Research Culture and Ethics

Topics: Informed consent, Bone marrow, Leukemia Pages: 5 (1200 words) Published: April 18, 2014
AT1 – Research Culture and Ethics
Case Study H – Gene Therapy
Word Count: 999
Uni ID: 211322231

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3/14/2014

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Ethics are moral principles that govern a researcher’s behaviour on conducting of an activity; values that embrace ethics are; Voluntas aegroti suprema lex (The will of the patient is the highest law), Salus aegroti suprema lex (The safety of the patient is the supreme law), primum non nocere (First, do no harm) and fairness and equality.1 The National Statement on Ethical Conduct (2007) encompasses ethical guidelines the Human Research Ethics Committees (HREC) practices to identify ethical issues that may be prevalent in research proposals.2 The HREC’s responsibility is to make sure participants are fully aware of the risks/benefits involved and that their consent is well informed. Ethical guidelines are not only there to protect the participants, but also ensure the longevity of clinical trials.2 Since the 1970; influence of ethics in medicine has been increasing; via use of “Institutional Review Boards to evaluate experiments on human subjects, establishment of ethics committees, implementation of the role of clinician ethicists, and integration of ethics into many medical school curriculums”.3

Case study H centers on a gene therapy trial, where bone marrow cells of a lymphocyte defective child are reconstituted using a retrovirus carrier. A functional gene carried by the “vector” repairs the faulty lymphocyte gene; and then inserted back into the patient to reconstitute their bone marrow to produce specific types of white blood cells that were formerly defective. According to researchers, gene therapy seemed more promising than the conventional treatment of unrelated donor bone marrow transplant since present lymphocytes identify self-MHC on repaired cells and prevent graft rejection; a high possibility via the transplant method.4

During treatment, the patient was unable to reconstitute bone marrow strongly and a top-up of modified gene was considered. However reports came in from Europe that 3 of their 12 patients in the trial had developed Leukaemia and 2 had died as a consequence. The cause of leukaemia was unknown, but a statement made by “HREC Chair A” suggested that a small fragment of gene had either stimulated proliferation of leukemia cells or stimulated an inhibitor that allowed to cells to reproduce4. Therefore the patient wasn’t topped up and treated with

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the conventional therapy; bone marrow transplant. Subsequently the patient died due to complications.4
Predominant ethical issues which arose from this case study include; response to an adverse effect, risk/benefit balance and consent. Risks were justified on the premise of treatment options available at the time. Risks associated with the vector were reasoned, as patients had a lower chance of survival with the conventional treatment. The ethical issue of adverse effect came in the form of patients developing leukaemia and as a result passing away; this caused the risk/benefits ratio to be increased. Risks also increased due to the limited amount of clinical data available; only 4 successful treatments resulted in Europe. Furthermore, the information regarding adverse effects resulting in leukaemia from other trials wasn’t available to the parent’s during the consent process, as it was only found out later; if informed about this earlier they may have opted for alternatives. Therefore, communicating these unknowns during consent is challenging due to the complexity of the treatment. The ethical issue to be discussed in detail is be of consent, as it’s an imperative issue since the participant is a child and would the obligation of the parents to provide free, informed consent. However; consent might be influenced through seeing their child in a desperate situation; where an element of coercion is always involved.4 The National Statement on Ethical Conduct (2007) states that consent must be...
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