Section outline

    • This module addresses key ethical considerations and regulatory guidance that influence the design and conduct of clinical studies. Real world examples of current and past clinical studies are incorporated to illustrate key ethical principles among diverse study populations. This module explains the process of informed consent and the role of the Institutional Review Board. Common methods to evaluate and regulate the safety of study participants including the use of Data and Safety Monitors are discussed, along with suggestions for procedures to maintain high data standards.

    • objective Objectives

    • After completing this module, students should be able to:

      • Review ethical principles and federal regulations relevant to clinical research
      • Explain the rationale for institutional review board (IRB) approval
      • Define informed consent and strategies for obtaining informed consent
      • Discuss scientific misconduct, authorship, conflicts of interest, and ethical issues in specific types of research.
      • Identify potential data and safety issues related to research
      • Discuss the potential role of a data and safety monitor

    • Readings Reading

    • In Designing Clinical Research, 4th Edition, by Hulley et al.

      • Chapter 14: Addressing Ethical Issues
      • Chapter 17: Implementing the Study and Quality Control

    • Additional resources and examples:

                UCSF DSMB guidelines

                NIH DSMB guidelines by institute

    • Lecture Lectures

    • Ethics in Research Slides File
    • Responsible Conduct of Research Slides File
    • Data and Safety Monitoring Slides File

    • Small Group Sections

    • Small group sections for this module take place on Monday during the fifth week for Track 3 (no section during Week 5 for Track 2, due to Labor Day).

      (See section roster for your assigned time and Zoom link):

    • Assignments Assignments

    • No written assignment for this topic in this year's course.