Important changes will be introduced to the regulatory environment for human biomedical research in the months ahead.
At a global level, the Council for International Organizations of Medical Sciences (CIOMS) will be finalising its proposed changes to the 2002 version of its International Ethical Guidelines for Biomedical Research Involving Human Subjects. This development comes at a time when the World Health Organization has committed to advancing research and development in epidemics or health emergency situations in the aftermath of the Ebola outbreak in West Africa. In the United States (US), funding for the National Institutes of Health (NIH) has increased by 6.64%, or US$2 billion. In the meantime, public consultation on proposed changes to the Common Rule – the policy of the US federal government for the protection of human subjects in biomedical and behavioural research – has commenced. Proposed changes to both of these regulatory frameworks include greater emphasis on public engagement and justice concerns.
In Singapore, the government has committed S$19 billion to a new 5-year plan for research and development initiatives, including health and biomedical sciences as one of four primary technology domains. A few months before, a new law has been enacted on human biomedical research to formalise many of the ethical requirements promulgated by the Bioethics Advisory Committee since 2002. This legal framework already has a profound impact on research infrastructures, such as tissue banks, in Singapore. The four feature papers in this issue provide a snapshot profile of a number of these developments.
In addition, this issue provides a number of updates on the research environment in the Asia-Pacific region. These include the inaugural international symposium on peptide that was held from 9th to 11th December 2015 in Singapore, the Singapore winners of the 2015 L’Oréal For Women in Science National Fellowships, and recent developments in relation to diagnostic imaging and in vitro diagnostics in Myanmar.
As we begin a new year, it is hoped that this issue of the journal will provide you with an impression of the evolutionary trajectory of the biomedical research environment, particularly in terms of its regulatory features.
With best wishes for 2016,
- Dr. Calvin WL Ho
-Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore
Guest Editor for APBN February 2016