Policy on Biosafety
|Original Policy Source||APPM Section 1. Item 5|
|Effective Adoption Date||09-16-2003|
|Last Review Date||07-15-2010|
Research Ethics / Intellectual Property
In accordance with the U.S. Department of Health and Human Services (DHHS) Guidelines for Research Involving Recombinant DNA Molecules, Northern Illinois University has established the Institutional Biosafety Committee (IBC) to oversee all research and teaching activities conducted at the University that involve the use of recombinant DNA and/or pathogenic organisms. The Vice President for Research and Graduate Studies (Vice President) is charged with ensuring compliance with the federal guidelines, with the assistance of the Graduate School's Office of Research Compliance.
The IBC consists of a minimum of five members who are appointed by the Vice President, subject to the concurrence of the President, for renewable three-year terms. In order to ensure that the membership collectively has experience and expertise in recombinant DNA technology sufficient to assess potential risk posed to public health or the environment by the proposed activity, the following individuals must be included:
- A representative knowledgeable in institutional commitments and policies, applicable law, standards of professional conduct and practice.
- A representative from the laboratory technical staff of the university.
- A representative with expertise in recombinant DNA technology, biological safety, and physical containment.
- Two representatives from the community who are not otherwise affiliated with NIU.
A quorum of the IBC is a simple majority of voting members; formal committee action requires a majority of those voting. One committee member will be designated by the Vice President as chair.
All personnel who conduct activities involving the use of recombinant DNA and/or pathogenic organisms are required to submit a curriculum vitae to the IBC chair to provide evidence that they are properly trained in microbiological and biosafety practices. Concerning the review of project protocols, the IBC must be notified of all activities that involve recombinant DNA and/or pathogenic organisms. Depending on the classification of the activity in the federal guidelines, additional review of the activity may be required. It is the responsibility of the principal investigator to determine the category of his/her research well in advance of the start of the project and to submit a completed protocol to the IBC with appropriate citation to the guidelines.
The IBC is also responsible for inspecting laboratory facilities (including greenhouses and animal facilities) in which research that involves recombinant DNA and/or infectious materials occurs, to ensure that satisfactory laboratory safety measures are in use. Inspections will be based on criteria established in both the federal guidelines (Appendix G) and the Laboratory Safety Monograph, published by the Public Health Service Centers for Disease Control and Prevention, and National Institutes of Health, May 1999, for proper laboratory practices under the appropriate biosafety levels. The Biosafety in Microbiological and Biomedical Laboratories manual, issued by the Centers for Disease Control and the National Institutes of Health, will also be used as primary sources of information. Unannounced inspections will be made annually at minimum.
The IBC will take appropriate action when a laboratory facility is found to be in noncompliance with the federal guidelines. Such action may include:
- informing the principal investigator and the department chair of the noncompliance,
- re-inspection to substantiate the facility is subsequently in compliance, and
- possible contact with the National Institutes of Health Office of Recombinant DNA Activities (ORDA) if significant noncompliance continues to occur.
It is the responsibility of the department chair to inform all new researchers of the existence of the IBC and ensure that the researcher(s) receive all pertinent information, e.g., copies of the IBC and federal guidelines. Should the department chair not have this information, it may be obtained from the Office for Research Compliance in the Graduate School.
The responsibilities of the principal investigator are summarized as follows:
- To oversee the training of all laboratory personnel associated with the researcher's project. This training is to be carried out prior to the initiation of the project and shall include informing research associates about laboratory safety procedures, accident techniques, and precautionary medical practices.
- To submit an "Application/Notification Form for Research Involving Recombinant DNA and/or Pathogenic Organisms."
The IBC also develops and coordinates the NIU Cadaver Acceptance Policy and the Health and Safety Policy governing laboratory procedures such as disposal of sharps, hazardous substances, and human body fluids which pose potential hazards other than chemical or radiation hazards. The IBC will act in an advisory capacity to identify potentially dangerous activities and work with the relevant units to develop appropriate guidelines and procedures.
Approved by Graduate Council, May 3, 1993
Modified by Institutional Biosafety Committee, August 5, 1999
Editorial change, September 16, 2003; July 15, 2010
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