Nursing case studies - planning a clinical trial and the importance of documentation.

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Legal Assessment 1 Part B






                Karla is a Registered Nurse working in an Aged Care Facility. She was working as an RN in South Sea Island Village previously. When she was working there, she had seen the miraculous cure of chronic wounds by the treatment with some crushed leaves soaked in salt solution. Karla had an idea to run her own clinical trial in the same issue at the faculty where she is working, as there will be more cases with chronic wounds, because they are aged people. This discussion paper reviews the issues and consequences that Karla may face while she is in trail.


         ANMC Code of Professional Conduct for Nurses in Australia (2008) explains, “Practice in accordance with laws relevant to the nurse’s area of practice”. Karla was working in a South Sea Island Village, which impact on the scope of practice of rural and remote area nurses, are inadequate preparation for the role, lack of access to education and training, personal and professional isolation and the lack of anonymity [Context of nursing – Dally, Speedy & Jackson (2006)]. If Karla wants to do her trail in the aged care facility, she has to get permission and she has to equalize herself with the guidelines provided as follows.

Evidenced based practice

Evidenced based practice includes, the discussion of the research process overshadowed, discussions of the relevance of the findings, and how they related to the clinical work [Potter & Perry’s fundamentals of nursing – Crisp &Taylor (2005)]. EBP is the use of the evidence for the improvement of quality and outcomes of health care. Karla should go through the following process of EBP [Medical Surgical Nursing - Lewis S N, Heitkmper M M, Dirksen S R (2000)]

 Providing a clinical trial

        She has to prove herself with the new method in the clinical setting a  success.

 Approval from the higher authority

        It is important to get the permission from higher authority to avoid further problems.

Getting the volunteer subjects for the trial and implement the trial

        If the RN wants to test a new drug not only must the institutions ethics committee approve the research, the act requires that the RN researcher meet the obligations of the Clinical Trial Notification Scheme [Legal Issues for Nursing Students Savage P (2007)].

Understand about the adverse reactions that may be able to happen and be prepared to manage them accordingly

        When she does the trial on a volunteer, she must be aware of the further consequences that may be able to happen from the trial.  She must be capable of reacting positively to the adverse reactions, if occurred. Karla has to practice her trail in a safe and competent manner [code of professional conduct for nurses in Australia (2008)]. Karla should respect the dignity, culture, ethnicity, values and beliefs of people receiving the trial, and of their colleagues. She should support the volunteers with their health, wellbeing and informed decision making. She must be aware that undertaking activities that are not within their scope of practice may compromise the safety of the individual. Therefore, Karla will be responsible for the entire safety of the volunteer. The nurse is responsible to ensure that nurse’s practice conforms to professional standards to enhancing the safety of the individual, any significant other person and colleagues [code of professional conduct for nurses in Australia (2008)]. Nurses should not practice outside their scope of practice [QNC scope of nursing practice (2005)]. Therefore, Karla must be aware of all the consequences, rules and regulation, nursing law Act under which Nurses governed. Karla should be aware of the professional code of practice.

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Autonomy is the freedom to decide and act. Autonomy consistent with the scope of professional nursing practice maximizes the effectiveness of the nurse (Hicks, 2003) [Potter & Perry’s fundamentals of nursing – Crisp &Taylor (2005)]. The client has to get enough time for the decision-making.


 Karla has the responsibility to get an informed consent from the volunteer to avoid the complications.  The process of informed consent provides subjects with complete information regarding the study’s risk, benefits and costs. The research subjects must give full and complete information regarding purpose of the study, procedures, ...

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