Table 1 Summary of the course modules
From: Education of research ethics for clinical investigators with Moodle tool
Modules with content | Form of assignment | Evaluation |
|---|---|---|
Initial examination: Basic knowledge in bioethics and legislation related to clinical research | Multiple-choice questions | Accept/fail |
• Knowledge about basic principles in bioethics | ||
• Knowledge of the Helsinki Declaration | ||
• Knowledge of the Finnish legislation | ||
• Principles of Good Clinical Practice | ||
Information on research legislation and international declarations | Essay | Individual feedback from tutor, accept/fail |
• National legislation regarding clinical research | ||
• The Helsinki Declaration | ||
• Principles of Good Clinical Practice | ||
Approvals from national authorities for different types of research | Essay | Individual feedback from tutor, accept/fail |
• Clinical drug trials | ||
• Clinical trials on medical device | ||
• Tissue research | ||
• Register based study | ||
• Studies with GMM (genetically modified micro-organisms) | ||
Research ethics | Essay | Individual feedback from tutor, accep/fail |
• Knowledge of the basic principles of bioethics: | ||
• basic ethical principles: respect for life and autonomy, | ||
• beneficence, avoiding harm, equitable selection of subjects, privacy and justice | ||
• risk/benefit assessment | ||
• elements of informed consent | ||
• privacy and confidentiality | ||
• integrity in science | ||
Preparing own study protocol | Written study protocol (5–10 pages) summary of the previous assignments | Individual feedback from tutor, accept/fail |
Final examination | 29 general multiple-choice question | Correct answer gives a point and false remove. Three trials. |
• Knowledge of basic principles in bioethics | ||
• Knowledge of the Helsinki Declaration | ||
• Knowledge of the Finnish legislations | ||
• Principles of Good Clinical Practice | ||
• Knowledge of national authorities for different research type |