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Quiz #2 Module 3 and 4

Module 3: Review the definition of competence in the introduction to chapter 2. Do you agree with this definition? What aspects of that definition need to be further clarified, or explained to get a full picture of what it means to be competent to make medical decisions? In "Standards of Competence"Allen E. Buchanan and Dan W. Brock outline 3 standards of competence. What are the three standards of competence outlined by the authors? What principles of biomedical ethics are supported or undermined by each of these standards What problems can you identify with each of these standards? Buchanan and Brock seem to be arguing for a modified process standard, but one that is relative to the decision being made.What do they mean by a modified process standard? They argue that the level of understanding is relative to risk and harm: "The greater the risk relative to other alternatives – where risk is a function of the severity of the expected harm and the probability of its occurrence – the greater the level of communication, understanding and reasoning skills required for the competence to make that decision."p.28 Complexity also affects the standard of competence required. How is it that the authors conclude that a patient could be competent enough to consent to treatment but not competent enough to refuse treatment? Do you agree with their assessment? The authors outline several possible defects in understanding that might undermine competence: "Factual misunderstanding" What are some examples of conditions or situations which might impede factual understanding? "Failure of the patient's choice to be based on his or her underlying and enduring aims and values" What are some examples of conditions or situations that might result in a choice which does not reflect patients long held values? Do these kinds of errors provide good reason to suggest that a patient is not competent to make medical decisions? What would the authors say?

Module 4:

Use these questions to guide the creation of study notes from this reading. What are the two essential components of an ethic governing the use of humans in research identified by the Canadian Institutes of Health Research? What are the 8 ethical principles identified by the Canadian Institutes of Health Research to guide the use of human subjects in research? Explain each in your own words.

1) 2) 3) 4) 5) 6) 7) 8)

Respect for human dignity Respect for free and informed consent Respect for vulnerable persons Respect for privacy and confidentiality Respect for justice and inclusiveness Balancing harms and benefits Minimizing harm Maximizing benefit

What kinds of conflicts might arise between these principles? What is a subject-centered approach research that involves human subjects? In the final sections of their article, the Canadian Institutes of Health Research consider academic freedom. What kinds of responsibilities do they argue go along with that freedom, especially when their research involves the use of human subjects?

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In many areas of research, subjects are participants in the development of a research project, and collaboration between the and the researcher in such circumstances is vital and requires nurturing Nevertheless, some research will require a more formal separation between subject and the researcher because of the nature of the research design. Subject-centered approach should take into consideration that researchers and research subjects may not always see the harms and benefits of a research project in the same way Researchers should also take into account that potential subjects who are asked to participate in research, may be overly influenced by such factors. Hope for other goals. This places extra demands on the researcher for accuracy, candour, objectivity and sensitivity. Researchers should also be aware that some research may be deliberately and legitimately opposed to the interests of the research subjects

They also consider the possible distinction between ethics and the law. Why is mere obedience to the law insufficient when considering the use of human beings in medical research?

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The legal context for research involving human subjects is constantly evolving, and varies from jurisdiction to jurisdiction Researchers institutions should have recourse to expertise to identify legal issues in the ethics review process The law tends to compel obedience to behavioral norms Ethics aims to promote high standards of behaviour through an awareness of values, which may develop with practice and which may have to accommodate choice and liability Though ethical approaches cannot preempt the application of the law, they may well affect its future development or deal with situations beyond the scope of the law...