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The Plight of women who become pregnant during clinical trials in Zimbabwe
Joshua Chigodora, Southern Africa HIV and Aids Information Dissemination Service (SAfAIDS)
April 19, 2006

Dambudzo is a domestic worker in one of Harare's northern suburbs. Like most domestic workers in the country, her monthly wage is approximately US$13. After falling ill on and off since 1994, she decided to go for HIV testing in January 2006. The result came up positive. Upon learning of the result, her husband Karikoga (a gardener at Dambudzo's workplace) also decided to get tested, and he also tested positive. Now that both husband and wife knew their HIV status, the question they asked was "what's next"? With their meagre wages, they cannot afford to buy ARVs even under the government rollout programme.

The pair visited one of the New Start Centres in the city (New Start Centres are voluntary counselling and testing centres supported by Population Services International). After receiving intensive counselling, the two were referred to one of the clinical research trial centres operating in Harare. The wife was enrolled at a different site than the husband.

The couple thought this was the end of their dilemma, but it was only the beginning of worse things to come for Dambudzo. Dambudzo went through all the pre-qualification tests, and signed the informed consent form. On returning two weeks later to start on the research programme, she had to undergo further tests, which included a pregnancy test. To her dismay, Dambudzo discovered she was pregnant, and that, this made her ineligible for the research programme according to the consent form that she signed. The officials simply told her that fact and sent her home.

Karigoga had no such problems, he is already on the programme.

While research may lead to effective treatments, programmes funded by western donors should not exploit local populations. National and international ethical principles and guidelines have been developed and are available in Zimbabwe. However, it is not clear what actually happens with the implementation of these guidelines in real situations. Dambudzo's case highlights the need to take context into account when defining principles for the protection of human subjects.

Officials at the clinical trials centre argue that they cannot be blamed for what is a clear violation of the conditions under which Dambudzo joined the research programme, but here we have a woman, poor, half literate, pregnant, HIV positive with a CD4 count of 27 and nowhere to turn to. The woman is just told come back after giving birth and thanks very much!!!

Yes Dambudzo should not have violated the rules, but did she even understand them? When talking to her one gets the feeling that she thought she was getting into a treatment programme rather than a clinical trial. It is clear from what she told me that she does not understand the goals of the research.

I doubt very much that the researchers under this project considered whether participants knew the meaning of informed consent and the problems that might arise in resource limited settings such as the case in Zimbabwe. Informed consent is essential in conducting clinical trials, however, there are so many obstacles in its application in real situations. For example, language problems and the lack of familiarity with technical terminology and concepts limits participants' understanding of the issues and the possible risks they are likely to be exposed to. Moreover most of them are desperate to have access to life saving treatment. How likely are they to refuse the conditions imposed?

The consent forms used in the research project are long and written in legal jargon. I doubt very much if all the participants read all the text, less still understand any of it. I doubt if even the researchers bothered to go through the document with the participants.

According to South African government guidelines: "If a patient withdraws from a study for any reason, or where a study is completed, they should be advised about the ongoing management of their condition. Except in cases where therapeutic efficacy is demonstrated, ongoing therapy should be according to the local standard of care. Costs of this care should be borne by the local health service, the patient's medical insurance or the patient themselves.

Many patients who participate in HIV/AIDS treatment trials have no alternative access to drug therapy. Where a patient has a therapeutic response to a study drug, that patient should be offered ongoing treatment. In designing studies, consideration should be given to the costs of long term provision of study drugs and of clinical monitoring, including the costs of medical staff. The duration of drug therapy in a study should be clearly stated in the patient information section of the informed consent document."

It is important to address the issue of post trial care during the inception stages of a clinical trial programme, yet the consent form used under this programme actually states the research programme is under no obligation to provide such care.

I make an appeal to the researchers to re-examine their approach based on the fact that the subjects they are dealing with are human beings, not animals. The sacrifices they made, albeit unknowingly, should be valued and treasured as this contributes to the betterment of those infected and affected and to human health in general.

Dambudzo needs assistance, and assistance now!!! I call upon the funders of this research, civil society, associations of people living with HIV and AIDS and the government to intervene and make her life meaningful.

Four questions immediately come to mind:

1. Are we not seeing a case of discrimination on the basis of gender?
2. Doesn't the research centre have a moral and ethical obligation to provide support services in the event of such an eventuality?
3. What are the human right and ethical issues here?
4. Why was she not referred to an MTCT programme?

Dambudzo and Karikoga's case may seem like an isolated incident, however, this could be just a tip of the iceberg. The couple's plight only came to light because they chanced upon someone who cares and who is knowledgeable about people's rights. How about the hundreds of poor people out there who are desperate for treatment, but have no idea what they are entitled to when joining clinical research programmes.

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