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Phylogenetic analysis of pathogens is an increasingly powerful way to reduce the spread of epidemics, including HIV. As a result, phylogenetic approaches are becoming embedded in public health and research programmes, as well as outbreak responses, presenting unique ethical, legal, and social issues that are not adequately addressed by existing bioethics literature. We formed a multidisciplinary working group to explore the ethical issues arising from the design of, conduct in, and use of results from HIV phylogenetic studies, and to propose recommendations to minimise the associated risks to both individuals and groups. We identified eight key ethical domains, within which we highlighted factors that make HIV phylogenetic research unique. In this Review, we endeavoured to provide a framework to assist researchers, public health practitioners, and funding institutions to ensure that HIV phylogenetic studies are designed, done, and disseminated in an ethical manner. Our conclusions also have broader relevance for pathogen phylogenetics.

Phylogenetic analysis -the study of the genetic relatedness between HIV strains -has recently been used in criminal prosecutions as evidence of responsibility for HIV transmission. In these trials, the expert opinion of virologists has been of critical importance. PitfallsPhylogenetic analysis of HIV gene sequences is complex and its findings do not achieve the levels of certainty obtained with the forensic analysis of human DNA. Although two individuals may carry HIV strains that are closely related, these will not necessarily be unique to the two parties and could extend to other persons within the same transmission network. Acceptable standardsFor forensic purposes, phylogenetic analysis should be conducted under strictly controlled conditions by laboratories with relevant expertise applying rigorous methods. It is vitally important to include the right controls, which should be epidemiologically and temporally relevant to the parties under investigation. Use of inappropriate controls can exaggerate any relatedness between the virus strains of the complainant and defendant as being strikingly unique. It will be often difficult to obtain the relevant controls. If convenient but less appropriate controls are used, interpretation of the findings should be tempered accordingly. ConclusionsPhylogenetic analysis cannot prove that HIV transmission occurred directly between two individuals. However, it can exonerate individuals by demonstrating that the defendant carries a virus strain unrelated to that of the complainant. Expert witnesses should acknowledge the limitations of the inferences that might be made and choose the correct language in both written and verbal testimony.

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In Canada, people living with HIV who do not disclose their HIV status prior to sexual acts risk prosecution for aggravated sexual assault even if they have sex with a condom or while having a low (or undetectable) viral load, they had no intent to transmit HIV, and no transmission occurred. In 2013, six distinguished Canadian HIV scientists and clinicians took ground-breaking action to advance justice by co-authoring the “Canadian consensus statement on HIV and its transmission in the context of the criminal law.” This effort was born out of the belief that the application of criminal law to HIV non-disclosure was being driven by a poor appreciation of the science of HIV. More than 75 HIV scientists and clinicians Canada-wide have now endorsed the statement, agreeing that “[they] have a professional and ethical responsibility to assist those in the criminal justice system to understand and interpret current medical and scientific evidence regarding HIV.” As some 61 countries have adopted laws that specifically allow for HIV criminalization, and prosecutions for HIV non-disclosure, exposure and transmission have been reported in at least 49 countries, the authors hope that others around the world will take similar action.

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