576. IRB Review of Research with Potentially Hazardous Biological Agents

Updated July 13, 2021

Human research with potentially hazardous biological agents requires additional safeguards, including review and approval by the University's Institutional Biosafety Committee (IBC) in addition to review and approval by the Institutional Review Board (IRB).

Potentially hazardous biological agents include but are not limited to the following:

• recombinant or synthetic nucleic acid molecules;
• cells or viruses containing recombinant or synthetic nucleic acid molecules;
• microorganisms/infectious agents including non-virulent and vaccine strains (e.g., bacteria, fungi, parasites, viruses, prions);
• biologically derived toxins or toxic products including mutated, truncated, or inactivated toxins;
• allergenic extracts when used for diagnosis or intervention;
• select agents per the Federal Select Agent Program (additional approvals apply);
• human blood, body fluids, tissue, or cells/cell lines (including those used for transplantation);
• non-human (animal) blood, fluids, tissues or cells;
• plants, and plant tissues or plant cell cultures;
• insects, and insect tissues or insect cell cultures; and
• animals infected with human pathogens or as sources of zoonotic diseases (i.e., diseases that can be transmitted from animals to people).

The University IRB prefers investigators submit documentation of IBC approval when submitting for IRB review but will accept concurrent review. In the latter case, IRB approval will be conditional, pending documentation of IBC approval.

The University IRB reviews consent documents to ensure compliance with the following requirements for informed consent:

• Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) at 45 CFR 46.116,
• Food and Drug Administration (FDA) at 21 CFR 50.25, and
• National Institutes of Health (NIH) (see compendium of NIH resources on informed consent).

Both the IRB and IBC will review unanticipated problems, serious adverse events, changes in protocol, informational items or updates submitted during the research, if appropriate.

Both IRB and IBC will review and follow reporting requirements and communication with PI's, sponsor, NIH Office of Biotechnology Activities, FDA, and OHRP.

Additional Requirements for Research Involving Nucleic Acid Molecules

NIH requirements (see NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules) apply to the following types of research involving recombinant or synthetic nucleic acid molecules in the U.S.:

• Research that is conducted at or sponsored by an institution that receives NIH support for recombinant or synthetic nucleic acid research; and
• Research developed with NIH funds that involves testing in humans of materials containing recombinant or synthetic nucleic acids.

NIH defines the following categories of nucleic acid molecules:

• Recombinant nucleic acid molecules: molecules that are constructed by joining nucleic acid molecules and that can replicate in a living cell.
• Synthetic nucleic acid molecules: nucleic acids or molecules that are chemically or by other means synthesized, amplified, or modified that can base pair with naturally occurring nucleic acid molecules).
• Molecules that result from the replication of recombinant or synthetic nucleic acid molecules.

NOTE: Some types of molecules are exempt from the NIH guidelines.

Additional regulations apply to 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. Specifically, no research participant shall be enrolled until the:

• Institutional Biosafety Committee (IBC) approval (from the clinical trial site) has been obtained
• Institutional Review Board (IRB) approval has been obtained.
• NIH Recombinant DNA Advisory Committee (RAC) review process has been completed (if applicable).

All Human Gene Transfer clinical trials are subject to FDA requirements for biological products and must comply with the additional for informed consent requirements as specified in NIH guidelines for informed consent for human gene transfer trials).