People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to limited (...) abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient. We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research involved continuous physiological monitoring of dying patients (...) prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care. Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval. Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed. All data relevant to the study are included in the article. (shrink)

Unsere Sicht der Demenz ist von kulturellen Metaphern geprägt. Sie ziehen Analogien zu vertrauten Erfahrungsbereichen und eröffnen so ein Verständnis von einem ansonsten schwer fassbaren und letzten Endes unergründlichen Geschehen. In zeitgenössischen Diskursen über die Demenz spielen insbesondere zwei biographische Metaphern eine maßgebliche Rolle: die der,Rückkehr in die Kindheit‘ und die des,Todes bei lebendigem Leib‘. Der Beitrag unterzieht beide Vorstellungen einer kritischen Reflexion. Er erläutert zunächst die kulturgeschichtliche Herkunft und Bedeutung der Kindheits- und Todesmetapher. Im Anschluss geht er ihren Implikationen (...) für das Verständnis von Demenz und die Einstellungen und Verhaltensweisen gegenüber den Betroffenen nach. Dabei kommt eine Lebensverlaufsperspektive zum Tragen, die die Bedeutung der zeitlichen Erstreckung und Verlaufsstruktur des menschlichen Lebens für die ethische Theoriebildung systematisch zu berücksichtigen sucht. Auf diese Weise lässt sich verdeutlichen, dass beide Metaphern die Altersdemenz letztlich einem anderen Punkt des menschlichen Lebens angleichen und sie damit in je unterschiedlicher Weise als eine Art biographischer Normabweichung auffassen. Die Auseinandersetzung erlaubt Schlussfolgerungen mit Blick auf medizin- und pflegeethische Debatten um Selbstbestimmung, Stellvertreterentscheidungen und Vorausverfügungen im Kontext der Altersdemenz. Auf einer theoretisch-konzeptionellen Ebene verdeutlicht sie darüber hinaus auch die Bedeutung einer biographie- und kultursensiblen Perspektive für die ethische Theoriebildung im Allgemeinen. (shrink)

The ‘best interests’ decision making standard is used in clinical care to make necessary health decisions for non-capacitated individuals for whom neither explicit nor inferred wishes are known. It has been also widely acknowledged as a basis for enrolling some non-capacitated adults into clinical research such as emergency, critical care, and dementia research. However, the best interests standard requires that choices provide the highest net benefit of available options, and clinical research rarely meets this criterion. In the context of modern (...) norms of bioethics, the best interests standard rarely supports surrogate consent for research and should not be accepted as a routine provision. (shrink)