A 32-year-old man with a history of hypertension enrolls in a randomized controlled trial comparing a new antihypertensive agent to standard care. He is randomized to the control arm. On day 45 of the study, he develops sudden onset expressive aphasia and right-sided hemiparesis. Brain MRI confirms an acute ischemic stroke in the left middle cerebral artery distribution. His blood pressure at presentation is 168/102 mmHg. The study investigators maintain the blinding protocol and do not inform the patient or his family about his group assignment, citing protocol adherence. Which of the following regulatory frameworks most directly mandates that researchers disclose adverse events and relevant trial information to study participants?
- A)The Hippocratic Oath
- B)The Health Insurance Portability and Accountability Act (HIPAA)
- C)The Common Rule (45 CFR 46)GABARITO
- D)The Belmont Report
- E)The Declaration of Helsinki
Explicação
The Common Rule (45 CFR 46) is the federal regulation that governs human subjects research protections and explicitly requires IRBs to ensure that informed consent includes disclosure of reasonably foreseeable risks, including serious adverse events. It mandat... Ver explicação completa e trilha adaptativa →