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  • Clinical trials still face gaps in ethical review


A survey of more than 200 developing-country health researchers has found that a quarter of clinical trials carried out in developing countries do not undergo any kind of ethical review in the host nation.

These gaps in the review process highlight the need for the capacity to conduct ethical review in developing countries to be "developed or enhanced," say the study's authors, from Johns Hopkins University, United States.

Concerns over the potential exploitation of research participants in developing countries — particularly when studies are funded by companies or research funding agencies based in wealthy nations — has prompted the development of ethical guidelines and codes of conduct for all health researchers.

For example, it is now widely considered to be essential that a case-by-case review of the ethical issues raised by a proposed clinical trial should be conducted both in host and in donor countries before the trial starts. But relatively little research has looked at how well this process is operating for clinical trials conducted in developing countries.

The new study was commissioned by the former US National Bioethics Advisory Commission, and published in last month's Journal of Medical Ethics. It aimed to probe the concerns and opinions of developing-country researchers about the ethical review process.

The study found that many research proposals appear to have escaped the attention of ethics panels in host countries. For example, 25 per cent of studies did not undergo any ethical review — by an institutional review board (IRB), ethics board or the Ministry of Health — in the country where the trial was to be conducted. And of the studies that did undergo an ethical check, the majority were only scrutinised at a local institution level.

Despite this, the authors conclude that the review process does generally happen, and that existing guidelines do offer some protection to research participants.

The researchers surveyed reported that there were notable differences between the issues raised with them by IRBs in developing countries and the United States. For example, US boards were much more likely to raise the need for local language consent forms, and to question whether participants were offered adequate confidentiality protection.

However, 83 per cent of the developing-country researchers surveyed criticised US IRBs for being insensitive to local culture. And more than half thought that such boards were more concerned with 'politics' than with actually protecting the interests of research participants.

Based on their conclusions, the authors of the study stress the importance of tapping into the experience of those conducting research in poorer nations. "It is time that the views of developing-country researchers play a vital role in determining the nature and type of ethical guidelines used in international collaborative research," they say.

Link to abstract of paper in Journal of Medical Ethics

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