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Live Webinar
on
Assessing Risk in Human Research Protocols
Date & Time: Tuesday, January 29, 2013
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Sarah Fowler-Dixon
Location: Online
Price : $195.00
Register Now
(for one participant)
Instructor Profile: Sarah Fowler-Dixon Education Specialist and instructor , Washington University
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
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. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. ....more
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. Risk rating also affects how elaborate a data safety monitoring plan will be required and measures put in place to protect privacy for the individuals and confidentiality of the data.
Why should you attend:
All researchers want their studies be reviewed and approved quickly. Risks in the study can slow the process as the level of risk assigned a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed,
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Areas Covered in the Session: Your Necessity is our Priority l l l l l l
What is risk assessment? Why is risk assessment important? How can you make preliminary risk assessments? What does risk assessment affect? What are some methods of reducing risks in a research study? Examples
Click here to register for this webinar Who Will Benefit: l l l l l l l l
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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