Universidade Nova de Lisboa

Universidade Nova de Lisboa

NOVA Medical School | Faculdade de Ciências Médicas

Ethics in Clinical Research

Code

191003

Academic unit

Nova Medical school | Faculdade de Ciências Médicas

Credits

6

Teacher in charge

Prof.ª Doutora Maria Alexandra Fernandes Tavares Ribeiro

Teaching language

Portuguese or English

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.

Prerequisites

 

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.

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.

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