IRB: Ethics & Human Research

Arriving at the End of a Newly Forged Path: Lessons from the Safety and Adverse Events Committee of the At Home/Chez Soi Project

The At Home/Chez Soi (AHCS) project was a multisite pragmatic randomized controlled trial evaluating the effectiveness of providing housing and psychosocial support for individuals who were previously homeless and suffered from a moderate or severe psychiatric illness. Over a two-year period, the project provided rent subsidies and housing as well as either assertive community treatment or intensive case management to help meet mental health needs to 1,265 participants across five Canadian cities. The project, the largest of its kind in the world, requires the review of adverse events that occurred in order to help maintain the safety of the participants, staff members, and other stakeholders. This paper describes some of the lessons learned from the AHCS project’s Safety and Adverse Events committee, the group charged with looking for patterns of safety concerns across the project sites and disseminating safety information. After describing some procedural challenges that arose, we describe three categories of substantive issues faced by the AHCS project, namely, those of safety, issues related to stigmatization and discrimination, and challenges associated with facilitating the transition of participants away from AHCS at the end of the study. We conclude by providing recommendations for future safety oversight committees.

Silva DS, Bourque J, Goering P, Hahlweg KA, Stergiopoulos V, Streiner DL, Voronka J. Arriving at the end of a newly forged path: Lessons from the safety and adverse events committee of the At Home/Chez Soi project. IRB: Ethics & Human Research 2014;36(5):1-7.