Loosen Informed Consent Requirement in Research Context: The Notions of Exception of Informed Consent and Default Options

A s i a n B i o e t h i c s R e v i e w J u n e 2 0 0 9 Vo l u m e 1 , I s s u e 2 158 Loosen Informed Consent Requirement in Research Context: The Notions of Exception of Informed Consent and Default Options The Terrain of Autonomy Autonomy is an important principle in bioethics. In Northern America, which emphasises the value of individualism, autonomy is often used as a principle to defend unethical manipulation and undue invasion, as well as to claim the right to certain treatments. Throughout the history of medical ethics, autonomy has won many battles in different clinical situations. For example, patient autonomy has been recognised in cases of passive euthanasia, including the right to refuse treatment and the right to die, the right to palliative care — or adequate pain control, the right to abortion — including the right to privacy, and minors’ right to consent to medical treatment.1 And in the cases of right to medical marijuana2 and physician assisted suicide, autonomy has been highlighted. In the context of clinical treatment and research, autonomy highlights the essential requirements of informed and voluntary consent of the patient. It seems that autonomy has been continuously extending its territory. People may ask: what is the border of the realm of autonomy? Are there any situations that justify limiting autonomy? Informed consent (IC) is the specified moral rule of autonomy. Examining the extent of application of IC and its limitation, represents those of autonomy and its limitation. This article will discuss these questions: What limitation does IC have? Under what circumstances and to what extent should we amend or even abandon the requirement of IC and recognise the notion of exception of consent? S T U D E N T V O I C E S 158–164 Asian Bioethics Review June 2009 Volume 1, Issue 2 159 What Are the Values and Elements of Informed Consent? Informed consent is the most effective doctrine to fulfil the research subject’s right to self-determination and well-being, and to protect the competent patient from undue manipulation and inhumane treatment in both experimental and clinical medical contexts.3 , 4 In order to obtain valid IC, one should realise the elements of IC and fulfil them. They consist of: (1) competence of the subject; (2) voluntariness, which means that the subject makes a decision without coercion and manipulation; (3) adequate disclosure of information; (4) understanding and (5) consent.5 Regarding consent, there are several dichotomies being discussed in different contexts, for example, self-determining vs. proxy, explicit vs. implicit, generic vs. specific, and prospective vs. retrospective (or deferred) consent. This article will discuss issues related to prospective and retrospective consent. What Are the Limitations of Informed Consent in Research? We identify the limitations of IC by asking: is IC a sufficient and necessary condition of an ethical experiment? Emanuel et al. asserts that “While IC is necessary in most but not all cases, in no case is it sufficient for ethical clinical research.”6 Emanuel noted that ethical clinical research should consist of, at least, these seven essential requirements: (1) social or scientific value; (2) scientific validity; (3) fair subject selection and concern of justice; (4) favourable and proportional risk-benefit ratio; (5) independent review such as institution review board (IRB); (6) respect of research subject through confidentiality and protection of privacy; and (7) IC requirement.7 Here we can see that IC alone does not guarantee an ethical research. As Truog et al. observe: “… the process of IC is not a goal or ideal in itself. Rather, IC is important because it is frequently essential for ensuring that the patient’s right to self-determination is respected.”8 Is IC necessary for an ethical conduct of research? According to a researcher who examined the effect of obtaining IC on study design and result, the study was postponed for six months after getting the subjects’ IC because the subjects felt anxiety after receiving the information. In addition to the need to reconstruct the original study design, the results of the research may be biased.9 Fully IC...