Of the approximate 6 billion people living on the planet Earth an estimated 33 million of them are infected with HIV. Of these people, 2.5 million were infected in the past year alone. Clinical trials involving HIV raise many sticky ethical issues. Much of the research regarding HIV transmission and prevention involves the participation of sexual partners. Balancing the risks and benefits of the individual with those of a couple while keeping a study valid is challenging.
Clinical trials studying HIV transmission rates among intravenous drug users (IDU’s) normally request the participation of their partners. To minimize risk to the study participants, the partner’s informed consent should communicate their participation is due to their partners drug use and potential HIV status. On the other hand, this violates the confidentiality of the drug user.
Trouble arises if the partner was formerly unaware of the drug use and/or the potential contraction of HIV. Partners leaving the relationship based on this information skew transmission rates. If they stay in the relationship, they may modify their risk behaviors, which again, can change the outcome of the study.
Are the researchers obligated to disclose HIV risk when the risk is the component being studied? How do you balance the rights of the individual in an informed consent process when you are working with a couple? How much information should be disclosed? Whose interests do you protect?
Arguments abound and as of yet, there does not seem to be a clear cut answer. The following will explore both sides of the argument.
Keeping it Confidential
Researchers could argue there really is not need to disclose the drug use or the HIV status. Disclosure in and of itself does not increase the risk of HIV transmission. If they are already having relations, the risk is already there. It does not become more likely the partner will contract HIV as soon as the risk becomes known.
Also, disclosure may not provide added protection. The partner may already be aware of their partner’s drug use/HIV status and will continue undertaking the risk of sexual relations with their partner regardless. Disclosure changes nothing.
From the perspective of the IDU study participant, disclosure of their drug use to their partner is a violation of their rights. It also may factor heavily in their decision to participate in the study or not. A study cannot exist without participants.
With these arguments, the question remains:
If disclosure is not mandatory and does not affect risk, why jeopardize the validity of the study?
On the other hand, full disclosure would seem to be the most ethical choice. If you were unknowingly in a relationship that risked your life, wouldn’t you want to know?
Full disclosure of the partners’ drug use and potential HIV-positive status minimizes the risk to the partner and allows them to make informed choices whether healthy or not.
Obviously any study involving HIV will include patient education on the transmission and prevention of the disease. Awareness allows for precautions. Beyond handing out free condoms and encouraging protected sex, these precautions can take other forms.
In many Eastern European countries, half of intravenous drug users are HIV-positive and 90% are positive for Hepatitis-C. Oftentimes in these countries, a partner previously unaware of any drug use will leave the relationship. This act alone the most effective precaution they can take to dramatically minimize their risk for infection.
Disclosure allows for a clear conscience and a future for more studies. How would a community react if they found out researchers willingly and knowingly allowed HIV-negative study participants to have unprotected sex with HIV-positive partners? Creating distrust and damaging community relations with researchers would not bode well for future study participation.
Further complications arise when professional ethic standards differ from local law. In some states in the US and parts of Europe it is illegal to disclose an individual’s HIV status without the patient’s consent. In other parts of the world physicians are mandated to notify partners. Obviously you have to follow local law mandates.
It’s a touchy argument with many sides. Where the balance lies between ethics and science is hard to say. Clearly at the heart of this issue lies a clear, concise, and culturally sensitive informed consent document that retains appropriate confidentiality while minimizing risk to study participants; all within the realm of prevailing local laws.
More detailed information on a study of informed consent practices for HIV populations and in Eastern Europe in particular, please see: Informed recruitment in partner studies of HIV transmission: an ethical issue in couples research by Louise-Anne McNutt, Elisa J. Gordon and Anneli Uusküla in the Journal of Medical Ethics.