Bloodborne HIV: Don't Get Stuck!

Research on HIV in Africa presents a mixed bag. A lot of researchers protect and respect participants. On the other hand, some researchers have not. Projects listed below violate the Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, articles 4: “It is the duty of the physician to promote and safeguard the health, well-being, and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.”[1]

Following people who didn’t know they were infected or at risk 

• During 1990-2004, researchers in Masaka, Uganda, followed HIV-positive men and women who didn’t know they were infected to see how they got sick and died, without giving any treatment for opportunistic infections or AIDS.
• Many projects followed people who did not know they were infected to watch them infect unsuspecting spouses, for example: circumcising men to watch women get HIV; and watching men and women infected spouses in Uganda and Tanzania.
• During 1997-2000 researchers in Harare, Zimbabwe, followed new mothers who did not know they were infected to watch them infect breastfeeding babies

Giving participants dangerous drugs

During 2015-18 researchers gave women Depo-Provera injections for birth control to see how many would get HIV. Before the trial began, evidence from multiple previous studies warned that Depo-Provera increased women’s risk to get HIV by 40%-50%.

Testing a drug to reduce mother-to-child transmission against a placebo (nothing) instead of the best available treatment 

Not investigating evidence research hurt participants

• Not investigating a baby’s death in a trial of circumcision methods in Botswana.
• Not investigating men getting HIV within weeks after circumcision in a trial in Kenya.

Using young women in high risk communities to study very early HIV infections

During 2012-16, researchers in KwaZulu-Natal, South Africa, followed young women in a high risk community, retesting them several times a week, to observe very new HIV infections. With such frequent tests, the study could have pin-pointed how women got HIV so as to warn others in the community. But it didn’t. The women didn’t have a lot of sexual risks, but they got HIV at the rate of 8.2%/year. Why?

Another study looked for very early infections in men and women with high risk behavior (sex workers, people reporting multiple recent partners in Kenya, Uganda, Tanzania, and Thailand) testing them several times a week. This study, too, did not look for the sources of very new HIV infections identified within 1-3 weeks of the infection event (sexual or skin-piercing).  

Not asking about and/or not reporting risks: this is also unethical!

According to the Declaration of Helsinki, article 28, it’s unethical for researchers to write incomplete or inaccurate reports: “Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.”[1] By that standard, most research on HIV risks in Africa has been unethical. A lot of it is incomplete by design[2,3] — not asking about bloodborne risks and not tracing and testing sex partners. But even when researchers do ask, they often withhold evidence that might point to blood-borne risks. For example:

• Not reporting fetal loss (abortions? what procedures?) in pregnant women later found with new HIV infections.
• Testing wives, but then not saying if men getting HIV in a circumcision trial had HIV-positive wives.
• Not reporting a lot of collected evidence on risks from 44 randomized controlled trials of interventions to prevent HIV. 

[Here’s another account of unethical research, with a table listing foreign sources of funding and foreign organizations that said the research was ethical.][4]

References

1. World Medical Association (WMA). WMA Declaration of Helsinki – ethical principles for medical research involving human subject, amended October 2013. Ferney-Voltaire, France: WMA, 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 29 January 2021).

2. Brody S, Potterat JJ. Establishing valid AIDS monitoring and research in countries with generalized epidemics. Int J STD AIDS 2004; 15: 1-6. Abstract available at: https://www.ncbi.nlm.nih.gov/pubmed/14769163 (accessed 27 October 2018).

3.  Potterat JJ. Why Africa? the puzzle of intense t=HIV transmission in heterosexuals. Chapter 7 in: Potterat JJ. Seeking the positives: a life spent on the cutting edge of public health. CREATESPACE 2015. Available at: http://home.earthlink.net/~jjpotterat/books-downloads.html (accessed 27 October 2018).

4. Annex 2: Unethical HIV research in Africa, in: Gisselquist D. Stopping Bloodborne HIV: Investigating Unexplained Infections. London: Adonis & Abbey, 2021. Available at: https://sites.google.com/site/davidgisselquist/anx2sbh (accessed 29 January 2021).