This course explores regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations and institutional review boards. Topics covered include IRB review, risk-benefit assessment, informed consent, confidentiality and HIPAA compliance, conflicts of interest, the inclusion of women and minorities in clinical research, and pediatric research.
Upon completion of this course, you will be able to:
- Explain the scope of application of the federal Common Rule and FDA human subject protection regulations
- Appreciate other key regulatory requirements applicable to clinical research, including the HIPAA Privacy Rule, NIH and FDA conflict of interest regulations, and NIH and FDA policies on the inclusion of women and minorities in clinical research
- Articulate the core requirements of institutional review board (IRB) review of clinical research
- Apply the regulatory standards governing clinical research to different types of research protocols
- Design IRB policies and procedures in light of applicable regulatory requirements
- Critique existing law and policies on research with human subjects
- Evaluate proposed changes in the regulations governing research with human subjects and assess their implications for researchers, research subjects, institutions and sponsors
- Recognize situations in which professional legal advice is necessary and communicate effectively with professional legal counsel
The Clinical Research and the Law course can be completed in just 8 weeks. Coursework must be completed in the sequence in which it is offered. You should plan to spend about 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.