IRB Considerations for Investigator-Initiated Research

Wednesday, November 29
Presentation: 1:00-2:00pm ET
Q&A: 2:00-2:15pm ET

When an investigator initiates a clinical trial on his or her own, without the support of an industry or federal agency sponsor, it can be an exciting opportunity to explore therapeutic possibilities near and dear to the researcher’s heart. Investigator-initiated research can also be quite challenging, as the researcher assumes the responsibilities of both principal investigator as well as of a study sponsor. Investigators new to the “sponsor-investigator” role are sometimes taken aback by the additional requirements of developing the protocol and informed consent, navigating regulatory reporting requirements, maintaining GCP and human subject protection compliance, and others.
In this webinar, Robert Romanchuk, IRB Vice Chair at Schulman IRB, will review the landscape of investigator-initiated research with a focus on the IRB’s perspective. He will explain common challenges IRBs face when reviewing investigator-initiated research and provide practical ways IRBs can work with and support those conducting this type of research.

Presentation Objectives
In this free webinar, attendees will:

  • Describe the range of investigator-initiated studies and how they differ from industry-funded and federally funded research
  • Recognize common challenges in investigator-initiated research
  • Apply practical strategies for supporting sponsor-investigators
Who Should Attend
  • IRB administrators and members
  • Institutional research administrators
  • Investigators and research support staff
  • Others involved in development and conduct of investigator-initiated research

Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.



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