Table 1 Ethical themes, potential concerns, and possible ways to mitigate risks in HIV remission clinical research involving potential risks for participants including analytic treatment interruption

(1) Recruitment and informed consent

Attaining genuine informed consent during or soon after diagnosis

When feasible and not undermining research quality, recruitment and informed consent should not take place immediately following HIV diagnosis

Offer or connect to (but do not require) immediate mental health and/or social services

Provide high-quality counseling during the informed consent process (and ensure that this is included in study protocols to be reviewed by ethics committees)

Staged informed consent [137], re-consent [138], or process consent procedures [139]

Caution in reinforcing the importance of AHI people for HIV remission studies during recruitment and consent

Therapeutic misconception or misestimation

Make clear statements of risks and (lack of) direct medical benefits from study interventions

Include formal assessments of people’s research comprehension and implementation of strategies to improve understanding during informed consent

Influence on participation decisions

Non-clinical personnel should approach patients about participation, not their primary caregivers, especially if the caregiver is the researcher [143]

(2) Transmission risks and partner protection for studies requiring longer duration ATI

HIV superinfection and transmission to partner(s)

Inform participants of infection risks and ask them to inform their partner(s). If possible, provide condoms and/or pre-exposure prophylaxis to participants’ partners [176]

Unintended social, legal, and economic consequences

During informed consent discuss possible risks to partners [173] as well as the potential for harm to the participant's relationships (e.g., stigma, conflict, abuse, the end of relationships)

Couples could be provided with counselling sessions and/or partners could be invited to study informational sessions

Knowingly exposing others to risk of HIV transmission is criminalized in some jurisdictions. Researchers should make participants aware of legal implications as appropriate

To avoid risks associated with seroconversion during ATI, researchers should consider excluding antibody negative participants from research involving analytical treatment interruption (ATI) [160]

(3) Ancillary and continuing care

Ancillary and continuing participant care

Provide care when participants have no viable alternatives, care is relatively inexpensive, participants would otherwise suffer, participants and researchers have an established relationship, and/or when the researchers owe a debt of gratitude [182]

Mental health, substance abuse, acute retroviral syndrome, and other comorbidities

Mental health, substance abuse, and other health issues should be expected among some participants; referrals to appropriate services should be considered when indicated