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Clinical research on trial

1 June 2003
The Lancet Neurology, Volume 2, Number 6

British neurologists have hit the headlines recently over alleged unethical conduct in clinical research. A neurophysiologist has been reprimanded by the UK General Medical Council for submitting false results in a phase III trial (see page 327), although he has not been struck off the Medical Register, a decision which has attracted some criticism. And UK neurologist and epilepsy expert Simon Shorvon was sacked from his position as Director of Singapore's National Neuroscience Institute (NNI) after a colleague raised concerns about the way a research study, led by Shorvon, was being done.

The NNI launched a formal inquiry into the conduct of Shorvon and the project manager, his PhD student V Ramachandran. In its report, the inquiry panel concluded that “... this project was badly managed and conducted unethically. The rights and the dignity of the human subjects were disregarded. What has been done to them will be unacceptable in any civilised country.” It may be hard to uncover the real truth in Shorvon's case, which some believe is a politically-driven witch hunt, but the case does highlight the need to do, and be seen to do, research ethically.

The ethical issues relating to research in human beings was addressed more than 50 years ago in the Nuremberg Code. The Code comprises ten “golden rules”, the most important of which stipulates that informed consent must be obtained from any human being participating in a research experiment. The central principle of the Declaration of Helsinki, adopted by the World Medical Assembly in 1964, is that the interests of the individual participant must always take precedence over the interests of science and society. Both these documents clearly set out an ethical code of conduct for any scientist or clinician involved in clinical research in human beings.

Many countries have well established procedures for ethics approval of clinical trials and research studies. In the USA, institutional review boards have been set up at all major research institutions to assess federally funded research proposals. In the UK, a research protocol must be approved by a local ethics committee (or a multicentre ethics committee if the research is to be carried out at more than four separate research centres): a similar situation exists in Singapore. But is this enough to guarantee the safety of participants in clinical research, now and in the future?

Once a research protocol has been approved by an ethics review committee or board, the investigator is obliged to carry out the study as detailed in the protocol. Although yearly reports are required for some ongoing research in some countries (eg, federally-funded research in the USA), elsewhere formal follow-up procedures are lacking. Whose responsibility should it be to ensure that researchers are sticking to the rules? Ethics committees are already chronically underfunded and understaffed, making ethics approval a sometimes lengthy process. It is therefore left to colleagues, or study participants, to voice any concerns they may have about the conduct of researchers or clinicians.

Another major concern is that clinical investigators are not living up to their ethical obligations. Although ethics courses are taught in some medical schools, the importance of research ethics (and other issues of medical ethics) should be emphasised and placed higher on the curriculum. According to research published in the Journal of Medical Ethics (2003; 29: 97–102), by the final year of medical school, students are more likely to engage in academic misconduct (such as forging signatures and falsifying course work). If dishonest students make for dishonest clinicians, which some studies suggest is the case, these results are particularly worrying. With newly qualified doctors under pressure to engage in research in order to broaden their experience and enhance their careers, the importance of ethical conduct needs to be hammered home. Ethics training should be compulsory for any clinician, whatever their academic position, who wishes to carry out a research project. This approach has been pioneered at the University of Rochester (NY, USA), which was the first to require all clinicians who do research on human beings to take, and pass, a course in research ethics.

The ramifications of unethical conduct in clinical research extend further than the reputations of the researchers in question. Patients who participate in clinical studies and trials place their trust in clinical researchers on the assumption that their well being is of the utmost importance. If this is not the case, who could blame them for becoming disillusioned with clinical research and clinicians alike?

Copyright © 2003, The Lancet Neurology