· State the ethical principles of clinical research;
· Understand the ethical and legal framework of human research;
· Relate concrete research situations with ethical implications;
· Contextualize good clinical practice in research;
· Describe the responsibilities of the various stakeholders in clinical research;
· Raise awareness of ethical review procedures;
· Recognize an acceptable benefit-risk relationship in a clinical trial;
· Explain the ethical and scientific issue of placebo-controlled studies;
· Identify areas of potential conflicts of interest;
· Recognize the implications of fraud or misconduct;
· Understand the importance of publishing and disseminating clinical trials;
· Recognize the importance of including vulnerable populations in clinical trials;
· Understand Informed Consent as a process;
· Identify the conditions for obtaining informed consent and re-consent.
Prof.ª Doutora Maria Alexandra Fernandes Tavares Ribeiro
Portuguese or English
· 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.
Lectures, and sessions of guidance and discussion by the teacher on specific cases. Discussion of papers.
Minimum attendance: 5 classes.
Failure to comply with minimum attendance (less than 5 classes) determines the failure to curricular unit.
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.
· Introduction to clinical research;
· Good Clinical Practices (GCP) in Research;
· Ethical evaluation of clinical studies;
· Informed Consent (CI);
· Research with vulnerable "populations";
· Conflict of interests, fraud, and misconduct;
· Publication and dissemination of clinical studies.
Programs where the course is taught: