Syllabus Information

1.2. Recommendations to take this course

As a mandatory subject from Grade is based on previously acquired knowledge by the student. It is very convenient to have passed all the subjects of previous courses and first semester. The working material of the subject may be in English so the student will need a good level of understanding written it.It aims to provide students an overview of aspects related to quality control and regulation surrounding experimentation and biochemical research resulting in the biotechnology industry. national and international bodies involved in regulatory activities are presented.

1.4. Activities and key dates

For students enrolled in the subject, places, times and dates of lectures and practical sessions will be public via Bulletin Board advertisements of the grade on the platform Moodle at the University of Zaragoza, https://moodle2.unizar.es/add/, and in the moodle page for the course. These routes will be also used to communicate enrolled students their distribution by groups of practical sessions, which will be organized by the coordination of degree.  Provisional dates will be available on the website of the Faculty of Sciences in the corresponding section of the Degree in Biotechnology: https://ciencias.unizar.es/grado-en-biotecnologia.

In this web there will be also available the dates of exams.

5.1. Methodological overview

The learning process that is designed for this subject is based on the following:

- This course is scheduled to address an intensification of theoretical knowledge with student participation. This strategy will allow the student to revise a topic, closely with an outstanding professional. This proccess approach the student to a research aspect which can provide a subsequent professional development.

5.2. Learning tasks

The program that the student is offered to help you achieve the expected results includes the following activities:

I. THEORETICAL classes. 4 ECTS. They are presented to students basic theoretical knowledge of the subject, which will focus on the above aspects, according to the program of the subject.
 
Downloadable documents interest web
 CSIC Research Ethics (http://www.csic.es/)
 Codi de pràctiques bones científiques PRBB (pdf 2.3M) [Download]
 Research ethics - Arbor Magazine No. 730
 HAS Science Ethics Code (PDF 255K) [Download]
 CBE Recommendations on CBP of Spain (pdf 321k) [Download]
 Stewards of Integrity - ESF (pdf 5.94M) [Download]
 CBP Research - University of Barcelona (pdf 535 k) [Download]
 
II. PRACTICAS classes (including presentation and exhibition of a work).2 ECTS. Students will gather information on a particular topic that will update helped by the teacher. Professor monitor  the individual work of students by scheduling tutoring sessions. Finally, the works are presented and debated in class.
A) LEGAL DOCUMENTS-BIOMEDICAL.
Formal structure, content, purpose and usefulness of the main documents (report, certificate, trade) to develop in the exercise of work activity.
Document processing and presentation
Analysis from an ethical and legal perspective
Expert reports
Forensic Genetics reports. criminal cases, identification, paternity testing
 B) VIDEOS AND ANALYSIS OF EVIDENCE
Program may informally complementary activities of interest to students consistent in seminars and lectures by experts, students will be announced during the course.
C) PRACTICAL EXERCISES
Analysis of working procedures, delivery notes and laboratory reagents sheets were made. In addition, complementary activities will be conducted in practice the subject of inventions and patents. documentation to students in class or through Moodle will be provided during the course.

5.3. Syllabus

They are presented to students the basic theoretical knowledge of the subject, which will focus on the above aspects.
 Agenda:
1. Biomedicine, Biotechnology and Law. Basic concepts. Historical evolution. Introduction to criminal, civil, labor and administrative implications of biotechnology.
2. Introduction to Bioethics. Ethics in Scientific Research. Historical background and current projection.
3. Rights of Persons and scientific research in biotechnology. Information and consent, legal and ethical issues.
4. Biotechnology in the Service of Society and the Administration of Justice. Scientific research in the Expert Forensic Science Application.
5. Identification and Forensic Genetics I.
6. Identification and Forensic Genetics II.
7. Prevention of Risks to Human Health in Laboratories. Biotechnology and Health. Implementing rules. Liabilities arising.
8. Safety Laboratories. Risks Biological, physical and chemical. Toxicology.
9. Testing of biotechnology products.
10. Invention, know-how, patents, others. National and European patents. 
11. Genetically Modified Organisms (GMOs). Reference standards. Use in bioremediation, agricultural, and others.
12. Biological Products and regulation. Specific cases.
13. Tests on animals. Regulations. Animal welfare. Ethics of Animal Experimentation.
14. Pre-clinical trials. Clinical Trials. Types and Phases. Feelingly. Harmonization of regulations. Ethical committees.
15. Quality Control I: Introduction to Quality Control (CC) and objectives.
16. Quality Control II: Integrated System CC.
17. Quality Control III: Overview of application of CC in Biotechnology.
18. Quality Control IV and abroad involved in the main quality standards agencies.
19. Validation. Definition. Reasons and architects of validation. Parameters and validation design. Documentation. Certificates. Good Laboratory Practices.

5.4. Course planning and calendar

Schedules of lectures and problems will coincide with the officially established and will be available at: https://ciencias.unizar.es/grado-en-biotecnologia.

The places, calendar and groups for training and practical sessions will be established in coordination with the rest of maters at beginning of course. The Coordinator will produce the groups of students for these activities at beginning of course to avoid overlaps with other subjects.

5.5. Bibliography and recommended resources

• La prueba del ADN en medicina forense : la genética al servicio de la ley en el análisis de indicios criminales y en la investigación biológica de la paternidad / directora Mª Begoña Martínez Jarreta Barcelona : Masson, 1999
• La prueba pericial médica en el derecho / coordinadora, Begoña Martínez Jarreta . - 1ª ed. Zaragoza : Servicio de Publicaciones, Universidad de Zaragoza, 1996
• Ciencia forense : revista aragonesa de medicina legal Zaragoza : Institución Fernando el Católico, 1999- [Publicación periódica] (Ver también enlaces Web)
• Enciclopedia de Bioderecho y Bioética / Carlos María Romeo Casabona (Director) Granada : Comares, 2011
• Vásquez Marías, Patricia. Documentos médico-legales / Patricia Vásquez Marías, Mª Begoña Martínez Jarreta . - [1ª ed.] Zaragoza : Institución Fernando el Católico, 2003
• Derecho sanitario y bioética : cuestiones actuales / coordinadoras Marina Gascón Abellán, Mª del Carmen González Carrasco, Josefa Cantero Martínez Valencia : Tirant lo blanch, 2011
• Tratado de Medicina del trabajo / Fernando Gil Hernández, [coordinador] ; [colaboradores, Víctor Alcalde Lapiedra, Mª Begoña Martínez Jarreta... et al.] . - 2ª ed. Ámsterdam ; Barcelona ; Madrid [etc.] : Elsevier Masson , D.L. 2011

Páginas web

Ética en investigación del CSIC

http://www.csic.es/
Cátedra de Derecho y Genoma Humano
http://www.catedraderechoygenomahumano.es

Instituto Borja de Bioética

http://www.ibbioetica.org/es/

Red de Comités de Ética de Universidades y Organismos Públicos de Investigación de España

http://www.ub.edu/rceue/

Observatori de Bioètica i Dret

http://www.pcb.ub.edu/bioeticaidret/

 Sociedad Internacional de Bioética

http://www.sibi.org/

 European Science Foundation

http://www.esf.org/

 Asociación Española de Bioética y Etica Médica

http://www.aebioetica.org/

 Comité de Ética de Experimentación Animal de la Universidad

http://www.unav.es/ceea/

Scientífic  and Cultural Organization UNESCO

http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/

 European Society for Agricultural and Food Ethics (EurSafe)

http://www.eursafe2010.es/

 Escuela Profesional de Medicina del Trabajo de la Universidad de Zaragoza

http://www.medicinatrabajo.es/

 American Academy of Forensic Science

http://www.aafs.org/

Federal Bureau of Investigation

http://www.fbi.gov/

Forensic Science Society

http://www.forensic-science-society.org.uk/index.html

 The American Society of Crime Laboratory Directors

http://www.ascld.org/

Society of Forensic Toxicologists

http://www.soft-tox.org/

Internet drug index

http://www.rxlist.com

Comisión Nacional de Seguridad y Salud en el Trabajo

http://www.mtas.es/insht/cnsst/index.htm

Salud laboral (Ministerio de Sanidad y Consumo)

http://www.msc.es/ciudadanos/saludAmbLaboral/saludLaboral/home.htm

Agencia Europea para la Seguridad y la Salud en el Trabajo

http://es.osha.europa.eu/

National Institute for Occupational Safety and Health (USA)

http://www.cdc.gov/niosh/

Organización Internacional del trabajo

http://www.ilo.org/public/spanish/index.htm

The World Health Organization

http://www.who.int/topics/occupational_health/en/