Is emergency research without initial consent justified? The consent substitute model.

摘要

We read with interest the article by Largent et al justifying the consent substitute model for emergency research. Emergency research and especially advancing resuscitation science raise some important ethical and regulatory issues because of the patient's incapacity to consent. We strongly agree that emergency research considered as a "public good" is feasible most of the time, thanks to the waiver of consent. However, we think that the pivotal role of the community and citizens is underestimated by the authors. Indeed, the waiver of consent requires a balanced relationship and full confidence between health care providers and society (patients, families, and citizens); one way to reinforce them is by public disclosure and community consultation prior to study initiation required by US regulations.