Ethical and Regulatory Aspects of Clinical Research
This course is offered to anyone interested or involved in the ethics of clinical research with human subjects. Participants represent multiple disciplines including research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students, and others.
Course Objectives
Upon completion of this course, you should be able to:
- Utilize a systematic framework for evaluating the ethics of a clinical research protocol.
- Identify, define, and consider ethical issues in the conduct of human subject research.
- Apply appropriate codes, regulations, and other documents governing the ethical conduct of human subject research to their own research.
- Describe the purpose, function, and challenges of IRBs.
- Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
- Identify and apply relevant considerations for assessment of research risks and benefits.
- Explore the ethical requirement of fair subject selection and its application.
- Appreciate ethical challenges with conducting international collaborative research in low- and middle-income countries.
View the 2023 course syllabus and more detailed information about previous years' courses.
2024 Course Information
Our annual Ethical and Regulatory Aspects of Clinical Research course will be offered in Fall 2024 (from September 25 to November 13).
Please e-mail questions or comments to bioethics-inquiries@mail.nih.gov.