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Bioethics and Legislation

Code: 101938
Credits: 3
2026/2027
Degree programme Type Course
Genetics OB 3

Contact lecturer

Name :
Mireia Sole Canal
Email :
mireia.sole@uab.cat

Teaching staff

Xavier Vallve Sanchez

Group languages

You can consult this information at the end of the document.

Prerequisites

There are no prerequisites for taking this course. In spite of this, to ensure the proper monitoring of the subject by the student and to achieve the learning outcomes proposed, it is recommended that the student have some basic knowledge about the techniques used in Biomedicine and Genetics as well as associated research, since many of them will appear throughout the development of their content and they will be given as known. On the other hand, in a scientific discipline like Genetics it is frequent to use sources of information, norms and international guidelines, in English. It is therefore recommended that students have some basic knowledge of this language

Objectives

The subject Bioethics and legislation has a complementary character within the degree and with it, it is intended that the student acquires knowledge about the Ethical and legal aspects related to Genetics and the associated research.
The training objectives are that the student, at the end of the subject, is able to:

1. Do diagnoses and genetic counseling and consider their ethical and legal dilemmas.

2. Apply and assume the basic principles in bioethics.

3. Make preconceptional genetic counseling taking into account its ethical and legal implications.

4. Apply the legislation for the protection of individual genetic data.

5. To elaborate, direct, execute and advise projects that require knowledge of genetics or genomics.

6. Apply the principles of the intellectual and industrial property right in the processes of product development and research.

7. Apply the patent regulations.

8. Apply the legal principles on research and product development.

9. Apply existing legislation to biomedical research in accordance with bioethical principles.

10. Develop strategies of analysis, synthesis and communication that allow to transmit the different aspects of genetics in educational environments

11. Explain the social perception of science and technology and its importance in communicating appropriately the achievements and the risks associated with the advancement of genetics.

12. Be able to communicate effectively, orally and in writing.

13. Apply theoretical knowledge to practice.

14. Assume an ethical commitment

15. the importance of quality and well-done work.

16. Demonstrate sensitivity in environmental, health and social issues, paying special attention to gender perspective 

Learning outcomes

  • CM31 (Propose solutions to diagnostic and assisted reproduction problems, evaluating their technical feasibility and ethical implications.) Propose solutions to diagnostic and assisted reproduction problems, evaluating their technical feasibility and ethical implications.
  • CM32 (Design strategies and projects in applied genetics considering technical resources and economic management.) Design strategies and projects in applied genetics considering technical resources and economic management.
  • KM25 (Identify the bioethical and legal principles of applied genetics and genomic research, integrating the gender perspective.) Identify the bioethical and legal principles of applied genetics and genomic research, integrating the gender perspective.
  • SM28 (Apply genetic and genomic techniques for diagnostic analysis in the context of human reproduction.) Apply genetic and genomic techniques for diagnostic analysis in the context of human reproduction.

Contents

PART I. PRINCIPLES OF BIOETHICS

Definition of Bioethics

Fundamental ethical theories in Bioethics

Analysis in bioethics

Basic principles in Bioethics

Other relevant principles in Bioethics

PART II. THE ETHICS IN RESEARCH

Ethical principles in scientific practice

Obligations of the researchers

Codes of Good Practices in Research

Ethical principles of research in Biomedicine

PART III. THE ETHICAL DESIGN OF EXPERIMENTATION WITH ANIMALS

Ethical aspects of animal research

The basic principles: the 3R

Legal aspects of the use of experimental animals: RD 53/2013

PART IV. THE ETHICAL DESIGN OF EXPERIMENTATION WITH HUMAN BEARS

Ethical principles

The subjects

Legal aspects of research in human beings, embryos and reproductive cells: Law 14/2007 and 14/2006

PART V: ETHICAL ASPECTS OF THE NEW TECHNOLOGIES

General concerns

Regenerative medicine

Personalized medicine

Reproductive medicine

Genetic modification

Genetic counseling

Genetic tests incapable of consenting

Use of genetic information

PART VI: OTHER LEGAL ASPECTS

Law 15/1999

Law 9/2003

Part VII: PATENTS

Intellectual and industrial property rights.

Patents and utility models.

Patents in chemistry, pharmacy and biotechnology.

Writing of the patent and infringement.

Patent documentation.

Learning activities and methodology

Title Hours ECTS Learning outcomes
Individual study 29 1.16 CM31, CM32, KM25, SM28
Lectures on theory 20 0.8 CM31, CM32, KM25, SM28
Case analysis: Preparation of discussion work 4 0.16 CM31, CM32, KM25, SM28
Seminars 4 0.16 CM31, CM32, KM25, SM28
Case analysis: Group discussion 12 0.48 CM31, CM32, KM25, SM28

The subject consists of theoretical classes and analysis and commentary of cases proposed in a format of Seminars. Organization and the teaching methodology that will be followed in these two types of training activities is described below


Theory classes:

The content of the theory program will be taught mainly by the teacher in the form of master classes with audiovisual support. Alternatively, the methodology of the \"flipped lessons\" will also be used, in which the topics are previously prepared by the student from material provided by the teacher and later worked with practical cases in the face-to-face sessions. Presentations used in class by the teacher will be previously available on the Virtual Campus of the subject. It is advisable that students print this material and take it to class, to use it as a support when taking notes. Although it is not essential to extend the content of the classes taught by the teacher, unless expressly requested by the latter.

It is recommended that students consult on a regular basis the books and recommended normative texts in the Bibliography section of this teaching guide in order to consolidate and clarify, if necessary, the contents explained in class.

On the other hand, the student will have to work individually the content of the legal texts referred to in this guide. We will provide the student with documents where the full text will appear and also a clearance of the normative text in order to facilitate this task.

In addition to the attendance to the classes, the follow-up of the subject will also imply an active role of the student, who will have to analyze and comment real cases and assumptions related to the contents of the theory program. It is intended that these cases serve to consolidate the previously worked contents in theory classes and also for students to develop a critical spirit in the face of ethical and legal problems related to research in Biomedicine. Anyway,this commentary of the cases will be done in the form of small work groups is intended to promote in the student the habit of teamwork and the critical argumentation between peers.

Seminars:

The students will do the analysis and commentary of 2 cases proposed outside the class schedule, in work groups between 4 and 6 people chosen by students must train at the beginning of the course. This discussion will be reflected in individual work that students will deliver (two deliveries only by group) in the established deadlines, works that will be evaluated by the teacher, sharing all the members of the group the same note (evaluation group).

Subsequently, there will be 2 seminar sessions, which will be devoted to the analysis and commentary of the cases and assumptions between the different groups. Each of these sessions will be attended by half of the set of groups, all the members of the discussion group being present. This will mean about 30 students in 5-6 groups. After reading the case, the teacher will lead the discussion. The interventions of the different students will also be evaluated by the teacher in the sense of highlighting the brightest and most passive students. The subject proposal will be done by the teacher at the beginning of the course and will be assigned to each subset of discussion groups. The proposal will include the guidelines and points to treat. Additionally, there will be a third seminar held during class hours, with the submission of the assignment taking place in the same session. This seminar will be carried out, as in the previous cases, in work groups of 4 to 6 students that must be formed at the beginning of the course. Attendance on the day of the seminar is necessary and essential in order to complete and submit the assignment.

Annotation: within the schedule set by the centre or degree programme, 15 minutes of one class will be reserved for students to evaluate their lecturers and their courses or modules through questionnaires.

Assessment

Continuous assessment activities

Title Weight Hours ECTS Learning outcomes
Evaluation of case comments 30% 1 0.04 CM31, CM32, KM25, SM28
Evaluation of the public discussion of cases. Seminars (individual assessment) 5% 2 0.08 CM31, CM32, KM25, SM28
Test of the theory contents: Semiobjective test 24% 1 0.04 CM31, CM32, KM25, SM28
Test of the theory contents: objective test 46% 2 0.08 CM31, CM32, KM25, SM28

Assessment

The module will be assessed through continuous assessment throughout the semester. It will consist of the following assessment activities:

  1. Theoretical content test (individual assessment): At the end of the semester, students will take a written test on the theoretical contents of the course, which they must complete individually. A sample of this type of test will be available on the course Virtual Campus. This test will consist of a series of objective and semi-objective questions on the corresponding topics of the theoretical programme. The objective questions will generally be multiple-choice questions. The semi-objective questions will be short-answer open questions.
  2. Assessment of the commentaries on the proposed cases (group assessment): The three assignments submitted by each group will be assessed. Compliance with submission deadlines will be taken into account; therefore, assignments submitted after the cases have been discussed in the seminars will not be accepted.
  3. Assessment of the public discussion of the cases. Seminars (individual assessment): Student contributions during the public discussion of the cases will be assessed individually. Outstanding contributions will be taken into account, as well as passive attitudes or lack of participation during the activity.

The relative weighting of each assessment activity will be as follows:

Theoretical content test:

  • Objective test: 46%
  • 23% for each test
  • Semi-objective test: 24%

Assessment of the commentaries on the cases: 30%

10% for each case. This assessment is NOT eligible for reassessment

Assessment of the public discussion of the cases. Seminars (individual assessment): +5%

This assessment is NOT eligible for reassessment

The aim of these assessment activities is to evaluate not only whether students have acquired the conceptual knowledge of the module, but, more importantly, whether they have understood it and are able to integrate and relate the different concepts to one another. The appropriate use of terminology when addressing the questions raised during assessment will also be valued, as well as students’ ability to work in groups and to argue and discuss the topics critically and rationally.


Reassessment exam

There will be a reassessment exam for students who have not obtained a grade of 3.5 or higher in each of the theory tests.

In order to be eligible for reassessment, students must previously have been assessed in a set of activities whose weighting is equivalent to at least two thirds of the total grade for the course or module. Therefore, students will receive a grade of “Not Assessable” when the assessment activities completed account for less than 67% of the final grade.

Students may choose to waive the grade obtained in any theory test and sit the reassessment exam.


Exam review

Exam reviews will be held by appointment and within the schedule proposed by the teaching staff.


Final grade

In order to pass the course, students must complete all the theoretical content tests. Out of a total of 10 points, students must obtain a grade of 3.5 or higher in each of the three partial tests and an overall grade of 5 or higher for all the assessment activities of the course.

Students who do not reach the minimum grade of 3.5 in any of the partial tests will not be able to pass the course and will receive a maximum final grade of 4.

NOT ASSESSABLE: Students will be considered “Not Assessable” when the assessment activities completed account for less than 67% of the final grade.


Single assessment

The single assessment consists of one comprehensive exam in which the contents of the entire theoretical programme of the course will be assessed. The exam will include multiple-choice questions and open-ended questions to be developed by the students. The grade obtained in this comprehensive exam will account for 70% of the final grade for the course.

The comprehensive exam will take place on the same date scheduled for the last continuous assessment test, and the same reassessment system as for continuous assessment will apply.

In order for the grade obtained in this comprehensive exam to be used in the calculation of the final course grade, students must obtain a grade of 3.5 or higher out of 10.

Submission of the case assignments will follow the same procedure as in continuous assessment. The grade obtained will account for 30% of the final grade for the course.


Other considerations

Any irregularity committed during an assessment activity (including academic fraud, plagiarism, or the improper use of AI, unless such use is explicitly authorized in the course syllabus) that may lead to a significant alteration of the assessment result will result in a grade of 0 for that assessment activity. If the course syllabus establishes that obtaining a minimum grade in that assessment activity is an essential requirement to pass the course, or if multiple irregularities occur in the assessment activities of the same course, the final grade for the course will be 0. Furthermore, the student may be subject to disciplinary proceedings in accordance with the applicable university regulations.




Bibliography

Basis references:

• Busquets E., Mir J. Fem bioètica. Institut Borja de Bioètica. Universitat Ramon Llull. Esplugues de Llobregat. 2009.   

• Carracedo A., Casado M. y González-Duarte R. (Eds) Documento sobre pruebas genéticas de filiación. Observatori de Bioètica i Dret de la Universitat de Barcelona. Noviembre 2006.

•Casado M. (ed.). Materiales de Bioética y Derecho. Ed. Cedecs. Barcelona. 1996.

• Casado M. (ed.) Sobre la dignidad y los principios. Análisis de la Declaración Universal sobre Bioética y Derechos Humanos de la Unesco. Editorial Aranzadi. Cizur Menor. 2009.

• Casado M. y Egozcue J. (Eds) Documento sobre células madre embrionarias. Observatori de Bioètica i Dret de la Universitat de Barcelona. Diciembre 2001.

• Casado M. y Egozcue J. (Eds) Documento sobre donación de ovocitos. Observatori de Bioètica i Dret de la Universitat de Barcelona. Abril 2001.

• Casado M. y Egozcue J. (Eds) Documento sobre investigación con embriones. Observatori de Bioètica i Dret de la Universitat de Barcelona. Julio 2000.

• Casado M. y Egozcue J. (Eds) Documento sobre nanotecnología y bioética global. Observatori de Bioètica i Dret de la Universitat de Barcelona. Abril 2001.

• Casado M. y Egozcue J. (Eds) Documento sobre selección de sexo. Observatori de Bioètica i Dret de la Universitat de Barcelona. Febrero 2003.

• Casado M., Lopez-Baroni M. Manual de bioética laica (I): Cuestiones clave. Edicions de la Universitat de Barcelona. Barcelona, 2018.

• Coughlin S. Case studies in public health ethics (2nd edition). American Public Health Association. Washington, 2009.

• Cuadernos de la Fundación Victor Grífols i Lucas. Problemas prácticos del Consentimiento Informado. Fundación Victor Grífols i Lucas. Barcelona, 2002.

• De Semir, V. La ética, esencia de la comunicación científica y médica. Cuadernos de la Fundació Victor Grífols i Lucas nº 25. Barcelona .2010.

• Egozcue J., Shenfield. F. (eds.). Responses to human cloning. Sèrie Jornades Científiques nº 5. Institut d’Estudis Catalans. Barcelona. 1998.

• García Manrique R. La medida de la humano. Ensayo de bioética y cine. Materiales de Bioética. Associació de Bioètica i Dret de la UB i Observatori de Bioèticai Dret. Barcelona 2008.

• García-Manrique R. (ed.) El cuerpo diseminado. Estatuto, uso y disposición de los biomateriales huamnos. Ed. Aranzadi. Navarra, 2018.

• Harris J. On cloning. Routledge. London. 2004.

• Institut Borja de Bioètica URL (eds.). Bioètica aplicada. Ed. Proteus. Cànoves. 2011.

• Jonsen A.R., Siegler M., Winslade W.J. Ética clínica. Ariel. Barcelona. 2005.

• Kuhse H., Singer P. (eds) A Companion to Bioethics. Blackwell Companions to Philosophy. 2nd edition. Willey-Blackwell. Hong Kong. 2012.

• Llácer M.R., Casado M. Buisan L. (Eds) Documento sobre bioética y big data: explotación y comercialización de los datos de los usuarios de la sanidad pública Observatori de Bioètica i Dret de la Universitat de Barcelona. Enero 2015. ISBN 978-84-475-4210-9

• López Baroni, M. J., Marfany, G., De Lecuona, I., Corcoy, M., Boada, M., Royes, A., Santaló, J., Casado, M. 2017. La edición genómica aplicada a seres humanos: aspectos éticos, jurídicos y sociales.   Revista de Derecho y Genoma Humano. Genética, Biotecnología y Medicina Avanzada / Law and the Human Genome Review. Genetics, Biotechnology and Advanced Medicine: 46, 317-340.

• López-Baroni M. Bioética y tecnologies disruptives. Ed Herder. Barcelona, 2021.

• López-Baroni M. El origen de la bioética como problema. Edicions de la Universitat de Barcelona. Barcelona, 2016.

• Macklin R. La ética y la investigación clínica. Cuadernos de la Fundació Victor Grífols i Lucas nª 23. Barcelona .2010.

• Martín A., Martín-Arribas M.C., di Donato J.H., Posada M. Las cuestiones ético-jurídicas más relevantes en relación con los biobancos. Instituto de Salud Carlos III. Madrid. 2005.

• Montero F., Morlans M. Para deliberar en los comités de ética. Fundació Doctor Robert. Universitat Autònoma de Barcelona. Barcelona. 2009.

• Rendtorff J.D. i Kemp P. (eds.) Basic ethical principles in European Bioethics and Biolaw. Institut Borja de Bioètica. Barcelona. 2000.

• Sánchez-Caro J., Abellán F. (eds.) Investigación Biomédica en España. Aspectos Bioéticos, Jurídicos y Científicos. Fundación Salud 2000 y Editorial Comares. Granada. 2007.

• Santaló J. 2011. Ethics and genetics. A quick view. Revista de Bioética y Derecho 21, 40-45.

• Santaló J. y Casado M. (Eds) Documento sobre bioética y edición genómica en humanos. Observatori de Bioètica i Dret de la Universitat de Barcelona. Diciembre 2016. ISBN 978-84-475-4063-1

• Santaló J., Berdasco M. 2022. Ethical implications of epigenetics in the era of personalized medicine. Clinical Epigenetics. doi: 10.1186/s13148-022-01263-1.

• SEF. Reproducción Humana Asistida. Protocolos de Consentimiento Informado. Madrid, 2002.

•Steinbock B. (ed.). The Oxford Handbook of Bioethics. Oxford University Press. Oxford. 2007.

Links:
Disponibles al Campus Virtual de l’assignatura (https://cv2008.uab.cat/)
Boletín Oficial del Estado: http://www.boe.es/
Berman Institute of Bioethics: http://www.bioethicsinstitute.org/
Clinical Trials: http://www.clinicaltrials.gov/
Comissió d’Ètica en Experimentació Animal i Humana de la UAB: http://www.recerca.uab.es/ceeah/
Comité de Bioética de España: http://www.comitedebioetica.es/
Council of Europe. Steering Committee on Bioethics: http://www.coe.int/t/dg3/healthbioethic/cdbi/default_en.asp
EuroBioBank: http://www.eurobiobank.org/
Fundació Grífols: http://www.fundaciogrifols.org/es/web/fundacio/home
Institut Borja de Bioètica: http://www.ibbioetica.org/es/#&panel1-1
Observatori de Bioètica i Dret: http://www.pcb.ub.es/bioeticaidret/
Stanford Encyclopedia of Philosophy: http://www.science.uva.nl/%7Eseop/
The European Group on Ethics in Science and New Technologies: https://ec.europa.eu/research/ege/index.cfm
The Hasting Center: http://www.thehastingscenter.org/
The Hinxston Group: http://www.hinxtongroup.org/
The Nuffield Council: http://www.nuffieldbioethics.org/
UNESCO. International Bioethics Committee: http://www.unesco.org/new/en/socialand-human-sciences/themes/bioethics/international-bioethicscommittee/

Software

Not applies

Course groups and languages

The information provided is provisional until November 30. After this date, you will be able to consult the language of each group through this link. To access the information, you will need to enter the course CODE

Type of teaching Group Language Semester Shift
(TE) Theory 63 Catalan second semester morning-mixed
(SEM) Seminars 631 Catalan second semester morning-mixed
(SEM) Seminars 632 Catalan second semester morning-mixed