Ministry Of Health Sets Up Inquiry Committee

21 Jan 2003

Over the weekend, there were media reports in Today (18th Jan) and ST (19th Jan) regarding alleged ethical lapses in the conduct of a clinical research study being carried out by the National Neuroscience Institute. BT (20th Jan) also carried a similar report.

The study referred to in these articles, aims to identify the major genes influencing disease susceptibility and the response to drug treatment, in 4 important neurological conditions namely epilepsy, Parkinson's disease, stroke and tardive dyskinesia. The project is funded by the Biomedical Research Council, a body under A* Star which awards research grants.

Applications for clinical research studies are assessed by the funding agency, in this case BMRC, for their scientific merit based on stringent review of the proposal by international and local experts. At the same time, where the study involves patients or patient materials, the study must receive approval by the research ethics committee of each hospital in which the study will be carried out, before the study can proceed. A central ethical requirement is that patients must give their informed consent after the important facts of the study had been explained to them, before they can be enrolled into the study.

The Ministry of Health takes a serious view about the need for proper adherence to ethical requirements in the conduct of clinical research.

The Ministry of Health will therefore set up a committee to carry out an inquiry into the alleged ethical lapses in the conduct of the NNI research project. The committee will be chaired by Dr Tan Chor Hiang, Deputy Director of Medical Services, and will include members from the National Medical Ethics Committee, and senior representatives from Singhealth and NHG and from BMRC.

The MOH committee will review the process of ethical approval of the NNI research project and the subsequent conduct of the study. The committee will identify lapses, if any, in the adherence to ethical practices in the conduct of the study and, if appropriate, make recommendations as to how these can be prevented in the future.

It is expected that the committee will take 2-3 weeks to complete its work. In the interim, the research project has been suspended pending the findings of the committee.