While there are clear ethical guidelines and regulations to
protect people who volunteer to directly participate in research studies, no
such framework exists to protect non-participants. Dr Liza Dawson, an ethicist
at the US National Institute of Allergy and Infectious Diseases, says that bioethics
tends to uniquely focus on the individual. She would prefer a ‘relational’
approach which considers the social relationships and networks that matter to a
As many participants express strong concern about not transmitting
HIV to their sexual partners, it is reasonable for researchers to help
participants to prevent this occurring, she says. Researchers doing so could be
framed as part of their primary obligation to the participants themselves. She
points out that in routine care (rather than in research studies), a clinician’s
primary commitment may be to the patient, but they often try to limit risks to
others. For example, clinicians give advice to people with sexually transmitted
infections about avoiding onward transmission and encourage them to engage with
Should researchers go further and make contact with a study
participant’s sexual partner or partners? They could then be fully informed
about the nature of the study and/or offered preventative services.
However, this could be complex. Many people do not have
steady partners and over the course of a study, their relationships may change.
The partners won’t necessarily want to be identified or to engage with the
There are particular concerns about confidentiality. Study
participants may not want their HIV status or involvement in the study revealed
to their sexual partners. They may not wish to discuss their sexual behaviour
with the researchers and clinicians. A recent set of guidelines on
running ATIs specifically excluded making any contact with sexual partners,
in order to respect confidentiality.
But ethicist Dr Nir Eyal of Rutgers University says that
individuals whose partners are not aware of their HIV status or study
participation should be excluded from studies in any case - because there is a
greater potential for harm to partners. (There’s more on exclusion criteria
later in this article). As a result, this confidentiality concern is unlikely
to arise in practice. Eyal says that stable partners should be contacted, but
the practical difficulties and confidentiality concerns of reaching out to
casual partners are likely to be too great.
He also suggests the novel approach of asking stable
partners for their consent to their partner taking part in the study. Offering
this veto would make the risk of HIV transmission “ethically more justifiable”
he says, as the person exposed to the risk had consented to it.
The partner could consider the balance of risks and benefits
for themselves. For both the person actually taking part and for their sexual
partner, the direct benefits are minimal or non-existent (so far, no HIV
remission studies have been clinically beneficial). For both, the main benefit is
altruistic - the knowledge that they are contributing to scientific research.
However the participant and the partner are exposed to different risks.
Researchers could be obliged to offer counselling and
information on the treatment interruption, condom use and PrEP to stable
partners. A further step would be for the researchers to actually provide PrEP
to those partners who would like to use it.
However, Professor Jean-Daniel Lelièvre of the Université
Paris Est Créteil argues that PrEP won’t be a solution to all problems. It is
not certain that PrEP will eliminate risk to sexual partners, given that there
are no data on its effectiveness in the context of the very high and sustained
viral rebounds that could occur in an ATI. Moreover, in communities where PrEP
is not generally available, is it ethical to selectively provide PrEP when others
at high risk of HIV are denied it?
One reason those running clinical trials might not want to
get further involved with participants’ sexual partners is that it would create
a direct relationship with them. Pharmaceutical companies and other trial
sponsors may be worried that this would imply that they would be legally (or
morally) responsible should a partner come to any harm.
Eyal argues that this stems from a misunderstanding of the
legal framework in which studies are conducted. There is no legal requirement
for study participants - never mind their sexual partners - to be compensated
if they come to harm. Moreover, he believes that taking care of sexual partners
is essential to preserving public trust in medical research generally and in HIV-cure
research specifically. Regardless of the formal position that sexual partners
are not study participants, “there is no guarantee that in the court of public
opinion, injury to a sexual partner would be judged any more leniently than
injury to a participant”.