Firstly, since this clinical trial is observing the effectiveness of the medication Morphine in males compared to females, and is not a newly invented ‘unapproved’ medicine, being monitored for chemical and biological effect within the human body. Therefore, The Clinical Trials legislation, Medsafe New Zealand and The Medicines Act 1981 are not needed for an established drug such as Morphine. However, for all clinical trials, approval by a New Zealand Health and Disability Ethics Committee under the umbrella of The National Ethics Advisory Committee, must be obtained before contacting the facilitating local DHB and the recruiting of participants commences. The Ethics committee, will determine whether the study complies with the requirements of The Privacy Act 1993 and the Health Information Privacy Code 1994, which are in place to safeguard a patient’s individual whereabouts or any aspects of their privacy that they do not wish to have disclosed as well as client safety. Furthermore, The Public Records Act 2005 and Health (Retention of Health Information Regulations) 1996, will also play a role, as both during and after the research has been completed, all participants consent forms and stati...
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...w what they are signing up as well as giving them a choice.
Certain participants, will be assessed and excluded from participation, such as individuals who have a sudden spinal injury due to an accident as it would be unethical to approach someone in critical care. Furthermore, anyone who may have a mental illness, or have a cognitively delayed condition will also be excluded, as giving consent and partaking may put more distress upon the patient, and they may not be well enough to understand what is being presented to them as well as their decision to partake in the trail may be misunderstood. Moreover, in all of these cases the situation could alter the statistical results and legal standing of this observational study as each of the above cases would be in breach of the New Zealand Public Health and Disability Act 2000, Health and Disability Commissioner Act 1994.
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