussion. In the revised version of the DoH, the WMA holds its main position to serve and protect human participants from potentially harmful research projects, while at the same time encouraging their involvement in ethical and scientifically valid research aiming to challenge and improve the understanding and treatment of disease.