Abstract:

Background
Student learning has gradually shifted from a teacher to a learner centered approach. In this context we developed a blended, learner driven, activity focused to identify the basic ethical principles applicable to clinical research.

Methods
The students (groups of 3 – 4 students each) were asked to review four main documents that address human experimentation: the Hippocratic Oath (c. a. 400 BC), the Nuremberg Code (1947) the Declaration of Helsinki (1964) and the UN Declaration of Bioethics (2006). Following their revision, all the students together watched the commercial film Extreme Measures, 1996 to identify and evaluate issues related to medical ethics portrayed in the film. Then, a debate would follow to ensure that the students develop and articulate a consistent critical analysis of the key points of the film. Finally the students submitted a synthesis of the documents and a short assay of their critical analysis of the research ethics positions portrayed in the film (utilitarianism, consequentialism, Kantian and principlism ethics). These assignments were assessed and contributed towards the general pharmacology module.

Results and discussion
The review of the four selected documents, led the students to recognize (1) the implemental gradual steps in each declaration and (2) the value of the patient as a person with full rights and dignity as the essence of each declaration. Interestingly, some students viewed the Nuremberg Code more subject oriented versus the Declaration of Helsinki as more method oriented. From these documents, but for most of the students based on the Hippocratic Oath, they concluded the principle of respect towards human goods that cannot be taken from the patient as the key feature in bioethics/ clinical research. The debate following the film brought forward some factors that may affect ethical decisions and their type, whether choosing one patient over another is a moral- or an ethic-based decision [first scene of the film]. Another point of debate was the scientist’s statement “what would you do to walk again?” that was interpreted in a more general context: “what would you do to preserve your quality of life?” This was analyzed from the four ethical perspectives mentioned above.

Conclusions
The post activity assays showed that the students reached the expected outcomes: knowledge of the researcher-volunteer relationship and identification of failures to follow Good Clinical Practices. Furthermore, they were provided with the opportunity to develop cognitive competences (critical and relational analysis) within the Bloom and Fink´s taxonomies of learning (knowledge, comprehension, analysis and fundamental knowledge respectively). This activity may be useful for medical, nursing and pharmacy students alike.

Keywords:

Bioethics, Medical Ethics, Medical Education, Instructional Design.