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
- Does the new outcome measure qualify as a deviation from the study protocol? (See section 22)
- Is the researcher required to send the new outcome measure to her IRB for review? Must the IRB approve the change?
- 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))