An IRB approved a study aiming to assess whether weekly back massages could relieve the pain of patients recovering from spinal surgery. A group that received the back massages would be compared with a group that did not. The initial protocol stated that the primary outcome measure would be self-reported pain levels. As the study was about to begin, however, a researcher read a newly-published article that indicated back massages may also have an effect on patients’ ability to carry out everyday tasks. The researcher therefore added a set of questions to participants concerning how well they can manage such tasks.

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

Questions for Discussion

1. Does the new outcome measure qualify as a deviation from the study protocol? (See section 22)
2. Is the researcher required to send the new outcome measure to her IRB for review? Must the IRB approve the change?
3. If the new outcome was measured without IRB approval, and the RI discovers this after the fact, should this be reported to the Director of Medical Services? (see section 23(3))