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Ethics in Health Research

Code: DMDB05     Acronym: ETINVS

Keywords
Classification Keyword
OFICIAL Ethics in Health Sciences

Instance: 2022/2023 - 1S

Active? Yes
Responsible unit: Graduate Management Unit
Course/CS Responsible: Dental Medicine

Cycles of Study/Courses

Acronym No. of Students Study Plan Curricular Years Credits UCN Credits ECTS Contact hours Total Time
DMDB 5 Official Plan from the 2021 school year 1 - 3 24 81

Teaching language

Portuguese

Objectives

This curricular unit (3 ECTS) aims at the following objectives:
- Knowledge of the fundamental legislation regarding the ethical principles in health research;
- To discuss the fundamental ethical issues in health research;
- To know the operating methodology of an Ethics Committee for Health;
- To develop competences for the submission of protocols to an Ethics Committee for Health;
- To discuss the connection between Ethics and healthcare costs;
- To analyze the fundamental issues in Bio-law;
- To satisfy the legal and ethical requirements to the development of a health science's research project.

Learning outcomes and competences

The theoretical exposure accompanied syllabus of the practical demonstration allows students to recognize the importance of taught subjects.

The relationship and interdependence between the theoretical and the practical application enables students to the achievement of learning objectives.

Working method

Presencial

Program

Fundamental principles of health care ethics.

Ethics in relation to the patient. Research and experimentation.

Ethics in health research.

Ethics Committee for Health

Ethical issues in animal research and experimentation.

Ethical issues in human research and experimentation - Clinical trials.

Research in particularly vulnerable groups.

Ethics committees and conflicts of interest.

Submission of protocols to Ethics Committees.

Ethical issues in emerging biomedical technologies.

Ethics and the costs of health care.

Fundamental legislation and regulations in health research.

Mandatory literature

Nunes, R.; Ensaios em Bioética, Brasília: Conselho Federal de Medicina, 2017.
Nunes, R.; Diretivas Antecipadas de Vontade, Brasília: Conselho Federal de Medicina, 2016.
Shamoo, A.E. & Resnik, D.; Responsible Conduct of Research, Oxford: Oxford University Press, 2009.
Nunes, R.; Gene-Ética, Coimbra: Almedina, 2013
Nunes, R. & Rego, G.; Prioridades na Saúde, Lisboa: McGraw-Hill, 2002.
Beauchamp, T. & Childress, J.; Principles of Biomedical Ethics, New York: Oxford University Press, 2001.
Serrão, D. & Nunes, R.; Ética em Cuidados de Saúde, Porto: Porto Editora, 1999.
Comissões de Ética.; Decreto-Lei n.º 80/2018 de 15 de outubro
Lei da investigação clínica.; Lei n.º 21/2014, de 16 de abril

Teaching methods and learning activities

The UC includes theoretical classes and theoretical-practical classes.

Theoretical exposition of the topics described in the syllabus;

Case studies performed within groups or individually followed by group discussions;

Analysis of research protocols/informed consent documents;

Use of trigger videos to generate discussions;

The writing of an informed consent form;

Review of protocols;

Elaboration of protocols for submission to Ethics Committees.

Evaluation Type

Distributed evaluation without final exam

Assessment Components

Designation Weight (%)
Participação presencial 50,00
Trabalho escrito 50,00
Total: 100,00

Amount of time allocated to each course unit

Designation Time (hours)
Estudo autónomo 57,00
Frequência das aulas 24,00
Total: 81,00

Eligibility for exams

In accordance with current legislation.

Calculation formula of final grade

Distributed evaluation without final exam.

Evaluation components:

- Performance in theoretical-practical classes (50%);

- Elaboration of a written work and its oral presentation (25%);

- Discussion of a work presented by another student of the course (25%).
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