Intended for healthcare professionals


Developing countries need stronger ethical guidelines on research

BMJ 2007; 334 doi: (Published 24 May 2007) Cite this as: BMJ 2007;334:1076
  1. Rory Watson
  1. Brussels

    The European Commission has begun to work more closely with developing countries to establish high ethical standards for research worldwide. It is examining ways to involve such countries more in drawing up, disseminating, and implementing ethical guidelines that are adapted to their specific circumstances.

    Impetus for the initiative came at a two day conference in Brussels last week on ethics, research, and globalisation that brought together 150 delegates from international organisations, governments, research bodies, and academia.

    Janez Potoènik, the European Union's commissioner for science and research, told participants: “Globalisation of research requires better implementation of international ethical guidelines. This is particularly true in areas like health research. But new areas, such as nanomedicine and bio-piracy, also call for new or adapted standards.”

    The conference learnt that of the 100 000 clinical trials carried out around the world each year, some 10% occur in developing countries, where patients are readily available, regulatory requirements are less strict, and costs are lower. By 2010 European and US drug companies are expected to spend $1.5bn (£0.8bn; €1.1bn) on trials in India alone.

    However, many developing countries, especially in Africa, do not have the logistical support, financial resources, or trained personnel to establish effective ethical committees or to supervise the research being carried out among their citizens.

    The European Commission now intends to use part of its long term research budget to help countries looking to develop their capacity to implement high ethical standards.

    Initially, the practical focus is expected to be on training key personnel, raising awareness, and creating an administratively efficient infrastructure. Once in place, national ethical committees should be able to assess clinical trials and ensure that the results of research are made publicly available.

    Dr Potoènik said that as the number of clinical trials in developing countries grows it is increasingly important to ensure that participants enjoy the best possible protection. “This requires analysis in many areas, including access to health care, cultural and local traditions, and the role of multinational companies, particularly in the pharmaceutical sector,” he said.

    The commission is hoping that its own ethics reviews may serve as an example that can be adapted to local conditions. These reviews ensure that EU funded research undertaken anywhere in the world complies with fundamental ethical principles. Those trials that do not—and 10% of research proposals for EU funding raise serious ethical and social issues—are rejected.

    This was the fate of a proposal to study forms of contraception in Gambia and Ethiopia. It was rejected by the EU committee examining it because ethics committees from the two countries' research institutes highlighted the intrusive nature of the study and the ancillary problems of informed consent and data protection.

    The EU already has several networks across different parts of the world to promote good governance and high ethical standards in medical research.

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