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UMBI procedures require allPrincipal Investigators register their research with human materials, potential pathogens, recombinant DNA, or select agents with the UMBI Institutional Biosafety Committee (IBC). The form is also available at UMBI Sponsored Programs Forms webpage.
Please fill in the form on your monitor screen.
If you have Adobe Acrobat 5.0 or 6.0, print to Adobe distiller to your hard drive, attach and email to: gilpin@umbi.umd.edu
OR
If you do not have Acrobat, print the document and mail to:
Research Compliance & Safety
UMBI Central Administration, Suite 200
Columbus Center
701 East Pratt Street
Baltimore, MD 21202
Human Materials Registration:
Human material to be registered include human tissue samples, blood, serum, plasma, internal body fluids (semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid) and any body fluid that is visibly contaminated with blood) from patients, volunteers, or cadavers as well as human-derived tissue culture cells. Common laboratory cell lines including HEK293 and HeLa are not exempt and must be registered. Also included are any unfixed tissue or organ from a human (living or dead), HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV- or HCV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV or HCV.
Pathogens or Potential Pathogens Registration:
Human or animal pathogens or potential pathogens to be registered include all bacterial, viral, fungal, parasitic microorganisms with a potential for vertical or horizontal transmission. Host-specific viruses and viral vectors commonly used for gene transfer must also be registered. This includes, but is not limited to E. coli, adenovirus, MuLV, and other commercially available or investigator-generated modified lentiviral and retroviral-based vectors.
Recombinant DNA Registration:
Recombinant DNA to be registered includes all research involving the use or manipulation of recombinant DNA. Recombinant DNA research is defined by the NIH Guidelines [Section IB] as either molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or DNA molecules that result from the replication of molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell. Recombinant DNA experiments considered "exempt" as defined within the NIH Guidelines must also be registered.
Select Agent Registration:
Select agent(s) are listed by the HHS Centers for Disease Control and Prevention (CDC) and the USDA Animal Plant Health Inspection Service (APHIS). These materials are considered: Non-overlap select agents and toxins; High consequence livestock pathogens and toxins (overlap agents); or USDA high consequence livestock pathogens and toxins (non-overlap agents and toxins). Laboratories intending to obtain select agents must be registered with CDC or APHIS through the UMBI Responsible Official and adopt the UMBI Security Policy. Contact Richard Gilpin at (410) 385-6329 gilpin@umbi.umd.edu for more information.
Laboratory Animal Research Registration:
Research with laboratory animals must be coordinated with the UMBI IACUC. Contact Richard Gilpin at (410) 385-6329 gilpin@umbi.umd.edu
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