Ethical intensive care research: development of an ethics handbook.

Conduct of research involving humans in the intensive care unit (ICU) setting is complex and challenging. The vulnerable nature of critically ill patients raises issues of patient safety, and informed consent is difficult. With an increasing global interest in human research ethics, broadened government mandates have targeted improvements in research participant protection and research governance. A parallel rise in health consumerism and advocacy for privacy and protection of personal health information requires a clear understanding of the research participant role and importance of risk disclosure. In addition, the potential for conflicts of interest in a climate of increasingly competitive research funding, requires caution and transparency in related financial and contractual arrangements. The Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) fosters collaborative ICU research activity. We have developed An Ethics Handbook for Researchers (EH) for the ANZICS CTG for intended use by researchers in Australian and New Zealand ICUs. The purpose of the EH is to act as a practical advisory guide/supplement; to add clarification regarding ethical issues specific to intensive care research, to assist in the expedition of ethics committee research submission and to summarise available useful resources. This article introduces a précis of key issues from the EH including specific ethical difficulties pertaining to ICU research, a summary of the process by which ethics committee decisions in Australia and New Zealand are informed, and the use of ethical checklists to assist researchers.