SINGAPORE - Should a minor be allowed to volunteer as a research test subject if his parents have given their consent?
Or can the caregivers of a mentally-disabled woman consent to this on her behalf?
These are the questions that the Health Ministry is hoping to tackle with a public feedback exercise on the new Human Biomedical Research Bill.
The Bill, to be raised in Parliament next year, will formalise standards for biomedical research. Examples of such research include tissue grafts, new surgical techniques, and diagnostic imaging.
Under the Bill, all research institutions have to notify the Ministry (MOH) before embarking on a new research project.
Researchers will also have to obtain written, informed consent from participants.
"This has been the practice in many research institutions for many years," an MOH spokesman said. "But there is no comprehensive law that applies to all - only guidelines."
Currently, the ministry spells out ethical standards for research projects in a set of operational guidelines.
The new Bill will take this a step further, listing the penalties for those who violate these standards.
For instance, someone who compels another person to take part in research by force or deception can be fined up to $100,000, jailed up to 10 years, or both.
Under the new Bill, there will also be stricter regulation of certain research areas, such as those dealing with animal chimeras - where human cells are inserted into animals.
MOH is hoping to get input on whether the proposed safeguards for research participants are adequate.
Its public consultation exercise started on Thursday, and will end Dec 18.
Those who wish to give their feedback can read the draft bill at www.moh.gov.sg/hbr and fill in the online form.
