Dr M. Nabeel Ghayur, of McMaster University Ontario, writes: I would like to add some points to Nature’s News Feature “Human-subjects research: trial and error”(Nature 448, 530-532; 2007), on the important topic of clinical-trial review by regional versus central review boards. I feel that the main question is not about who conducts the review, but about it being performed thoroughly and diligently.

It is more than 40 years since the unanimous approval of the Declaration of Helsinki, yet we are still faced with many challenges in this area of research on human subjects. Episodes such as the fatal testing of gene therapy on Jesse Gelsinger in 1999 and the TeGenero fiasco in 2006 of severe side effects of a phase-I monoclonal antibody in six men, demonstrate that the need for stringent measures when it comes to clinical trials involving humans cannot be over-emphasized.

The need for stringent oversight is even more vital at a time of widespread outsourcing of trials from the West to developing countries, particularly in Africa and Asia. Many of these countries remain without concrete laws and legislation, sometimes without even functioning ethics committees in individual health-care institutions. It is imperative that trials are monitored to the best standards available worldwide.

We hear of cases such as that of Ru Huang of Johns Hopkins, accused of being engaged in unethical trials involving testing of drugs in India without formal consent (see Nature 412, 466; 2001). More recently, the pharmaceutical giant Pfizer was sued by Government of Nigeria for $9 billion for allegedly carrying out trials in children without parental or official approval. These examples surely reflect the importance of strict ethics review of clinical trial proposals irrespective of the authority responsible for performing it.

However, as outlined in your News Feature, it does not make sense to have unnecessarily time-consuming bureaucracy, as delays can be equivalent to introduction of beneficial therapies. Informed consent forms should be kept as simple, short and meaningful as possible. Increasing the length of a form so as not to miss any information can make it harder for the patient to grasp, particularly a potential participant from a country where people are less well-educated and who will struggle to read and understand scientific and ethical jargon. There is a dire need to make the process of ethics review extensive, yet concise and effective, both for investigators and patients.