Human Gene Transfer Protocols
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Description
Human gene transfer, also known as gene therapy, is the process of introducing genetic material (DNA or RNA) into a person’s cells to treat or prevent disease. This experimental technique aims to compensate for defective genes, prompt the body to produce therapeutic substances, or activate the immune system to fight disease.
Penn’s Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) must review and approve all human gene transfer and recombinant vaccine protocols prior to initiation of enrollment.
Details:
- NIH reporting requirements
- Scope and definition of human gene transfer
- Submission requirements for clinical trials
- Review and approval workflow (IBC + IRB)