Oakland University Biosafety
Graham Health Center
408 Meadow Brook Road
Rochester, MI 48309

Overview

Projects requiring IBC review must be submitted using the online application via the RAM 3.0 system. Submissions will be subjected to a pre-review to check for completeness and major deficiencies before they are shared with the IBC for full committee review. Applications which are gone through prereview process must be resubmitted at least two weeks in advance, to ensure review at the next scheduled meeting. Applicants are encouraged to review the list of topics on these pages, prior to initiating an application. Work may not begin, until a formal notice of IBC approval is issued by Dr. Judette Haddad, Regulatory Compliance Coordinator.

Exempt from IBC review: Those projects and proposals involving the use of  common  non-infectious  microorganisms or recombinant DNA techniques exempt from NIH Guidelines do not require approval from the IBC, but must be registered with the IBC. All such experiments may be conducted at Biosafety Level 1 containment. The Biological Safety Officer  (BSO), Mr. Domenico Luongo, must be contacted and he will determine if a proposal should be reviewed by the full committee. Please complete the Exempt Recombinant DNA Registration Form to determine if your project is exempt according to the NIH Guidelines for Recombinant DNA (rDNA). ( Exempt rDNA Form)
Roles and
Responsibilities

Institution

Each institution conducting (or sponsoring) research is responsible for ensuring that it is conducted in full conformity with the provisions of the NIH Guidelines.  The institution shall:

  • Establish and implement policies that provide for the safe conduct of research
  • Establish an Institutional Biosafety Committee
  • Appoint a Biological Safety Officer (who is also a member of the Institutional Biosafety Committee)
  • Assist and ensure compliance with the NIH Guidelines by Principal Investigators conducting research
  • Ensure appropriate training for the Institutional Biosafety Committee Chair and members, Biological Safety Officer and other containment experts, Principal Investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines.
  • Report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses.
  • Institutional Biosafety Committee (IBC)

On behalf of the institution, the IBC is responsible for:

  • Reviewing research conducted at (or sponsored by) the institution for compliance, and approving only those research projects that are found to conform to the NIH Guidelines.
  • Reviews shall include: (i) independent assessment of the containment levels required for the proposed research, and (ii) assessment of the facilities, procedures, practices, and training and expertise of personnel involved.
  • Notifying the Principal Investigator of the results of the IBC's review and approval.
  • Periodically reviewing recombinant DNA research conducted at the institution to ensure compliance with the NIH Guidelines.
  • Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research.
  • Reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the appropriate institutional official and NIH/OBA.
  • The Institutional Biosafety Committee may not authorize initiation of experiments that are not explicitly covered by the NIH Guidelines, until NIH establishes the containment requirement.


Biological Safety Officer (BSO)

The Biological Safety Officer's duties include, but are not be limited to:

  • Periodic inspections to ensure that laboratory standards are rigorously followed
  • Reporting to the IBC and the institution any significant problems, violations of the NIH Guidelines, and any significant research-related accidents or illnesses of which the BSO becomes aware
  • Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant DNA research
  • Providing advice on laboratory security
  • Providing technical advice to Principal Investigators and the IBC on research safety procedures.
  • The Biological Safety Officer shall be a member of the IBC
  • Principal Investigator (PI)

 The Principal Investigator (must be a full-time OU or OU-WBSOM faculty) is responsible for full compliance in the conduct of research, including:

  • Initiate or modify no recombinant DNA research that requires IBC approval prior to initiation or modification.  Approval is provided only in writing.
  • Be adequately trained in good microbiological techniques
  • Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken
  • Instruct and train laboratory staff in: 1) practices and techniques required to ensure safety, and 2) the procedures for dealing with accidents
  • Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed
  • Adhere to IBC approved emergency plans for handling accidental spills and personnel contamination
  • Comply with shipping requirements for hazardous materials and recombinant DNA molecules
  • Report any significant problems, violations, or any significant research-related accidents and illnesses to the BSO, Animal Facility Director, and IBC
Standard
Operating Procedures
Standard Operating Procedures (SOPs) are required for all hazardous laboratory procedures conducted in Oakland University Laboratories. Laboratory Procedures conducted at Biosafety Level 2 or above are categorized as hazardous laboratory procedures requiring an SOP to be submitted with your IBC application. SOP templates are provided below to guide you in developing your SOP. If you have any questions please contact the Biosafety Officer at extension 4314.

Describing Experimental Procedures
in IBC Application

Section 1.0 of the IBC Application provides Biosafety Committee members information on the biosafety practices that will be incorporated in your experimental procedures. The focus of your description should  be  on laboratory procedures that will directly utilize infectious agents, rDNA, cultured cell lines, and/or human derived materials.  It is ESSENTIAL that you focus upon likely routes of exposure and procedures for the minimization of biohazardous risk. The following link provides an example of the format and content required to appropriately complete "Section 1" of your IBC application.

Example Section 1 - Experimental Procedure

Revisions to
Approved Applications

Any changes to an approved application must be approved by the IBC prior to implementation.

Applicants desiring to make changes to an approved application should email a detailed list of the proposed revisions to the Biosafety Officer  (luongo@oakland.edu).

Minor revisions: changes that WILL NOT affect the approved application's biosafety level, are accomplished via revision of the online application ( RAM 3.0 system).

Major revisions: changes that WILL affect the approved application's biosafety level require submission of a NEW application via the RAM 3.0 system.