All Serious Internal Adverse Events related or possibly related to the gene transfer intervention must be reported to the external sponsor of the research study (if applicable) and to the IRB, and Food and Drug Administration using the following criteria:
1. Unexpected, fatal or life-threatening internal Adverse Events related or possibly related to the gene transfer intervention must be reported to the external sponsor (if applicable), IRB within 24 hours of learning of the event. If the sponsor of the human gene transfer research study is a University investigator, reporting of the adverse event to the FDA should occur as soon as possible but no later than 7 working days following the sponsor’s initial receipt of the information. (If the human gene transfer research study is externally sponsored, it is the responsibility of the external sponsor to report the adverse event to the FDA.)
2. Unexpected, Serious (but not fatal or life-threatening) Internal Adverse Events Related or Possibly Related to the gene transfer intervention, must be reported to the external sponsor (if applicable), IRB as soon as possible but no later than 5 calendar days of the reaction. If the sponsor of the human gene transfer research study is a University investigator, reporting of the adverse event to the FDA should occur as soon as possible but no later than 15 working days following the sponsor’s initial receipt of the information. (If the human gene transfer research study is externally sponsored, it is the responsibility of the external sponsor to report the adverse event to the FDA.)
3. Any follow up information related to an Unexpected, Serious Adverse Event Related or Possibly Related to a gene transfer intervention should be reported promptly to the external sponsor (if applicable) and IRB. If the sponsor of the human gene transfer research study is a University investigator, reporting of the follow up information to the FDA should occur as soon as possible but no later than 15 working days following the sponsor’s receipt of the information. (If the human gene transfer research study is externally sponsored, it is the responsibility of the external sponsor to report the follow up information to the FDA.)
4. If an Unexpected, Serious Adverse Event occurs after the end of the clinical trial and it is determined to be related or possibly related to the gene transfer intervention, the reaction should be reported promptly to the external sponsor (if applicable), and IRB. If the sponsor of the human gene transfer research study is a University investigator, reporting of this Adverse Event information to the FDA should occur as soon as possible but no later than 15 working days following the sponsor’s receipt of the information. (If the human gene transfer research study is externally sponsored, it is the responsibility of the external sponsor to report this adverse event information to the FDA.)
5. If, after further evaluation, an Unexpected, Serious Internal Adverse Event initially considered not to be related to the gene transfer intervention is determined to be Related, then the Unexpected, Serious Internal Adverse Event should be reported promptly to the external sponsor (if applicable), and the IRB. If the sponsor of the human gene transfer research study is a University investigator, reporting of the adverse event to the FDA should occur as soon as possible but no later than 15 working days of this determination. (If the human gene transfer research study is externally sponsored, it is the responsibility of the external sponsor to report this determination to the FDA.)
The above reporting requirements apply to all research research studies involving gene transfer interventions regardless of the source of the research funding.
References
45 CFR 46.103(b)(5)
21 CFR 56.108(b) (1), 312.53 (c) (vii) and 312.66 – Investigators are required to report promptly to the IRB all unanticipated problems involving risks to human subjects or others
OHRP - Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unant...)
NIH Biosafety and Recombinant DNA Policy (https://osp.od.nih.gov/biotechnology/biosafety-and-recombinant-dna-activ...)
Standard Operating Procedures for the Education and Compliance Office for Human Subject Research (http://www.ecohsr.pitt.edu/SOPs/)