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Institutional review boards (IRBs) routinely review studies employing observational research design. This type of research is non-interventional and comprised of cohort studies (prospective or retrospective), cross-sectional survey research, or case-control studies.

Using case-based examples coupled with didactic information, this webinar explores the types of observational research IRBs frequently encounter, and imparts best practices for comprehensive and efficient protocol review.


Learning Objectives

  • Identify the key characteristics of the three main types of observational research studies (cohort, cross-sectional, and case-control).
  • Recognize the risks to subjects related to each observational research design.
  • Understand the types of bias associated with each study design.
  • Apply IRB review criteria to observational studies for effective protocol review and constructive feedback for the investigator.
  • Discuss the level of IRB review typically employed for the various types of observational studies.
  • Explain when a waiver of consent and a waiver of HIPAA authorization would be appropriate.



Graduate Students, HRPPs, IRB Members and Administrators, Institutional Officials, Researchers


Meet the Presenter

Ilene Wilets, PhD, CIP – Icahn School of Medicine at Mount Sinai
Ilene Wilets, PhD, CIP, is an IRB Chair with the Icahn School of Medicine at Mount Sinai in New York. She is an Associate Professor in the Department of Environmental Medicine and Public Health, an Associate Professor in the Department of Global Health and Health Systems Design at Mount Sinai, and Adjunct Associate Professor with the Clarkson University-Mount Sinai Program in Bioethics.