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How are study subjects made aware of possible costs associated with participation?
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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

The FDA informed consent regulations require the consent document to include a description of any additional costs to the subject that may result from participation in the research. IRBs should ensure that the informed consent documents outline any additional costs that will be billed to study subjects or their insurance company as a result of participation in the study. IRBs should also ensure that any such charges are appropriate and equitable.

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