An employee at institution A, a physical therapy centre, wishes to conduct an investigation into the effects of a new massage technique developed by the employee on relieving pain in individuals who suffer from chronic back problems. Institution A does not routinely conduct human subjects research, and as such is not registered as a research institution with Ministry of Health (MOH) and has no IRB. The employee will be collaborating with institution B, a hospital with a patient pool that would be recruited into the study; the employee of Institution A would visit patients at Institution B and administer the massage. Furthermore, a researcher at institution C, a university, is interested in collaborating with the employee to design the study, analyse the results and write it up for publication. Both institutions B and C have IRBs; B is registered with MOH as a research institution. Institutions A and B are based in Singapore; institution C is a foreign university without permanent presence in Singapore.

Developed for use at the February 2016 CENTRES workshop on the Human Biomedical Research Act. © 2016 National University of Singapore.

Questions for Discussion

1. How could governance of the research be managed to ensure compliance with the HBRA?
2. What individuals are responsible for ensuring that the research is properly approved by an IRB, and that the protocol does not deviate from that approved by the IRB? (see esp. section 22)