Please respond to this case after you have completed your application and critique of your three chosen theories.
Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. They are conducted in a series of phases, each designed to address a separate purpose. Without completed clinical trials new medicines and treatments cannot be approved and brought to market.
Patient enrolment is the most time consuming aspect of the clinical trial process and is the leading cause of missed clinical trial deadlines.
In New Zealand hospitals thousands of critically ill or unconscious patients have been enrolled in research without consent in clinical trials to test treatments. Researchers claim that their aim is to get permission from relatives of the patient and then obtain ‘retrospective’ consent once the patient has recovered, however this method raises a number of ethical issues.
An alternative could be that all patients presenting at a public hospital automatically ‘opt in’ to be research participants for any hospital based clinical drug trial that has ethical approval.