You have just read the results of the successful, but small-scale, LIMIT-2 trial of Magnesium in acute myocardial infarction (available in Indicative readings section) and now wish to set up your own large-scale trial of the drug.

Scenario

Imagine you are the Chief Investigator and you are planning to set up a large-scale trial of this simple, low-cost treatment (intravenous magnesium) for acute myocardial infarction, in a large number of sites in Europe, USA and South America.   You will be preparing all the documentation and consent materials with your research team (and not contracting this out to a contract research organisation).  Before you submit any documentation for approval by ethics committees, you will need to gather different types of information from various sources to demonstrate it is  ethical to undertake the trial. In parallel, the Chief Investigator must design a process to obtain informed consent in the specific type of patient to be recruited in the variety of health care settings where the trial will be conducted.

Your tasks

a)    Describe your information required to prepare the ethics committee submission. Draw up a list of the key types of information you will need to include in your submission  for ethical approval in order to establish it is ethical to undertake the trial.

b)    Design the process of informed consent.  Consider the practical aspects of obtaining informed consent in this trial.  Your task is to describe in outline  how you would develop, test and validate the process of obtaining and documenting consent from patients in this large-scale international study.

c)    Describe your choice of design and defend your chosen approach.

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