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This series of commentaries and papers, published by The Lancet, examines the challenges to achieving a balance between trade and health.

It includes analyses of the WHO and World Trade Organisation (WTO), arguing that they facilitate trade before the health of poor people. Other authors explore issues such as global trade governance, intellectual property rights on life-saving drugs, and how trade practices adversely affect diet and exploit workers.

Richard Smith, from the London School of Hygiene and Tropical Medicine, and colleagues outline an agenda for action to strengthen the evidence on trade and health links, build capacity within health on trade issues and assert health goals in trade policy. They make specific recommendations for the WHO and WTO, donors, governments, nongovernment organisations and academics.

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".

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.

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