Compliance

Biosafety - Roles and Responsibilities for Recombinant DNA



Roles and responsibilities

Excerpt from WMU policy for recombinant DNA biosafety
The safe conduct of experiments involving recombinant DNA depends on the individual conducting such activities. It is beyond the scope of this policy to anticipate every possible situation. Motivation and good judgment are the key essentials to protection of health and the environment.

The Western Michigan University Policy for Recombinant DNA Biosafety (this policy) in conjunction with the NIH Guidelines is intended to assist the institution, Recombinant DNA Biosafety Committee, biological safety officer for recombinant DNA, and the principal investigator in determining safeguards that should be implemented. It is the responsibility of Western Michigan University (and the Recombinant DNA Biosafety Committee acting on its behalf) to adhere to the intent of the NIH Guidelines and to ensure that recombinant DNA activities comply with the NIH Guidelines. The roles and responsibilities, as outlined in the NIH Guidelines, constitute an administrative framework in which safety is an essential and integral part of research involving recombinant DNA molecules.

Responsibilities of Western Michigan University

    1. Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH Guidelines
    2. Establish and maintain a Recombinant DNA Biosafety Committee (RDBC) that meets the requirements and carries out the functions outlined in Section VIII.B. of this policy (Sections IV-B-2-a and IV-B-2-b of the NIH Guidelines)
    3. Appoint a biological safety officer for recombinant DNA (BSO) who shall be a member of the RDBC and carry out the duties specified in Section VIII.C. of this policy (Section IV-B-3 of the NIH Guidelines)
    4. Appoint an expert in plant, plant pathogen, or plant pest containment principles who shall be a member of the RDBC
    5. Appoint an expert in animal containment principles who shall be a member of the RDBC
    6. Ensure that when the institution participates in or sponsors recombinant DNA research involving human subjects: (i) the RDBC has adequate expertise and training (using ad hoc consultants as deemed necessary), and (ii) all aspects of Appendix M of the NIH Guidelines have been appropriately addressed by the principal investigator prior to submission to NIH/ORDA
    7. Assist and ensure compliance with the NIH Guidelines by principal investigators conducting research at the institution
    8. Ensure appropriate training for the RDBC chair and members, BSO and other containment experts, principal investigators, and laboratory staff regarding laboratory safety and implementation of the NIH Guidelines and ensuring that the principal investigator has sufficient training
    9. Determine the necessity for health surveillance of personnel involved in connection with individual recombinant DNA projects, and if appropriate, conduct a health surveillance program for such projects; establish and maintain a health surveillance program for personnel engaged in large scale research or production activities involving viable organisms containing recombinant DNA molecules and for personnel engaged in animal research involving viable recombinant DNA-containing microorganisms which require BL3 or greater containment at the laboratory scale
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Responsibilities of the Recombinant DNA Biosafety Committee

The RDBC chair is responsible for ensuring that the RDBC members are appropriately trained and qualified for appointment to the RDBC and for recommending continued training for RDBC members as needed to fulfill the responsibilities of RDBC membership as outlined below.

On behalf of the institution, the Recombinant DNA Biosafety Committee (RDBC) is responsible for:

    1. Reviewing recombinant DNA research conducted at or sponsored by the institution for compliance with the WMU Policy for Recombinant DNA Biosafety (this policy) and with the NIH Guidelines, and approving those research projects that are found to conform with the NIH Guidelines; this review shall include:
      1. independent assessment of the containment levels required by the NIH Guidelines for the proposed research,
      2. assessment of the facilities, procedures,practices, and training and expertise of personnel involved in recombinant DNA research, and
      3. ensuring compliance with all surveillance, data reporting, and adverse event reporting required by the NIH Guidelines
    2. Notifying the principal investigator in writing of the results of the RDBC's review; the RDBC may approve or disapprove a project or may make recommendations for revisions which would lead to approval
    3. Lowering containment levels for certain experiments as specified in Section III-D-2-a of the NIH Guidelines
    4. Setting containment levels as specified in Sections III-D-4-b and III-D-5 of the NIH Guidelines
    5. Periodically reviewing recombinant DNA research conducted at Western Michigan University to ensure compliance with the NIH Guidelines and the WMU Policy for Recombinant DNA Biosafety (this policy)
    6. Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research
    7. The RDBC may not authprize initiation of experiements which are not explicitly covered by the NIH Guidelines until NIH (with the advice of RAC) establishes the containment requirement
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Responsibilities of the Biological Safety Officer for Recombinant DNA (BSO)

    1. Periodic inspections to ensure that laboratory standards for recombinant DNA research are rigorously followed
    2. Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant DNA research
    3. Providing advice on laboratory security related to recombinant DNA research activities
    4. Providing technical advice to principal investigators and the RDBC on research safety procedures
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Responsibilities of Department Chairs and/or Unit Directors

    1. Provide departmental approval for the principal investigator to conduct the work specified in the project registration form
    2. Determine that the facilities and procedures proposed in the project registration form are adequate for the safe conduct of the research and the safety of other personnel—faculty, staff, and visitors—using the facilities within which the research is conducted
    3. Ensuring the continued safety and security during the conduct of the research, along with strict compliance with the NIH Guidelines and the WMU Policy for Recombinant DNA Biosafety (this policy)
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Responsibilities of the Principal Investigator

On behalf of the institution, the principal investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research. As part of this general responsibility, the principal investigator shall:

    1. Adhere to the RDBC-approved requirments for posting biohazard warning signs on the entrance to his/her laboratory as outlined in Section IV of this policy
    2. Initiate or modify no recombinant DNA research until that research or the proposed modification thereof has been reviewed and approved by the RDBC and has met all other requirements of the NIH Guidelines
    3. Determine which class of the NIH Guidelines for covered experiments apply to the proposed research and ensure that appropriate procedures are followed in completing the registration document for RDBC project review
    4. Report any new information bearing on the NIH Guidelines to the RDBC and to NIH/ORDA
    5. Be adequately trained in good microbial techniques and ensure that laboratory staff are appropriately trained
    6. Adhere to RDBC-approved emergency plans for handling accidental spills and personnel contamination
    7. Comply with shipping requirements for recombinant DNA molecules specified in Appendix H of the NIH Guidelines
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For submissions by the principal investigator to NIH/ORDA, the principal investigator shall:

    1. Submit information to NIH/ORDA, with notice to the RDBC, for certification of new host-vector systems
    2. Petition NIH/ORDA, with notice to the RDBC, for proposed exemptions to the NIH Guidelines
    3. Petition NIH/ORDA, with concurrence of the RDBC, for approval to conduct experiments specified in Sections III-A-1 and III-B of the NIH Guidelines
    4. Petition NIH/ORDA, with notice to the RDBC, for determination of containment for experiments requiring case-by-case review
    5. Petition NIH/ORDA, with notice to the RDBC, for determination of containment for experiments not explicitly covered by the NIH Guidelines
    6. Ensure that all aspects of Appendix M of the NIH Guidelines have been appropriately addressed prior to the submission of human genotherapy experiments to NIH/ORDA
    7. Submit a completed and signed project registration form to the research compliance coordinator for RDBC review including all information and correspondence received from NIH/ORDA.

      NOTE: Approval of a research project or other information from NIH/ORDA is not a substitute for RDBC approval to conduct the research.

For submissions by the principal investigator to the RDBC, the principal investigator shall:

    1. Make an initial determination of the required levels of physical and biological containment in accordance with the NIH Guidelines
    2. Select appropriate microbiological practices and laboratory techniques to be used for the research
    3. Submit the initial research protocol and any subsequent changes to the research compliance coordinator who will forward the protocol to the RDBC for review and approval or disapproval
    4. Remain in communication with the RDBC through out the conduct of the project

Prior to initiating research, the principal investigator shall:

    1. Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken
    2. Instruct and train laboratory staff in
      1. the practice and techniques required to ensure safety, and
      2. the procedures for dealing with accidents
    3. Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection)

During the conduct of the research, the principal investigator shall:

    1. Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed
    2. Investigate and report any significant problems pertaining to the operation and implementation of containment practices and procedures in writing to the biological safety officer for recombinant DNA (BSO), greenhouse/animal facility manager (if applicable), the RDBC, NIH/ORDA, and other appropriate authorities
    3. Correct work errors and conditions that may result in the release of recombinant DNA materials
    4. Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics)
    5. Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines
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Questions? Email our research compliance coordinator.

 
Office of the Vice President for Research
Western Michigan University
210 W Walwood Hall
Kalamazoo, MI 49008-5456 USA
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