Friday, January 18, 2013

Guidelines on standards of care in research: when is deviancy acceptable?

For years there have been overheated discussions about the standard of care provided to participants in health research, particularly in low-resource settings. Is it ever ethically justified to design a research study where participants in Benin with a standard of care inferior to what patients would routinely receive in (say) Baltimore, Maryland? There is no consensus on the issue, and even an influential international ethics document speaks out of both sides of its mouth on this one.

Every once in awhile, a study emerges that seems to offer (some) research participants inferior care, and the whole tumultuous debate is unleashed anew. This is what happened with the Starting Antiretroviral Therapy at Three Points in Tuberculosis Therapy (SAPIT) study in South Africa a couple of years ago. This randomized controlled trial randomized HIV-positive patients with tuberculosis to receive antiretroviral treatment earlier or later after starting TB treatment. The 'delayed arm' of the study seemed to violate WHO guidelines that recommended starting antiretroviral treatment in such patients as soon as possible after TB treatment was initiated. When the study was stopped due to heightened mortality in the delayed arm, commentators cried foul. The researchers, they claimed, should have followed the guidelines, and should have known what would happen in the delayed arm when they did not.

Seema Shah and Reider Lie have just published an interesting piece in the Journal of Medical Ethics on this topic, asking about when it can be justified to deviate from guidelines about standards of care and prevention. They remind us that guidelines, while useful, are not fixed and divine commandments: they may be based on insufficient evidence, they may change while a study is being conducted, they may be objects of controversy and disagreement. Not everyone is likely to agree with Shah and Lie's account of when deviations from clinical or prevention guidelines are ethically justified, or their interpretation of the SAPIT trial on the basis of their account, but they may have found tranquil angle to the passionate debate over standard of care in research. If such a thing exists.

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