A recent article by Canadian Medical Association Journal discusses how the Helsinki doctrine is under review. The World Medical Association will revise the Declaration of Helsinki before the famous doctrine celebrates its 50th anniversary in 2014. Revisions are not uncommon to the doctrine as the association usually conducts updates every five to six years. The review will seek agreement among physicians representing more than 100 countries on new draft guidelines to shield people engaging in clinical trials which is sure to spark great debate.
There is an increasing number of global bodies creating their own research ethics guides, giving life science companies and researches numerous of standards to follow. Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group says “Ultimately, it’s not an enforceable document — it doesn’t hold the status of laws or regulations in any particular country. So while it’s frequently cited as an important document that describes basic ethical principles for protecting human subjects in medical research, currently it doesn’t bind any physician researcher in a legal way”.
The requirement for agreement among members orders the length of the review process, which can take two to three years. Controversial topics are again expected to include whether companies are required to only identify or actually to provide after study care to trial participants; what constitutes “standard” care in a resource-poor country or setting; and whether placebos should ever be used instead of standard of care.
To learn more and read this article, click here.