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Live Webinar on
Study Risk and How it Affects Approval Date: Thursday, June 12, 2014 Duration:
60 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Sarah Fowler-Dixon
Overview: 45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." How the study is designed can minimize potential risks to participants. Studies that are deemed "minimal risk" have greater options when it comes to using an expedited review system and options for consent.
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What is risk assessment?
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Why is risk assessment important? How can you make preliminary risk assessments?
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What does risk assessment affect? What are some methods of reducing risks in a research study? Examples
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Principal Investigators / Sub-Investigators. Clinical Research Scientists (PKs, Biostatisticians,) Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting Staff QA / QC Auditors and Staff Clinical Research Data Managers Human Research Protection Professionals
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About Speaker Sarah Fowler-Dixon Education Specialist and instructor , Washington University Sarah Fowler-Dixon PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.... more
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