Review of the two version of declaration of Helsinki (2013 and 2008): challenges and changes

The Declaration of Helsinki is one of the most important international documents in medical research ethics on human subjects which has been revised 7 times and the last revision was in 2013. Researchers must be informed of the principle of Helsinki declaration and the latest changes in order to respect the rights of participants in medical research. In this study, the last version of the declaration are compared with the previous version (2008). The evaluation of the changes and challenges of the final revision can be helpful in modification of the ethical codes of our country. The 2013 version included a number of important changes; it has been categorized into more clear and detailed sections. So this version has a better structure and more practical as well. The 2013 version places more emphasis on vulnerable groups and includes a separate section on the compensation and treatment of injuries due to research. The revised version of the Declaration of Helsinki also emphasizes obtaining of the informed consent (even in researches on material or data contained in biobanks) and post-trial access.