1. Policy level The policy and legislation development process in practice (politicians and scientists are involved) differs from the ideal model (politicians, scientists, NGOs, ethics committees should be involved) A pressure to develop legal regulations comes from the outside (EU) and from the scientists who want to conduct certain types of biobank research. Only National Genome Project has clear requirements regarding informed consent process. There is lack of regulations for other types of biobank research, for instance, there are even no legal definitions of “biomedical research” or “biobank”. Ratification of Oviedo Convention was long (almost 9 years), without a discussion between policy- makers. Latvia has not yet ratified the Additional Protocol, concerning Biomedical Research. Conflicts of interests in research are typically overlooked; the scientist can be politician, researcher and physician simultaneously. There is lack of transparency in the system of ethics committees; lack of information for general public about activities of committees; no clearly defined responsibilities; no advisory opinions are issued by the Central Medical Ethics Committee. Research practice Even in situations where there are clear legal requirements for informed consent, the quality of informed consent procedure may be compromised because of lack of researchers’ competence and motivation. “There [in hospital] they just come to you and ask if I would mind to participate in Genome Project. What I should do there? Oh, nothing special, you just need give some blood. Oh, okay. That’s the way it goes.” (Genome Project donor) 1 There are different local and situational bioethical practices in obtaining informed consent. Most of the donors are patients at hospitals at the moment of collection of samples. Traditional models of physician-patient communication dominate in such situations. ”Well, where it was made, here in the hospital, had some kind some of project and doctor asked my consent.” (Genome Project donor ) 2 Many researchers and physicians evaluate the informed consent as just a formality. “They [patients] did not have any clearness about those genes. I said, that’s not for us, but for our next generations. In other words, neither I completely understood that [Genome Project] nor did they. More or less that’s all for science.” (family physician, who recruits patients for Genome Project). 3 Some scientists perceive collections of human tissue and cell samples as personal property. Society level Informed consent to biobank research: a need for ethical framework and coherent national regulation in Latvia Zane Linde, University of Latvia, Faculty of Biology Signe Mežinska, University of Latvia, Faculty of Humanities Ilze Mileiko, University of Latvia, Faculty of Biology There is deficiency of publicly available information on biobanking and no public discussion on ethical aspects of biobank research. There is lack of experience of participatory practices. The responsibilities regarding development of legal and ethical framework are left to experts (politicians and scientists). “Well if say to me, it is a marker of analysis... I fully believe in the man who gave the oath of Hippocrates and appreciate the professional responsibility, either, and if he is a villain then I cannot intervene there.” (Genome Project donor) 4 There is no discussion on possible future developments of informed consent requirements in terms of liberalism and communitarianism. The media is not as an intermediary between government, science and society. Only some bioethical issues, such as GMOs, are broadly covered by mass media. 1,2,4 Aivita Putnina. Population genome project in Latvia. Centre for bioethics and biosafety. 2008 3 Zane Linde. Genetic biotechnologies in daily practice of medicine (Master Thesis). 2010 Scientific knowledge European Social Fund project “Capacity building for interdisciplinary biosafety research” Nr.2009/0224/1DP/1.1.1.2.0/09/APIA/VIAA/055 International conference "From informed consent to no consent? The challenges of new ethical frameworks“ Tartu, Estonia November 4 - 6, 2010