This briefing paper provides an overview of known examples of unethical clinical trials for pharmaceuticals with a focus on developing countries. The study makes the following general observations :
- unethical trials have occurred around the world, in both developed and developing countries. In some cases, the trials had not been approved by an ethical review committee or institutional review board, or approval had been given for an unethical trial design
- the research organisations involved range from relatively unknown local companies to leading multinational some of the unethical trials are of a recent date, some were even being carried out in 2005 or 2006
- the nature of ethical concerns appears to be rather diverse and relates to all paragraphs of the Declaration of Helsinki (DoH) of the World Medical Association (WMA)
- lack of voluntary, informed participation and adequately informed consent are probably the most common problems. Trials with experimental drugs of which the safety for testing in humans had not yet been established may be among the most alarming examples.
The paper also lists a number of examples of unethical medical trials. Examples are given from countries including: Nepal, India, Argentina, Uganda, China and Nigeria. For each example the paper lists the drug which was tested and what it could potentially be used for, sponsors, research organization, period of the trial and location.