Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.

OBJECTIVE: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. METHODS: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited. RESULTS: 108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations. CONCLUSION: In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.

Six Propositions against Ageism in the COVID-19 Pandemic.

The risk of developing severe illness from COVID-19 and of dying from it increases with age. This statistical association has led to numerous highly problematic policy suggestions and comments revealing underlying ageist attitudes and promoting age discrimination. Such attitudes are based on negative stereotypes on the health and functioning of older adults. As a result, the lives of older people are disvalued, including in possible triage situations and in the potential limitation of some measures against the spread of the pandemic to older adults. These outcomes are unjustified and unethical. We develop six propositions against the ageism underlying these suggestions to spur a more adequate response to the current pandemic in which the needs and dignity of older people are respected.

Illegitimate authorship and flawed procedures: Fundamental, formal criticisms of the Declaration of Helsinki.

Some of the recent criticisms published during and after the last revision process of the Declaration of Helsinki are directed at its basic legitimacy. In this article we want to have a closer look at the two criticisms we consider to be the most fundamental. The first criticism questions the legitimate authorship of the World Medical Association to publish a document such as the Declaration. The second fundamental criticism we want to examine argues that the last revision process failed to meet the standards for fair, democratic procedures. Although both criticisms deny the formal legitimacy of the Declaration in the most fundamental way, they have never been addressed in detail in a single article. We refute most of the related arguments. However, acknowledging some of the points made, improvements for future revision processes and versions of the Declaration of Helsinki are outlined.

Toward a global geroethics - gerontology and the theory of the good human life.

Gerontologists have proposed different concepts for ageing well such as 'successful ageing', 'active ageing', and 'healthy ageing'. These conceptions are primarily focused on maintaining health and preventing disease. But they also raise the questions: what is a good life in old age and how can it be achieved? While medical in origin, these concepts and strategies for ageing well also contain ethical advice for individuals and societies on how to act regarding ageing and old age. This connection between gerontology and ethics is overlooked by both schools of thought. We thus develop this research programme for a systematic geroethics in four steps. First, we analyze 'successful ageing' as put forward by Rowe and Kahn as a paradigmatic example of a gerontological conception of ageing well. Then, in a second step, we move from criticisms within gerontology to an ethical perspective; in particular, we want to clarify the problem of the claim of universal validity of conceptions of the good life. In a third constructive step, we explain how the 'capabilities approach' could be applied in this context as a normative foundation for the implicit normative assumptions of gerontological conceptions of ageing well, such as a particular choice of functionings, the ethical relevance of human agency, and the resulting claims of individuals towards society. Finally, using a concept developed by the German philosopher Ursula Wolf, we systematically develop the different aspects of the connection between ageing well and the theory of the good life in their full complexity and show their interconnectedness.

Research ethics for a globalised world: the revised CIOMS international guidelines.

On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.

The normative dimensions of extending the human lifespan by age-related biomedical innovations.

The current normative debate on age-related biomedical innovations and the extension of the human lifespan has important shortcomings. Mainly, the complexity of the different normative dimensions relevant for ethical and/or juridicial norms is not fully developed and the normative quality of teleological and deontological arguments is not properly distinguished. This article addresses some of these shortcomings and develops the outline of a more comprehensive normative framework covering all relevant dimensions. Such a frame necessarily has to include conceptions of a good life on the individual and societal levels. Furthermore, as a third dimension, a model for the access to and the just distribution of age-related biomedical innovations and technologies extending the human lifespan will be developed. It is argued that such a model has to include the different levels of the general philosophical theories of distributive justice, including social rights and theories of just health care. Furthermore, it has to show how these theories can be applied to the problem area of aging and extending the human lifespan.