SciDev.Net

This series of commentaries and research articles — published by The Lancet, the Peking University Health Sciences Centre and the China Medical Board — addresses China's major health challenges, strategies and future. It has been produced by a group of 63 scientists from 10 countries with Chinese scientists making up two-thirds of the authors.

The research papers give scientific evidence on key health issues including the emergence and control of both infectious and chronic non-infectious diseases in China as well as the performance of China's healthcare system.

Authors of the series' commentaries further discuss a range of topical issues affecting China's health system, including the state of biomedical science and technology (see 'Progress in Chinese biomedicine a massive challenge'), medical research ethics, the lessons learnt from China's schistosomiasis control programme and the challenges the country faces in controlling HIV/AIDS.

The WHO has provided its own estimates of how non-communicable diseases are set to rise in developing countries. These authors pool data from national registries and international databases to compare data on the differing burden from individual diseases. They outline the risk factors associated with the diseases.

The main three killers are cardiovascular disease, diabetes, and cancer. The paper ranks different types of cancer by how many people in developing countries they kill (lung and breast cancer are the deadliest) and also ranks diabetes prevalence by country (India, followed by China, has the highest prevalence).

To tackle these diseases, say the authors, people need to look closely at the risk factors in their life – eating healthily and exercising can do much to reduce the chances of getting one of these diseases.

This 'sounding board' article in the New England Journal of Medicine is the most substantive of the three articles that stimulated international debate about the ethics of placebo-controlled trials in developing countries (the other two were editorials in the New England Journal of Medicine (see above) and The Lancet).

Lurie and Wolfe take the view that placebo-controlled trials of a less expensive course of antiretrovirals to prevent mother-to-child transmission of HIV were unethical and would lead to hundreds of preventable HIV infections in infants. They identify 18 placebo-controlled trials involving more than 17,000 women, of which two trials were conducted in the United States and the remainder in developing countries. All the participants in the US studies received some form of antiretroviral treatment. In contrast, some or all of the participants in 15 of the trials in developing countries (nine of which were funded by the US) were not provided with such treatment.
 
The authors list areas of agreement between the critics and supporters of such trials, and conclude that the sole point of disagreement is over what is the most appropriate standard of care to provide to the control group. They argue that given the current scientific evidence it would be possible to design shorter, more affordable antiretroviral treatment programmes without the need to conduct placebo-controlled trials.

In this article Brian Vastag looks at the initial mixed response to the October 2000 revision of the Declaration of Helsinki, in particular those provisions relating to the use of placebos and the availability of therapies to participants after research is over.

The views range from enthusiastic support — Delon Human, Secretary General of the World Medical Association suggests that the revision is an ideal that sets an ethical standard "which I don’t think can be set high enough" — through to disapproval — Robert Temple MD, director of the FDA’s Office of Drug Evaluation comments, "I think it’s scientifically and ethically incorrect".

The article goes on to outline ongoing controversies about what standards of care are ethical in research in developing countries. It concludes that while the question of who should meet the costs of satisfying the Declaration's requirements is unclear, the revised Declaration provides developing countries with "the leverage to demand more consideration from medical researchers".

A debate is now underway within the relief community about the proper ethical guidelines to apply when doing research in refugee populations and among internally displaced peoples. Refugees are vulnerable subjects for research for several reasons. For example, they are often part of complex emergencies where human rights abuses are rampant, and because they have limited political rights.

International guidance on research ethics, such as the Declaration of Helsinki and CIOMS guidelines, do not address the special circumstances raised when enrolling refugees in research. Jennifer Leaning explains that the debate pivots on the tension between the need to develop evidence-based emergency health measures and the need to protect vulnerable populations from possible exploitation or harm. The article contains a summary of proposed guidelines to reduce the risk of unethical research being conducted amongst refugee populations.

(Free registration with The Lancet is required to view this article.)

In October 2000 — a time when there was great attention and intense public controversy surrounding clinical (especially multinational) research — the World Medical Association (WMA) adopted the 5th revision of the Declaration of Helsinki. These revisions are the most substantial adaptations to be made for 27 years. A commitment to revise the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected, and that ethical standards evolve.

This article presents an overview of the process of revision and the major changes made to the declaration. While the authors acknowledge that several of the revisions are clear improvements on the previous version, they also highlight a number of concerns and complain that the new revision is "imprecise and ambiguous". A number of potentially controversial additions to the declaration are specifically identified, including provisions relating to conflicts of interest, monitoring and oversight of research, what should happen after research is over, benefits from research, vulnerable populations, research on those unable to consent and the use of placebo controls.

(Free registration with The Lancet is required to view this article.)

This article discusses the challenges of applying ethical principles in epidemiological research (including respect for people, non-maleficence, beneficience, and justice) to population research on domestic violence, an area where poorly designed research could put women in violent relationships at substantial risk. The article draws on experiences from the WHO Multi-country Study on Women’s Health and Domestic Violence Against Women, from the International Research Network on Violence Against Women, and one author's research in Nicaragua. Examples from a number of developing and developed countries are discussed.

Concerns include ensuring the safety of respondents in a context in which many live with their abuser, protecting confidentiality when breaches could provoke an attack, and ensuring the interview process is affirming and does not cause distress. The article concludes that the inherent risks involved in such research can only be justified if, during interviews, information on available services is provided and immediate referrals are made when necessary, if high-quality data are obtained (which requires minimising the under-reporting of violence), and if findings are used to raise awareness of, and improve services for, women who experience domestic violence.

(Free registration with The Lancet is required to view this article.)

Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews.

Every element of a research ethics review — the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations — can be affected by the political and human rights background in which a study is done. For example, research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group.

Chris Beyrer and Nancy Kass advise that researchers should determine whether research could or should be done by consulting human rights organisations and when possible a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.

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