Universitat Internacional de Catalunya
Legislation and Biobanks
Other languages of instruction: Catalan, Spanish
Teaching staff
Teachers: Dr Natalia Felipe - nfelipe@uic.es Visiting hours: Students can contact by email for any queries.
Introduction
A biobank is a facility that collects, stores and distributes biological material and data associated with such material. The OECD in 2001 defined biobanks as centers of biological resources. They consist of service providers and deposits of living cells, genomes of different organisms and information concerning inheritance and function of biological systems.
Pre-course requirements
None.
Objectives
This course presents good practices and seeks to establish a guide for procedures based on experience and framed by ethical and legal standards, which set the guidelines for the operation of Biobanks for Biomedical Research. Therefore, this course is applicable to all staff of Biobanks for Biomedical Research and health or research institution staff, in the practice of biomedical research with biological material and/ or data of human origin.
- Know the basic bio-ethical concepts and their relation to the use of human biological samples for biomedical research and particularly the use of genetic data.
- Understand the fundamental rights of the donor of the sample as an individual and as a member of society and the guarantees biobanks must have to ensure compliance.
- Know the basic bio-ethical concepts and their relation to the use of human biological samples for biomedical research and particularly the use of genetic data.
- Understand the fundamental rights of the donor of the sample as an individual and as a member of society and guarantees must have biobanks to ensure compliance.
- Know the law and recommendations for bio-safety in laboratories working with human samples, be able to handle the usual biobank samples and work with appropriate personal protective measures without risk to the rest of the staff in all units of the biobank.
- Know the computer program biobank management, work independently with it at the user level and be able to plan and implement specific projects for collecting a particular collection of samples.
- Understand and be able to develop autonomously all work processes of the biobank, from receiving and recording the samples to be split, extraction of nucleic acids and storage of mononuclear cells.
- Learn how to handle equipment used for immune-magnetic separation and flow cytometers, separators and specific techniques to be able to perform separations autonomously, cell populations of peripheral blood, bone marrow or other tissues
. - Acquire the necessary knowledge of the processes of sample storage, security mechanisms and protection and storage systems and conditions for each type of sample biobank.
Competences/Learning outcomes of the degree programme
- CB10 - Acquire learning skills that allow them to continue studying in a self-directed and autonomous mode.
- CB7 - To apply the acquired knowledge, and develop their ability to solve problems in new environments within broader (or multidisciplinary) contexts related to their field of study.
- CB8 - Integrate knowledge and deals with the complexity of formulate judgments based on scientific evidence, from information that may be incomplete or limited, include reflecting on social and ethical responsibilities linked to the application of their knowledge and judgments.
- CE10 - Know how to apply the epistemological, ethical, legal and humanitarian exercise in research and dissemination of results.
- CG1 - Ability to integrate new knowledge through research and study, and deal with complexity
- CG3 - Self learning ability in the development of new techniques, in the knowledge of new scientific concepts and in the search of new scientific information
- CG4 - Ability to argue and defend own scientific ideas and listen, analyze, evaluate and respond to the ideas of another person.
- CT1 - Ability to work in multidisciplinary and multicultural groups
Learning outcomes of the subject
1. The student knows the current legislation applicable to the field of clinical research and the laboratory.
2. The student knows the legislative and Biobank management principles.
3. The student knows the workflow in a Biobank.
Syllabus
Topic 1 Introduction and basic bioethical concepts.
Topic 2 Legislation and bio-safety.
Topic 3 Biobank information management.
Topic 4 Cell separation techniques used in Biobanks.
Topic 5 Sample storage process.
Teaching and learning activities
Online
Educational material in pdf format, review articles, links to Royal Decree and biobank websites.
Evaluation systems and criteria
Online
EC (Continuous assessment): 20% (participation and visits in the course)
PFE (Final exam: test format): 80%