Research consent for an investigational drug when you have ties to the sponsor
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Mr. Harold Okafor is a 68-year-old retired school principal, 90 kg, scheduled tomorrow for a right total knee replacement under spinal anesthesia with an adductor canal block. A research coordinator has given him the consent form for an IRB-approved, randomized, double-blind trial. The surgeon will inject either an investigational extended-release local anesthetic or standard bupivacaine around the knee; everyone also gets the usual block and pain medicines.
You are the site's principal investigator. The sponsor pays the department a set amount for each enrolled patient to cover research staff costs, and in the year before the study opened it paid you speaking fees, which stopped when you became investigator; the hospital's research office has both on file. Mr. Okafor asked to talk with you before deciding.
Your task: answer his questions about the study and confirm his decision.