Biosafety - University Policy for Recombinant DNA Biosafety
Western Michigan University recognizes the importance of supporting a broad spectrum of research activities. Cognizant that these activities may be accompanied by some risks, the University requires recombinant DNA research activities be reviewed and only be conducted under the auspices of the Recombinant DNA Biosafety Committee (RDBC). This policy is in full compliance with applicable federal and state laws and regulations. Adherence to this policy shall not exempt the research from compliance with other applicable laws, regulations or policies (e.g., research with human subjects or research with animals).
This policy is applicable to all recombinant DNA research which is conducted at or sponsored by or under the aegis of Western Michigan University. No activity involving the construction or handling of recombinant DNA molecules or organisms and viruses containing recombinant DNA molecules shall be initiated without review by and approval of the WMU Recombinant DNA Biosafety Committee RDBC).
III. Coordination with Other Research Compliance Regulations
Recombinant DNA research projects may sometimes involve other elements that require review and approval prior to the conduct of the research. RDBC approval of a recombinant DNA research project will always be contingent upon receipt of such approvals and will not be effective until all requisite reviews have been completed and approvals received. The following represent other compliance requirements for research at Western Michigan University:
For further information on any of the requirements of these review systems, contact the research compliance coordinator.
IV.Definition of Recombinant DNA Molecules
In the context of this policy, recombinant DNA molecules are defined as either
- molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or
- molecules that result from the replication of those described in (i) above.
Synthetic DNA segments likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or pharmacologically active agent) shall be considered as equivalent to their natural DNA counterpart. If the synthetic DNA segment is not expressed in vivo as a biologically active polynucleotide or polypeptide product, it is exempt from this policy.
Genomic DNA of plants and bacteria that have acquired a transposable element, even if the latter was donated from a recombinant vector no longer present, are not subject to this policy unless the transposon itself contains recombinent DNA.
V. Recombinant DNA Biosafety Committee
The Recombinant DNA Biosafety Committee (RDBC) shall be comprised of no less than five members. The Committee shall fulfill the responsibilities described in the Guidelines for Research Involving Recombinant DNA Molecules(NIH Guidelines).
- Committee Membership
The RDBC members shall be selected so that they collectively have experience and expertise in recombinant DNA technology and the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with WMU (apart from membership on the RDBC) and shall represent the interest of the Kalamazoo area with respect to the health and protection of the environment. The vice president for research or his/her designee shall be a permanent member of the RDBC.
- Appointment of Members
Members of the RDBC shall be appointed by the president or his/her designee. A list of recommendations will be made to the president by the RDBC. Appointments should be for a period of three years (effective January 1) and initial terms should be staggered so that no more than one-third of them shall expire in any year.
The RDBC chair shall be designated by the president or his/her designee and perform those duties normally associated with that office. The biological safety officer for recombinant DNA (BSO) shall be designated by the president and perform the duties described in Section IX.C. of this policy. The research compliance coordinator shall serve as secretary and will maintain the records of the RDBC.
The RDBC shall meet at least twice annually. A schedule of meetings shall be publicly posted. Meetings will be open to the public whenever possible, consistent with protection of privacy and proprietary interests.
A quorum for conducting business shall consist of two-thirds of current members. At least one member not affiliated with WMU (apart from serving on the RDBC) must be present. The meetings will follow recognized parliamentary procedure.
No member may participate in or be involved (except to provide information)in the review or approval of a project in which he or she has been or expects to be engaged or has a direct financial interest.
When additional expertise is required, the RDBC may obtain the services of consultants to provide it.
The RDBC will present an informational annual report of research activity to the vice president for research.
The vice president for research shall file an annual report with NIH/ORDA which includes: (i) a roster of all RDBC members clearly indicating the Chair, contact person, BSO, plant expert, and animal expert, and (ii) biographical sketches of all RDBC members (including community members).
- RDBC Records and Information
The RDBC shall maintain files and records in the office of the research compliance coordinator containing the following information:
- The original(not a copy) project registration document submitted by the principal investigator for review by the RDBC
- Correspondence related to specific recominant DNA research activities
- Copies of RAC, NIH/ORDA and/or FDA decisions, as applicable
- Proceedings related to renewal, modification, or termination of research projects
- Copies of agenda and minutes of RDBC meetings, along with detailed comments on projects reviewed and decisions of the RDBC
- Documentation of RDBC membership, including credentials and training of current members
- Copies of reports and correspondence related to problems, violations of NIH Guidelines, accidents, and illnesses related to research projects
VI. Experimental Classes and Procedures
The different classes of experiments and particular constraints applying to each (e.g. containment requirements) are found in the Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines). The latest Amendment to the NIH Guidelines was published in the October 31, 1997 issue of the Federal Register. The current NIH Guidelines are available on line or upon request from the research compliance coordinator. As these regulations are modified by subsequent agency action, those modifications shall be incorporated into this policy. A summary description of each class of experiment and the associated required procedures are outlined in the following subsections.
- Experiments that require RDBC approval, Recombinant DNA Advisory Committee (RAC) review, and NIH director approval before initiation
Experiments in this class cannot be initiated without submission of relevant information on the proposed experiment to the Office of Recombinant DNA Activities (NIH/ORDA), the publication of the proposal in the Federal Register for 15 days of comment, review by the RAC, and specific approval by the NIH. The containment conditions or stipulation requirements for such experiements will be recommended by RAC and set by NIH at the time of approval. Such experiments require RDBC approval before initiation. Definitions and examples are presented in III-A of the NIH Guidelines.
- Experiments that require NIH/ORDA and RDBC approval before initiation
Experiments in this class cannot be initiated without submission of relevant information on the proposed experiment to NIH/ORDA. The containment conditions for such experiements will be determined by NIH/ORDA in consultation with ad hoc experts. Such experiements require RDBC approval before initiation. Definitions and examples are presented in III-B of the NIH Guidelines.
- Experiments that Require RDBC and HSIRB approvals and NIH/ORDA registration before initiation
Research proposals involving the deliberate transfer of recombinant DNA or, DNA or RNA derived from recombinant DNA, into human subjects (human gene transfer) will be considered through a review process involving NIH/ORDA and RAC. Experiments in this class cannot be initiated without submission of relevant information on the proposed human gene transfer experiments to NIH/ORDA and RAC for review and approval, Investigational New Drug (IND) application submission to FDA, and application for review and approval by the RDBC. Approval must also be obtained from the WMU Human Subjects Institutional Review Board (HSIRB) and the IBC and IRB of each institution at which recombinant DNA material will be administered to human subjects. The submission, review, and approval process is detailed in III-C of the NIH Guidelines.
- Experiments that require RDBC approval before initiation
Experiments in this class require submission of a registration document to the RDBC for review and approval prior to initiation of the experiments. Definitions and examples are presented in III-D of the NIH Guidelines. Practices for the physical and biological containment for recombinant DNA research involving plants are specified in Appendix P of the NIH Guidelines; practices for the physical and biological containment for recombinant DNA research involving animals are specified in Appendix Q of the NIH Guidelines.
- Experiments that require RDBC notice simultaneous with initiation
Experiments in this class require submission of a registration document to the RDBC at the time of initiation of the experiments. Definitions and examples are presented in III-E and III-F of the NIH Guidelines. Approval by the RDBC prior to initiation is not required unless the RDBC determines the investigator has incorrectly classified the experiments.
VII. Research Facility Biohazard Warning Signs
- Biosafety Level 1 (BL1) Facilities
A biohazard sign must be posted on the entrance to the laboratory or facility whenever infectious agents are present. The sign must include the name of the agent(s) in use and the name and telephone number of the Principal Investigator.
- Biosafety Level 2 (BL2) Facilities
A biohazard sign must be posted on the antrance to the laboratory or facility when etiologic agents are in use. The sign must include the name of the agent(s) in use, the biosafety level, the required immunizations, the name and telephone number of the Principal Investigator, any personal protective equipment that must be worn in the laboratory or facility, and any procedures required for exiting the laboratory or facility.
- Biosafety Level 3 (BL3) or Biosafety Level 4 (BL4) Facilities
When infectious materials or infected animals are present in the laboratory, facility, or containments module, a hazard warning sign, incprporating the universal biohazard symbol, must be posted on all laboratory/facility and animal room access doors. The hazard sign must identify the agent(s) in use, list the names and telephone numbers of the Principal Investigator and other responsible person(s) (including the Biological Safety Officer for Recombinant DNA, the Animal Facility Manager, if applicable, and the Research Compliance Coordinator), and indicate any special requirements for entering laboratory or facility, such as the need for immunizations, respirators, or other personal protective measures.
VIII. Forms and Project Registration Procedures
- Registration for recombinant research
The project registration form delineating the required relevant information for notification and/or review is available on line or upon request from the research compliance coordinator. Project registration forms which are obtained on-line must be completed, signed, and paper copies submitted to the research compliance coordinator for review by the RDBC. It is not possible, at this time, to submit project registration forms electronically. Project registration forms must be completed and resubmitted annually to the RDBC for each project involving recombinant DNA molecules.
- Registration and review procedures
- Investigators will be notified in writing by the RDBC of the next scheduled meeting and the deadline for submission of the registration form for each project to be reviewed at that time. This notification will include instructions to be used to access on-line forms. The RDBC will also provide each investigator with a copy of the most current NIH Guidelines and WMU Policy for Recombinant DNA Biosafety (this policy) to assist in the completion of the registration document.
- The principal investigator must complete and sign one registration form for each new or continuing project to be reviewed by the RDBC. For each project, only one individual may function as the principal investigator and must take responsibility for that project and its compliance with the NIH Guidelines and this policy.
- After the principal investigator has signed the project registration form, the principal investigator must obtain the signature of his/her department chair and/or unit director on the project registration form. After the department chair and/or unit director has signed the project registration form, the principal investigator must submit the original project registration form and the prescribed number of copies to the research compliance coordinator. Project registration forms lacking one or more original signatures cannot be accepted for RDBC review.
- All project registration forms must be submitted to the research compliance coordinator. The submission for each project must include the original registration document (with the original signature of the principal investigator and his/her department chair and/or unit director) and the prescribed number of copies as indicated on the project registration form. The research compliance coordinator assigns each project a unique number and distributes the copies to the members of the RDBC for review.
- At a convened meeting, the RDBC reviews all project registration forms submitted since its last meeting.
- The RDBC will notify the principal investigator in writing of the results of the Committee's review. The RDBC may approve or disapprove a project or may make recommendations for revisions which would lead to approval.
IX. Roles and Responsibilities
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 the Institution (Western Michigan University)
- Establish and implement policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with the NIH Guidelines
- 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)
- 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)
- Appoint an expert in plant, plant pathogen, or plant pest containment principles who shall be a member of the RDBC
- Appoint an expert in animal containment principles who shall be a member of the RDBC
- Ensure that when the institution participates in or sponsors recombinant DNA research involving human subjects: (i) the RDBC has adequate expertise and training (using the ad hoc consultants as deemed necessary), (ii) and all aspects of Appendix M of the NIH Guidelines have been appropriately addressed by the principal investigator prior to submission to NIH/ORDA
- Assist and ensure compliance with the NIH Guidelines by principal investigators conducting research at the institution
- 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
- 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
- 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:
- 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: (i) independent assessment of the containment levels required by the NIH Guidelines for the proposed research, (ii) assessment of the facilities, procedures, practices, and training and expertise of personnel involved in recombinant DNA research, and (iii) ensuring compliance with all surveillance, data reporting, and adverse event reporting required by the NIH Guidelines
- 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
- Lowering containment levels for certain experiments as specified in Section III-D-2-a of the NIH Guidelines
- Setting containment levels as specified in Sections III-D-4-b and III-D-5 of the NIH Guidelines
- 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)
- Adopting emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research
- The RDBC may not authorize initiation of experiments which are not explicitly covered by the NIH Guidelines until NIH (with the advice of RAC) establishes the containment requirement
- Responsibilities of the Biological Safety Officer for Recombinant DNA (BSO)
- Periodic inspections to ensure that laboratory standards for recombinant DNA research are rigorously followed
- Developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant DNA research
- Providing advice on laboratory security related to recombinant DNA research activities
- Providing technical advice to principal investigators and the RDBC on research safety procedures
- Responsibilities of Department Chairs and/or Unit Directors
- Provide departmental approval for the principal investigator to conduct the work specified in the project registration form
- 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
- 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)
- 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:
- Adhere to the RDBC-approved requirements for posting biohazard warning signs on the entrance to his/her laboratory as outlined in Section IV of this policy
- 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
- Determine which class of the NIH Guidelines for covered experimentsapply to the proposed research and ensure that appropriate procedures are followed in completing the registration document for RDBC project review
- Report any new information bearing on the NIH Guidelines to the RDBC and to NIH/ORDA
- Be adequately trained in good microbial techniques and ensure that laboratory staff are appropriately trained
- Adhere to RDBC-approved emergency plans for handling accidental spills and personnel contamination
- Comply with shipping requirements for recombinant DNA molecules specified in Appendix H of the NIH Guidelines
For submissions by the principal investigator to NIH/ORDA, the principal investigator shall:
- Submit information to NIH/ORDA, with notice to the RDBC, for certification of new host-vector systems
- Petition NIH/ORDA, with notice to the RDBC, for proposed exemptions to the NIH Guidelines
- 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
- Petition NIH/ORDA, with notice to the RDBC, for determination of containment for experiments requiring case-by-case review
- Petition NIH/ORDA, with notice to the RDBC, for determination of containment for experiments not explicitly covered by the NIH Guidelines
- 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
- 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:
- 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 to the research compliance coordinator who will forward the protocol to the RDBC for review and approval or disapproval
- Remain in communication with the RDBC throughout the conduct of the project
Prior to initiating research, the principal investigator shall:
- 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 (a) the practice and techniques required to ensure safety, and (b) the procedures for dealing with accidents
- 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:
- 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 biological safety officer for recombinant DNA (BSO), greenhouse/animal facility manager (if applicable), the RDBC, 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)
- Comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines
X. Procedures for Reporting Adverse Issues to NIH/ORDA
Western Michigan University recognizes the importance of reporting any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH/ORDA within 30 days. Such reporting is the responsibility of the institution, the Recombinant DNA Biosafety Committee (RDBC), the biological safety officer for recombinant DNA (BSO), and each principal investigator.
Information concerning noncompliance with the NIH Guidelines may be brought forward by any person. It should be delivered to both NIH/ORDA and the institution (WMU). Western Michigan University, generally through the RDBC, shall take appropriate action and shall forward a complete report of the incident recommending any further action to the NIH/ORDA.
Whenever possible, the following procedures will be followed:
- Immediately following the problem, violation, accident or illness, the principal investigator must notify the biological safety officer for recombinant DNA (BSO) and the greenhouse/animal facility manager, if applicable.
- Within 7 days of notification by the principal investigator, the biological safety officer for recombinant DNA (BSO) must notify the Recombinant DNA Biosafety Committee (RDBC). If necessary, an emergency meeting of the RDBC may be convened to discuss the report.
- Within 7 days of notification by the biological safety officer for recombinant DNA (BSO), the Recombinant DNA Biosafety Committee (RDBC) must submit a written report of the problem, violation, accident, or illness to the vice president for research.
- Within 7 days of submission of the written report from the Recombinant DNA Biosafety Committee (RDBC), the vice president for research, on behalf of the institution, shall file a formal report with NIH/ORDA detailing the incident.
Email our research compliance coordinator.