Bob is a 72 year old male who is in good general health. He receives a letter in the mail from a local university research department asking if he would be interested in participating in a research study. That letter is accompanied by another letter outlining the purpose of the research. It is explained by the researcher that men over the age of 70 commonly develop an abdominal aneurism. If the aneurism grows to a certain size, the blood vessel walls become very thin and there is a risk that it will rupture, which has an accompanying high risk of death. The aim of the research is to try to identify those men who do have an early-stage aneurism and by monitoring them over a period of time, to be able to intervene at an earlier stage and, therefore, reduce risk of premature death. Initially all those who agree to participate will be screened to ensure they are otherwise healthy and an abdominal scan will be performed. Those who are found to have evidence of an aneurism will be seen regularly over a three year period to document whether the aneurism progresses and if so, they will be referred for surgery. The participants are required to attend 6 monthly scans at a nominated medical centre over the 3 year course of the study. Potential participants are invited to contact the researcher if they wish to participate and a time is made to meet the researcher for any further discussion, to sign the consent form, and to set up a time for the screening and scan. While the scans will be undertaken at no cost to Bob, no reimbursement is to be offered for travel or parking. Bob was found to be in the group with an early stage aneurism and he duly attended all the required scans over the course of the study. At the end of the study, Bob was referred to a private consultant vascular surgeon for ongoing monitoring of his aneurism. This was at Bob’s own expense. After you have read the NHMRC National Statement on Ethical Conduct in Human Research and the Information Privacy Principles https://www.cpdp.vic.gov.au/menu-privacy/privacy-laws-and-standards/privacy-laws-and-standards-ipp reflect on and answer the following question: What sorts of issues might arise for ethical consideration in the intended research? In answering this, you might want to consider: 1. What undue distress might be caused for participants by the discovery of having an aneurism and what would be ethically required of the researchers in regard to such? 2. What privacy considerations would need to be taken into account? 3. What financial burden costs would need to be considered? 4. Are there other ethical issues not covered in the above suggestions? Write your response as an essay. You will need to include your own opinions, thoughts and knowledge as well as referencing the relevant considerations from the National Statement, Privacy Principles and other pertinent literature. This assignment will help you demonstrate your achievement of the following subject learning outcomes: • Identify and discuss what are the major ethical principles that provide the basis of clinical care and for research on humans • Identify and discuss strategies to ensure the ethical rights of humans are maintained in practice and in research.
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