RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS (PIs)
Principal Investigators (PIs) are responsible for timely submission of IBC protocols. Please use the forms below. As a “living” document, the NIH guidelines and other guidelines are periodically revised to keep pace with the changing state of science and medicine. In accordance with the changing state and with the Section IV-B-2-b-(5) of the NIH guidelines, IBC reviews the protocols annually. It will assist the responsibility of PIs to "remain in communication with the IBC (Section IV-B-7-c-(4))." It will also facilitate updated coverage of your research. To make your project current, please submit the IBC Annual Update Form each year. IBC protocols, including exempt protocols, will expire after one year if a PI fails to submit an annual update form.
PIs are also responsible for full compliance with the TUC Guidelines as required by the NIH Guidelines, as required by the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard and CalOSHA Bloodborne Pathogens Standard (Subchapter 7, Group 16, Article 109, 5193. Bloodborne Pathogens), and as required by the Centers for Disease Control and Prevention (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL).
Other responsibilities are summarized in the Section IV-B-7 of the NIH Guidelines.
(1) Submit IBC Initial Review Form to register your study. For your convenience, useful sites for BSL determination are listed below.
(2) Submit IBC Annual Update Form each year to keep the protocol active. Exempt research
must also be reviewed annually by submitting IBC Annual Update Form. Failure to submit
the Annual Update Form will result in expiration of the protocol.
(3) If you move your room, need protocol modifications, or start a new project, your original protocol will not cover your research. Please submit either IBC Initial Review Form or Annual Update Form depending on your case.
Deadline for submission is 14 business days before the next IBC meeting.
IBC AND OTHER FORMS
IBC Initial Review Form
IBC Annual Update Form
Chemical Hygiene Plan (Contact Environmental Health & Safety Manager)
Hazard PPE Form
Pathological Waste Pickup Form
Hazardous Waste Pickup Form
USEFUL SITES TO DETERMINE BIOSAFETY LEVEL
PHAC Pathogen Safety Data Sheets (Canadian resource; Commonly used at UC)
EXEMPT RESEARCH OR NOT
There are many discussions available online. The NIH Guidelines define the exempt experiments (Section III-F). However, research compliance including exempt experiments depends on experiments of each PI. Collection and shipping of certain blood are likely exempt, while the same experiments with research require IBC review. Synthesis of non-hazard chemicals is exempt while using the chemicals for biological research requires IBC review. The purchase, transfer or breeding of some BL1 transgenic rodents is exempt, while research on the exempt rodents requires IBC review. A Q&A at UC Irvine and discussions elsewhere include the description that exempt mice may get infected with a zoonotic, infectious agent. For example, laboratory-acquired infections (LAI) with LCMV are well documented in rodent-human transmission (BMBL, Section VIII-E). BMBL further points out that breeding of the nude or immunodeficient SCID mice, cells, and body fluids may pose a special risk for LAI.
Here is a quick way to tell what is needed:
- IBC initial review and annual renew are needed for research that falls into the exempt experiments (Section III-F).
- IBC review is not needed for research involving in vitro nucleotide experiments AND not using the cells, for example, a teaching lab doing only in vitro PCR reactions (Cornell Univ Q&A).
IBC is currently updating forms and websites. If you have any suggestion and feedback, please feel free to contact IBC Chair.
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