SINGAPORE — Proposed laws to regulate all types of human biomedical research — including on human embryos and human-animal combinations — were passed in Parliament today (Aug 18), with the aim of protecting research subjects and tissue donors.

With such research growing beyond the public sector, the new framework will ensure it is done ethically and responsibly. The framework will also make clear the rights and duties of various parties.

The Human Biomedical Research Bill, on which the Workers’ Party abstained from voting, has two separate but related regulatory frameworks for human biomedical research and human tissue.

The first requires researchers to be supervised and controlled by a research institution. Research proposals must be approved by an institutional review board appointed by the institutions. Researchers must obtain appropriate consent from research participants, who have the right to change their mind.

Participants unable to give their own personal consent can only be enrolled in research where their participation is essential – where research of comparable effectiveness cannot be carried out without the participation of that particular class of persons, said Minister of State for Health Lam Pin Min. This safeguards patients such as those with late-stage Alzheimer’s disease, for instance.

Under the human tissue regulatory framework, human tissue may only be obtained through “altruistic donations” — with commercial trading banned — and must be used according to the donor’s wishes. Donors’ confidentiality will be protected.

The highest penalties under the Bill – for the most serious offences such as forcing someone to be a research subject - are a fine of up to S$100,000 and up to 10 years in jail.

Six Members of Parliament engaged in the debate, raising questions on whether participants who experience adverse effects will be compensated, the independence and potential liabilities of the institutional review board, and ensuring research institutions do not flout regulations.

Some said the new laws would boost public confidence in the conduct of medical research. Many patients greet offers to take part in medical research studies “with a degree of distrust and trepidation”, said Tanjong Pagar MP Chia Shi-lu. “This should not be the case. In many developed nations, patients often compete to be eligible to participate in such research, either because it allows them an opportunity to contribute to the greater good, or because it gains them expedited access to advanced therapies that may otherwise not be open to them.”

A comprehensive regulatory framework gives greater peace of mind to participants, he said.

Dr Lam said researchers will be ethically obliged to compensate subjects who suffer “significant injury” from their participation, even if the researchers are not at fault.

The Health Ministry will take a risk-based approach to regulation, focusing more on institutions and tissue banks “of higher risk” based on the types of research or tissue handled, and their track record over time, said Dr Lam.

The Bill does not impose criminal sanctions on individual institutional review board members – who must include at least one scientific member, one layperson and whose chairperson must be a registered medical practitioner - for decisions made in discharging their functions, he said.

The Opposition Workers’ Party (WP) abstained from voting on the Bill after Dr Lam said it was not necessary to refer it to a Select Committee.

WP MP (Aljunied) Pritam Singh wanted a Select Committee to look into clauses that “confer significant powers” to various entities, among other things. He said the Bill gives “extraordinarily wide powers” to chairmen of institutional review boards to waive the need for appropriate consent, should the research be considered as for the greater public good.

But Dr Lam said the board “as a body” may waive consent requirements only after several criteria are met. The Bill underwent extensive consultations and the authorities will continue to engage stakeholders on its implementation, he said.