Ethics in Clinical Research

Objectives

· 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.

General characterization

Code

191003

Credits

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

Teaching methodologies:

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.

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

· 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

Programs where the course is taught:

Master in Clinical Research Management