Navigate the maze of regulatory requirements applicable to clinical research with human participants
Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval
Analyze proposed regulatory changes and assess their potential impact on researchers, research subjects, institutions, and sponsors
This course immerses students in the laws, regulations, and ethical guidelines applicable to designing clinical research in the United States, the European Union, and elsewhere in the world. Topics covered include an overview of the regulatory framework in the US, the EU, and other regions; the role of international ethical guidelines; ethical and regulatory considerations in choosing a study methodology; informed consent; confidentiality and data protection; the inclusion of women and minorities in clinical research; pediatric research; and post-trial obligations.