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Project Group Description
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1.Group - Biosafety of genetically modified organisms

The text of the Cartagena protocol states: “Biosafety … refers to the need to protect human health and the environment from the possible adverse effects of the products of modern biotechnology. At the same time, modern biotechnology is recognized as having a great potential for the promotion of human well-being, particularly in meeting critical needs for food, agriculture and health care.

Biosafety of Genetically Modified Organisms (GMO) is one of the most hotly debated issues in biotechnology. While GMOs offer unprecedented opportunities in agriculture and medicine, and are indispensable in basic research, there are unsettled concerns about the impact of GMOs on environment, food and feed safety, as well as human health. Biosafety assessment of GMOs must be based on reliable research, which is efficiently communicated to governmental institutions and general public.

University of Latvia is a recipient of funding from the European Social Fund to carry out a three year research project “„Capacity building for interdisciplinary biosafety research”, which among other topics aims to study biosafety of GMOs. GMO biosafety work package of the project involves scientists from the Laboratory of Bioanalytical Methods and the Centre for Bioethics and Biosafety, Faculty of Biology, University of Latvia. The experimental part of the work package encompasses assessment of the structural and gene expression stability of different transgenes in a model plant Arabidopsis thaliana over several generations, as well as the potential impact of transgenic plants on the soil microorganisms. In addition, the project has a very strong science dissemination aspect, aiming at providing scientifically sound and comprehensible information to the public. Even though numerous studies on various aspects of GMO safety and risk assessment have been conducted in European Union and worldwide, their impact on public awareness of the issues related to biosafety of GM crops is still unsatisfactory. The project aims to facilitate the communication between scientists and public by forming an interdisciplinary panel of biosafety experts to provide unbiased information on GMO biosafety via public discussions, internet forum and publications in public media.

While public discussions on GMO biosafety usually are limited to environmental risks and potentially adverse effects of GM crops, the benefits of contained use of GMOs is often ignored, although GMOs play crucial role in basic research, e.g., the determination of human genome sequence would not have been possible without use of recombinant DNA technology and genetically modified microorganisms. The project will aim to introduce to the general public the achievements of modern biotechnology that have been brought about by responsible use of GMOs in basic research.

Even though GM crops are grown and distributed on a global scale, the regional characteristics, such as climatic, biological and cultural aspects, need to be addressed for efficient communication of the GMO biosafety issues to the local public. Currently, possibility of cultivation of GM crops in Latvia is hotly debated and necessity for establishment of GMO-free zones is being considered by local authorities. While such activities tend to ignore the fact that neither of the two GM crops authorized for cultivation in EU is suitable for Latvia due to the climate conditions, the pest distribution and the absence of necessary processing industry, they do reflect the lack of understanding in governmental institutions and general public about biosafety of GMOs. Therefore, the project will aim to increase general awareness of presence and distribution of GMOs around the world, in EU and in Latvia, while at the same time trying to address the most relevant issues related to GMO biosafety as perceived by Latvian public.


2. Group - Biosafety criteria for somatic stem cells and cell therapy clinical trials

Somatic stem cells are internal reserves of human body and support tissue and organ regeneration during our lifetime. Therapies based on stem cells isolation and expansion have potential to improve treatment of several diseases. Somatic stem cell therapies already are used in clinics, particularly blood stem cell transplants in cancer treatment, and patient specific cartilage replacement. In the future, there is potential for stem cell treatment for wide variety of diseases including myocardial infarction, ischemia of limbs, Parkinson's disease, multiple sclerosis, and muscle damage. Large number of cell therapy clinical trials is already recruiting patients and scientific research constantly updates proposed mode of action as well as efficacy and biosafety issues.

Stem cell therapies represent a spectrum of different cell-based products with varying amount of scientific data and clinical experience.  Similarly, perceived risks associated with different types of stem cells are not the same. Therefore, biosafety risk based approach for cell therapy development and data requirements is recommended. There are two principal characteristics that define stem cells - capacity to self-renew/ expand and differentiate along multiple lineages- and both are important for clinical applications. However, at the same time these characteristics can be seen as cause of additional risks such as tumorigenicity and unintended differentiation. The same biosafety risk factors have to be monitored and tested after cell culture expansion in laboratory.

One of the research topics for European Social Fund project „Capacity building for interdisciplinary biosafety research” at University of Latvia is the development of biosafety criteria for stem cell cultivation and cell product clinical trials. This activity is implemented at Laboratory of Bioanalytical Methods and Department of Biotechnology and Microbiology, University of Latvia. Current cell therapy legislation provides general requirements for biosafety but does not define particular detection methods/ criteria required to prove fulfilment of requirements. This is related to the diversity of stem cell types and cell therapy applications, which can create necessity for personalized assessment criteria depending on protocols and objectives. Besides, legislation provides EU member states with option to monitor “hospital exemption” cases at the national level. There is also need to develop new, updated test methods that can be employed to prove safety profile based on state of the art knowledge in stem cell biology. Scientific knowledge in the field of stem cell biology and advancements in development of stem cell-based therapies are rapidly increasing. Biosafety criteria are evolving along with stem cell science and clinical experience with stem cell based therapies and these issues will be addressed in this project. Main outcome is development of capacity for somatic cell and therapy individualized risk identification, definition of appropriate marker/ criteria panels and introduction of new methodology to assess biosafety compliant with EU legislation requirements.


3. Group - Biosafety study on bacteria: determining virulence and drug resistance markers

 Staphylococci, particularly, Staphylococcus epidermidis, have been regarded for a long time as relatively innocuous inhabitants of the human skin and nasal flora.  The high prevalence of pathogenic Staphylococcus aureus and opportunistic Staphylococcus epidermidis infections during the last years can be explained by the increased use of indwelling catheters and implanted devices. Drug resistant staphylococci are dangerous by their ability to colonize in healthy people and in medical personnel for a long time and to spread when appropriate conditions appear. These resistant bacteria can affect people in the community and are difficult to threat by common antibiotics. The astounding ability to respond in a short time to the antibiotic challenge in staphylococci can be explained by a multiple resistance mechanisms, encoded both by extrachromosomal mechanisms and by chromosomal genes.

It is important to evaluate the risk of emerging resistant and virulent bacteria in the community. Patients coming from hospitals, e.g. after prolonged drug therapy, can spread resistant and virulent bacteria within the community. In its turn, the community became a reservoir of resistant bacteria. Noticeably, the percentage of carriage of resistant staphylococci in Latvian community is not known yet.

The aim of this study is to determine novel and to implement already known markers of resistance and virulence for the staphylococci. The main focus will be on mechanisms, which drive usually innocent bacteria from human microflora to become virulent. The selected markers will be tested in two groups of samples, presented, firstly, by healthy people from the community (outward) and, secondly, by isolates from clinical cases. This will benefit in determining new molecular criteria of biological risk rising from the mentioned bacteria. This project will contribute to better knowledge about risk of resistance spread in Latvia outside hospitals. An additional goal is educative work on risk for society, especially for immunocompromised people, created by antimicrobial therapy through the decades of years.


4. Group - Biosafety and Governance in Biotechnology Domain

The field of biotechnology continues to evolve rapidly, and this highly active development in different directions of bioresearch arises the problems related to regulatory and control issues in this field. In many countries management of biotechnologies and biosafety becomes an urgent issue for governmental institutions and also public and public organizations. As well as biological, technological and methodological components which could be seen as common objectivity all over the globe biosafety also involves social and legal components which come from local cultural and historical context in developing and using certain technologies. Discussing controversies biotechnology arises and elaborating necessary regulation to provide biosafety scientific perspective is conjunct with ethical, social ones; that is why citizen involvement and communicating technology issues is seen at the global scale as crucial element of wholesome biosafety oriented technology governance.

Biotechnology governance in Latvia is hindered due to absence of independent assessment available with participants not directly interested in accomplishing research. At the current moment state is the actor undertaking controlling role, but its regulatory function is weak because of mistrust in population. Thus public involvement might be crucial and effective way to enable shared responsible attitude and biotechnology development with taking in account the interests of marginal groups of society and providing gender equality especially in gender sensitive cases such as in vitro fertilization and stem cells. At the same time Latvia has no stable tradition of civic discussions and no instruments for public involvement in technology evaluation. Also citizens don’t perceive taking active position and participation in decision-making and regulating processes like their duty and responsibility. There are just several exceptional cases with extraordinary, in comparison to usual, public activities in expressing their position to biotechnology issues, which resulted with changes on institutional level. Moreover research in Latvia regarding ethical, religious, moral, social and legal aspects of biotechnology is conducted with great precaution when in relation to biosafety issues and issues regarding public mistrust in the capability of government organizations, scientists and politicians to control and regulate the biotechnology field.

Controversies of biotechnology development and its application take it manifestation in legal regulation or its absence on different scale - global, regional (EU), local. Bio law is rapidly developing field which links up different academic disciplines and increasingly reveals challenges which emerges due to biotechnology development. Legal regulation of biosafety substantially affects content and mode of biotechnology research and practical implementation of new technologies. Legal regulation of biosafety, on the one hand, must ensure the development of biotechnology, and must to protect environment, health and socio-economic values, on the other. Analysis of biosafety law, identification of legislation gaps and elaborating of improvement suggestions is necessary to   provide responsible and professional action of all involved stakeholders and to protect society from consequence of unaccountable action.

One of the research topics for European Social Fund project „Capacity building for interdisciplinary biosafety research” at The University of Latvia is development of criteria and methodology of biosafety according to evaluation of social, ethical un legal factors and  quality of governance in biotechnology field. To accomplish the objectives of this dimension of the project researchers from the Centre for Bioethics and Biosafety work on several interconnected research stages. The research of this group concentrated on exploring social and legal factors affecting involved stakeholders’ position and consequences of it concerning governance of development and application of biotechnology in context of biosafety in four different biotechnology fields: plant, human and bacteria genetics; stem cells’ research and therapies; pathogenic bacteria and antibacterial therapy; in vitro fertilization. Research includes evaluation of influence of biotechnology governance practices on biosafety criteria implementation and providing recommendations for good and with public interests consistent biosafety governance practice implementation, as also development of theory and practice of biosafety law in Latvia.