Universitat Internacional de Catalunya - Barcelona

Clinical Research Ethics

• code 12179
• course 1
• term Semester 2
• type OB
• credits 2

Main language of instruction: Catalan

Other languages of instruction: English, Spanish

Head instructor

Dra. Laia WENNBERG - lwennberg@uic.es

Other instructors

Dra. Mireia LLAURADO - mllaurados@uic.es

Office hours

To agree with the teacher

The scientific activity has some ethical criteria that orient in the task of the investigation in its different experimental or academic slopes. In this subject you will know what they are, how to take into account different aspects related to the research ethics, both in the design and execution of the project and in the authorship, financing and conflicts of interest.

There are no prerequisites.

1. To know the ethical issues that regulate the research.
2. Rate from an ethical point of view the different reserach designs.
3. Rate from an ethical point of view the different research designs.

• CB10 - To have the learning competences that allow them to continue to study in a way that will have to be mainly independent.
• CB8 - To able to incorporate their knowledge and cope with the complexity of formulating judgements based on information that, since it is incomplete or limited, includes reflections on the social and ethical responsibilities linked to the application of their knowledge and judgements.
• CB9 - To be able to communicate their conclusions and the knowledge and arguments supporting these conclusions to specialised and non-specialised audiences in a clear and unambiguous manner.
• CE10 - The ability to critically analyse and discuss research results and transmit the relevant outcomes
• CE8 - To know how to assess research projects and protocols
• CE9 - To know how to apply specific theoretical and practical knowledge to health science research.
• CG4 - The ability to articulate and defend one's own scientific ideas in an ethical way with regard to the research process
• CT1 - The ability to integrate within an established, multidisciplinary and multicultural work team.
• CB6 - To have and understand knowledge that provide a basis or opportunity to be original in terms of the applkication of ideas, often within a research context.
• CB7 - To know how to apply the knowledge acquired and resolve problems in unknown or little known environments within broader (or multidisciplinary) contexts related to their area of study.
• CG1 - The ability to incorporate new knowledge acquired through research and study and cope with complexity.

1. The student recognises and reflects about the different ethical dilemmas of the research.
2. The student knows the different international laws of the ethics research.
3. The student distinguishes the designs of research and realises a critical estimation of them.

1. Ethics of the research in sciences of the health and in people. 
2. Committee of ethical of the research in health sciences. 
3. Writing and content of the informed consent.
4. Participation of the human in experimental studies in health sciences. 
5. Ethics applied to the evaluation of projects and studies of research in health sciences. 
6. Ethics of the scientific publication.
7. International laws on ethics of the research in health sciences.

The formative activities will follow the following dynamic:

1. Exhibition class: exhibition session made by the teacher that have as a purpose, transmit some introductory knowledges of the subject to stimulate the reflection of the student.
2. Autonomous learning: study of the subject from the indicated bibliography.
3. Seminar or mentoring group: dicussion of problems and cases.
4. Written exercise: individual realisation of a comment of a text, or of a brief essay of personal reflection by the students about the main theme exposed in class.
5. Method of the case.

The assessment of students is done through oral and written assignments as directed by the teacher.

• Galende Domínguez, Inés. La ética en investigación clínica y los comités de ética en investigación clínica. Fundación AstraZeneca, 2008.

• Keyeux, Genoveva i cols. Ética de la investigación en los seres humanos y políticas de salud pública. UNESCO y Universidad Nacional de Colombia. 2008. Disponible a: http://unesdoc.unesco.org/images/0015/001512/151255s.pdf

• Galende, I. La ética en investigación clínica: la Declaración de Helsinki-Seúl 2008. JANO 2009;1754:35-41.