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Consent no placebo for medical research

04 Nov 2013

The world’s peak doctor association has tightened rules governing medical research and condemned the use of chemical weapons and the criminalisation of homosexuality.

The World Medical Association General Assembly, meeting in Fortaleza, Brazil, has issued a revised Declaration of Helsinki setting out more stringent ethical principles to guide clinical trials, as well as adopting resolutions regarding the use of chemical weapons and the treatment of homosexuality as a medical disorder.

The Assembly, attended by former AMA Presidents Dr Mukesh Haikerwal and Dr Andrew Pesce, adopted tough new rules intended to ensure medical research was conducted in an ethical manner consistent with the Declaration of Geneva, which requires that the health of patients will be a physician’s primary consideration.

In the ninth revision to the Declaration of Helsinki since it was first adopted in 1964, the WMA has imposed new and additional obligations on researchers to safeguard the interests of research subjects.

Under the new provisions, every research study involving human subjects must be registered in a publicly accessible database before any subjects are recruited, and researchers have a duty to make the results of their study – included any negative or inconclusive findings – publicly available.

Under the new rules, research must only be carried out using vulnerable groups where the study is being conducted in response to the health needs of these groups and cannot be carried out using a non-vulnerable group.

The Declaration also demands that there be “appropriate compensation and treatment for subjects who are harmed as a result” of taking part in medical research.

Dr Pesce said the Assembly held lengthy discussions about the ethics of using placebos, as opposed to the best currently available treatment, in clinical trials.

Ultimately, it was decided that the use of placebos could be justified, but only in particular circumstances.

Under the provisions of the revised Declaration, the effectiveness of any new treatment must be tested against of the best proven interventions, except where no proven intervention exists, where there are “compelling and scientifically sound methodological reasons” for using a placebo, or where using a placebo will not expose test subjects to “additional risks of serious or irreversible harm” as a result of not receiving the best proven intervention.

In addition to ethical rules guiding medical research, the Assembly debated the portrayal of homosexuality as a disease or criminal behaviour in many countries.

In a statement issued following the discussion, the WMA strongly condemned all forms of stigmatisation, criminalisation and discrimination based on a person’s sexual orientation.

In particular, the Assembly took issue with the persistent portrayal of homosexuality as a disease, and associated practices and policies that seek to “convert” homosexuals.

“Homosexuality itself is not a disease,” WMA President Dr Margaret Mungherera said. “It is the stigmatisation and discrimination experienced by people with a bisexual or homosexual orientation which can be harmful to health.

“So-called ‘conversion’ or ‘reparative’ therapies exacerbate these negative health effects, and represent unethical practice.

“Therapies which claim to be able to convert homosexuality into asexual or heterosexual behaviour have no medical indication, involve questionable methods, and must be denounced as unethical.”

Dr Pesce said the motion faced vigorous opposition from associations based in African, Asian and Middle Eastern countries, but was supported by a wide range of delegates, including those from Russia and the Vatican.

The Assembly also passed a motion condemning the use of chemical weapons. But Dr Pesce said it was only endorsed after references to specific countries were removed because of objections from Russia and Japan.

Motions on the role of physicians in identifying children the victims of illegal adoption and child trafficking, the commercialisation of reproductive material and the involvement of physicians in screening participants in reality television programs have been referred to national medical associations for further consideration.

Adrian Rollins

Image by Wikipedia, used under Creative Commons licence

Published: 04 Nov 2013