There are three major questions to be answered when talking about the ethical aspects of HIV cure research. The first is rather simple: When is the risk/benefit balance acceptable? There are riskier procedures being explored to possibly cure HIV, such as stem cell transplants. These procedures often have double-digit rates of failure associated with them (low double-digits, but still significant), and there is no guarantee that such procedures will actually create a functional cure for the disease; however, if they do work, there is a great benefit-that benefit being that the patient can live essentially antiretroviral therapy-free.
Federal regulations require that risks be “reasonable” when weighed against any expected benefit; this ensures that the risks don’t outstrip any benefit and put potential patients in danger. However, playing it safe isn’t necessarily within the realm of many clinical researchers who are continuously pushing themselves to find a cure, as well as the constant outside pressures for progress from lobbyists and activists who donate money to fund this research. Discretion needs to be used when selecting projects to pursue and what subjects to include in the projects. Besides, there’s something to learn from projects that fail, so researchers shouldn’t be discouraged from being bold about what they try-within reason.
The regulatory roadblocks in place when it comes to HIV research are both a help and a hindrance. The Food and Drug Administration (FDA) has strict limits on the number of participants in cure-related HIV studies. The FDA is focusing on not putting participants in any undue risk due to the experimental nature of some of the studies. High-risk studies face the most scrutiny, so those clinical studies start with a smaller number of participants until the results are consistent and predictable enough to add more people to the mix.
The focus of HIV cure research has been on HIV reservoirs, and the clinical studies reflect that. The goal is that these reservoirs-places where latent HIV hides in the body during antiretroviral drug therapy so the drugs can’t find it-are the last bastions of safety for HIV within the body, and if a certain procedure can break through those reservoirs and eliminate the virus or at least reduce it to a level where the body’s own immune system can keep it in check (in other words, a functional cure), then that is an avenue worth traveling down if the risk is manageable enough. Sometimes, the risk isn’t manageable, and that’s where problems arise.