Learning Objectives
Upon completion of this course, participants should be able to:
- Cite historical events that influenced current ethical guidelines and federal regulations
- Identify and explain the eight core values central to RAPS’ Code of Ethics
- Outline the necessary elements for obtaining valid and meaningful informed consent
- Discuss institutional review boards (IRBs), their membership requirements and scope as well as how IRBs are regulated and the protections they ensure
- List study criteria necessary to be approved by an IRB
- Define compliance and describe why it is critical for individuals and corporations
- Identify common compliance and ethical issues presented in the market place, including concerns and special considerations for publicly traded companies
Target Audience
This course is intended for regulatory professionals and support staff, medical personnel (physicians, nurses), clinical investigators, research personnel, quality systems (compliance) managers, legal professionals, statisticians and corporate management.