MSDSs

Recombinant DNA Safety Program

2.0 Responsibilities

General responsibilities relating to health and safety at the University are described in Chemical and Biological Safety in Laboratories, which is distributed to deans, department heads, center directors, and principal investigators.

Northwestern University is responsible for ensuring that the research is conducted in full conformity with the provisions of the NIH guidelines. This section describes and assigns those responsibilities.

2.1 University President

The President of Northwestern University, upon recommendation of the Vice President for Research, shall appoint the RDSC.

2.2 Office for Research Safety

The Office for Research Safety (ORS) is responsible for coordinating the recombinant DNA safety program for the University.

2.3 Recombinant DNA Safety Committee

The RDSC has established and implemented policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH guidelines. The RDSC is comprised of at least five members who collectively have experience and expertise in recombinant DNA technology. They possess the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment. Two members are not affiliated with the University (apart from their membership on the RDSC) and represent the interest of the surrounding community with respect to health and protection of the environment. The Chemical and Biological Safety Officer and a laboratory technical staff member also serves as members.

The RDSC is responsible for reviewing recombinant DNA research conducted at or sponsored by the University for compliance with the NIH guidelines as specified in Section III of the guidelines. The committee approves those research projects that are found to conform with the NIH guidelines. This review shall include:

• an independent assessment of the containment levels required by the NIH guidelines for the proposed research
• assessment of the facilities, procedures, practices, and training and expertise of personnel involved in recombinant DNA research
• notifying the principal investigator of the results of the committee's review
• reviewing recombinant DNA research conducted at Northwestern University 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/Office of Recombinant DNA Activities (ORDA) within 30 days
• establishing subcommittees or ad hoc committees as necessary to carry out its overall responsibilities
  

2.4 Chemical and Biological Safety Officer

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

• periodic inspections to ensure that laboratory standards are rigorously followed (Note: laboratories are periodically inspected as part of the laboratory safety program)
• reporting to the RDSC and the University any significant problems, violations of the NIH guidelines, and any significant research-related accidents or illnesses
• 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 RDSC on laboratory safety procedures.
  

2.5 Principal Investigator

The principal investigator is responsible for full compliance with the NIH guidelines in the conduct of recombinant DNA research. As part of this responsibility, the principal investigator shall:

• make an initial determination of the required levels of physical and biological containment in accordance with the NIH guidelines
• select appropriate microbiological practices and laboratory techniques to be used for the research
• submit the initial research protocol and any subsequent changes (e.g., changes in the source of DNA or host-vector system), if covered under Sections III-A, III-B, III-C, III-D, or III-E of the guidelines, to the RDSC for review and approval or disapproval
• remain in communication with the RDSC throughout the duration of the project
• 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 the practices and techniques required to ensure safety and 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
• investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the Chemical and Biological Safety Officer, the RDSC, NIH/ORDA, and other appropriate authorities
• correct work errors and conditions that may result in the release of recombinant DNA materials
• ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics)
• initiate or modify no recombinant DNA research which requires RDSC approval prior to initiation (see Sections III-A, III-B, III-C, and III-D of the guidelines) until that research or the proposed modification thereof has been approved by the RDSC and has met all other requirements of the NIH guidelines
• determine whether experiments are covered by Section III-E of the guidelines and ensure that the appropriate procedures are followed
• report any significant problems, violations of the NIH guidelines, or any significant research-related accidents and illnesses to the Chemical and Biological Safety Officer, RDSC, NIH/ORDA, and other appropriate authorities (if applicable) within 30 days
• report any new information bearing on the NIH guidelines to the RDSC and to NIH/ORDA
• be adequately trained in good microbiological techniques adhere to RDSC-approved emergency plans for handling accidental spills and personnel contamination
• comply with shipping requirements for recombinant DNA molecules

Submissions by the Principal Investigator to the NIH/ORDA are covered in section IV-B-7-b of the NIH guidelines. For example, these submissions can cover certifying of new host-vector systems or determining level of containment. See the guidelines for exact requirements.

[ Up ] [ RDNA Safety - 1.0 Introduction ] [ RDNA Safety - 2.0 Responsibilities ] [ RDNA Safety - 3.0 Approval Procedures ] [ RDNA Safety - 4.0 Laboratory Inspections ] [ Spill Procedures for RDNA Labs ]

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External ORS Links: Northwestern Home | Vice President for Research | Big 10 EH&S Links | Risk Management | Employee Safety Handbook

ORS - Evanston • 2145 Sheridan Road • Tech NG71 • Evanston, IL 60208
ORS - Chicago • 303 E. Chicago Avenue • Ward B106 W223 • Chicago, IL 60611
Phone 847/491-5581 or 312/503-8300 • FAX 847/467-2797 or 312/503-0547
e-mail researchsafety@northwestern.edu
Last Revision 05/16/2007
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