Consent in emergency research: new regulations

摘要: The Medicines for Human Use (Clinical Trials) Regulations 2004 Performing emergency medical research in situations where patients are unable to give their own informed consent has long been a thorny issue. For example, common problem is whether or not patient the middle of having an acute myocardial infarction can really weigh up information few minutes and properly trial thrombolytic.1 legal basis incapacitated changed profoundly on 1 May 2004. On this date 2004 came into force, UK implementation Directive 2001/20/EC European Parliament. These laws may seem remote everyday practice but they should be interest all physicians, as even those involved will directly affected by consequences these changes. We only provide effective, evidence based care if available from well structured clinical trials. If new regulations do take account research, trials medicine inhibited prevented over burdensome bureaucracy, we able advance our knowledge high quality care. From outset it emphasised that changes law discussed article apply participation research. latest normal treatment, physicians familiar with implications Mental Capacity Act 2005. ### framework The detailed legislation found Schedules 2 .2 Key issues contained within Part 5 “Conditions principles which relation adult” (see box …