The World Medical Association, the global representative body for physicians, has finally approved a revised Declaration of Helsinki governing the ethics of medical research involving human participants. It is the fifth time that the document, acknowledged as the cornerstone of research ethics, has been revised since it was drawn up in 1964.
The revised Declaration, published today, was adopted at the WMA’s annual general assembly in Edinburgh, which ended at the weekend.
Dr. Delon Human, Secretary General of the WMA, said that because of significant changes in the field of medical research, it was essential to revise the ethical guidelines applicable to research.
“The WMA’s main objective is to serve and protect our patients, especially those who are involved in potentially harmful research projects. At the same time we applaud and encourage the use of ethical research to find new ways to cure disease”.
He said that changes to the Declaration included a change in structure to more clearly define the additional standards necessary when research is combined with medical care. New guidelines have also been included to call for absolute transparency regarding economic incentives involved in research.
Dr. Human added: “What has easily been the most contentious issue is the standard of treatment that should be assured to human participants involved in research projects. The WMA has affirmed its position that at the conclusion of any research study, every patient entered into a research project should be assured of the best proven prophylactic, diagnostic and therapeutic methods identified by that study”.
“The WMA has also been very concerned about the possible exploitation of so-called “poor” nations for research by companies from so-called “rich” countries. New guidelines in the Declaration will now call on researchers to make sure that there is a reasonable possibility that the local participants in a study, including their fellow countrymen, would be able to benefit from the results (whether positive or negative) of such studies”.
The revised Declaration of Helsinki will be distributed to the World Health Organization, National Bioethics Commissions, Patient Representative Groups and other relevant stakeholders. The full text of the revised Declaration of Helsinki is being posted on the WMA website (www.wma.net). The full text of the document is available on request.