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Case Study B
Clinical trial comparing two products used following
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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