Women's Health and Human Rights in HIV Prevention Research

The Joint UN Programme on HIV/AIDS presented evidence at Barcelona, 2002, suggesting that the HIV epidemic in much of the developing world is in its early stages and will worsen unless checked by prevention measures. In response, large-scale clinical trials of interventions have been started, or are about to be started, in developing countries. In many trials, including those of methods to prevent mother-to-child HIV transmission or of vaginal microbicides, only women of reproductive age will be enrolled. Unfortunately, many of these women will not have access to basic medical services for women's health problems or to reproductive or human rights. This situation will create massive ethical challenges for researchers in HIV prevention trials. We report four cases from our experience of doing HIV clinical research in Africa and the Caribbean that highlight these challenges.

Physical and sexual violence against women is unfortunately common in developing countries (case 1). Thus, in studies with women of reproductive age, a substantial proportion will be undergoing physical and sexual abuse. Many of these women can exert little control over their lives because of their socioeconomic situation and entrenched gender power imbalances. Abused women often have no legal recourse in countries in which laws to prevent domestic abuse are non-existent or poorly enforced, with no family able or willing to intervene, and with no social institution to turn to for help. When these women volunteers develop a trusting relationship with the professional staff of a research team, they may view this relationship as a lifeline to escape their intolerable life situation and divulge their peril to the research team. The question arises: what is the obligation of a researcher, who has initiated a relationship with a volunteer, when the volunteer discloses that herlife is in danger because of physical or sexual violence?

Case 1

During the course of a study of HIV transmission, an HIV-negative female volunteer reported to a member of the study team that she was being physically and sexually abused by her HIV-positive husband. The husband refused to use condoms, and beat his wife if she refused unprotected sexual intercourse. He also threatened to beat her child from a previous marriage if she refused intercourse. She was afraid to leave her husband because he was paying for food and school for their children. She had no independent income and no family to help her financially. The volunteer did not tell the study team this information during her first few meetings, but only divulged the information after she had developed a trusting relationship with the team.

In some developing countries, prevention and treatment for diseases that affect only women, such as breast cancer and cervical cancer, do not exist or are reserved for an elite few (case 2). In studies of women of reproductive age that include physical and pelvic examinations, breast and cervical cancers will inevitably be found. Researchers cannot refer women for appropriate treatment because none exists. The question arises: do researchers who discover a potentially curable cancer during the course of a physical examinatin done for research purposes have an obligation to find care for the woman?

Case 2

A woman was participating in a study in which a cervical swab was taken to test for sexually transmitted infections. On inspection, the woman's cervix had a visible lesion. The woman was diagnosed with invasive cervical carcinoma. She was referred to three hospitals, but none were able to provide care for cervical cancer. Eventually, it was established that no hospital in the country could provide appropriate care. Plans were made to send the woman to a neighbouring country, but before her paperwork was ready, she developed metastatic disease and died.

Women's reproductive rights in many developing countries are extremely restricted (case 3). Abortion is often strongly discouraged or illegal. Conversely, in other countries, abortion is encouraged or even mandated. Clearly, HIV prevention researchers cannot be expected to untangle the ethical issues surrounding abortion rights. However, if researchers want to enrol women of reproductive age, then neither can they ignore such issues. The question arises: how can researchers best protect the welfare of female volunteers in a developing country with restrictive reproductive laws?

Case 3

During the course of an HIV clinical study in a developing country in which abortion is illegal, a female participant became pregnant. The woman said that she did not want to have the child because she was not married and feared the social consequences. The woman stated that she was going to seek care from a local person who did abortions. A few days later, the woman presented to the local hospital in septic shock. She died. Autopsy results showed a grossly inflamed uterus with fetal remnants and traumatic perforation.

Our system of ethics regulation has truly arrived at an Orwellian state when an ethics committee reprimands a health-care professional for providing care to a dying sex worker, when fear of coercion takes precedence over the imperative to save a human life (case 4). The South African ethicist Solomon Benatar has advocated for a radical shift in the approach to research ethics in developing countries. He advocates for greater partnership between researcher and volunteer, between rich countries and poor countries, and notes the importance of placing research ethics in the context of social justice. The question arises: how can researchers who are working in developing countries help reform ethics guidelines so that research ethics and social justice are not in contradiction?

Case 4

A sex worker who was participating in a research study became pregnant. When she went into labour, she sought the assistance of a traditional birth attendant. Her labour was arrested and the fetus died in utero. Without money or family, and relying on the advice of the attendant, she delayed seeking advanced medical care. Her sex-worker peers found her several days later, on the floor of the attendant's home, near death, in a pool of blood. They collected enough money for her to seek medical care, and the sex worker underwent an emergency caesarean section and treatment for septicaemia. After 1 day of antibiotic treatment the money was used up and the drugs were stopped. Desperate, the peers sought the assistance of the expatriate research investigator who gave the equivalent of US$10 of study funds to pay for more antibiotics. Unfortunately, the sex worker died before antibiotics could be resumed. When this event was reported to the US-based Institutional Review Board, the investigator was seriously reprimanded for having provided money for the care of the sex worker, since this was thought to be coercive.

There are no easy answers to the questions raised by these cases. Nonetheless, researchers in developing countries will inevitably face similar situations. When HIV prevention investigators enrol a poor woman from a developing country into a research protocol, and thereby enter into a relationship with her, they also enter into her world of suffering and social injustice. The ethics challenge is to define and prioritise researchers' responsibilities within this social context. To deny any responsibility or demand total responsibility are untenable extremes.

We think that an ethical middle ground can only be established through meaningful discussion between researchers and the community from which volunteers are enrolled. Research sponsors should be prepared to fund such a dialogue, recognising that its creation will not be easy. Members of the community who can effectively and fairly represent the community's interest will need to be identified. Means of communicating complicated medical research material and social information about the community need to be developed so that researchers and community members can discuss relevant issues. Research sponsors should be prepared to accept community recommendations, which will probably include provision of health care for research volunteers. Reciprocally, communities who choose to participate in research need to understand that research sponsors have finite resources and that the community itself will need to make difficult decisions on how these resources will be divided.

Specifically, women's health and human rights issues should be discussed with female community members and their advice incorporated into the study protocol before launching HIV prevention trials in developing countries. If possible, researchers and community members should try to develop practical solutions before studies are started. For example, women's groups or local counsellors could be identified who will be able to help women undergoing domestic violence or who have an unwanted pregnancy during the course of the research protocol. A clinical site could be designated and funds allocated for treatment of cervical or breast cancers detected during the course of a trial. Generally, we should be striving towards a participatory research model that includes potential study participants and community members as partners in study design and implementation.

In conclusion, there are no easy answers, but avoiding the difficult ethics problems surrounding women's rights and health in HIV prevention trials is not a solution. Rather, by avoiding these challenges now, we risk stalling critical HIV prevention research in the future. It is surely better to discuss these disturbing issues and produce practical, even if imperfect, solutions than to idly accept comfortable avoidance and provide no solutions for the female volunteers in HIV prevention trials.

Footnote numbers omitted.

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