Declaration of Helsinki: What Does the Future Hold?
2014
s medical students, we are mainly exposed to the rules and regulations that are set out in front of us; always wear your name tag, never be late, no whispering during tests, do not talk unless spoken to during your surgery rotation (just kidding on the last one). However, that is just the beginning of the ubiquitous rules that are present in medicine, with medical research being no exception. Within the world of medical research, the Declaration of Helsinki (DoH) has long been considered the cornerstone document explaining the ‘rules’ of ethical human research. Developed in 1964 by the World Medical Association to protect the rights of research subjects, it originally contained a set of 11 articles explaining the basic ethical duties of physicians in regards to research. The original version took aspects of the Nuremburg Code and Declaration of Geneva to incorporate human experimentation with the physician’s ethical role in the process and delineated a patient’s rights regarding informed consent, privacy, and safety. Since then, it has undergone seven revisions and has grown from 11 to now 37 articles, with categories ranging from General Principles to Risks to Informed Consent (http://www.wma.net/en/30publications/ 10policies/b3/index.html). Though considered comprehensive and accurate in some aspects, it has not been without controversy over the years. Therefore, this year, which commemorates the 50th anniversary of the document, we must ask, how has the relevance of DoH changed, and will it change further in the future?
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