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Case Study B

Clinical trial comparing two products used following neurosurgery

The study

Dr B wants to compare the safety and effectiveness of two products used to achieve a watertight closure of patients' brain membranes following neurosurgery. Both products have already been clinically approved and are commonly used by surgeons. The current evidence does not indicate that either product is safer or more effective than the other, but no research has been conducted that directly compares the two products.

Dr B proposes to conduct a study on consumers undergoing neurosurgery, who would be randomly allocated to receive one of the two products. Dr B would then collect data about the safety and effectiveness of each product.

The consumers are mostly having surgery in relation to brain tumours and are likely to have reduced capacity to make decisions. Some of the potential participants may have brain injuries, cognitive impairments, intellectual disabilities, mental illnesses or be in intensive care. While some of the proposed participants may be able to provide informed consent, others will not have the capacity to do so. Dr B believes that both groups need to be included in the research in order to gather useful data that can be generalised to other consumers in the future.

Dr B intends to include consumers who are unable to give consent, and then seek "delayed consent" from any consumers who regain the capacity to consent after the trial. If any of those consumers refuse consent after regaining capacity, their data will be removed from the study.

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