Laboratory Inspection Program for Institutional Biosafety Committee Approvals
Introduction
Purpose
Indiana University has developed the Laboratory Inspection Program for Institutional Biosafety Committee (IBC) Approvals to ensure that all laboratories with IBC protocols are inspected and meet certain protocol specific laboratory standards before IBC approval is granted. This program is intended to promote a safe laboratory working environment and to ensure compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the Biosafety in Microbiological and Biomedical Laboratories, 5th ed. Guidelines, and the OSHA Bloodborne Pathogens Standard 29 CFR 1910.1030.
IBC Inspection Form
Click here to print a copy of the IBC Inspection Form.Scope
The Laboratory Inspection Program for Institutional Biosafety Committee Approvals establishes the training and inspection elements required for all Indiana University Principal Investigators (PI) utilizing biological materials to receive IBC protocol approval. The Laboratory Inspection Program for Institutional Biosafety Committee Approvals pertains to all IBC protocols and research that fall under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, all non-recombinant DNA Biological Safety Level 2 or higher protocols, and protocols and research that have been otherwise required to be reviewed and approved by the IBC committee.
- University Environmental Health and Safety is responsible for:
- Developing, updating, and promulgating inspection and training requirements;
- Maintaining inspection and training records;
- Communicating any deficiencies and working with supervisors to correct deficiencies; and
- Revising and updating the program as necessary.
- Principal Investigators are responsible for:
- Ensuring that all personnel follow the specific requirements outlined in the inspection including all necessary training requirements;
- Correcting any deficiencies noted in the inspection before study approval;
- Notifying Univeristy Environmental Health and Safety for the respective campus if deviations from the inspection requirements occur; and
- Notifying Univeristy Environmental Health and Safety for the respective campus of any spills or accidental exposures.
- Employees are responsible for:
- Understanding and adhering to the specific requirements outlined in the inspection;
- Completing applicable training; and
- Contacting PIs and Univeristy Environmental Health and Safety for the respective campus if deviations from the inspection requirements occur and if questions arise.
Program elements
Biological Laboratories
This program applies to laboratories comprising four different biological safety levels: Biological Safety Level 1, Biological Safety Level 2, Biological Safety Level 2 with BL3 practices, and Biological Safety Level 3.
- Biological Safety Level 1
Biological Safety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in healthy adult humans, and present minimal potential hazard to laboratory personnel and the environment.
- Biological Safety Level 2
Biological Safety Level 2 is suitable for work involving agents associated with moderate human disease for which treatment and or vaccination is commonly available.
- Biological Safety Level 2 with BL3 practices
Biological Safety Level 2 with BL3 practices is suitable for agents associated with moderate human disease but where the manipulations of those agents necessitate additional safety precautions to reduce the risk of aerosol exposure.
- Biological Safety Level 3
Biological Safety Level 3 is suitable for work involving indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.
Laboratory Inspection Frequency
Each laboratory that falls into the scope of this program shall be inspected before IBC approval is granted. Laboratory inspections are required upon the submission of a new protocol, a major amendment to an existing protocol, when the laboratory room changes or whenever an amendment is submitted that would change the risk assessment of the study. The necessity for a laboratory inspection is at the discretion of Univeristy Environmental Health and Safety for the respective campus. An annual inspection may be accepted in place of a separate IBC inspection as deemed appropriate by the Univeristy Environmental Health and Safety for the respective campus.
Laboratory Inspection Requirements
Each laboratory that falls into the scope of this program shall be inspected using the IBC Inspection Form.
Laboratory Inspection Follow Up
Upon inspection of the laboratory any deficiencies must be corrected or addressed before approval of the proposed IBC protocol. Deficiencies will be documented and an inspection report sent to the PI. Univeristy Environmental Health and Safety for the respective campus would be available to provide advice to the PI to address and correct any deficiencies in a timely manner for approval.
Training and Recordkeeping
The training courses required for protocol approval will depend on the biological safety level of the study and the work involved. Trainings can include but are not limited to BSL1, BSL2, BSL3, animal work, viral vector, biological shipment and bloodborne pathogens. Training requirements will be stated during the study review process. Univeristy Environmental Health and Safety for the respective campus will ensure that the proper trainings are completed and records retained for reference.
References
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, March 5, 2013, Department of Health and Human Services
- Biosafety in Microbiological and Biomedical Laboratories, 5th edition, U.S. Department of Health and Human Services
- OSHA Standard 29 CFR 1019.1030
- Indiana University Laboratory Safety Policy
- Indiana University Biosafety Manual - PDF
Appendix
Click here for the IBC Inspection Form
Revisions
Updated: July 30, 2014