title: How to protect incompetent clinical research subjects involved in critical care or emergency settings.
abstract: Clinical research is an essential component of medical activity, and this is also true in intensive care. Adequate information and consent are universally considered necessary for the protection of research subjects. However, in emergency situations, the majority of critical patients are unable to consent and a valid legal representative is often unavailable. The situation is even more complex in Italy, where the relevant legislation fails to specify how investigators should manage research in emergency or critical care setting when it involves incompetent patients who do not have an appointed legal representative. While special measures for the protection of incompetent subjects during emergency research are necessary, not allowing such research at all dooms critically ill patients to receive non-evidence-based treatments without the prospect of improvement. The recently-issued EU Regulation n. 536/2014 will probably help shed light on this situation. Indeed, it specifically addresses the issue of "research in emergency situations" and introduces detailed rules aimed at protecting patients while allowing research. In this article, we argue that obtaining informed consent during emergency research on incompetent subjects in unrealistic, and that in most cases substituted judgment on the part of a proxy carries major flaws. Strict criteria in evaluating the risk-benefit ratio of proposed intervention and a careful evaluation of the trial by a local or national Research Ethics Committee are perhaps the most practicable solution.
authors.affiliation: Servizio Qualità, Sicurezza ed Accreditamento, Azienda ULSS n. 6, Vicenza, Italy - nereo.zamperetti@ulssvicenza.it.
authors.forename: Nereo
authors.initials: N
authors.lastname: Zamperetti
authors.forename: Mariassunta
authors.initials: M
authors.lastname: Piccinni
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Citerio
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mistraletti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gristina
authors.forename: Alberto
authors.initials: A
authors.lastname: Giannini
mesh_terms: D003422:Critical Care / Q000331:legislation & jurisprudence; D016638:Critical Illness; D004630:Emergencies; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007558:Italy; D016743:Mental Competency / Q000331:legislation & jurisprudence; D015337:Multicenter Studies as Topic; D035842:Research Subjects / Q000331:legislation & jurisprudence; D018570:Risk Assessment