Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

[European ethics committees in transition: challenges of new requirements]. / Europäische Ethikkommissionen im Wandel: Herausforderungen durch neue Rahmenbedingungen.

Guided by the example of ethics committees in medicine, the ethical review system of research projects in Europe is increasingly expanding to other disciplines such as psychology, the social sciences, and engineering, especially when human subjects are directly involved or personal data are collected. However, ethical reviews are not uniformly regulated in most European countries.With the new EU Regulation No. 536/2014, which is expected to come into force in 2020, it is intended to standardize the work of medical research ethics committees for clinical trials. Clear deadlines and the use of a central electronic EU portal are also given in order to accelerate the approval process for economic reasons. Member states are left free in terms of the scope of the ethical review, but this would run counter to unification and could lead some to choose a test model that excludes the evaluation of the methodology and risks of a study and thus contributes less to the protection of the participants.The European Research Ethics Committees have been working together since 2005 within the European Network of Research Ethics Committees (EUREC). For a discussion on the impact and implementation of the new EU Regulation and on the development of the EU portal, EUREC has provided a forum for a qualified debate.In this period of change, it is not clear yet which direction the ethics committees will develop. Professional management can have a positive impact on the quality of the ethics review. However, the marginalization inherent in the EU Regulation is counteracting the increasing evaluation of nonmedical research projects and adequate protection of subjects.

Attitudes toward the right to autonomous decision-making in psychiatric genetic testing: Controversial and context-dependent.

Recent breakthroughs in psychiatric genetics have identified genetic risk factors of yet unknown clinical value. A main ethical principal in the context of psychiatric research as well as future clinical genetic testing is the respect for a person's autonomy to decide whether to undergo genetic testing, and whom to grant access to genetic data. However, experience within the psychiatric genetic research setting has indicated controversies surrounding attitudes toward this ethical principal. This study aimed to explore attitudes concerning the right of individuals to self-determine testing and disclosure of results, and to determine whether these attitudes are context-dependent, that is, not directly related to the test result but rather to specific circumstances. N = 160 individuals with major depression or bipolar disorder and n = 29 relatives of individuals with either illness completed an online-questionnaire assessing attitudes toward genetic testing, genetic research, disclosure of results, incidental findings, and access to psychiatric genetic test results. Generally, the right of the person's autonomy was considered very important, but attitudes varied. For example, half of those who considered that children should have the right to refuse psychiatric genetic testing even against their parents' will, also state that they should be tested upon their parents' wishes. Also, the majority of respondents considered the physician entitled to disregard their stated wishes concerning the disclosure of incidental findings in case of good treatment options. Thus, researchers and clinicians must be aware that attitudes toward psychiatric genetic testing are often mutable and should discuss these prior to testing.

[Mental diseases and genetic disposition: ethical aspects]. / Psychische Erkrankungen und genetische Dispositionen: ethische Aspekte.

The handling of predictive genetic tests especially in the field of mental diseases requires a sensitive approach. In particular internet-based direct-to-consumer offers cannot provide an appropriate interpretation of the onset probabilistic data. Instead, a doctor-patient relationship should cater for clarity through hermeneutic and non-technicistic assistance with respect to the necessity of a test as well as with a view to the interpretation of the test results.

Advance directives for future dementia can be modified by a brief video presentation on dementia care: An experimental study.

OBJECTIVES: To investigate whether life-sustaining measures in medical emergency situations are less accepted for an anticipated own future of living with dementia, and to test whether a resource-oriented, in contrast to a deficit-oriented video about the same demented person, would increase the acceptance of such life-saving measures. DESIGN: Experimental study conducted between September 2012 and February 2013. SETTING: Community dwelling female volunteers living in the region of Bonn, Germany. PARTICIPANTS: 278 women aged 19 to 89 (mean age 53.4 years). INTERVENTION: Presentation of a video on dementia care focusing either on the deficits of a demented woman (negative framing), or focusing on the remaining resources (positive framing) of the same patient. MAIN OUTCOME MEASURES: Approval of life-sustaining treatments in five critical medical scenarios under the assumption of having comorbid dementia, before and after the presentation of the brief videos on care. RESULTS: At baseline, the acceptance of life-sustaining measures in critical medical situations was significantly lower in subjects anticipating their own future life with dementia. Participants watching the resource-oriented film on living with dementia had significantly higher post-film acceptance rates compared to those watching the deficit-oriented negatively framed film. This effect particularly emerges if brief and efficient life-saving interventions with a high likelihood of physical recovery are available (eg, antibiotic treatment for pneumonia). CONCLUSIONS: Anticipated decisions regarding life-sustaining measures are negatively influenced by the subjective imagination of living with dementia, which might be shaped by common, unquestioned stereotypes. This bias can be reduced by providing audio-visual information on living with dementia which is not only centred around cognitive and functional losses but also focuses on remaining resources and the apparent quality of life. This is particularly true if the medical threat can be treated efficiently. These findings have implications for the practice of formulating, revising, and supporting advance directives.

Fostering responsible research with genome editing technologies: a European perspective.

In this consensus paper resulting from a meeting that involved representatives from more than 20 European partners, we recommend the foundation of an expert group (European Steering Committee) to assess the potential benefits and draw-backs of genome editing (off-targets, mosaicisms, etc.), and to design risk matrices and scenarios for a responsible use of this promising technology. In addition, this European steering committee will contribute in promoting an open debate on societal aspects prior to a translation into national and international legislation.

Bioethics in Germany: debates and infrastructure.

In Germany the public awareness on ethical problems of the application of medicine and life sciences on human beings is very high. It can be observed that German Society is rather sensitive concerning bioethical issues. Politics supports this attitude. Many articles in professional journals as well as in newspapers cover bioethical issues. Conferences and workshops on a professional and an educational level deal with topics on ethics of life sciences and ethics in general. Moreover, in the case of bioethics many different disciplines contribute with relevant considerations to the process of opinion and judgment formation. This paper summarizes the main ethical and legal debates on bioethical issues in Germany, specifies the focus of leading German centres of bioethics and biolaw, and explains the tasks, services and networking of the German Reference Centre for Ethics in the Life Sciences (DRZE) which was founded by the Federal Government.