Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (IRBs or Research Ethics Committees (RECS)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of EU Member States; and European laws differ widely. The article gives an overview of European regulations in the field of REC review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria--the Research Committee for Scientific and Ethical Questions (RCSEQ). Finally, important European initiatives for the future are pointed out.

As past events have shown, disasters can have a tremendous impact on the affected population’s health. However, research regarding the long-term impact on a systems level perspective is still scarce. In this multi-case study, we analyzed and compared the long-term impacts on the public health system of five disasters which took place in Europe: avalanche (Austria), terror attack (Spain), airplane crash (Luxembourg), cable-car tunnel fire (Austria), and a flood in Central Europe. We used a mixed-methods approach consisting of a document analysis and interviews with key stakeholders, to examine the various long-term impacts each of the disasters had on health-system performance, as well as on security and health protection. The results show manifold changes undertaken in the fields of psychosocial support, infrastructure, and contingency and preparedness planning. The holistic approach of this study shows the importance of analyzing long-term impacts from the perspective of the type (e.g., disasters associated with natural hazards) and characteristic (e.g., duration and extent) of a disaster, as well as the regional context where a disaster took place. However, the identified recurring themes demonstrate the opportunity of learning from case studies in order to customize the lessons and apply them to the own-disaster-management setting.

Anti-doping rule violations (ADRVs) can lead to sports-related and legal sanctions, thus, being knowledgeable is important. Research into this knowledge and how athletes and their support personnel (ASP) perceive the control mechanisms and the appropriateness of (legal) sanctions is still scarce. This explorative study aimed to examine the knowledge and perception of existing (legal) sanctions in Austria, by distributing a questionnaire to Austrian athletes and ASP covering the topics of knowledge related to legal and sports-related consequences associated with a specific ADRV presented in a case study, their trust and satisfaction with specific agencies (based on the European Social Survey (ESS)) and perceived efficiency and effectiveness of the doping control system. Data were analyzed descriptively. All respondents (N = 59) agreed on a ban from sport to be appropriate. Knowledge about legal consequences and the trust in the judiciary and the sport governing bodies was moderate (6.82 out of 10). Perceived appropriate consequences were on average higher than the likely sanctions to be faced. Future prevention should include trust building measures in the institutions and the control system, improvement in terms of access to law and education for the target group and critical reflection on the existence of social norms. Furthermore, the implementation of risk management aspects should be part of future approaches.

For patients, innovations in healthcare can be both a great blessing (when saving people’s life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health technology assessment (HTA) plays a crucial role at European Union level, forming an evidence-based, transparent basis for decision making through joint assessments. However, pricing and reimbursement aspects are exempt from collaborative assessments, since these are in the responsibility of the EU Member States: according to Art. 168(7) TFEU the ‘organisation and delivery of health services and medical care [… including] the allocation of the resources assigned to them’ remain an exclusive competence of Member States. However, future challenges may require further cooperation.

Biomedical research and international collaborations in biomedical research become more and more important--economically and politically, making harmonised legislation for human research subject protection indispensible. The European Convention on Human Rights and Biomedicine is the first binding contract under international law to protect human rights in the field of biomedical research. Almost 10 years after its entry into force neither Germany nor Austria have signed or ratified the Convention. Research involving incapacitated adults is one of the key issues in this context. This paper analyses the Convention and other European, US and international legislation, focusing on research involving incapacitated adults in "nontherapeutic" trials. It shows that a ban of "non-therapeutic" research involving incapacitated adults leads to an unjust exclusion of this patient group, leading to uncertainty and disadvantages in medical treatment.