"Ethical and Regulatory Oversight of Trauma Research: How to Minimize the Trauma of IRB Review"

By definition, research that involves subjects who have experienced traumatic, violent or stressful events poses ethical and regulatory challenges. Institutional Review Boards (IRBs) may raise legitimate concerns with such research, stemming from their mandate to protect the rights and welfare of all human research participants. In particular, IRBs are charged to extend additional protections to vulnerable subjects, but have a variable understanding of that vulnerability and the means by which to protect. As a backdrop to any study-specific issues, investigators, IRBs and their supporting institutions are operating in a general climate of increased scrutiny and liability. Taken together, these factors have conspired to create an environment in which conducting trauma research is at best difficult. At worst, vital research may be halted altogether, to the detriment of survivors and society at large.

This presentation will examine the ethical and regulatory issues that arise in the review of trauma research, including those relating to recruitment, risk-benefit assessment, informed consent and confidentiality. In addition, tips will be given for negotiating these challenging areas with the IRB(s) that must review. An appreciation of these factors is important for both investigators and IRBs, in order to promote a collegial and productive process that allows research to proceed in a safe and ethical manner.