A RESEARCHER sifting through genetic data could well stumble on information not related to his effort, but which could have a big impact on a study participant's health - say for instance a faulty gene warning of a high cancer risk.
Previously, the scientist was not compelled to tell the person involved. Now, the participant gets to decide from the outset if he wants to be informed of such "incidental findings", according to new guidelines released by Singapore's bioethics watchdog yesterday.
The Bioethics Advisory Committee (BAC), in releasing the 51 guidelines and refinements, had gone through its 15-year body of work that included laws and recommendations on everything from cloning to confidentiality, and fine-tuned them to keep pace with technological changes and research developments.
"Science is developing so fast, and we need to match that development with proper ethical guidelines," said BAC chief Richard Magnus.
The guidelines took into accountdevelopments such as human genome sequencing advancements, which have made it much cheaper and easier for scientists to get their hands on large amounts of a person's biological data.
Rapid technological advances, the committee noted, meant that it was no longer possible to promise absolute anonymity, and researchers must inform participants of this difficulty.
Noted committee member Professor Kon Oi Lian, head of the division of medical sciences at the National Cancer Centre Singapore: "We live in an age of big data, not just big biological data but also big banking, retail data, and it's becoming increasingly obvious that these types of big data converge and impinge upon the whole notions of confidentiality and privacy, and we have had to take that into account."
BAC, an independent body established by the Government in 2000 to address ethical, legal and social issues arising from biomedical sciences research in Singapore, will be submitting the guidelines to the Government, which may decide to make them into law.
Mr Magnus, a former chief district judge, added: "Those that are not hard-coded in the law at the moment become soft law - they represent institutional best practices for human biomedical research."
Among those consulted during the three-year effort were research, government and healthcare institutions, professional and religious organisations, as well as members of the public.
One of the groups, the Islamic Religious Council of Singapore (Muis), told The Straits Times that the consultative approach was commendable.
"Many of the ethical guidelines explained... take into account the views and concerns of various scientific and religious bodies," said a spokesman.
And key research bodies here such as the Agency for Science, Technology and Research (A*Star), and the National University of Singapore Institutional Review Board applauded the effort, which they said was timely.
Some notable guidelines
1 Seeking consent again for the use of biological materials or personal information from individuals who turn 21.
- Researchers now have to get his consent again when a minor reaches 21 if the research is ongoing.
- Previously, there were no guidelines for the use of stored biological material and long-term follow-ups of minors.
2 Management of clinically significant incidental findings.
- Researchers now have to ask participants if they would like to be informed of any clinically significant incidental findings, which would have clear implications for their health. If they say yes, researchers must oblige.
- In its 2005 Genetic Report, the Bioethics Advisory Committee said that researchers did not need to disclose such findings if they did not wish to do so.
3 Difficulty in ensuring complete anonymity.
- Researchers must now inform participants of the difficulty in ensuring complete anonymity, although they are expected to take proper security safeguards.
AUDREY TAN
