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Case Study D

Clinical trial regarding use of adrenaline

The study

Dr D wants to study the use of adrenaline in the treatment of cardiac arrest. Adrenaline has been used as a routine treatment for cardiac arrest for over 50 years, but its safety and efficacy have not been tested fully. Several previous studies suggest that while adrenaline may help to restart the heart initially, it may also lower overall survival rates and increase brain damage. While these studies have led to significant concerns about whether adrenaline could be harming consumers, the body of evidence is not yet strong enough to change current practice.

Dr D proposes a large clinical trial to gather further information. The trial would be randomised, double-blind and placebo-controlled. This means that some of the participants would receive adrenaline and some would receive a placebo (in this case, salt water). During the trial, neither the participants nor the paramedics would know who was being given adrenaline and who was being given salt water.

No consumer undergoing treatment for cardiac arrest would be able to provide informed consent to participate in the study, so Dr D proposes to enrol consumers in the trial without obtaining consent. She considers that the research is important to ensure the best outcomes for consumers who have cardiac arrests in the future, and that it cannot be conducted on consumers who are able to provide consent. 

To deal with this issue, Dr D suggests an "opt-out" process for consent. Consumers not wishing to be enrolled in the study would be able to opt out by requesting a bracelet with "NO STUDY" engraved on it. Awareness of the study would be raised through a public information campaign.  

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