| Considerations regarding risks |
| • HIV cure clinical investigators have an ethical duty to convey understanding of risks to potential study participants. Risks must be minimized and they must be reasonable in relation to the potential benefit that study participants may realize. Ethical guidelines must continue to protect study participants against unacceptable risks. |
| • It is important to differentiate the risks that stem from investigational interventions or agents, study visit procedures, and monitoring-related risks, and understand how deviations from standards of care (e.g. analytical treatment interruption) can add to the actual and perceived risks. |
| • The heterogeneity of HIV cure clinical studies and the scientific uncertainty make the reliability of risk/benefit judgments difficult. Caution should be exercised when evaluating the various HIV cure research strategies. Care must be taken prior to exposing HIV cure study participants to substantial likelihood of serious risks, particularly since PLWHIV have excellent treatment options to maintain health. |
| • It is important to remember that potential participants may believe that more benefits may be realized than is possible, particularly in early phase studies, which may cause them to be willing to accept more risk exposure. There should be sustained education efforts around HIV cure research and the potential risks for PLWHIV interested in participating in research. Verification of understanding should be implemented as part of the informed consent process. |
| • More formative research is needed on actual and perceived risks of participating in HIV cure clinical studies, involving collaboration between biomedical researchers, social scientists and other stakeholders including community representatives. Attention should also be devoted to risk communication and evaluating future risks by HIV cure biomedical investigators, such as development of cancer many years after study participation has ended. |
| • Social harms should be captured as part of HIV cure clinical research participation, and interview protocols should seek to discover if they have occurred. |
| Considerations regarding unacceptable risks |
| • Perceptions of what constitutes too much risk or unacceptable risks should be taken into account when designing and approving studies, as they influence the ethical development and implementation of HIV cure research. |
| • There should be safeguards in place to ensure that unnecessary risks are not built into study protocols, and policy-makers/bioethicists have a role to play in creating such policies. |
| • More empirical research is needed on what represents too much risk in HIV cure research as the field is evolving quickly and there is scientific uncertainty associated with the various modalities under investigation. |
| Considerations regarding benefits |
| • Researchers have the responsibility to report the associated lack of anticipated clinical benefits in early-phase HIV cure studies. |
| • Researchers need to appreciate that study participants may perceive and receive tremendous psychosocial and emotional benefits from being in a study. |
| • Researchers should clearly distinguish between individual and societal benefits in informed consent forms, including potential benefits from the interventions (if any) versus inclusion benefits. |
| • Compensation should not be presented as a benefit to HIV cure research participation. |
| • Examinations and study interventions should not be considered guaranteed benefits of HIV cure study participation. Laboratory tests may lead to greater knowledge and understanding of one own’s health status, but sometimes individual research results are not shared with study participants since they do not have immediate clinical relevance. |
| • HIV cure research participants should know that interventions in Phase I and Phase II clinical trials are experiments that evaluate basic safety and they are meant to generate knowledge for the benefit of society. They should be reminded that only a small minority of early-phase studies lead to effective interventions. |
| • HIV cure researchers should be reminded that HIV cure research participation relies fundamentally on altruism of study participants. |
| • More empirical research is needed to understand perceived and actual benefits of participating in HIV cure clinical studies, involving collaboration between biomedical researchers, social scientists and other stakeholders, including community representatives. |
