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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

By the end of this course, participants are 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 and apply relevant considerations for assessment of research risks and benefits.
  • Explore the ethical requirement of fair subject selection and its application.
  • Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.
  • Appreciate ethical challenges with conducting international collaborative research in low- and middle-income countries.

Course Syllabus

View a final version of the 2022 course syllabus.

Course materials from 2022 and previous years can be viewed at the links below.

2023 Course Information

Our annual Ethical and Regulatory Aspects of Clinical Research course will be offered in Fall 2023 (September 20–November 1).

Please e-mail questions or comments to

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