Christian Lenk

Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?

Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees (RECs). The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk. Design: In a questionnaire, REC chairpersons had to evaluate five different scenarios with (in parts) non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved. Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios. Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than “minimal”, the chairpersons’ decisions differ widely. Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary.

Is the commercialisation of human tissue and body material forbidden in the countries of the European Union

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles.

Legal and ethical consequences of international biobanking from a national perspective: the German BMB-EUCoop project

The international transfer of human biomaterial and data has become a prerequisite for collaborative biomedical research to be successful. However, although a national legal framework for ‘biobanking’ has already been formulated in many countries, little is known about how an international exchange of data and samples might affect the legal position of national biobanks and their donors. The German Telematics Platform and the Competence Network ‘Congenital Heart Defects’ jointly instigated a project (BMB-EUCoop) to (i) identify and assess the legal risks ensuing for biobanks and their donors in the context of Europe-wide research collaborations, (ii) devise practical recommendations to minimize or avoid these risks, and (iii) provide generic informational text, contracts and agreements to facilitate their practical implementation. Four different countries were included in the study; namely, the UK, Netherlands, Austria and Switzerland. The results of the study indicate that the degree of similarity between legal systems in different countries varies according to the respective field of jurisdiction. Although personality and property rights have long been enshrined in virtually identical pieces of law, the applicable medical professional regulations were found to be somewhat heterogeneous. Furthermore, clear-cut differences were often found to be lacking between regulations that reflect either ‘soft law’ or the nationally binding ‘hard law’ that has emerged from it. In view of the potential ambiguities, the experts uniformly concluded that the rights and interests of national (in this case, German) biobanks and their donors would be best protected by explicitly addressing any uncertainties in formal contractual agreements.

Ethics, EBM, and hospital management

Matters of hospital management do not figure prominently on the medical ethics agenda. However, management decisions that have to be taken in the area of hospital care are in fact riddled with ethical questions and do have significant impact on patients, staff members, and the community being served. In this decision making process evidence based medicine (EBM) plays an increasingly important role as a tool for rationalising as well as rationing health care resources. In this article, ethical issues of hospital management and the role of EBM will be explored, with particular reference to disease management programs, diagnosis related groups, and clinical pathways as recent developments in the German health care system.

A Unified European Approach on Tissue Research and Biobanking? A Comparison

As is by now a well-investigated fact that human tissue research and biobanking is not regulated by a common legal framework in Europe so far, this article aims to step beyond this rather descriptive finding. By focussing on central issues of biobank research, the authors do not only highlight common trends and perspectives in the regulation of human tissue research across the countries of the European Union and Switzerland but also identify the ethical and legal foundations for some of the persisting differences in this field. Their analysis bears on the premise that certain countries hold similar research traditions and are united by common ethical and legal pathways for regulating research. Based on their distinction of seven country groups and their respective regulatory frameworks, the authors finally draw some overall conclusions regarding the future regulation and potential legal harmonization of this field within the European Union.

Biobanks and tissue research

Biobanks and tissue research , Biobanks and tissue research , کتابخانه دانشگاه علوم پزشکی و خدمات درمانی بوشهر

Donors and Users of Human Tissue for Research Purposes

Research with human tissue has often no direct benefit for the participating patients or test persons. Researchers, who want to use human tissue for their projects have to seek mechanisms to motivate tissue donors which are practicable in the framework of a specific study design. As some former cases show, there is a potential conflict of interests between researchers and patients which sometimes even culminates in legal proceedings with counterintuitive outcomes. The article presents two prominent cases and analyzes notions of justice for the field of tissue extraction and research and the distribution of possible benefits to researchers and patients. The Aristotelian conception of justice and distribution serves as a starting point for this analysis. Criticism concerning the commercialisation of the human body is taken into account and a variety of commercial as well as non-commercial forms of benefit-sharing are proposed and discussed with regard to the specific character of the research study. Thinking the categories of study type and potential benefits together results in a chart with customized benefits for each research study. The article comes to the conclusion that forms of benefit-sharing are an adequate instrument to avoid conflicts of interests in projects which are based on research with human tissue. It seems to be important to choose the right form of benefit-sharing for a specific project, dependent on the project’s characteristics and potential benefits for the patients.

Ein Modell zur Konstitution von Nutzungsrechten an menschlichem Gewebe und Körpermaterialien

Der medizinische Fortschritt fuhrt zu einer Veranderung der Wahrnehmung des menschlichen Korpers. Korpereigene Materialien und Gewebe, die fruher nach einer Operation, einer Geburt oder einer diagnostischen Masnahme als Abfall entsorgt wurden, stellen nun mitunter einen wertvollen Rohstoff fur die medizinische Forschung dar (Annas 1999; Weiss 2006; Check 2006). Zugleich hat sich ein normatives Vakuum gebildet, in dem unklar ist, wie der Umgang mit solchen Materialien in Zukunft geregelt werden soll. Das hier vorzustellende Modell zur Konstitution von Nutzungsrechten an menschlichem Gewebe ist als theoretische Voruberlegung gedacht, wie das beschriebene Problem gelost werden konnte.