Research Ethics Practice Test

A hospital pharmacy conducts a pharmacogenomics study to optimize dosing of an antiepileptic drug. The consent form explains study procedures and risks, but it does not address how genetic data will be stored, who will have access, or whether results could be shared outside the care team; the study has ethics committee approval and cites GCP. A resident suggests using identifiable genetic data in future unrelated projects without re-consent. What is the primary ethical concern in this study?

A pharmacy clinic studies a new migraine medication and uses a consent form that states participation is voluntary, but the pharmacist tells patients they will be “moved to the back of the line for refills” if they decline. The protocol has ethics committee approval and the team states they follow GCP and the Belmont Report. Confidentiality protections are appropriate. What is the primary ethical concern in this study?