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ORA FAQs
What sections of the Informed Consent have the greatest impact with regards to research billing compliance?

COSTS-

 i.      What will be provided by the sponsor?

 ii.      What additional costs might the subject incur?

 

COMPENSATION FOR INJURY-

 i.            Is the sponsor paying for everything including adverse events?

 ii.            Will the subject’s insurance pay for it or will the cost shift to the subject?

 

45 CFR 46.116(b)(3): Department of Health and Human Services (DHHS) Regulations on the Protection of Human Research Subjects; and 21 CFR 50.25(b)(3):  FDA Regulation on Human Subjects, Informed Consent


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