NATIONAL NEUROSCIENCE INSTITUTE (Breach of ethical standards by bio-medical researchers)

Mdm Halimah Yacob asked the Minister for Health (a) how such a serious breach of ethical standards in the conduct of medical research on human subjects at the National Neuroscience Institute could have taken place and remained undetected for so long; (b) what safeguards will be instituted to prevent such breaches and better protect patients from unauthorised medical tests undertaken by bio-medical researchers as well as ensure that medical records are not released for purposes other than the treatment of patients without their consent and whether these safeguards can be made public; (c) what steps will be taken to educate patients of their rights so that they too can better protect themselves when confronted with such situations; and (d) what control mechanism is in place to prevent the use of questionable research methods on human subjects for bio-medical research.

The Minister for Health (Mr Lim Hng Kiang): The conduct of research on human subjects in Singapore has to be carried out in accordance with rules which are internationally accepted and which are based on the Helsinki Declaration. Under these rules, the welfare of the human subjects is paramount. The research procedure must also be approved by independent Ethics Committees of Hospitals from where the research is to be conducted.

In the NNI project, investigations show that Prof Shorvon and his assistant, Dr Ramachandran (who was the Project Manager), deliberately subverted the rules. They did not tell the Hospital Ethics Committees the exact tests that were going to be conducted on the human subjects. They misled the Ethics Committees into thinking that they were only going to extract blood. In fact, they carried out other tests which had not been approved. These tests were not conducted with proper safeguards and exposed the human subjects to unacceptable risks. The two doctors also did not tell the human subjects the whole truth about the tests. There was a clear and deliberate breach of the Helsinki Declaration and our own national guidelines.

The unapproved testing started in May 2002. Most of the human subjects were, however, tested in the period November to December 2002. By January 2003, the unethical actions came to light and the project was suspended. There was thus a period of about 5 to 6 months where the unapproved testing was carried out.

Such conduct is serious and unacceptable. We will not tolerate this. Research is important. But it has to be carried out ethically. That has to be the foundation on which we build our biomedical research capability.

There is nothing seriously deficient about the systems and procedures that we had put in place. The problem was that we had two doctors in the project who very deliberately circumvented the rules. It is not easy to legislate against such conduct. Everyday research is being carried out ethically. Most people are honest. Drs Shorvon and Ramachandran are the exception. Their conduct was exposed when the human subjects and their doctors complained.

We have to look carefully at what we can do. To prevent any errant researcher from attempting to beat the system by seeking out loopholes, we will look at how we can further strengthen the existing systems. The Ministry appointed a Committee of Inquiry to look into the system and procedures relating to the ethics approval and conduct of the study in question. The Committee made several recommendations to strengthen the ethics approval process in hospitals for clinical research, ensure the medical confidentiality of patient information in hospitals, and improve the standards for the conduct of clinical research.

My Ministry will study the NNI Panel's report as well as its Committee of Inquiry's Report, and will do what is necessary to strengthen the components of the existing research oversight system. The hospital ethics committees and research monitoring process would be strengthened, so that any deviations from the approved stated protocols are detected and remedied early.

But we do not want to put in so many rules to counter dishonesty that we end up seriously affecting honest researchers. Experience shows that such rules will not always deter dishonesty anyway. What is really needed, in addition to strengthening the existing systems, is strong leadership in the various institutions that deal with research, and a strong culture of ethics. There has to be strong leadership with a deft touch, so that the freedom to do proper research is not curbed by bureaucracy while, at the same time, errant researchers are pulled up quickly. We will look into this seriously.

The Ministry will also look into the education of patients and the general public about their role in medical research.

Dr Lily Neo (Jalan Besar): Could the Minister comment whether the patients under the unethical medical research suffered any side effects or long-term effects as a result of unacceptable withdrawal of their long-term medication?

Mr Lim Hng Kiang: As I said, the tests that were conducted on the patients were done without the knowledge of their supervising doctors. So, that is a clear breach of ethics. The impact of the tests on them varies and the patients are now being watched over by their doctors.

Mr S. Iswaran (West Coast): I understand from the media that two charges have been brought against the PhD student for causing grievous hurt and cheating. I just want to seek confirmation whether that is indeed the case, and whether similar charges are being brought against the lead investigator, Dr Shorvon.

Mr Lim Hng Kiang: It is indeed correct that the two charges have been brought against Dr Ramachandran. He has left the country and we have put up a warrant of arrest and are seeking his extradition back to Singapore.

As for Prof. Shorvon, he has accepted the findings of the Report and we are taking the findings up with the professional Medical Council to take professional action against him.