Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of 'broad consent', which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR 'research condition' provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

Legislation of direct-to-consumer genetic testing in Europe: a fragmented regulatory landscape.

Despite the increasing availability of direct-to-consumer (DTC) genetic testing, it is currently unclear how such services are regulated in Europe, due to the lack of EU or national legislation specifically addressing this issue. In this article, we provide an overview of laws that could potentially impact the regulation of DTC genetic testing in 26 European countries, namely Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, the Netherlands and the United Kingdom. Emphasis is placed on provisions relating to medical supervision, genetic counselling and informed consent. Our results indicate that currently there is a wide spectrum of laws regarding genetic testing in Europe. There are countries (e.g. France and Germany) which essentially ban DTC genetic testing, while in others (e.g. Luxembourg and Poland) DTC genetic testing may only be restricted by general laws, usually regarding health care services and patients' rights.

Should Europe follow the US and declare obesity a disease?: a discussion of the so-called utilitarian argument.

In 2013, the American Medical Association (AMA) decided to recognize obesity as a disease. One of the main arguments presented in favor of this was broadly 'utilitarian': the disease label would, it was claimed, provide more benefits than harms and thereby serve the general good. Several individuals and groups have argued that this reasoning is just as powerful in the European context. Drawing mainly on a review of relevant social science research, we discuss the validity of this argument. Our conclusion is that in a Western European welfare state, defining obesity as a disease will not on balance serve the general good, and that it is therefore more appropriate to continue to treat obesity as a risk factor. The main reasons presented in favor of this conclusion are: It is debatable whether a disease label would lead to better access to care and preventive measures and provide better legal protection in Europe. Medicalization and overtreatment are possible negative effects of a disease label. There is no evidence to support the claim that declaring obesity a disease would reduce discrimination or stigmatization. In fact, the contrary is more likely, since a disease label would categorically define the obese body as deviant.

Weight-based discrimination: an ubiquitary phenomenon?

BACKGROUND: Despite strong indications of a high prevalence of weight-related stigmatization in individuals with obesity, limited attention has been given to the role of weight discrimination in examining the stigma obesity. Studies, up to date, rely on a limited basis of data sets and additional studies are needed to confirm the findings of previous studies. In particular, data for Europe are lacking, and are needed in light of a recent ruling of the European Court of Justice that addressed weight-based discrimination. METHODS: The data were derived from a large representative telephone survey in Germany (n=3003). The dependent variable, weight-based discrimination, was assessed with a one-item question. The lifetime prevalence of weight discrimination across different sociodemographic variables was determined. Logistic regression models were used to assess the association of independent and dependent variables. A sub-group analysis was conducted analyzing all participants with a body mass index ⩾25 kg m(-)(2). RESULTS: The overall prevalence of weight-based discrimination was 7.3%. Large differences, however, were observed regarding weight status. In normal weight and overweight participants the prevalence was 5.6%, but this number doubled in participants with obesity class I (10.2%), and quadrupled in participants with obesity class II (18.7%) and underweight (19.7%). In participants with obesity class III, every third participant reported accounts of weight-based discrimination (38%). In regression models, after adjustment, the associations of weight status and female gender (odds ratio: 2.59, P<0.001) remained highly significant. CONCLUSIONS: Discrimination seems to be an ubiquitary phenomenon at least for some groups that are at special risk, such as heavier individuals and women. Our findings therefore emphasize the need for research and intervention on weight discrimination among adults with obesity, including anti-discrimination legislation.