Topic outline

Historical Overview

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Values and Concepts of Ethics for Research Involving Humans

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Overview of Normative Frameworks and Introduction to Research Ethics Evaluation

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Ethical Review Process and Potential Role of Patients

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Clinical Trials in Non-Standard Situations

’Clinical trials in non-standard situations’ presentation by Markku Toivonen Toivonen, MD, PhD Scientific Director NDA Regulatory Science Ltd

Provided unmodified from: EURORDIS Training Module on Methodology. Access:


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