Human gene transfer is the deliberate transfer into human research participants of either recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or synthetic nucleic acid molecules.
All clinical research protocols involving use of investigational biological products (biologics) in human subjects conducted by Weill Cornell Medicine’s (WCM) faculty and staff must be reviewed and approved by both the Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC) prior to initiation.
Biological agents/products subject to review by the WCM IBC are Investigational New Drugs (INDs) or vaccines containing an agent(s) that resembles a disease-causing microorganism or microbial toxin-producing agent, including: bacteria, viruses, prions, rickettsia, fungi, and parasites that have potential to affect the health of humans.
Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.”
Cellular Therapy produts include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells.
Gene therapy and Cellular therapy products are both biological products regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). Clinical studies in humans require the submission of an investigational new drug application (IND) prior to initiating clinical studies in the United States.
Recombinant Oncolytic Viruses
Genes delivered by:
Human Microbiome Studies (Studies Using Human Microbiota)
The IBC submission and review process takes place in the Research Safety module within the Weill Research Getaway (also known as WRG-RS).
Step 1: Select Clinical Safety Application for IBC/RSC - Initial.
Step 2: Enter the protocol title (must be the same as Human Subjects (IRB) protocol).
Step 3: Enter the name of the PI and click Continue. A new window will appear.
Note that your name will appear by default. If you’re entering this on behalf of a PI, please update their name!
Step 4: Click the dropdown menu and choose the application applicable to your protocol:
If uncertain which application to use, please contact the IBC at firstname.lastname@example.org or (646) 962-7233.
Step 5: Fill out the IBC Application.
Step 6: Link the IBC Application to corresponding Human Subjects (IRB) protocol within WRG - Human Subjects module.
Step 7: Ensure that the following documents must be available in WRG-HS module:
Step 8: Click the “Submit” button.
The submission will undergo review by the convened committee, the IBC determines the appropriate biological safety level and issues approval.
NOTE: Additional WCM approvals may be required before study initiation (e.g., Radiation Safety Committee approval, Investigational Pharmacy or Pathology approvals).
Any changes that could potentially impact the initial biosafety risk assessment require an amendment to previously approved IBC Application. These changes must be submitted to the IBC for review prior to initiating these changes, following the same submission process within the WRG-RS by creating the amendment to previously approved application.
Amendments that require IBC approval may include, but are not limited to changes in one of the following:
The Principal Investigator must submit the adverse events that are (1)“unexpected”, (2) “related” or “possibly related” and associated with the use of the biological product/human gene product or therapy and (3) the event suggests that the research places WCM subjects at greater risk of harm than was previously known or recognized. If ALL of the three (3) conditions are met, submit the Immediate Report in accordance with WCM Immediate Reporting Policy.
Immediate Reports should be sent to the IBC at email@example.com.
The Principal Investigator must submit an annual report to the IBC, which is due on or before the IBC Application expiration date. The protocol's IBC Annual Report must be submitted within the WRG-RS module.
The protocol's IBC Annual Report must include the following information:
Updated Investigator’s Brochure
Updated Clinical Protocol
Updated Informed Consent Form(s)
Clinical and general safety training meets the needs of clinicians and other staff who may be exposed to a bloodborne pathogen or hazardous chemical, but do not work in a laboratory. Participation is required on an annual basis under OSHA regulations for all staff and students who do not work in a laboratory but do come in direct contact with patients; handle clinical specimens; routinely work in a clinical environment; or handle biological (red bag/sharps) waste. This includes graduate students, medical students, physicians, post-doctoral fellows, clinical and housekeeping staff.
Clinical and General Safety training may be completed as follows:
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