Singapore Guideline for Good Clinical Practice (SGGCP) is the primary regulatory document which needs to be observed when conducting trials in Singapore. Last revised in 1999 by Ministry of Health (MOH), the SGCCP regulate conduct of clinical trials in Singapore along with The Medicine (Clinical Trials) Regulations and the Medicine Act. For all research studies involving human subjects or their tissues and organs, MOH made it mandatory that ethics committees are established to provide scientific reviews of their study protocols. The establishment of this committee involved all hospitals, both government and restructured. Thus “Institutional review boards” (IRB) was born and its guidelines was designed by The Bioethics Advisory Committee (BAC).
IRB play a central role as the gateway for ethnics review of “all Human Biomedical Research carried out under the auspices of its appointing institution” (MOH 2007 p.04). Individual researcher and institutions bear the ultimate ethical responsibility for governing their research. Based on the IRB’s Operational Guidelines (MOH 2007), three fundamental ethical principles; respect for persons, beneficence and justice must be followed in conducting biomedical research involving human. Potentially vulnerable populations must be given special attention.
The following sections will examine one of the vulnerable population–children. It is primarily challenging for the Ethics committees in assessing pediatric related research as the above principles discussed may conflict with some issues. Vague definitions of principle of equipoise, minimal risk and informed procedures are some contributing factors. The role of ethic committees in evaluation of risk and their impact in pediatric research will be given more focus.
PubMed database is primarily used in the search. Combination of keywords are used including of ‘ethics committees’, ‘research’, ‘children’, ‘pediatric’, ‘risk’, ‘ethics’ and ‘assessment’.
Children as a population sampling
In Singapore, 21 years is the age of majority under the common law. For any individual below the age of 21, Clinical Trial regulation states that parent’s or legal representative’s consent must be obtained for participation in trials. This present an ethical dilemma where the children’s autonomy become their parent or legal guardian, assuming that they have the children’s best interest at heart. The risk-benefit ratio of the research is then left to parents and IRBs to determine.
Risk assessment in pediatric research
According to U.S. Department of Health and Human Services (HHS) and Pediatric Clinic of North America (Laventhal et al., 2012), there are four definable risk in human research. In Singapore, the risk are less definitive, 2012 BAC guidelines describe only “research involving minimal risk such as surveys” and “risks involving more than minimal risks such as those involving invasive procedures”