Princípios éticos de investigação biomédica e introdução aos estudos biomédicos em países de baixa renda
Objectives
1. Students will acquire knowledge on the basic principles of bioethics applied to biomedical research.
2. They will be able to identify and describe the generic challenges of a biomedical research study protocol and the difficulties of designing and implementing ethically sound study protocols, namely in special settings and vulnerable populations.
3. They will develop skills to cope with these difficulties, in order to be able to produce a study protocol suitable for submission to an Ethics Committee.
General characterization
Code
9512057
Credits
Available soon
Responsible teacher
Available soon
Hours
Weekly - Available soon
Total - 28
Teaching language
PT
Prerequisites
Not applicable
Bibliography
Not applicable
Teaching method
The Unit is organized in lectures introducing the themes, followed by group discussion. Case studies will be presented and discussed in support of the learning objectives.
Evaluation method
Assessment will be continuous during the contact time. Students with a research project already defined will be asked to produce a Study Protocol to be submitted to an Ethics committee. For others, the analysis and discussion of a real-life case will be requested.
Subject matter
I. Historical aspects of the development of ethics applied to biomedical sciences.
II. Basic ethical concepts in biomedical research involving human subjects (respect, beneficence and justice).
III.Principles of clinical studies and clinical trials.
IV. Ethics in animal experimentation.
V. Contents of a Study Protocol.
VI. Essential elements of the Informed Consent form.
VII. Submitting a Study Protocol to the Ethical Committee.
VIII. Ethical challenges in clinical studies in low and middle income countries.