Tuesday, August 11, 2009

Ethics in Medicine and Biomedicine - The Singapore Story (Part 2)

To be fair, the MOH did start looking at the ethics of medical practice as early as 1994. It was then that the shadowy National Medical Ethics Committee was set up. I say shadowy because it is really difficult to find information about the NMEC, its functioning, who the Chairman is and who her members. Contrast this to the more recently set up Bioethics Advisory Committee which was set up by Cabinet in 2000, "to address the ethical, legal and social issues arising from biomedical sciences research in Singapore".

Anyway, the NMEC was established by MOH in 1994.

The NMEC published "Ethical Guidelines on Research Involving Human Subjects" in 1997, but the real driver for development was the implementation of the Singapore Good Clinical Practice programme in 1997/8, which was driven by the increasing pressures to have internationally acceptable levels of human research subject protection as we engage in clinical research (particularly pharmaceutically related research) and human experimentation.

The clinical research heritage of our ethics committees can be seen in what exists in the hospitals today. After 10 years of development, the restructured hospitals utilize centralized institutional review boards (IRBs) operating at the cluster level. Thus SingHealth has its Centralised IRB model, and NHG calls hers the DSRB (Domain Specific Review Board). A visit to their respective websites will show very clearly that their mission is essentially to review and approve clinical research.

SingHealth CIRB does not publish its mission but their website makes it clear their work is principally to review research protocols : "...clinical research protocols involving any number of SingHealth institutions and hospitals will be reviewed by one Centralised Institutional Review Board (CIRB)."

NHG DSRB on the other hand, states more clearly: "The DSRB's primary objective is to safeguard the rights, safety, and well-being of human research subjects in the National Healthcare Group and her institutions."

So in Singapore at the moment,:

a] there are three bodies, The Singapore Medical Council, The National Medical Ethics Committee of the MOH and the Bioethics Advisory Committee, who issues guidance documents and advisories;
b] medical practice and clinical research is covered legally under the rather outdated and unwieldy Medicines Act 1975 and the Medicines (Clinical Trials) (Amendment) Regulations 1998;
c] Local hospital ethics committees interpret said guidelines issued by above committees, and approve clinical research protocols.

A number of things need to be recognized:

a] The regulation of ethics in the medical profession exist only in the form of guidances and advisories.
b] The regulation of medical ethics is principally towards meeting pharmaceutical research needs, and exists only in the authority invested in local hospital ethics committees.
c] Lastly and most importantly, the function and performance of the local ethics committees is poorly regulated. Although there is guidance provided with respect to the structure and procedures, there is no systematic regulation of the quality of work. It remains unclear how 'trained' and 'professional' ethics committee members are. Ethics committees even at the centralised IRB systems have never been formally audited and only recenty (2007) did the NHG DSRB seek accreditation with the US based Association for Accreditation of Human Research Protection Programs (AAHRPP).

Do we have a robust enough system in place to deal with the impending tsunamis of organ trade, euthanasia, embryonic stem cell research and cloning technologies?

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