Abstract
BACKGROUND: In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown. METHODS: We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission. RESULTS: Forty-two relatives returned the questionnaire of which 41 were completed by direct family members and in one case by a friend to the patient.The majority of relatives (36/42) were positive/positive with some scepticism towards performing drug trials in unconscious ICU patients and 30/42 would most likely accept trial-participation by their relative. The majority (30/42) agreed that they should decide if their relative was to participate in a drug trial and 24 of these found that the treating clinician/ICU consultant should also consent. The majority (27/42) found that deferred consent would be acceptable if there was a limited time frame for initiation of treatment, however 8 respondents found this unacceptable when the intervention was a new drug.The majority of relatives stipulated that adherence to legislation, treatment benefit for the study patient and for future patients, no patient-risk or -discomfort and development of new drugs were important factors if their relative was to participate in an ICU drug trial. When questioned about doctors' motives for performing drug trials the wish for drug development and better patient care were highly rated among relatives. CONCLUSIONS: In general, relatives to unconscious ICU patients expressed positive attitudes to drug trials in the ICU and the inclusion of their relative in drug trials. Consent by next-of-kin and deferred consent was acceptable to the majority of relatives.