Monday, July 11, 2011

Outsourcing Trials: An Ethics Vacuum?

A report from the 7th World Congress of Science Journalists, courtesy The Guardian in the UK--
--raises a specter that we've addressed previously, that by moving clinical trials to developing nations, the pharmaceutical industry is making use of a setting in which protection of human research subjects may not be as stringent.

The developing-world advantages for the contract research organizations (CROs) that run these trials for Pharma are first, lower costs, and second, readier availability of subjects who are not already taking a bunch of meds.

The article states, " 'Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding,' said Ames Dhai, director of the Steve Biko Centre for Bioethics at the University of Witwatersrand, South Africa.

"While many countries have set ethical standards for clinical trials, this is not a guarantee they will be respected by those who perform the trials. 'The problem is implementing these [ethical] guidelines and the imperialistic attitude of researchers and sponsors who come to the country and frequently disregard our process,' Dhai added."

The article goes on to mention both South Africa and India as two research settings in which subject abuse can readily occur.

PS: Before we go tsk-tsking about the low ethical standards in other countries, we also have to ask if US institutions are up to the task of protecting subjects-- for example,

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