Risk assessment is the process by which the IRB determines whether a study is minimal or greater than minimal risk. The level of risk assigned on a research protocol affects other determinations in a given study.
All researchers want their studies be reviewed and approved quickly. Risks in the study can slow the process as the level of risk assigned on a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed, additional protections put in place, frequency of review, consent requirements, negotiation of indemnification language and several other factors. Understanding how risk levels are assigned and making preliminary determinations when designing the study can help you put protections in place that would reduce the level of risk that could provide greater flexibility in areas of your protocol such as mode of review, consent, or data safety monitoring.
According to 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. 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. The more that is done to reduce or minimize potential risks to research participants, the fewer regulatory requirements there are, reducing burdens on the researchers and their teams.
In this session, expert Sarah Fowler-Dixon will provide in-depth insights on research studies that are assigned a risk rating, what that risk rating means, what you can do to minimize risks to participants, and much more!
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Who Should Attend?
- Dr. David Lim
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...
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