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Helsinki Declaration
Course: Bachelors of Law - 3 years (L.L.B. 3)
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University: University of Mumbai
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Declaration of Helsinki
The Declaration of Helsinki was created in 1964 by the World Medical Association (WMA). The
WMA was established seventeen years before in 1947, and was created to handle the growing
concern of unethical medical practice which became more apparent during and after World War
II. The WMA is an international representative organization for members of the medical
community including doctors, researchers, dentists, and more. While the WMA is a well-
respected body which is cited by health organizations around the world, it does not have any
legal authority. Therefore, the Declaration of Helsinki is an ethical guideline, rather than a
document with international legal implications. The Declaration set the standard for ethical
human experimentation conducted by researchers.
Throughout history, the Declaration of Helsinki has had significant influence on many medical
governing bodies and guidelines including the International Conference on Harmonisation’s
Good Clinical Practice Guidelines, the U.S. FDA, the Council for International Organizations of
Medical Sciences’ Guidelines for Biomedical Research, and the United Nations Education,
Scientific, and Cultural Organizations’ Declaration on Bioethics and Human Rights. The
document was created to set a balance between the interests of humanity and individual patients
who are part of clinical trials. The basic principles include respect for individuals, the right to
make informed decisions, recognition of vulnerable groups, and more.
The Declaration of Helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and
2008. The fifth revision, in 2000, caused considerable controversy regarding issues such as
whether the document should be revised at all, the restating of Article 29 which dealt with
placebo use, and what the medical community should be required to do to treat patients after they
have undergone a medical trial. After this revision, the U.S. FDA refused to refer to the new
version and instead continued using the document from 1989. In 2006, the U.S. FDA
discontinued referring to the Declaration at all. Also, the European Commission only uses an
older version from 1996. This lack of cohesion has weakened the Declaration of Helsinki’s
influence over the years. However, it is still viewed as a pioneering effort to ensure that patients
involved in clinical trials are treated with the fairness around the world.
A. INTRODUCTION
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a
statement of ethical principles for medical research involving human subjects, including research
on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should
not be applied without consideration of all other relevant paragraphs.
2. Although the Declaration is addressed primarily to physicians, the WMA encourages other
participants in medical research involving human subjects to adopt these principles.