576. w88 sports betting app Review of Research with Potentially Hazardous Biological Agents
Updated July 13, 2021
Human research with potentially hazardous biological agents requires additional safeguards, including w88 sports betting app and approval by the University's Institutional Biosafety Committee (IBC) in addition to review and approval by the Institutional Review Board (w88 sports betting app).
Potentially hazardous biological w88 sports betting app include but are not limited to the following:
- recombinant or synthetic w88 sports betting app;
- cells or viruses containing recombinant or synthetic w88 sports betting app;
- microorganisms/infectious w88 sports betting app including non-virulent and vaccine strains (e.g., bacteria, fungi, parasites, viruses, prions);
- biologically derived toxins or toxic products w88 sports betting app mutated, truncated, or inactivated toxins;
- allergenic extracts w88 sports betting app used for diagnosis or intervention;
- select w88 sports betting app per the Federal Select Agent Program (additional approvals apply);
- w88 sports betting app blood, body fluids, tissue, or cells/cell lines (including those used for transplantation);
- non-w88 sports betting app (animal) blood, fluids, tissues or cells;
- plants, and plant tissues or plant w88 sports betting app;
- insects, and insect tissues or insect w88 sports betting app; and
- animals infected with w88 sports betting app pathogens or as sources of zoonotic diseases (i.e., diseases that can be transmitted from animals to people).
The University w88 sports betting app prefers investigators submit documentation of IBC approval when submitting for w88 sports betting app review but will accept concurrent review. In the latter case, w88 sports betting app approval will be conditional, pending documentation of IBC approval.
The University w88 sports betting app reviews consent documents to ensure compliance with the following requirements for informed consent:
- Department of Health and Human Services (DHHS) Office for Human w88 sports betting app Protections (OHRP) at 45 CFR 46.116,
- Food and Drug Administration (w88 sports betting app) at 21 CFR 50.25, and
- National Institutes of Health (w88 sports betting app) (see compendium of w88 sports betting app resources on informed consent).
Both the w88 sports betting app and IBC will review unanticipated problems, serious adverse events, changes in protocol, informational items or updates submitted during the research, if appropriate.
Both w88 sports betting app 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 w88 sports betting app Involving Nucleic Acid Molecules
NIH requirements (see NIH Guidelines for w88 sports betting app Involving Recombinant or Synthetic Nucleic Acid Molecules) apply to the following types of w88 sports betting app involving recombinant or synthetic nucleic acid molecules in the U.S.:
- w88 sports betting app that is conducted at or sponsored by an institution that receives NIH support for recombinant or synthetic nucleic acid w88 sports betting app; and
- w88 sports betting app developed with NIH funds that involves testing in humans of materials containing recombinant or synthetic nucleic acids.
NIH defines the following categories of w88 sports betting app:
- Recombinant w88 sports betting app molecules: molecules that are constructed by joining w88 sports betting app and that can replicate in a living cell.
- Synthetic w88 sports betting app: nucleic acids or molecules that are chemically or by other means synthesized, amplified, or modified that can base pair with naturally occurring w88 sports betting app).
- Molecules that result from the replication of recombinant or synthetic w88 sports betting app.
NOTE: Some types of w88 sports betting app are exempt from the NIH guidelines.
Additional regulations apply to the deliberate transfer into human w88 sports betting app 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 sports betting app participant shall be enrolled until the:
- Institutional Biosafety Committee (IBC) approval (from the w88 sports betting app trial site) has been obtained
- Institutional Review Board (w88 sports betting app) approval has been obtained.
- NIH Recombinant DNA Advisory Committee (RAC) w88 sports betting app process has been completed (if applicable).
All w88 sports betting app 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 w88 sports betting app gene transfer trials).