HIV cure research, like all medical research, is governed by distinct legal regulations. However, while regulations play a role, medical ethics go beyond what is required by law -- and not all research that is technically legal is also ethical, experts say.
Each of the three current approaches to a cure for HIV poses its own risks, explained speakers in a recent CUREiculum webinar entitled "The Ethics of HIV Cure Research":
- Gene modification therapy may not be scalable enough to be spread globally and may have different effects based on race, gender or regional variations in the HIV virus ("clade"); moreover, changes to the genome could become hereditary.
- The "kick and kill" strategy may cause the latent HIV reservoir, as well as cancer, to increase since some of the latency reversing agents used are known carcinogens.
- Immune modulators could trigger the development of an autoimmune disease and may not be a sustainable approach because the antibodies used in passive immunization have a half-life.
They cautioned that early research into a cure for HIV presents special challenges since study participants are unlikely to derive a direct, personal benefit from the clinical trial.
In addition, some studies require analytic treatment interruptions (ATIs) to determine whether a particular strategy is working. An ATI refers to intentional, carefully monitored and temporary cessation of antiretroviral treatment as a part of the study. This may pose risks not only to study participants, but also to their sexual partners, who are more likely to be infected if their partners are not on antiretroviral treatment.
To mitigate the potential effects of ATIs, only volunteers who are relatively healthy -- without comorbidities and with a relatively high CD4 cell count -- are selected for study, their viral loads are carefully monitored and antiretroviral treatment is resumed immediately once a predetermined viral load has been reached. Participants are counseled on safer sex practices and pre-exposure prophylaxis may be considered for their partners.
In addition to detrimental physical effects, taking part in clinical research may also cause social or emotional problems, presenters noted. While participants' informed consent is an absolute prerequisite for any clinical study, volunteers may agree to the research in the mistaken belief that they will derive personal health benefits and/or be cured of HIV by the particular study.
In that context, the language used to describe the research may influence perception of the trial. Consider the associations most people have with words such as "study," "trial" or "experiment," presenter Laurie Sylla, B.S.W., M.H.S.A., asked. Or think about expectations for research into the control of HIV, its remission or its cure. Scientific terms, such as "remission," must also be translated into lay language so that volunteers understand exactly what they are agreeing to.
Operational safeguards to ensure an appropriate risk-benefit ratio for research volunteers include institutional review boards or ethics review committees that approve a proposed study before it is conducted, and data safety and monitoring boards that check that this ratio is maintained during the course of a trial.