25-08-2017, 09:32 PM
Assessing Risk in Human Research Protocols
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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.
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.
Areas Covered in the Session
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