Critiques of the vaccine injury reporting system have long been part of Kennedy’s efforts to questions the safety of ...

Investigators are required to report ... event is related or possibly related to the research procedures; The basis for determining that the research study, or the problem/event, places subjects at an ...

Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...

Methods: We searched the Vaccine Adverse Event Reporting System for reports of ... including 35 (17%) that were serious. Among the 169 nonserious reports, more than half (88; 52%) described ...