New ethics guidelines for human biomedical research

SINGAPORE - The rights of participants who take part in biomedical research will be better protected, under new guidelines launched on Tuesday (June 23) by the Government's Bioethics Advisory Committee.

Among other things, those who volunteer for trials will be assured of compensation if anything goes wrong.

And if a minor under the age of 21 refuses to take part in research, his wishes must also be respected. Previously, only consent from a a parent or guardian was needed.

Patients can also request to be informed of any incidental findings - medical results that were not being looked for, but could highlight health risks, for instance.

For example, a gene mutation predisposing a person to a treatable breast tumour could be uncovered during unrelated research; or a bright area caught during an MRI scan might highlight a brain tumour.

What was in the past a grey moral area has now been clearly spelt out in the new guidelines: researchers now do have an obligation to, at the very least, ask participants if they would like to be informed of clinically significant findings. And if so, the researcher is obligated to inform the participant.

The new ethics guidelines were fine-tuned based on past papers put together by the committee, and took into account opinions of members of the public, experts and religious groups. Altogether, 88 research, governmental and healthcare institutions, and professional and religious organisations were asked for their comments.

"The review took into account new scientific, regulatory, social and legal developments, and incorporated recommendations on recent emerging issues such as the management of incidental findings, to ensure that the guidelines are up-to- date on both local practices and international best standards," the committee said in a statement on Tuesday.

The Bioethics Advisory Committee, which has 31 members from Singapore and abroad, was established by the Government in December 2000 to address the ethical, legal and social issues arising from human biomedical research, and its applications.

Its role is to develop and recommend policies to the Government on these issues, with the aim of protecting the rights and welfare of the public - especially research participants - while allowing the biomedical science research to realise its full potential.

The new guidelines are not yet legally binding, although they could, if accepted, become law.

Until then, they will provide guidance on the ethical, legal and social rights and responsibilities of all stakeholders in human biomedical research, especially research participants.

Committee chairman Richard Magnus said: "We sought to reconcile any apparent discrepancies, and to clarify any uncertainties that have emerged since publication of our original reports.

"This resulting document therefore contains the most current views of the (committee), advocating the standards expected of researchers and research institutions in Singapore, and setting out a framework for the ethics review of human biomedical research."

Emerging issues, such as the relative ease and low cost of genome sequencing, helped shape the review.

The Ethics Guidelines for Human Biomedical Research is available at http://www.bioethics-singapore.org/index/publications/reports.html.

audreyt@sph.com.sg