Recombinant DNA and/or Infectious Biohazards in Teaching and Research (A-81)
Original Implementation: January 29, 2013
Last Revision: none
The Stephen F. Austin State University (SFA) Institutional Biosafety Committee (IBC) is responsible for the review of research and teaching activities that involve biological agents, toxins, or recombinant DNA (rDNA). This review process ensures that all university activities comply with government regulations set forth by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). The IBC shall consist of university faculty and community representatives as set forth by the NIH Guidelines, and will meet monthly, or on an as-needed basis, to review faculty research proposals that involve biological agents, toxins, or rDNA and biosafety issues at the university. Other than compliance with federal agency requirements, the main goal of the IBC is to minimize risks to faculty, staff, students, facilities, the community, and the environment while using rDNA and biohazardous materials. The IBC also ensures compliance with laws and regulations regarding the receipt, use, storage, transfer/shipping, and destruction of biohazardous or potentially biohazardous materials. All IBC procedures should be followed in conjunction with other relevant SFA policies and procedures.
The provost and vice president for academic affairs is the designated Institutional Official (IO) and is ultimately responsible for compliance with this policy and accompanying procedures. The IBC will review and approve or reject all activities involving any known or potential rDNA/biohazardous materials, unless those materials are exempt under federal regulations and as set forth in this policy.
This policy applies to all activities, teaching or research, that involve rDNA and/or biohazardous materials as defined in Section 5, below, that are:
- conducted by university faculty or staff;
- conducted using property and/or facilities owned by the university; and/or
- stored at any university-owned facility
IBC policies and procedures apply to all faculty, staff, students, visitors, and agents (and their employees) that are engaged in teaching or research activities involving rDNA and/or biohazardous materials.
4.0. IBC Registration with the National Institutes of Health
The IBC will maintain active registration with the NIH Office of Biotechnology Activities (OBA) for purposes of rDNA research. A report will be filed with OBA at the beginning of each fiscal year that includes an updated list of IBC members, indicating the role, contact information and biosketch of each member. The OBA will be notified immediately upon a change in IBC membership, and this notice will include a revised list of members, contact information and biosketches. It is the responsibility of the IBC Chair to notify OBA of changes in IBC membership and for submitting the annual report on behalf of the university. The Office of Environmental Health, Safety and Risk Management (EHS&RM) is the official repository of IBC records.
5.0. Definitions of rDNA and/or Biohazardous Materials
The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) define rDNA molecules as either: (1) molecules that are constructed outside of living cells by joining of natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (2) molecules that result from the replication of those described in (1) above. Synthetic DNA segments that have the potential to produce harmful or potentially harmful polynucleotides or polypeptides (e.g. toxins, and pharmacologically active agents) are considered equivalents to their natural DNA counterparts.
5.2. Infectious Biological Agents
Infectious biological agents include biological agents and/or biologically-derived materials that present or that may present a risk to the health and welfare of humans or animals, whether directly through infection or indirectly through damage to the environment. Categories of potentially infectious biological materials include:
- human, animal and plant pathogens (bacteria, parasites, fungi, viruses, prions);
- all human blood, blood products, tissues, and bodily fluids;
- cultured cells and potentially infectious agents these cells may contain or can support the proliferation of;
- clinical specimens; and
- infected or potentially infected animals and animal tissues
5.3. Select Agents and Toxins
The Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), and the United States Department of Agriculture (USDA) have identified select agents and toxins that have a high potential to pose a major threat to public, animal or plant health. These agents are subject to protocol and regulatory oversight by these agencies. The HHS/CDC list of select agents and toxins (including those that overlap with USDA) are identified at 42 CFR 73.3 (HHS list) and 42 CFR 73.4 (Overlap list). The USDA list of select agents and toxins are identified at 9 CFR 121.3.
Because SFA does not have a permit of registration with the CDC or USDA, the receipt, use, or storage of select agents and toxins that are not deemed to be excluded by HHS criteria is not permissible.
6.0. Risk Assessment and Selection of Appropriate Safeguards
Teaching or research activities that involve rDNA and/or biohazardous materials are classified on the basis of potential risk to humans. Risk classification determines the type of biological and physical containment level(s). There are no facilities at the university certified to conduct Biosafety Level 3 (BSL-3) or BSL-4 research or teaching. The primary investigator (PI), course instructor (CI) or course coordinator (CC) have the primary responsibility to conduct initial risk assessments and determine the appropriate level of risk and biological/physical containment level prior to the possession or use of rDNA and/or biohazardous material. The initial level of risk and biological/physical containment levels for rDNA and/or biohazardous materials is submitted to the IBC, and is subject to review and approval by the IBC. The director of the EHS&RM may make risk and biological/physical containment level recommendations to the IBC for all teaching or research involving rDNA and/or biological hazards.
6.1. Risk Group Classification
Agents are classified into three risk groups according to their relative pathogenicity for healthy adult humans. These three risk groups are:
- Risk Group 1 (RG-1) – Agents that are not associated with disease in healthy adult humans.
- Risk Group 2 (RG-2) – Agents that are associated with human disease that is rarely serious and for which preventative or therapeutic interventions are often available.
- Risk Group 3 (RG-3) – Agents that are likely to cause serious or lethal disease in humans for which preventative or therapeutic interventions are not usually available.
The following resources are available for reference when determining the risk group of a particular rDNA and/or biohazardous agent:
- NIH Guidelines, Appendix B, Classification of Human Etiologic Agents on Basis of Hazards.
- BMBL, Section VII, Agent Summary Statements.
- Canadian Laboratory Biosafety Guidelines.
- World Health Organization Biosafety Guidelines.
- American Biological Safety Association’s Risk Group Classification for Infectious Agents.
6.2. Factors Used in Determining Risk Groups
In addition to the risk group of the respective agent, the following factors should be considered in assessing risk and determining the level of physical and biological containment:
- pathogenicity of the biohazardous material – disease incidence and severity;
- virulence – the relative pathogenicity of the agent and any virulence factors;
- operations – the method by which the agent will be utilized during the teaching or research;
- route of transmission – the potential for aerosol transmission;
- stability of the agent – factors such as desiccation, exposure to sunlight or ultraviolet light, or exposure to chemical disinfectants;
- infectious dose and communicability of the agent – the range from the healthiest immunized individual to the individual with the least resistance;
- concentration of the agent – the concentration of the agent and the activities planned;
- origin of the biohazardous materials – factors such as geographic location, host and nature of the source;
- availability of data from animal studies – can be useful in the absence of data from studies involving humans;
- established availability of immunizations/vaccines and/or treatment – the unavailability or limited supply of immunizations/vaccines and/or treatment may impact the risk involved in the use of biohazardous materials; and
- gene product effects such as toxicity, physiological activity, and allergenicity
Any strain that is known to be more hazardous than the wild-type strain should be considered for handling at a higher containment level. Certain attenuated strains, or strains that have lost certain virulence factors, may qualify for a reduction in the containment level compared to the wild-type strain. See NIH Guidelines, Section V-B, and Section I-IV.
6.3. Biological and Physical Containment (Biosafety Level)
The final assessment of risk, based on the agent’s risk group and other risk factors, should be used to determine the appropriate biosafety level (BSL-1 or BSL-2) for the rDNA and/or biohazardous materials. The level of biosafety describes the degree of physical and biological containment required to contain rDNA and/or biohazardous materials in order to reduce or eliminate the potential for exposure of all personnel, whether inside or outside of the facility, as well as the environment.
Following is a general description of the acceptable biosafety levels at the university:
- Biosafety Level 1 (BSL-1) – Suitable for work involving biohazardous materials of a minimal potential hazard to personnel and the environment.
- Biosafety Level 2 (BSL-2) – Suitable for work involving biohazardous materials of a moderate potential hazard to personnel and the environment. The biohazardous materials are associated with human disease that is rarely serious and for which preventative or therapeutic interventions are often reliable.
Additionally, there are specific biosafety levels for work with rDNA and/or biohazardous agents involving plants or animals. Additional information on these can be found in the BMBL and the NIH Guidelines Section III and Appendix P (plants) and Q (animals).
As previously noted, SFA does not have facilities for BSL-3 or BSL-4 containment and all teaching or research involving the use or possession of agents requiring these levels of containment is strictly prohibited in or on any university-owned property.
7.0. Biosafety Regulations and Guidelines
Thispolicyis based on the following regulations and guidelines:
- NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
- The university is responsible for ensuring that teaching or research using rDNA is conducted in compliance with these guidelines. This requires a combined effort of the PI, CI, or CC along with the IBC, EHS&RM, and other university official(s).
- The university is responsible for ensuring that teaching or research using rDNA is conducted in compliance with these guidelines. This requires a combined effort of the PI, CI, or CC along with the IBC, EHS&RM, and other university official(s).
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm
- This document, published by the CDC and NIH, is considered to be the standard for biosafety and contains guidelines for microbiological practices, safety equipment, and facilities that constitute the four biosafety levels. .
The responsibility for biosafety in teaching and research ultimately lies with the provost and vice president for academic affairs, who oversees the IBC, the safety officer, and faculty and staff who obtain, possess, or use rDNA and/or biohazardous materials. It is the role of the IBC to review, approve/reject, and provide oversight and guidance to individuals at the university, or that use property owned by the university, who seek to use or possess rDNA and/or biohazardous materials for teaching or research. The possession and/or use of rDNA and/or biohazardous materials at the university, or in conjunction with the university, must be conducted with safeguards in place to protect against environmental release.
8.1. General PI, CI, or CC Responsibilities
The PI, CI, or CC shall:
- Not initiate or modify any teaching or research involving rDNA and/or biohazardous materials subject to IBC approval under thispolicy or NIH Guidelines until the proposed teaching or research modification(s) has been approved by the IBC;
- Immediately report any significant problems or accidents and illnesses to the EHS&RM safety officer, the IBC chair, and any other university committee or official that has reviewed and approved the research activity (e.g. the Institutional Animal Care and Use Committee or the Radiation Safety Officer); and
- Comply with all local, state, and federal requirements when teaching or research involves rDNA and/or biohazardous materials.
8.2. PI, CI, or CC Responsibilities Prior to Initiation of Teaching or Research Involving rDNA and/or Biohazardous Materials
Prior to initiation of teaching or research involving rDNA and/or biohazardous materials, the PI, CI, or CC must:
- Review all applicable guidelines and regulations and become familiar with all safety procedures and requirements related to the rDNA and/or biohazardous materials involved.
- Develop Standard Operating Procedures (SOPs) incorporating biosafety procedures or a biosafety manual prepared specifically for the teaching or research classroom or laboratory. Each manual must include a protocol submitted to the IBC that describes the potential biohazards and the precautions to be taken (e.g. hazards and risks, immunizations, personal protective equipment, decontamination, storage and disposal, and/or spill procedures). Copies of this manual must be located in each teaching and research classroom or laboratory and made readily accessible to all personnel including the IBC Chair.
- Establish policies and procedures to limit access to those individuals who have been properly advised on all potential hazards and meet specific entry requirements (e.g. immunization, or training on the use of protective clothing or equipment).
- Instruct all personnel and students on the potential hazards associated with the teaching or research activities, the necessary precautions to prevent exposures, and exposure evaluation procedures. Ensure that all personnel receive annual training updates or additional training as necessary for all procedural and/or policy changes.
- Instruct personnel and students in aseptic techniques and in the biology of the organisms or agents used so that potential biohazards are understood and appreciated.
- Instruct and train personnel and students in the practices and techniques required to ensure safety and the procedures for dealing with and reporting accidents, spills, and illnesses.
- Comply with all required occupational health requirements, including ensuring that all personnel know the reasons and provisions for precautionary medical practices implemented and ensuring that personnel are offered, at no cost, appropriate immunizations or tests for the biohazardous materials handled or potentially present.
8.3. PI, CI, or CC Responsibilities During the Conduct of Teaching or Research Activities Involving rDNA and/or Biohazardous Materials
During teaching or research or any other use of rDNA or biohazardous materials, the PI, CI, or CC must:
- Limit or restrict access to the teaching or research laboratory or classroom when work with the rDNA and/or biohazardous materials is in progress, including a determination of who may be at increased risk.
- Provide personal protective equipment required for work with the respective rDNA and/or biohazardous material.
- Supervise the safety performance of the teaching or research staff and personnel to ensure that the required safety practices and techniques are employed.
- Correct work errors and conditions that may result in the release of rDNA and/or biohazardous materials.
- Ensure the integrity of the biological and physical containment (biosafety level).
- Ensure the security of rDNA and/or biohazardous materials at all times.
8.4. Specific Responsibilities Regarding rDNA
The NIH Guidelines are applicable to all rDNA research conducted within the United States. It is the responsibility of the university to ensure that rDNA teaching or research conducted at or sponsored by the university, irrespective of the funding source, complies with the Guidelines as a condition of funding.
8.5. General PI, CI, or CC Responsibilities Regarding rDNA Teaching or Research
In addition to all responsibilities discussed above, the PI, CI, or CC must:
- Not initiate or modify any rDNA research that requires prior IBC approval before initiation, until that research or the proposed modification(s) has been approved by the IBC and has met all other requirements of the NIH Guidelines.
- Determine whether experiments are covered by Section III-E, Experiments that Require Institutional Biosafety Committee Notice Simultaneous with Initiation, of the NIH Guidelines, and ensure that all appropriate procedures are followed.
- Report any significant problems with the NIH Guidelines, or any significant teaching- or research-related accidents and illnesses to the safety officer, the IBC chair, the director of the Office of Research and Sponsored Programs (ORSP) as appropriate, and any other appropriate university committees or officials that have approved the research.
- Report any new information bearing on the NIH Guidelines to the IBC and to the NIH OBA.
8.6. PI, CI, or CC Responsibilities for Submissions to the NIH OBA
As per Section IV-V-7-b of the NIH Guidelines, the PI, CI, or CC must:
- Submit information to the NIH OBA, with notice to the IBC, for certification of new host-vector systems.
- Petition the NIH OBA, with notice to the IBC, for proposed exemptions to the NIH Guidelines.
- Petition the NIH OBA, with notice to the IBC, for approval to conduct teaching or research specified in NIH Guidelines Section III-A-1, Major Actions under the NIH Guidelines, and Section III-B, Experiments that Require NIH OBA and Institutional Biosafety Committee Approval before Initiation.
- Petition the NIH OBA, with notice to the IBC, for determination of containment of experiments requiring case-by-case review.
- Petition the NIH OBA, with notice to the IBC, for determination of containment for experiments not covered by the NIH Guidelines.
8.7. PI, CI, or CC Responsibilities Regarding Access to Teaching or Research Facilities
All teaching and research facilities are property of the university and subject to university rules on access. All faculty, staff, and personnel are required to allow access to their facilities that are registered for rDNA and/or biohazardous materials to the IBC and the EHS&RM, and the ORSP director for routine laboratory inspections.
8.8. Environmental Health, Safety, & Risk Management Duties
It is the responsibility of the director of the EHS&RM to provide access to a safety officer(s) to aid in the protection of university students, faculty and staff from possession or use of rDNA and/or biohazardous materials. The safety officer’s duties include, but are not limited to:
- periodic (minimum of one per fiscal year) inspections of all laboratories and classrooms conducting rDNA and/or biohazardous research to ensure that proper standards are strictly followed;
- reporting to the IBC Chair any significant problems, violations of NIH Guidelines, and any significant accidents or illnesses;
- assisting the PI, CI, or CC with the development of emergency plans for handling accidental spills and personnel contamination;
- investigating accidents involving rDNA and/or biohazardous materials;
- providing information on spills and incidents to the IO, who will inform public health officials as required;
- providing advice on laboratory security; and
- providing advice to the IBC, faculty and staff on safety procedures.
9.0. IBC Responsibilities
The IBC is established to provide local review and oversight of research utilizing rDNA and to review a variety of experimentation that involves biological materials and other potentially hazardous agents..
9.0.1. IBC Responsibilities as per NIH Guidelines Section IV-B-2-b:
- Review and consider for approval teaching or research activities involving rDNA that is sponsored by, or conducted at, the university for compliance with the NIH Guidelines. This relates to initial and annual review of approval and modifications to all proposals and activities.
- Assess facilities, procedures, practices, training, and expertise of personnel taking part in teaching or research involving rDNA.
- Notify the PI, CI, or CC and ORSP if appropriate of the IBC’s review results, including approval or rejection.
- Assess, modify and finalize containment levels for teaching or research involving rDNA.
- Adopt and implement emergency plans set forth with the assistance of the safety officer for accidental spills and personnel contamination resulting from rDNA research.
- Review and report, along with the safety officer, any significant problems with or violations of the NIH Guidelines, accidents, or illnesses to the IO (the provost and vice president for academic affairs) and to the NIH OBA as required by section IV-B-1-j of the NIH Guidelines.
9.0.2. Other IBC Responsibilities
- Develop appropriate procedures to supervise the possession and/or use of rDNA and/or biohazardous materials as outlined by the NIH and/or BMBL.
- Suspend or terminate IBC protocol approval for any teaching or research involving rDNA and/or biohazardous materials immediately upon a finding of noncompliance or a finding that such use or possession poses an immediate threat to the health and safety of the community.
- Review the IBC policies and procedures and modify as necessary to ensure compliance with federal, state, and university requirements.
- Review all teaching and research protocols that include the possession or use of rDNA and/or biohazardous materials for compliance with the NIH Guidelines and the BMBL.
As part of the review process, the IBC will:
- assess the containment levels (BSL-1 or BSL-2);
- assess the facilities, procedures, practices, training, and expertise of personnel involved in teaching or research using rDNA and/or biohazardous materials; and
- ensure compliance with the NIH Guidelines and BMBL for all surveillance, data reporting, and adverse event reporting requirements.
9.0.3. Teaching or research that requires IBC approval include those that involve:
- The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally.
- The deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants (human gene transfer).
- The deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 ng/kg.
- Using Risk Group 2 or Risk Group 3 agents as host-vector systems.
- The cloning of DNA from Risk Group 2 or greater agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems.
- The use of infectious or defective Risk Group 2 or greater agents.
- Whole animals in which the animal’s genome has been altered by stable introduction of rDNA or DNA derived into the germ-line (transgenic animal).
- Viable rDNA-modified microorganism tested on whole animals.
- Genetically engineered plants by rDNA methods.
- More than 10 liters of culture (over the entire length of the project).
- The formation of rDNA molecules containing two-thirds or more of the genome of a eukaryotic virus.
Teaching or research requiring BSL-2 containment must be reviewed and approved prior to the initiation of experiments. Teaching or research using BSL-1 containment must also undergo IBC review, and must be submitted no more than one month after the onset of the respective teaching or research methods. Teaching or research involving select agents and/or select toxins that are not deemed to be excluded by HHS criteria, or require BSL-3 or BSL-4 containment will not be approved.
9.1. IBC Membership
Per the NIH OBA, the IBC is composed of at least five voting members who are recommended for appointment by the IBC chair; recommendations will be considered for approval by the provost and vice president for academic affairs. Members must represent the faculty and the community at large, and will have the experience and expertise required to identify potential risks to public health, animal and plant health or products, and the environment. The IBC will be composed of the following:
- at least one individual with expertise in rDNA technology and/or biological safety and/or physical containment;
- at least one scientist with expertise in biological safety and physical containment;
- at least one individual with expertise in the use, storage, transfer, and disposal of biohazardous materials;
- at least one scientist with expertise in plant, plant pathogen, or plant pest containment principles;
- at least one scientist with expertise in animal containment principles;
- one individual representing laboratory technical staff;
- an EHS&RM safety officer; and
- at least two members who are not affiliated with the university and who represent the interests of the surrounding community with respect to health and protection of the environment.
A single member can represent more than one of the above criteria. The IBC may invite consultants knowledgeable in community attitudes and the environment to its meetings as necessary to assist in the review process, but such consultants shall not vote.
9.2. IBC Chair Appointment
The IBC chair is appointed by the provost and vice president for academic affairs to a four-year term. The chair shall be a qualified faculty or staff member who is currently pursuing research involving rDNA and/or biohazardous materials. Whenever possible, the IBC chair shall be granted a one course release each semester.
9.3. IBC Chair Responsibilities
The chair shall recommend the IBC members, preside over the IBC meetings, serve as one of two contacts for all regulatory agencies (in addition to the safety officer), and act as a liaison between the academic community and the IBC. IBC members will vote on a member of the IBC to serve as vice chair in the chair’s absence. The chair will divide the IBC into subcommittees that will review all submitted teaching or research protocols to determine their exempt or non-exempt status and provide details back to the entire IBC.
9.4. IBC Regular Meetings and Minutes
The IBC will publicly meet at least four times each fiscal year and more often as necessary to review and approve protocols and conduct continual review or approved protocols. Before each regular meeting, members of the IBC will receive a copy of all materials to be reviewed at the meeting.
Minutes of IBC meetings will include:
- attendance of members and guests;
- IBC actions taken on each reviewed protocol and any required modifications for IBC approval;
- a record of members who are absent due to a conflict of interest; and
- the basis for rejecting any protocols that are reviewed.
Section II-A and Section III of the NIH Guidelines cite items that the IBC should consider with respect to the review of proposed rDNA teaching or research. These include:
- agent characteristics (e.g. virulence, pathogenicity, environmental stability);
- types of manipulations planned;
- source(s) of the inserted DNA sequences (e.g. species);
- nature of the inserted DNA sequences (e.g. structural gene, oncogene);
- host(s) and vector(s) to be used;
- whether an attempt will be made to obtain expression of a foreign gene, and if so, the protein that will be produced;
- containment conditions to be implemented; and
- applicable sections of the NIH Guidelines (e.g. Section III-D-1, Section III-E-1, etc.)
IBC meeting minutes will include references for each of the above criteria, as appropriate, for each protocol. The intent of the minutes will be to provide sufficient detail about the discussions of these matters to document the committee’s rationale for particular decisions. All minutes will be made publicly available by the university upon request.
9.5. Emergency Meetings
The IBC chair may call an emergency meeting of the committee as necessary to address noncompliance issues or serious/unexpected events involving biohazardous materials at the university.
9.6. Attendance and Quorum
Members are expected to attend the majority of all IBC meetings, whether regular or emergency meetings. Those that attend 50% or less of the total meetings in an academic year will be contacted by the IBC chair to increase their attendance. Members who continue to fail to attend meetings on a regular basis will be removed from the committee.
Final approval or rejection of non-exempt protocols involving rDNA and/or biohazardous materials requires a majority vote of present voting IBC members. Members who have a conflict of interest in the project (i.e. are acting as the PI, CI, or CC, have a financial interest in the project, etc.) shall not be present during the IBC’s initial or continuing review (deliberations and voting) of the protocol. Those with a conflict of interest are still required to submit any information requested by the IBC. If a quorum is lost at any time during the meeting, the meeting will be adjourned and no further action shall be taken by the IBC until a quorum is established.
9.7. IBC Records Retention
The following records will be retained by the IBC chair for a minimum of three years after the completion of the research or teaching protocol for non-funded activities and for funded activities by the retention date established by the ORSP:
- IBC meeting minutes;
- all protocols and attachments; and
- a list of all IBC members.
All IBC procedures will be posted on the ORSP and EHS&RM websites. The IBC will maintain its original NIH OBA registration, and all correspondence, annual reports, and notices of new members until the IBC is no longer registered with NIH OBA. These records will be maintained by the ESH&SM department.
9.8. Adverse Event Reporting Requirements
Any and all teaching and/or laboratory incidents must be reported to the PI, CI, or CC. Any incident that exposes or has the potential to expose any individual, either directly or indirectly, to any uncontained agent, toxin, or chemical must be reported immediately, on the day of occurrence, to the ESH&SM department, and the IBC chair. As per Section IV-B-2-b-(7) of the NIH Guidelinesany significant problems, violations of the NIH Guidelines, or any significant research orteaching-related accidents and illnesses related to rDNA must be reported to the NIH OBA within 30 days of the event. In the case of an rDNA exposure in a BSL-2 setting, all spills and incidents must be reported to the NIH OBA immediately. Adverse events that must be reported include but are not limited to any overt exposure or potential exposure such as a needle stick, splashes of rDNA, or contamination from equipment failure. Adverse events may also occur due to a breach in containment that may be determined to exert an overt or potential exposure to any individual. Because rDNA is considered biohazardous, any and all incidents involving disposal of rDNA must also be reported.
The university considers all rDNA and/or biohazardous incidents to be reportable to the IBC and EHS&RM, regardless of whether they have been determined to be exempt from the NIH Guidelines. A mandatory investigation and internal report will be completed for all incidents. If there is any doubt regarding whether events should or should not be reported, the safety officer or the IBC chair should be consulted.
9.8.1. Method of Adverse Event Reporting
It is the responsibility of the PI, CI, or CC to be properly trained, and to train all personnel in proper safety methods and adverse event reporting to university officials. Any incident must be immediately reported to the safety officer, whose contact information can be found on the EHS&RM website as well as the IBC chair. A phone call to the University Police Department will also result in contact of the safety officer and IBC chair.
The safety officer or IBC chair will report all significant incidents involving rDNA and/or biohazardous materials to the IBC via the Rapid Response Team (RRT). The RRT is a subcommittee of the IBC appointed annually by the IBC Chair. Permanent members of the RRT include the safety officer, IBC chair, director of ORSP, and the director of EHS&RM. The RRT will evaluate any incident that involves rDNA and/or biohazardous materials within 24 hours of receiving the report, and will immediately notify all members of the IBC, EHS&RM, and the IO. It is preferred that all personnel submit the Adverse Event Form when submitting a report to the safety officer and IBC chair; however, depending on the time of occurrence and severity of the event, this may not be the case. The RRT will use the Adverse Event Form to make a formal report to the IBC and IO, and in required instances to the NIH OBA. The IBC is responsible for review of all reported incidents provided by the RRT.
9.9. Compliance Oversight and Appropriate Actions Taken
The IBC has the authority to address all non-compliance issues with this policy and related procedures, the NIH Guidelines, the BMBL, and/or other state and federal requirements. Non-compliance of any type by an individual may result in the IBC taking one or more of the following actions:
- suspending the use and/or storage of rDNA and/or biohazardous material;
- terminating the IBC-approved protocol for the rDNA and/or biohazardous material;
- confiscating the rDNA and/or biohazardous material;
- destroying the rDNA and/or biohazardous material;
- any action necessary to protect the public and/or the university, including transfer of locks on research labs and/or teaching classrooms/labs to suspend activity; and
- reporting to the NIH, CDC, USDA, and/or any other local, state, or federal agency.
10.0. IBC Review
Any faculty or staff member, or other personnel who wants to possess or use rDNA and/or biohazardous materials, including those whose protocols are deemed exempt by the NIH Guidelines, must submit a protocol permit registration document with the IBC. The IBC will review and approve any and all teaching and/or research activities involving: (1) rDNA; (2) infectious agents capable of infecting humans, animals, or plants; and (3) any other potentially biohazardous materials. Neither the university nor the IBC will approve any use or possession of select agents and toxins that are not deemed to be excluded by HHS criteria. Any questions on exemptions to the select agents and toxins should be directed to the IBC chair. Some federal regulations allow exemption for some types of rDNA use; however, applications for rDNA projects must be submitted to the IBC so that the IBC is aware of the activities and can verify that they are exempt.
No personnel will obtain or use rDNA and/or biohazardous materials until the respective protocol has been approved by the IBC. Modifications of approved protocols should not occur until approved by the IBC.
10.1. IBC Review of Teaching or Research Involving rDNA and/or Biohazardous Materials
Any teaching or research involving rDNA and/or biohazardous materials conducted on or in university-owned property is subject to review and approval by the IBC. The PI, CI, or CC must submit an IBC Permit Registration form to the IBC chair. Approval must be obtained before initiating any teaching or research involving rDNA and/or biohazardous materials.
If teaching or research involving rDNA falls into any of the conditions below, approval by the NIH, NIH OBA, and its committees, in addition to the IBC, is required:
- Experiments Requiring IBC Approval, RAC Review, and NIH Director Approval Before Initiation (See NIH Guidelines, Section III-A) – This includes experiments considered as Major Actions under the NIH Guidelines and experiments involving the deliberate transfer of a drug resistance trait to microorganisms that do not acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture.
- Experiments Requiring NIH OBA and IBC Approval Before Initiation (See NIH Guidelines, Section III-B) – This covers experiments involving the cloning of toxin molecules with LD50 of less than 100 ng/kg body weight.
- Experiments Requiring IBC and IRB Approvals and RAC Review Before Research Participant Enrollment (See NIH Guidelines, Section III-C) – These experiments involve the deliberate transfer of rDNA, or DNA or RNA derived from rDNA, into human subjects (human gene transfer).
- Experiments Requiring IBC Approval Before Initiation (See NIH Guidelines, Section III-D) – Full board review and approval required before commencing research. This category covers the following subsections: (1) experiments using RG-2, RG-3, RG-4 or restricted agents as host-vector systems; (2) experiments in which DNA from RG-2, RG-3, RG-4, or restricted agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems; (3) experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems; (4) experiments involving whole animals and/or whole plants; and (5) experiments involving more than 10 liters of culture.
- Experiments Requiring IBC Notice Simultaneous with Initiation (See NIH Guidelines, Section III-E) – This includes experiments not included in NIH guidelines Sections III-A, III-B, III-D, III-F, and their subsections. Under thispolicy, IBC approval is required prior to initiation of the teaching or research.
- Exempt Experiments (See NIH Guidelines, Section III-F) – Refer to the list below for a list of rDNA molecules that are exempt from the guidelines. Under these IBC policies, protocol and approval of the exempt status by the IBC is required prior to initiation of the teaching or research. The IBC chair has the authority to make this determination and provide information on all decisions made to the IBC through meeting agendas and minutes.
If an rDNA experiment falls into NIH Guidelines Section III-F (Exempt) and into either Sections III-D or III-E as well, the experiment is considered exempt from the NIH Guidelines, but is still subject to approval of exempt status prior to initiation of teaching or research activities.
10.2. Notice of IBC Action
After reviewing the submitted IBC Permit Registration form, the IBC chair will provide written notification of the chair’s/IBC’s decision (approved or rejected) to the PI, CI, or CC, and to ORSP, as applicable. In some instances, the IBC and/or IBC chair may require additional information to complete the review process. In such instances, the IBC chair will contact the PI, CI, or CC to request further information which must be submitted to the IBC before any further action will be taken regarding the IBC Permit Registration. If the requested information is not submitted to the IBC at least one month prior to the next scheduled IBC meeting, the respective IBC permit registration will be rejected, and the PI, CI, or CC will be required to resubmit their application.
10.3. Length of Approval of IBC Permits Involving rDNA and/or Biohazardous Materials
IBC approval of permits for rDNA and/or biohazardous materials is valid for three years. All IBC approvals must undergo an annual review, unless a shorter period is determined to be required by the IBC. The IBC will inform each PI, CI, or CC of the date upon which the annual review must be complete. Each PI, CI, or CC must submit the Annual Permit Renewal Form to the IBC at least one month prior to the next meeting of the IBC. The IBC chair will notify the PI, CI, or CC of all decisions that are made.
10.4. Modifications to Approved Protocols
No changes or modifications to the approved IBC permit should be implemented without prior review and approval of the IBC. This includes, but is not limited to, modification of rDNA and/or biohazardous materials, procedure changes, changes in personnel, termination or transfer of the approved agents, or changes that increase the risk of the project and/or the biosafety level. An IBC Amendment Form must be submitted to the IBC for review and approval. The IBC chair will notify the PI, CI, or CC, and ORSP, as applicable, of all decisions that are made.
Cross Reference: NIH Guidelines for Research Involving Recombinant DNA Molecules; Biosafety in Microbiological and Biomedical Laboratories (BMBL); 42 CFR 73.3; 42 CFR 73.4; 9 CFR 121.3.
Responsible for Implementation: Provost and Vice President for Academic Affairs
Contact for Revision: Institutional Biosafety Committee Chair
Forms: Permit Registration, Annual Renewal, Adverse Event, BSL2 SOP Template, BSL2 Manual Template
Board Committee Assignment: Academic and Student Affairs