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WMA strengthens ethics rules for human research subjects

The World Medical Association (WMA) says recent amendments to its Declaration of Helsinki (DoH) deliver a strong message about the need to provide more protection for people who participate in medical research.

"The changes place more obligations on the sponsors of research, on the researchers themselves and on host governments to protect research subjects," Dr. Margaret Mungherera, the WMA president, said after the revisions were approved during the WMA's annual assembly in Brazil in October.

The DoH, considered one of the world's most significant statements on the ethical principles surrounding medical research involving human subjects, including research on identifiable human material and data, was first adopted by the WMA in 1964. The changes approved in Brazil marked the seventh time it has been amended.

A Canadian perspective was included in the revision process because the CMA's director of ethics, Dr. Jeff Blackmer, served on the expert working group responsible for the DoH review.

The declaration spells out 37 principles on issues ranging from the use of placebos to research involving subjects who are physically or mentally incapable of giving consent. "The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent," it says.

"We have spent two years consulting our national medical association members, outside experts and the public, and we are satisfied that today we have a declaration that requires greater transparency about medical research, greater accountability and increased patient safety," said Mungherera.

The WMA represents 106 national medical associations, including the CMA.

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