The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. (...) We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews the views of social researchers (...) engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we fail to (...) observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large. (shrink)

In euthanasia and/or assisted suicide of persons with dementia, the controversy has mostly focused on decisionally incapable persons with very advanced dementia for whom the procedure must be based on a written advance euthanasia directive. This focus on advance euthanasia directive-based EAS has been accompanied by scant attention to the issue of decision-making capacity assessment of persons with dementia who are being evaluated for concurrent request EAS. We build on a previous analysis of concurrent request EAS cases from the Netherlands, (...) which showed that many such cases involve persons with significant cognitive impairment. We use illustrative cases to describe the difficulty of determining decisional capacity in persons whose stage of dementia falls between severely impaired and mildly impaired. We show that the Dutch practice of capacity assessment in such dementia cases is difficult to reconcile with the widely accepted functional model of capacity—a model explicitly endorsed by the Dutch euthanasia review committees. We discuss why such deviations from the standard functional model might be occurring, as well as their ethical implications for dementia EAS policy and practice. (shrink)

Im Zuge einer Änderung des Arzneimittelgesetzes im November 2016 hat der Deutsche Bundestag beschlossen, dass gruppennützige Arzneimittelforschung mit nicht-einwilligungsfähigen Erwachsenen unter bestimmten Bedingungen erlaubt sein soll. Das entsprechende Gesetz wird voraussichtlich im Jahr 2020 in Kraft treten. Das ethische Problem dieser Forschung besteht darin, dass Personen, die nicht in der Lage sind, ihre Einwilligung in die Forschung zu erteilen, nicht vom medizinischen Fortschritt ausgeschlossen werden sollen. Der Gesetzgeber hat versucht, diesen Konflikt zu lösen, indem er die Zulässigkeit der gruppennützigen Forschung (...) mit nicht-einwilligungsfähigen Erwachsenen an die Voraussetzung geknüpft hat, dass Studienteilnehmer ihre Einwilligung zuvor in einer Probandenverfügung erteilen. Der Beitrag hat das Ziel, die neue Regelung zur gruppennützigen Forschung mit nicht-einwilligungsfähigen Erwachsenen aus ethischer Sicht zu bewerten. Die Frage, ob die Gesetzesänderung weitere Forschung ermöglichen wird, hängt wesentlich davon ab, ob man mit Blick auf Studien, die sowohl eigennützige als auch gruppennützige Maßnahmen umfassen, eine Gesamtbetrachtung oder eine Einzelbetrachtung dieser Studien vorzieht. In unserem Beitrag argumentieren wir für eine Einzelbetrachtung. Es wird weiterhin die Auffassung vertreten, dass die im Gesetzgebungsverfahren vorgeschlagene Probandenverfügung die Selbstbestimmung der Patienten fördern kann, wenn sie mit Blick auf die mit der Teilnahme verbundenen Eingriffe ein Mindestmaß an Bestimmtheit erreicht.Zusammenfassend wird die Auffassung vertreten, dass gruppennützige Forschung mit nicht-einwilligungsfähigen Erwachsenen trotz der genannten Bedenken unter bestimmten Bedingungen ethisch zulässig sein kann. In der Gesamtabwägung erscheint dabei die eindeutige Definition und strenge Beachtung der Bedingungen der EU-Verordnung 536/2014 mit Blick auf einen ethisch gerechtfertigten Einbezug von nicht-einwilligungsfähigen Erwachsenen in gruppennützige Forschung als besonders bedeutsam. (shrink)

BackgroundAssessment of capacity to consent to treatment is an important legal and ethical issue in daily medical practice. In this study we carefully evaluated the capacity to consent to treatment in patients admitted to an acute medical ward using an assessment by members of the medical team, the specific Silberfeld's score, the MMSE and an assessment by a senior psychiatrist.MethodsOver a 3 month period, 195 consecutive patients of an internal medicine ward in a university hospital were included and their capacity (...) to consent was evaluated within 72 hours of admission.ResultsAmong the 195 patients, 38 were incapable of consenting to treatment (unconscious patients or severe cognitive impairment) and 14 were considered as incapable of consenting by the psychiatrist (prevalence of incapacity to consent of 26.7%). Agreement between the psychiatrist's evaluation and the Silberfeld questionnaire was poor (sensitivity 35.7%, specificity 91.6%). Experienced clinicians showed a higher agreement (sensitivity 57.1%, specificity 96.5%). A decision shared by residents, chief residents and nurses was the best predictor for agreement with the psychiatric assessment (sensitivity 78.6%, specificity 94.3%).ConclusionPrevalence of incapacity to consent to treatment in patients admitted to an acute internal medicine ward is high. While the standardized Silberfeld questionnaire and the MMSE are not appropriate for the evaluation of the capacity to consent in this setting, an assessment by the multidisciplinary medical team concurs with the evaluation by a senior psychiatrist. (shrink)