576. IRB Review of w88 casino with Potentially Hazardous Biological Agents

Updated July 13, 2021

Human w88 casino with potentially hazardous biological agents requires additional safeguards, including review and approval by the University's Institutional Biosafety Committee (IBC)in addition tow88 casino and approval by the Institutional w88 casino 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 w88 casino but will accept concurrent w88 casino. 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 w88 casino 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 w88 casino, if appropriate.

Both IRB and IBC will w88 casino and follow reporting requirements and communication with PI's, sponsor, NIH Office of Biotechnology Activities, FDA, and OHRP.

Additional Requirements for w88 casino Involving Nucleic Acid Molecules

NIH requirements (see NIH Guidelines for w88 casino Involving Recombinant or Synthetic Nucleic Acid Molecules) apply to the following types of w88 casino involving recombinant or synthetic nucleic acid molecules in the U.S.:

• w88 casino that is conducted at or sponsored by an institution that receives NIH support for recombinant or synthetic nucleic acid w88 casino; and
• w88 casino 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 w88 casino participants of either recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or synthetic nucleic acid molecules. Specifically, no w88 casino participant shall be enrolled until the:

• Institutional Biosafety Committee (IBC) approval (from the clinical trial site) has been obtained
• Institutional w88 casino Board (IRB) approval has been obtained.
• NIH Recombinant DNA Advisory Committee (RAC) w88 casino process has been completed (if applicable).

AllHuman 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).