Biobanks and Biological Samples Management

Objectives

This course focuses on the importance of biobanks as key infrastructures to support clinical research. At the end of UC students should be able to:

1- Recognize ethical, legal and social issues when implementing and operating a biobank.

2- Describe methods of sample processing and quality monitor in a biobank.

3- Identify systems of management and data organization in the biobank context.

4 - Develop a biobanking business plan.

5- Contextualize biobanks in clinical research.

General characterization

Code

191008

Credits

Responsible teacher

Prof.ª Doutora Ana Gabriela da Silva Cavaleiro Henriques

Hours

Weekly - Available soon

Total - Available soon

Teaching language

Portuguese or English

Prerequisites

Bibliography

· Karimi-Busheri F. (2015). Biobanking in the 21st Century. Springer. ISBN 978-3-319-20579-3.

· Dilllner J. (2011) Methods in Biobanking. Humana Press. ISBN 978-1-59745-423-0.

· Solbakk J.H., Holm S. and Hofmann B (2009). The Ethics of Research Biobanking. Springer. ISBN 978-0-387-93871-4.

· Biobanks for Europe A challenge for governance. European Comission (2012).

· Lei n.o 5/2008 de 12 de Fevereiro e Lei n.o 12/2005.

· OECD Guidelines on Human Biobanks and Genetic Research Databases (2009).

· Karimi-Busheri F. (2015). Biobanking in the 21st Century. Springer. ISBN 978-3-319-20579-3.

· Dilllner J. (2011) Methods in Biobanking. Humana Press. ISBN 978-1-59745-423-0.

· Solbakk J.H., Holm S. and Hofmann B (2009). The Ethics of Research Biobanking. Springer. ISBN 978-0-387-93871-4.

· Biobanks for Europe A challenge for governance. European Comission (2012).

· Lei n.o 5/2008 de 12 de Fevereiro e Lei n.o 12/2005.

· OECD Guidelines on Human Biobanks and Genetic Research Databases (2009).

Teaching method

The methodology applied intends to motivate the student in the learning process, promoting their independent research and critical thinking capacities. Various methods will be used, including lectures that will provide the adequate basis to explore additional contents, independently of the student background. Some classes can be taught via e-learning. Specialists in the different topics will be invited whenever possible for a seminar. The individual and/or group works, the discussion of relevant topics and the critical analysis of articles and/or practical cases/problems solve, will allow the acquisition and integration of knowledge related to the subject. The programatic contents presented and the knowledge acquired during the sessions will be also usefull in the preparation of a biobanking business plan.

Evaluation method

The discipline evaluation is discreet, comprising three moments for student´s evaluation. The knowledge acquired and the capacity to integrate and analise information will be assessed by written exam (50%), articles presentation, group work and /or resolution of case studies/problems (25%) and biobanking business plan (25%).

Subject matter

The course will be taught in an integrated manner by addressing the following topics:

I Biobanks: ethical, legal and social considerations.

II- Informed Consent and privacy of participants.

III- Biological samples processing: from sampling-to-freezer.

IV- Standardization and quality management in biobanking.

V - Sample management systems and clinical information in a biobank.

VI - Cost and sustainability of biobanks.

VII- Planning a biobank: organization and infrastructures.

VIII Planning a bionbak: business model Canvas.

IX - Biobanks as a resource in clinical research: case studies.

Programs

Programs where the course is taught:

Master in Clinical Research Management