- Recombinant DNA
- Select Agents and Biological Toxins
- Biological materials (cells, tissues, fluids, etc.) derived from humans and non-human primates
- Particularly Hazardous Chemicals
- UT Dallas
- Committee Chair
- Biological Safety Officer (BSO)
- Committee Coordinator
- Principal Investigators
The University of Texas at Dallas (UTD) conducts research involving recombinant DNA (rDNA) and receives funding from the National Institutes of Health (NIH) for at least part of this research. According to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), an institution receiving any NIH funds for rDNA research must comply with the NIH Guidelines for all rDNA research.
To ensure compliance with these requirements, the University has established the Institutional Biosafety and Chemical Safety Committee (IBCC). The IBCC is responsible for the oversight, administration, and review of UTD laboratory policies and projects involving research with recombinant or synthetic nucleic acid molecules and hazardous biological materials that may pose safety, health, or environmental risks.
Under the NIH Guidelines Section IV-B-2, an institution’s “responsibilities need not be restricted to recombinant DNA”. Accordingly, the Committee also operates as 1) the institutional chemical safety committee to develop policies for the acquisition, safe handling and storage of hazardous chemical materials that require oversight under local, state and federal guidelines, as well as 2) the Institutional Review Entity (IRE) as described in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.
To this end, the IBCC assists and advises Principal Investigators (PIs) and other researchers in meeting their responsibilities to ensure that the biological and chemical aspects of the research are conducted in a safe manner using established safety standards, principles, and work authorization. Safe research includes worker safety, public health, agricultural and environmental protection, ethics, and compliance with applicable safety standards and UTD Policies.
The IBCC also provides recommendations to the University Safety and Security Council for the development of policies that will provide for the safe conduct of research and ensure compliance with local, state, and federal regulations and guidelines.
At UTD, the IBCC reviews all recombinant DNA research conducted at or sponsored by the University to verify all protocols meet or exceed the standards outlined in the NIH Guidelines, and approves those research projects that comply with the Guidelines. The IBCC is also charged with the review and oversight of research involving pathogens, select agents, biological material from human or non-human primates, or particularly hazardous chemicals.
Recombinant DNA is defined here as: molecules that are constructed by joining natural or synthetic DNA segments to DNA molecules, that can replicate in a living cell, and the molecules that result from the replication of those cells. Section III of the NIH Guidelines covers the different types of rDNA research and the levels of review required for each, ranging from exempt to full review by the NIH depending on the safety risk posed. At UTD, ALL rDNA research must be reviewed by the IBCC, even if it is “exempt” to ensure the correct status. The NIH Guidelines also cover risk assessment for various types of organisms that may be source, vector or host.
A pathogen or infectious agent is any agent associated with disease in healthy human adults. There are four Risk Groups (RGs) discussed in the NIH Guidelines which generally correlate with the biosafety levels described in the CDC publication “Biosafety in Microbiological and Biomedical Laboratories (BMBL)”. Agents in RG2/BSL2 or higher are considered human pathogens. In addition to human pathogens, the IBCC also reviews any research involving any biological agents with the potential to cause disease in plants or animals, as these may pose a significant environmental hazard.
The US PATRIOT Act, signed into law on October 26, 2001, places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. Some of these agents are defined by the Department of Health and Human Services (DHHS) as posing a severe threat to public health and are regulated by 42 CFR 73. Other agents defined by the United States Department of Agriculture (USDA) as posing a severe threat to animal or plant health are regulated by 7 CFR 331 and 9 CFR 121. Any request to use select agents at UTD requires review and approval by the IBCC before these agents may be obtained. There are also many other government requirements that must be completed in order for these agents to be brought onto campus, including registration and background checks. The IBCC also requires the registration of any biological toxins with an LD 50 < 1 mg/kg body weight in any vertebrate model via any route of exposure.
Biological material includes, but is not limited to: cells/tissue, blood, saliva, urine, spinal fluid, serum, feces, breast milk, semen, or any other such materials or fluids of human or non-human primate origin. Any of these substances, containing or consisting of human cells or the cells of other primates, may contain known or heretofore unknown communicable diseases, and therefore pose a potential hazard. Such materials are automatically classified as RG2/BSL2 and must be handled accordingly. In addition to IBCC approval, PIs must consult with the IRB before collecting or obtaining any human biological materials other than established cell lines for DNA work.
Chemicals known to be of particular hazard to human life and health are subject to the review of the Committee prior to the initiation of work. In addition, the Committee may also establish a standardized set protocols and procedures for the utilization of some of the more commonly used chemicals listed under its purview. In lieu of submitting registration for each particularly hazardous chemical, the PI may choose to adopt the protocols and procedures previously established by the Committee, if available.
A broad array of available research and regulatory expertise is important for the IBCC given the range of recombinant DNA research that the committee reviews. The NIH requires that the IBCC have members selected who collectively have the experience, expertise, and capability needed to assess the breadth and safety of recombinant and synthetic nucleic acid molecules as well as other biological and chemical agents as needed to identify any potential risks to workers, public health, or the environment. The Responsible University Official (RUO) for the Committee is the Vice President of Administration.
The President of the University, with assistance from the IBCC Chair and the Biosafety Officer, shall formally nominate and appoint no fewer than 5 members who collectively have experience and expertise in:
- Recombinant DNA technology, the capability to assess the safety of research with rDNA, the ability to identify any potential risk to public health or the environment, general issues of laboratory biosafety, and the use of infectious materials
- Plants, plant pathogens, or plant pest containment principles when such experiments are conducted at the institution.
- Animal containment principles when any rDNA research involving animals is conducted at the institution.
- The field of human gene transfer when the institution conducts or sponsors any research with rDNA involving human subjects
- Chemical safety, preferably as it pertains to particularly hazardous substances.
- A minimum of 2 members who live or work in the surrounding community with no affiliation to the University outside of their participation on the Committee. These members must have the appropriate knowledge/training to represent the interest of the community with respect to health and protection of the environment.
Since many fields of study may overlap, members are permitted to fulfill multiple requirements, except that of University faculty/staff serving as non-affiliated members.
- The Vice President of Research (or designee)
- The University Biological Safety Officer (BSO)
- Responsible University Official (or designee)
A non-voting representative will serve as both Committee Secretary and Coordinator. If needed, additional consultants, competent in the corresponding research area and familiar with Federal, State and Local regulations, may be called in by the Chair. These consultants will not have a vote.
IBCC membership is a minimum three‐year period of service. Members may be appointed for subsequent three year terms if they are willing to continue to serve. Member terms should be staggered such that no more than one-third of the appointed Committee members are replaced in a given year.
The Chair of the Committee is appointed for a two year term. Additionally, the Chair will also serve as an ex-officio member of the University Safety and Security Council for the duration of his or her term.
If a member resigns or fails to attend three meetings throughout the calendar year, the Chair may request that the University President appoint another qualified member to serve out the remainder of the unexpired term.
It is the policy of this Committee that no member of the IBCC may be involved (except to provide information requested by the IBCC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest. Each member is expected to notify the IBCC chair in these circumstances and recuse themselves when such proposals are being discussed and are up for a vote. In addition, if the Chair is PI on a project, the Biological Safety Officer or another senior IBCC committee member present at the meeting will sign the approval form if the project is approved.
The University, as a condition of NIH funding, must ensure that all recombinant DNA research conducted at or sponsored by UTD is conducted in compliance with the NIH Guidelines regardless of funding source. The University places institutional authority with the UTD IBCC to review, approve, require modifications to secure approval, disapprove, suspend or terminate research activities involving rDNA as well as other biological and chemical hazards and ensure research is conducted in full conformity with the provisions of the NIH Guidelines.
- Ensures that PIs are aware of the responsibility to register research involving recombinant DNA and biohazards with the Committee.
- Reviews recombinant DNA research conducted at or sponsored by the University for compliance with the NIH Guidelines, makes requests for modifications if required, and approves, when appropriate, those research projects that are found to conform to the NIH Guidelines.
- In accordance with the NIH Guidelines and after a thorough risk assessment, lowers containment levels for research that falls under Section III-D-2-a, Experiments in which DNA from Risk Group 2 or higher, or Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic Host-Vector Systems
- Sets containment levels that are not established by the NIH Guidelines.
- Adopts emergency plans covering accidental spills, personnel contamination, and research-related illness resulting from rDNA research activities.
- Makes recommendations for medical surveillance that may be required for staff, students, and faculty to the Safety and Security Council.
- Reviews, makes requests for modifications if required, and approves, when appropriate, research involving: microorganisms and viruses that are pathogenic to humans, animals or plants; biological materials from human and non-human primates; or particularly hazardous chemicals the Committee deems necessary to regulate.
- Reviews previously approved protocols annually to ensure continued compliance with the NIH Guidelines.
- Conducts the local review, requests for modifications, and approval of all University research activities involving the possession and use of Select Agents and Select Agent Toxins, to assure that these activities and the related
- Recommends to the RUO and/or the Safety and Security Council sanctions on any individual whom the IBCC determines has violated the terms of an approved protocol, has conducted projects subject to its authority without gaining appropriate IBCC approval, or has otherwise violated any provision of applicable federal, state, and local regulations and guidelines, or institutional policies regarding subjects under its purview.
- Performs a biennial review of the IBCC’s compliance with the Guidelines and submits the findings to the RUO. The review shall be performed using assessment tools available from the NIH Office of Biotechnology Activities.
- Stipulates terms for updating and renewal of registrations and send reminders notifying Investigators when protocol renewals are required.
- Supports information flow between the IBCC, the IRB, and the IACUC. The IBCC Coordinator shall report any protocol involving vertebrate animals to the Institutional Animal Care and Use Committee (IACUC), and report any protocol involving human research participants to the Institutional Review Board (IRB).
- Assesses any existing facilities contemplating research for proper engineering controls.
- Reviews construction plans to ensure that new facilities comport with the conditions and containment measures described in the NIH Guidelines.
- Reports any significant problems with, or violations of the NIH Guidelines and any significant research related exposures, accidents or illnesses to the RUO and the NIH Office of Biotechnology Activities (OBA) within 30 days.
- Submits an annual report summarizing the Committee’s activities to the Committee on Committees. The Chair shall submit an annual report to NIH OBA that includes a roster of IBCC members, member roles, and biographical sketches of each member.
- Sends Annual Certification of Research form to appropriate Department Heads on or about January 1st requesting they certify
- Serves as an ex-officio member of the University’s Safety and Security Council.
- Ensures that PIs are aware of the responsibility to register research involving recombinant DNA and biohazards with the Committee
- Participates in the development and implementation of training necessary for PIs, research personnel, and new IBCC members as described in the NIH Guidelines.
- Oversees initial inspection of the laboratory to ensure proper engineering controls and appropriate level of containment prior to the initiation of work
- Reviews periodic inspections for all laboratories and associated facilities of PIs with protocols reviewed by the Committee to ensure that laboratory standards are rigorously followed and remain in compliance in NIH regulations.
- Investigates potential violations of the NIH Guidelines and reports findings to the Committee.
- Serves as the Institutional Contact for Dual Use Research (ICDUR) for the University as necessary.
- Facilitates communication within the committee: forwards new protocols to committee for review, sends meeting reminders to committee members, schedules follow-up meetings with PIs if committee deems it necessary, etc.
- Manages correspondence for the committee; the Coordinator will act as the primary contact and respondent for all administrative inquiries via phone and e-mail. Technical inquiries shall be forwarded to the Chair/BSO before issuing an official IBCC response. The Coordinator also notifies the PI of the results of the IBCC’s review and sends notifications of any upcoming protocol renewal or expiration dates to the PI.
- Records and archives meeting minutes, as well as any protocols received, and any other official IBCC-related documents.
- Ensures full compliance with the NIH Guidelines in the conduct of rDNA research for all research personnel on the project.
- Submits an initial research protocol and any subsequent changes for each project involving any of the hazards falling under the Committee’s scope of review (described above) to the Committee for approval or disapproval.
- Waits to initiate or implement changes in any rDNA research activities subject to review under the NIH Guidelines until after that research or proposed modification thereof has been approved by the IBCC.
- Trains and provides proper documentation for their laboratory staff in the practices and techniques required to ensure safety as well as training regarding the procedures for dealing with accidents, spills, or contamination.
- Has adequate training and experience in good microbiological techniques.
- Assumes responsibility for supervising the safety performance of the laboratory staff, including monitoring PPE compliance.
- Reports any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Biological Safety Officer (where applicable), Animal Facility Director (where applicable), Institutional Biosafety Committee, NIH/OBA, and other appropriate authorities (if applicable) within 30 days.
A. Review Process
Anyone working with materials covered in the scope of review by the IBCC must have their research reviewed by the Committee whether the research is funded by NIH or not. This document applies to all research conducted at or sponsored by the University.
- The PI may initiate a committee review by submitting a Protocol Registration Form or a Protocol Amendment Form via e-mail to firstname.lastname@example.org.
- The Coordinator verifies that the form is complete and apropos before sending it out to the Committee to be considered for review at the next scheduled meeting. If the deadline for the upcoming meeting has passed, the protocol may be reviewed at the following meeting.
- The BSO shall review the protocol’s proposed containment level and ensure a baseline inspection of the facility has been performed in accordance with the inspection schedule for that laboratory’s designated Risk Level, and that the laboratory is in full compliance with the NIH Guidelines. The BSO shall report findings to the committee at the meeting.
- The Committee convenes to review all protocols submitted by the deadline and for each, assigns one of four possible outcomes:
- Approved as written – the Committee has no concerns regarding the protocol and work may begin immediately.
- Tabled pending modifications and designated member review – the Committee has some minor concerns regarding the protocol. The PI must address the Committee’s concerns in writing and resubmit the form. The Chair shall designate a single member (or sub-committee where necessary) with expertise in the area to review the modified protocol. The designated member(s) shall notify the PI, the Coordinator, and the Committee once a decision has been reached; however, only the signatures of the Chair and the BSO are required for full approval. Work may begin as soon as the PI receives notification of approval.
- Tabled pending modifications and re-review by full IBCC at next convened meeting – the Committee has raised some moderate concerns regarding the protocol, or minor concerns that are beyond the Chair’s scope of expertise. The PI must modify and resubmit the protocol for a full committee review at the next meeting. No work may begin until after the Committee has reached a decision.
- Declined – the Committee has found a number of significant concerns with key components of the proposed research outlined by the protocol. No work may begin on this project.
- The Coordinator will notify the PI in writing of the Committee’s decision, as well as the expiration date for any approved protocol. Once a protocol has been Approved as written, work may begin immediately.
- Approvals may be effective for up to 3 years, depending upon the nature of project. The PI must submit a new Protocol Registration Form before the expiration date of the initial protocol to avoid interruption of ongoing research. Protocols may be re-approved only by full committee review when they expire or at the discretion of the committee. The IBCC may revoke an approval if it is determined that the research is not in compliance with NIH Guidelines or the UTD biosafety manual.
- For the life of the protocol, the PI must submit an Annual Renewal Form each year. This will ensure that previously approved protocols remain compliant with any new or updated regulations. The Chair (or appropriate designee when necessary) shall review the document and approve or recommend corrections to the protocol. Annual Renewals require the signatures of the Chair and the BSO, but do not need to be brought before a full committee review.
- The Coordinator will send out a reminders two months before any pertinent application deadlines that directly precede the expiration date or annual renewal date for a protocol. If the IBCC does not receive and approve the appropriate form by the expiration date, the Coordinator may issue a Cease and Desist Notice. Any further work on the expired project violates the NIH Guidelines and must be reported to the NIH OBA.
- The PI must notify the IBCC of any significant changes to an already approved protocol BEFORE implementing said changes using the Protocol Amendment Form. The form will be considered for review at the upcoming Committee meeting if it was received by the application deadline. No significant change to any protocol may be implemented until after it has been reviewed and approved by the IBCC. Failure to comply will result in a violation of the NIH Guidelines and must be reported to the NIH OBA. Submission of a Protocol Amendment Form does not affect the life or expiration date of the original protocol.
- In the case of a declination or revocation of any of the aforementioned forms by the IBCC, the PI may appeal the decision to the University Safety and Security Council, which may in turn defer to the judgment of the NIH OBA.
- In fulfillment of its service to the University, the IBCC shall consider for review all submitted protocol registrations, amendments, and renewals within 60 days of the submission date. To this end, the Committee is expected to convene at regular intervals at a time that accommodates the members. An application deadline shall be set approximately two weeks before each meeting to ensure members have adequate time to prepare. Upcoming IBCC meetings and application deadlines will be available on the IBCC calendar.
- To comply with NIH Guidelines, the meeting dates, times, and locations will be posted online to facilitate participation by the general public. Any comments from the public concerning IBCC actions, along with the IBCC response, must be forwarded to the NIH OBA.
- PIs are encouraged to participate in the meetings, particularly if the project is novel or especially complex and the IBCC would benefit from a full description of the activities. However, the PI will be asked to wait outside while the Committee makes a decision regarding any protocol with which he or she may be involved.
- The Coordinator shall record meeting minutes detailing important information such that it provides sufficient detail to serve as a record of major points of discussion as well as the Committee’s rationale for particular decisions, documenting that the IBCC has fulfilled its review and oversight responsibilities
- The Chair, with the assistance of the Coordinator and BSO, will develop and distribute a proposed agenda before the meeting. The basic outline for an IBCC meeting is as follows:
- Call to Order
- Quorum Sensing
- Reminder: Conflict of Interest Requirements
- Approval of the Previous Meeting Minutes
- Previously Tabled Submissions
- New Protocol Submissions
- New Business
- The Chair, or the Vice-Chair in the Chair’s absence, calls the meeting to order, moderates discussion, and adjourns the meeting once all items have been discussed.
- In order for the meeting to proceed, a Quorum must be present. A Quorum is defined as no less than five voting members, including two non-ex-officio members with expertise in the area(s) relevant to the protocol(s) on the agenda.
- Discussion of each protocol will begin with one member of the committee providing a synopsis of the proposal, followed by opening the floor to any concerns. After all issues have been voiced, the Committee will deliberate to decide which of the four designations the protocol will be assigned. The PI, if present, will be asked to step outside during this process and may return once a decision has been reached.
- Approval requires a two thirds vote but every effort should be made to gain unanimous approval. If more information is needed or if there are serious problems with the proposal, the committee will notify the applicant as to what is needed and take it up again at the next scheduled meeting. If there are only some small changes needed, the Chair may designate members with expertise in the protocol area to re-review the protocol once the PI has made the appropriate modifications.
- The public may contact email@example.com to request copies of the meeting minutes.
The following standards have specific requirements for IBCC’s and biological work:
- Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines). 2013
- Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, CDC and NIH. 2009
- US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. 2014
- UTD Biosafety Manual. 2015
- UTD Chemical Hygiene Plan. 2015
Additional biosafety standards related to UT Dallas biological work are summarized below:
- Bloodborne Pathogens Standard, Occupational Safety and Health Administration (OSHA) 29 CFR 1910.1030
- Select Agents and Toxins, Health and Human Services (HHS) 42 CFR 73
- Animal Pathogens, Pests, and Importation USDA 9 CFR Parts 92, 94, 95, 96, and 122
- Importation of Human Pathogens, U.S. Public Health Service (USPHS) 42 CFR 71