Seeing a familiar face at a study site is not uncommon in either biomedical or social and behavioral research. Oftentimes researchers and institutional review board (IRB) staff discover that a subject in one of their trials was enrolled, is planning to enroll, or is currently enrolled in multiple studies. This creates a potentially unsafe situation for the subject and risks compromising study data. It also puts investigators and IRBs at risk of violating the subject’s confidentiality and autonomy should they confront or expose the individual. Learning to weigh these risks enables IRBs and researchers to make informed decisions to prevent and manage problems related to simultaneous and sequential study enrollment. (Presented on April 13, 2016)
Federal regulations are silent on this issue, and so it falls on institutions to address multiple study enrollments on a local level. How can researchers modify their recruitment strategies to prevent co-enrollment? And how can IRBs best support and guide researchers?
During this webinar, an IRB professional and an experienced researcher:
- Defined and estimated the prevalence of simultaneous and sequential study enrollment across the research enterprise
- Discussed best practices for IRBs and investigators to address this complex situation
- Presented multidisciplinary case studies from a range of research activities to aid attendees in recognizing and preventing co-enrollment at their own institutions
- Provided clear considerations for policy development
What will I learn?
By the end of this intermediate-level webinar, attendees were able to:
- Appreciate and navigate the tension between subject autonomy, risk, confidentiality, and data integrity when it comes to simultaneous and sequential study enrollment
- Provide informed support to their local research community for how to effectively manage this scenario
- Draft a Standard Operating Procedure (SOP) related to policy on co-enrollment
Who should attend?
IRB chairs, members, administrators, and staff; researchers and research staff; as well as other compliance personnel benefited from this webinar.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1 continuing education credits towards CIP recertification. Learn More »
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DupCheck is a web-based tool used globally to screen for duplicate patients and volunteers in clinical trials across studies, sponsors and therapeutic areas. Duplicate enrollment harms both study participants and studies.
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