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Use of Biohazardous Materials in Research and Instruction

Introduction

To ensure safe handling, storage, and disposal of potentially biohazardous materials, as defined below, used in University research or instructional projects. Enforcement of this policy by the University is meant to provide a safe working atmosphere and a well controlled research and instructional environment.

Policy

All University research and instructional activities involving biohazardous materials, as defined below, shall be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to the use of any such material. The IBC will report directly to the Provost Council. Projects submitted for sponsorship by external agencies must be submitted for IBC review prior to acceptance of funding. IBC reviews and approvals are coordinated by Environmental Health and Safety located at 616 Brodhead Avenue #197 (X84251).

Projects involving material(s) included in any of these categories should be submitted for IBC approval.

  1. Infectious agents requiring handling conditions above Biosafety Level-1. (Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories.)
  2. Recombinant DNA and/or recombinant vectors.
  3. Human blood and blood products, human body fluids, human cell cultures, and/or human tissue.
  4. Microbial toxins (>1 mg of pure toxin, or solutions with concentrations of >1 mg/ml pure toxin).
  5. Pathogenic organisms.
  6. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.

The IBC also serves as an advisory committee for University projects that involve possible biohazards that do not appear to fall into one of these six areas. When it is unclear as to whether a material constitutes a potential biohazard, the IBC should be consulted. Questions should be directed to the IBC or to Environmental Health and Safety located at 616 Brodhead Avenue #197 (X84251).

IBC - Institutional Biosafety Committee
A committee appointed by the Vice Provost for Research and Department Heads to review the use of biohazardous agents in research. This committee reports directly to the Provost Council. The membership of this committee includes Lehigh faculty and staff with expertise in relevant areas. In addition, at least one member of the local community is appointed to the committee to represent local concerns. The purpose of the IBC is to develop policies for consideration and enactment by the Provost Council and establish guidelines to ensure that the University complies with NIH, OSHA, and all other Federal, State, and local guidelines.
Biohazardous Material
A biohazardous material is one that is biological in nature, capable of self-replication and has the capacity to produce deleterious effects upon other biological organisms, particularly humans.
Applicability

This policy applies to all research and instructional activities, sponsored, and unsponsored, conducted under the auspices of the University. University projects involving the use of biohazardous materials at other institutions should receive Institutional Biosafety Committee (IBC) approval from the cooperating institution in addition to the Lehigh University IBC.

Requests for Biohazards Reviews

IBC review and approval may be obtained by forwarding a copy of the Biosafety Registration Form and/or Questionnaire for Research With Recombinant DNA or Pathogenic Organisms to Environmental Health and Safety, 616 Brodhead Ave. #197. The form(s) should be filled out completely and signed by the principal investigator. If necessary, supporting materials (relevant sections of a grant proposal, research protocols, etc.) should be submitted with the form(s). The form(s) will be reviewed and if found to be complete, approval will be granted by the IBC. Upon receiving approval from the IBC, the Chairperson of the IBC will issue a project approval letter to the principal investigator. It is the responsibility of the principal investigator to ensure that approval letters are properly directed to any funding agency or sponsor.

NOTE: IF THE SCOPE OF YOUR RESEARCH CHANGES, PLEASE KEEP IN MIND THE APPROPRIATE FORM(S) MUST BE MODIFIED AND RESUBMITTED TO THE IBC FOR REVIEW AND APPROVAL.
For more information regarding this policy, contact Environmental Health and Safety 610-758-4251.
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