Obtaining Personal Written Informed Consent during Clinical Trials

When describing the study the physician /SSC should cover the following:

•  That it is a research procedure, and which aspects are experimental - it may or may not be beneficial to the subject - e.g. placebo.
•   The purpose of the trial.
•  Details about the drug under investigation. If there is a placebo arm to the study, this must be carefully     explained.
• The design of the trial, for example ‘double dummy’ or ‘crossover’. Often a
•  The number of people involved.
•  Duration of the trial. If the trial is a long-term one, enthusiasm is required.
•  Number of visits involved and duration of the visits. The area where the patient will be seen and by whom.
• Procedures involved, for example blood tests, ECGs, urine samples and chest x-rays - how many and how often.
•  The responsibilities of the subject if he/she participates.
•  Out of pocket expenses and the receipt procedure. If a taxi account is set up for thestudy, then this will be explained. If payments are entailed, the details must be covered, including the arrangements for pro-rated payments.
•  The risks involved to the subject and any benefit that might be expected. If no clinical benefit is intended, the subject must be told.
• Questions about the patient’s medical history will be asked and disclosure of all medication the patient is taking, which will be kept up to date if changes occur.
• Alternative procedures or treatments.
• If the study has a specific exclusion criterion, for example a left ventricle ejection fraction <350/0, but this is measured only after the patient has given written consent, this exclusion will be carefully explained, Providing written informed consent does not mean definite progression into the study.
• The availability of compensation and treatment if needed.
• That, because it is a study, written consent is needed which is voluntary and there is no penalty for refusal.
• The right to withdraw from study medication at any time without affecting their future medical care. Similarly, if the Investigator thinks that the study medication is not suiting the patient, then the medication would be stopped.