Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and (...) motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs. (shrink)

Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.

For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers’ understanding and reactions. We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with (...) members from the documents’ target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers’ understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future. (shrink)

Genetic database initiatives have given rise to considerable debate about their potential harms and benefits. The question arises as to whether existing ethical frameworks are sufficient to mediate between the competing interests at stake. One approach is to strengthen mechanisms for obtaining informed consent and for protecting confidentiality. However, there is increasing interest in other ethical frameworks, involving solidarity — participation in research for the common good — and the sharing of the benefits of research.

According to surveys and opinion polls, citizens in Nordic welfare societies have positive, supportive attitudes towards medical research and biobanking. In Finland, it was expected that this would result in the active biobank participation of patients and citizens. Indeed, public support has been rhetorically utilised as a unique societal factor and advantage in the promotion of Finnish biobanks, underlining the potential Finland offers for the international biomedical enterprise. In this paper, we critically analyse the use of notions such as ‘willing (...) population’ and ‘engaged people’ in the promotion and legitimation of biobanking. First, there is a seeming contradiction between positive attitudes and actual participation rates, as biobanks have faced unexpected challenges in participant recruitment during the first years of their operations. As a result, the concept of a willing population was redirected to problematise the necessity of informed consent. Second, we question whether it is even meaningful to assume the existence of an informed and engaged population with regard to biobanking. Therefore, we suggest that it is problematic to talk about a willing population at the same time as the relevance of the informed consent system is being questioned by biobank actors and policy makers. We analyse this tension in relation to existing data on Finnish people’s attitudes, pointing out that positive, supportive views do not directly transform into high participation rates; nor do they justify the claims of policy makers and biobank proponents that people are willing to participate, when in fact surveys report that people know very little about biobanks. (shrink)