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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 has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

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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