Over at ScienceDaily, there's really interesting story-behind-the-story coverage of a groundbreaking but ethically complex scientific trial. Last year, the HIV Prevention Trials Network 052 trial made headlines when it showed antiretroviral therapy decreases transmission of HIV from HIV-positive individuals to their HIV-negative sexual partners. The trial is also testing whether antiretroviral drugs should be given starting soon after HIV infection is discovered, as opposed to waiting to begin therapy until HIV infection is more advanced.
Answering these questions clearly has tremendous public-health value, especially given that these findings are coming from a randomized clinical trial, the type of research that has long been considered the "gold standard" for good scientific evidence. However, the still-ongoing trial has provided scientists with several big ethical challenges, which are described in a new scientific paper published in the June 2012 issue of Clinical Trials. In particular, as the trial has progressed, researchers have had to figure out how to deal with new scientific knowledge garnered from other experiments that used different methods. The ScienceDaily story explains:
Study participants were randomly assigned to two groups - one that would receive ART earlier, and the other at a later stage of HIV progression. This became a source of ethical tensions as the trial progressed and enthusiasm for earlier ART treatment grew, whereas previously it had been considered potentially unsafe. For example, in November 2009 the World Health Organization (WHO) issued new guidelines recommending that ART treatment begin earlier.
The authors point to the "constant threat" from observational and ecological study data, and the official guidelines they inspire, as posing a critically important ethical lesson of HPTN 052: whether and how a randomized trial should respond in light of them. "As these necessary changes were made, they threatened the very research that might support or refute the recommendations themselves," they write.
The fact that the scientists were testing HIV transmission rates also raised ethical concerns:
The authors also address the question of the study's potential to encourage unsafe sex for the sake of research results into the transmissibility of HIV, a common ethical issue raised in HIV research. The authors assert that "including a 'prevention package' is ethically obligatory," and should include methods known to be effective and accessible to participants.
The whole story is definitely worth reading.