REVIEW OF THE TWO VERSION OF DECLARATION OF HELSINKI (2013 AND 2008): CHALLENGES AND CHANGES

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FADAEI FATEMEH; ZAHEDI LADANNAZ; FARAHANI ZAHRA; GHASEMZADEH NAZAFARIN

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Journal: Iranian Journal of Medical Ethics and History of Medicine Year:2016 | Volume:9 | Issue:3 Page(s): 75-92

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Title

REVIEW OF THE TWO VERSION OF DECLARATION OF HELSINKI (2013 AND 2008): CHALLENGES AND CHANGES

Author(s)

FADAEI FATEMEH | ZAHEDI LADANNAZ | FARAHANI ZAHRA | GHASEMZADEH NAZAFARIN | Issue Writer Certificate

Keywords

DECLARATION OF HELSINKIQ2

RESEARCH ETHICSQ2

INFORMED CONSENTQ3

PLACEBOQ3

Abstract

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.

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APA: Copy

FADAEI, FATEMEH, ZAHEDI, LADANNAZ, FARAHANI, ZAHRA, & GHASEMZADEH, NAZAFARIN. (2016). REVIEW OF THE TWO VERSION OF DECLARATION OF HELSINKI (2013 AND 2008): CHALLENGES AND CHANGES. JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE, 9(3), 75-92. SID. https://sid.ir/paper/135435/en

Vancouver: Copy

FADAEI FATEMEH, ZAHEDI LADANNAZ, FARAHANI ZAHRA, GHASEMZADEH NAZAFARIN. REVIEW OF THE TWO VERSION OF DECLARATION OF HELSINKI (2013 AND 2008): CHALLENGES AND CHANGES. JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE[Internet]. 2016;9(3):75-92. Available from: https://sid.ir/paper/135435/en

IEEE: Copy

FATEMEH FADAEI, LADANNAZ ZAHEDI, ZAHRA FARAHANI, and NAZAFARIN GHASEMZADEH, “REVIEW OF THE TWO VERSION OF DECLARATION OF HELSINKI (2013 AND 2008): CHALLENGES AND CHANGES,” JOURNAL OF MEDICAL ETHICS AND HISTORY OF MEDICINE, vol. 9, no. 3, pp. 75–92, 2016, [Online]. Available: https://sid.ir/paper/135435/en

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