This version of the course guide is provisional until the period for editing the new course guides ends.

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Biochemistry: Legal and Social Aspects

Code: 100897 ECTS Credits: 3
2025/2026
Degree Type Year
Biochemistry OB 3

Contact

Name:
Marta Martin Flix
Email:
marta.martin@uab.cat

Teachers

Xavier Vallve Sanchez

Teaching groups languages

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


Prerequisites

There are no prerequisites for taking this course, but it is recommended that students have basic prior knowledge of research and basic and advanced techniques in the fields of biology, biosciences, and biomedicine. It is also important that students have a good level of English to enable them to take advantage of the bibliographies, websites, and reports provided in that language. Finally, it is important that students in this course demonstrate an open, participatory, communicative, respectful, and curious attitude during the learning activities.


Objectives and Contextualisation

The subject Biochemistry: Legal and Social Aspects has a complementary character to the degree and is intended for students to acquire knowledge about the ethical and legal aspects related to Biochemistry, biosciences and associated research.

The educational objectives are that students, upon completing the subject, are able to:

  • Know and apply the basic principles of bioethics.
  • Apply legal principles in the context of the manipulation of biological systems and the application of molecular life sciences.
  • Apply legal principles regarding the research and development of bioproducts.
  • Apply the principles of intellectual and industrial property law in the research and development of bioproducts.
  • Apply patent regulations.
  • Explain the social perception of science and technology and their importance in adequately communicating the achievements and risks associated with biomedical advances, especially those related to biochemistry.
  • Know how to communicate effectively both orally and in writing.
  • Promote a critical attitude committed to gender equality and social justice in the bioethical field.
  • Assume an ethical commitment.
  • Identify the problems arising from the progress and application of technology in human beings, genetics, and the beginning and end of life.
  • Create an appropriate discussion space to facilitate the adoption of well-founded personal positions and possible consensus that allow for an evaluation of existing social conventions and one's own moral convictions.

Learning Outcomes

  1. CM34 (Competence) Integrate economic principles with corporate social responsibility and sustainable development.
  2. KM35 (Knowledge) Describe the legal and ethical foundations of molecular life sciences.
  3. KM36 (Knowledge) Describe the principles of intellectual and industrial property law in the development of biotechnological products.
  4. SM36 (Skill) Perform a biotechnological risk analysis in the development of new foods, medicines, medical devices and genetically modified organisms (GMOs).
  5. SM37 (Skill) Apply the principles of bioethics and patent law to the research and development of new products in the field of biochemistry and biotechnology.
  6. SM38 (Skill) Analyse the principles of the organisation and management of the functional areas of a company in the field of biochemistry and biotechnology.

Content

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. ETHICS IN RESEARCH

  • Ethical Principles in Scientific Practice and Biomedical Research
  • Obligations of Researchers
  • Codes of Good Practice in Research

PART III. ETHICAL DESIGN OF ANIMAL TESTING

  • Ethical Aspects of Animal Research
  • Basic Principles: The 3Rs
  • Legal Aspects of the Use of Experimental Animals: RD 53/2013

PART IV. ETHICAL DESIGN OF HUMAN EXPERIMENTATION

  • Ethical principles of human research,
  • The subjects
  • Legal aspects of research on human subjects and human samples: Law 3/2018, RD 1716/2011, Law 14/2007 and 14/2006

PART V: ETHICAL ASPECTS OF NEW TECHNOLOGIES

  • Genetics, genetic engineering and biotechnology, reproductive medicine, and gene editing.
  • Bioethics and genetic and health data: databases and use of data. Law 3/2018, Regulation 2016/679, and Art. 5 of Law 14/2007.

PART VI: OTHER LEGAL ASPECTS

  • Law 15/1999
  • Law 9/2003

Part VII: PATENTS

  • Intellectual and industrial property rights.
  • Patents in chemistry, pharmacy, and biotechnology.
  • Patent drafting and infringement.
  • Patent documentation.

Activities and Methodology

Title Hours ECTS Learning Outcomes
Type: Directed      
Seminars 3 0.12 CM34, KM35, KM36, SM36, SM37, SM38, CM34
Theoretical sessions 19 0.76 CM34, KM35, KM36, SM36, SM37, SM38, CM34
Type: Autonomous      
Case study: discussion preparation 3 0.12 CM34, KM35, KM36, SM37, CM34
Case study: general discussion 15.5 0.62 CM34, KM35, KM36, SM37, CM34
Study 29 1.16 CM34, KM35, KM36, SM36, SM37, SM38, CM34

The course consists of theoretical lectures and analysis and discussion of proposed cases in a seminar format.

THEORY: The content of the theoretical program will be taught primarily by the faculty in the form of lectures with audiovisual support. Some classes will use the flipped lessons methodology, in which the topics are prepared in advance by the students based on material provided by the faculty and subsequently worked through with practical cases in face-to-face sessions. The presentations used in class by the faculty will be previously available on the Virtual Campus for the course.

Although it is not essential to expand on the content of the classes taught by the faculty, unless specifically requested by the faculty, it is advisable that students regularly consult the documents referenced in the theoretical classes (which will be available on the Virtual Campus), as well as the bibliographic material recommended in this teaching guide, to consolidate and clarify the content explained.

Students should individually work on the content of the legal texts referenced in this guide. To facilitate this task, students will be provided with documents containing the full text and a copy of the regulatory text (Virtual Campus).

In addition to class attendance, the proper functioning of the course requires students to play an active role, participating in solving case studies and practical exercises related to the contents of the theoretical program. This type of work will be carried out in small groups to promote cooperative and thought-based learning.

SEMINARS: There will be three seminar sessions throughout the course, and half of the class will attend each session. At the beginning of the course, students will be required to form groups of four to six people. It is important that all group members attend the seminars on the same day, as collaborative and in-person activities will be carried out during the seminars. The cases discussed during the seminars will be previously available on the Virtual Campus.

ATENTION: Attendance at the seminars is mandatory and essential to pass the course.

Bioethics Seminars (2 seminars): Each group will work on two bioethical cases throughout the course. These cases must be submitted in writing before the corresponding seminar date. During the seminar, the case will be graded and discussed jointly. Each group will receive two anonymized papers from other groups to grade. The evaluation will be conducted using a common rubric and include a numerical grade and a justified commentary. This commentary will be reviewed by the faculty and included as part of the evaluating group's grade, with the aim of encouraging rigorous, critical, and constructive evaluation.

Patent Seminars (1 seminar): Each group will prepare a case related to legal issues and/or patents and submit it on the day of the seminar session. This will then be followed by a discussion between the groups, moderated and guided by the faculty.

USE OF AI: In this subject, the use of Artificial Intelligence (AI) technologies is permitted as an integral part of the assignment, provided that the final result reflects a significant contribution from the student in analysis and personal reflection. Students must clearly identify which sections were generated with this technology, specify the tools used, and include a critical reflection on how they influenced the process and final outcome of the assignment. Lack of transparency in the use of AI will be considered a breach of academic honesty and may result in a penalty on the assignment grade, or greater sanctions in serious cases.

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

Continous Assessment Activities

Title Weighting Hours ECTS Learning Outcomes
Bioethical practical case 15% 1 0.04 KM35, SM36, SM37
Seminars assesment 30% 2 0.08 CM34, KM35, KM36, SM36, SM37, SM38
Theoretical content assessment: bioethics 28% 1 0.04 KM35, SM36, SM37
Theoretical content assessment: legal and patents 27% 1.5 0.06 CM34, KM35, KM36, SM37, SM38

CONTINUOUS ASSESSMENT:

THEORY (55%): To assess the theoretical content of the course, a short-question and/or multiple-choice exam will be administered. There will be one test to assess bioethics content (28%) and another to assess patent content (27%). The grade obtained in these exams will account for 55% of the course grade. For the theory grades to be averaged among themselves and with the rest of the course grades, a minimum score of 3.5 points must be obtained in each theory test. Students who obtain a grade lower than 3.5 in any of the tests may retake the content on the day of the final retake exam.

To be eligible for retake, students must have submitted at least 67% (i.e., more than 3) of the scheduled assessment activities, considering the following as assessment activities: i) each theoretical content assessment test; ii) each seminar.

PRACTICAL CASE STUDIES (15%): In the case of the bioethics section, on the day of the theoretical exam, each student must individually solve a practical case in the field of bioethics. The grade obtained for solving the case will account for 15% of the course grade.

SEMINARS (30%): The evaluation of the seminars is based on prior preparation, the quality of the presented work, and active participation during the sessions. The three papers presented by each group will be evaluated. Compliance with the deadlines will be taken into account; papers submitted after the case discussions in the seminars will not be valid. All group members will receive the same grade.

Bioethics Seminars (20%): Each group must submit a written solution to two bioethical cases in advance. The cases will be anonymized and, on the day ofthe seminar, will be evaluated by two different groups using a common rubric. Each evaluating group will issue a numerical grade and a justified comment, which will be reviewed by the faculty. This comment will be assessed as part of the evaluating group's grade to ensure rigorous and constructive peer assessment. Therefore, for each group, the seminar grade will be the numerical average of the grades received by the evaluating groups, weighted by the faculty's grade on the evaluations they gave to other groups.

Patent Seminar (10%): Each group will submit a case related to legal issues and/or patents, which will be discussed and commented on with the faculty, who will evaluate the work presented by each group.

The objective of these tests is to assess not only whether students have acquired conceptual knowledge but, more importantly, whether they have understood it and are able to integrate and relate it to each other. Furthermore, students will also be assessed for their use of appropriate terminology when addressing the questions posed during the assessment, as well as their ability to work in groups and critically and rationally argue and discuss the topics covered.

To pass the course, students must complete all theoretical content tests. Out of a total of 10 points, students must obtain a grade equal to or higher than 3.5 points in each of the three partial tests and an overall grade equal to or higher than 5 points for all the assessment tests for the course. Students who do not achieve the minimum grade of 3.5 points in any of the partial tests will not be able to pass the course and will receive a maximum final grade of 4 points.

SINGLE ASSESSMENT:

The single assessment consists of a single summary test in which the entire theoretical content of the course will be assessed. The exam will consist of multiple-choice questions, short questions, and a practical case study and a student-developed case study. The grade obtained in this summary test will account for 70% of the final grade for the course.

The summary test will be administered on the same date as the last continuous assessment test, and the same resit system will be applied as for the continuous assessment.

In order to use the grade obtained in this summary test as an average for the final grade for the course, a grade equal to or greater than 3.5 out of 10 is required.

Case submissions will follow the same procedure as for the continuous assessment. The grade obtained will account for 30% of the final grade for the course.

GENERAL CONSIDERATIONS:

  • Students who are unable to attend an individual assessment test for a justified reason (such as a health problem, death of a relative up to the second degree, accident, elite athlete status and a compulsory competition or sporting activity, etc.) and who provide the corresponding official documentation to the subject faculty and explicitly state their inability to take an exam, a police report, justification from the competent sports organization, etc., to the subject coordinator will be entitled to take the test on another date. The degree coordinator will ensure this is arranged, after consulting with the subject faculty.
  • Students who have passed the theory exams, the practical case, and the seminars may take the exam to IMPROVE THEIR MARK. They will be examined on the theory exam and will complete a new practical case. To be able to take the exam to improve their mark, they must renounce their previously obtained mark in writing (email), notifying the faculty responsible for the subject at least three days before the make-upexam. The grade taken will be the grade for the last exam/practical case completed.
  • NON-ASSESSABLE: Students will receive a grade of non-assessable if they have attended less than 67% (i.e., 3 or fewer) of the scheduled assessment activities. Assessment activities include: i) each theoretical content assessment test; ii) each seminar.

Bibliography

Basic Bibliography

• 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:

Berman Institute of Bioethics: http://www.bioethicsinstitute.org/

Boletín Oficial del Estado: http://www.boe.es/

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

Disponibles al Campus Virtual de l’assignatura (https://cv2008.uab.cat/)

EuroBioBank: http://www.eurobiobank.org/

European Patent Academy: http://www.epo.org/about-us/office/academy.html

Fundació Grífols: http://www.fundaciogrifols.org/es/web/fundacio/home

Observatori de Bioètica i Dret: http://www.pcb.ub.es/bioeticaidret/

OEPM: http://www.oepm.es

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/

UNESCO. International Bioethics Committee: http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/international-bioethics-committee/

WIPO: http://www.wipo.int


Software

Not applies


Groups and Languages

Please note that this information is provisional until 30 November 2025. You can check it through this link. To consult the language you will need to enter the CODE of the subject.

Name Group Language Semester Turn
(SEM) Seminars 331 Catalan second semester morning-mixed
(SEM) Seminars 332 Catalan second semester morning-mixed
(TE) Theory 33 Catalan second semester morning-mixed