XI. Reporting of Adverse Events

  1. Investigators who have received approval from the FDA to initiate a human gene transfer protocol must report any serious adverse event (SAE) immediately to the local IRB, IBC and NIH OBA, followed by the submission of a written report filed with each group. The requirements for reporting SAEs in human gene transfer research are found in Appendix M-I-C-4 of the NIH Guidelines. The form to use in reporting SAEs is the Template for Reporting Adverse Events In Human Gene Transfer Trials.

  1. Reporting SAEs through the HAWK IRB system will inform the Director of EHS and the BSO of the submission through an automated email notification. The BSO will forward the information to the IBC Chair and IBC for discussion, if appropriate; events that are unexpected and possibly associated with the gene transfer product must be reported to OBA by the PI within 15 calendar days of sponsor notification, unless they are fatal or life threatening, in which they must be reported within 7 calendar days.