a. What are the potential harms and benefits associated with this study? To what extent are the harms and benefits balanced? How might the harms be minimized? How might the benefits be maximized?

Potential harms: This research has the potential to cause psychological harm to the research subjects. In order to answer questions about the escape experience, each subject will have to recall the fire in some detail. This may cause distress while the questionnaire is being completed, and possibly for some time afterwards. The potential for harm may be minimized through provision of further post-trauma counselling to research subjects. Counsellors should be independent of the research team.

Potential benefits: Society may benefit from this research by obtaining information that will help in the evacuation of large buildings in emergencies. Some of the research subjects may benefit psychologically from using their experiences to help others.

Harms-benefit balance: Putting measures in place to minimize the potential for psychological harm (i.e., post-trauma counselling) helps to balance the potential harms and benefits of this research.

b. How might the proportionate approach to ethics assessment
apply to this study?

Subjects may differ in their perception of risks and benefits of this research. For example, some research subjects may talk in detail about their escape experiences with family, friends or a counsellor. For these research subjects, the research project may entail no greater probability and magnitude of possible harms than those encountered in their everyday life related to the research. Other research subjects may be unable or refuse to talk about their escape experiences in any detail. For these research subjects, the research may entail a greater probability and magnitude of possible harms than those encountered in their everyday life related to the research. Given the potential risks of harm to at least some of the research subjects, the REB likely would take greater care in the review of this research. Expedited REB review is not appropriate.

In addition to the annual status report, the researchers might propose to the REB a mechanism for monitoring the reactions of research subjects to the questionnaire. For example, part of the post-trauma counselling might consist of a debriefing about the questionnaire. The reactions of the research subjects might be reported anonymously to the researchers, who would then present a summary of the monitoring results to the REB on a regular basis. Research subjects should be told, as part of the free and informed consent process, that the results of the debriefing would be reported to the researchers for the monitoring purposes, but that individual subjects would not be identified, and that the information collected in the questionnaire and the debriefing would not be linked.