Ethics in Clinical Research
Objectives
General characterization
Code
191003
Credits
6
Responsible teacher
Prof.ª Doutora Maria Alexandra Fernandes Tavares Ribeiro
Hours
Weekly - Available soon
Total - Available soon
Teaching language
Portuguese or English
Prerequisites
Bibliography
· The Oxford Textbook of Clinical Research Ethics. Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller and Davis Wendler (Eds.) Oxford University Press, 2008.
· Ethical Issues in Clinical Research. A Practical Guide. Lo B.; Lippincott Williams & Wilkins (Eds), Philadelphia, 2010.
· ICH-GCP ICH Harmonised Tripartide Guideline. Guideline for Clinical Practice E6(R2), 2016.
· Bioética e Vulnerabilidade. Ana Sofia Carvalho (Coord.), Almedina, 2008.
· Investigação Biomédica. Reflexões Éticas, Paula Martinho da Silva (Coord), CNECV, Gradiva, 2008.
· Direitos do Homem e Biomedicina. Instituto de Bioética, UCP, Universidade Católica Editora, 2003.
Teaching method
Evaluation method
Final exam (multiple-choice test) with 40 questions scored for 80%.
Written work (maximum 4 pages, space and a half, Times New Roman, pitch 12) on one of the topics covered in the class scored for 20%. It must include a critical analysis/reflection on the topic presented and must be previously proposed and discussed with the teacher. The final rating (exam and written work) is normalized to a 0-20 scale.
Subject matter