All institutions that receive funding from the National Institutes of Health (NIH) for research involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic nucleic Acid Molecules (NIH Guidelines). Researchers at institutions that are subject to the NIH Guidelines must comply with the requirements even if their own projects are not funded by NIH.
The Institutional Biosafety Committee (IBC) is charged with review and oversight of research and instructional projects involving recombinant deoxyribonucleic acid (DNA), synthetic nucleic acids, or biohazardous material to ensure that recombinant and synthetic nucleic acid molecule research is in compliance with NIH Guidelines; and all research and instructional projects involving biohazardous material comply with university policies, regulatory requirements and industry best practices.
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IBC Registration Forms
The IBC is comprised of faculty, safety professionals, and members of the community. University safety professionals serve as ex-officio members of the committee. Faculty and community members are appointed by the Vice Provost of Research for renewable three year terms. Collectively, the membership of the IBC includes:
Experience and expertise in:
- Recombinant and synthetic nucleic acid molecule research; and
- Biosafety and physical containment
- Institutional policies;
- Applicable laws;
- Standards of professional conduct and practice;
- Community attitudes; and
- Environmental considerations
The capability to:
- Assess the safety of research and instructional projects involving recombinant and synthetic nucleic acid molecules and biohazardous material; and
- Identify potential risks to public health and safety.
If you are interested in serving on the IBC, please contact EHS.
IBC Meeting Schedule
The IBC meets on the first Friday of the month, except in January and July, when the committee meets on the second Friday of the month.
Deadline for Submission
IBC Registration forms submitted up to fifteen working days prior to the upcoming meeting will be considered for the upcoming meeting. The Biosafety Officer will conduct a preliminary review and contact the Principal Investigator or Course Instructors with any questions or concerns about the submission.
Principal Investigators and Course Instructors are encouraged to submit their IBC registration forms as early as possible to ensure sufficient time is available to resolve any questions or concerns that arise prior to the meeting. Submissions will not be forwarded for committee review until they are complete and preliminary concerns have been resolved.
How to Submit a Protocol or Project for IBC Review
- Complete an IBC Registration form following IBC Registration Instructions.
- Submit the form to firstname.lastname@example.org at least fifteen working days prior to the meeting at which you want your protocol to be reviewed.
- Be available for and responsive to questions that may arise during the review process. Protocol review takes place in two stages:
• Stage 1: Preliminary review by the Biosafety Officer
• State 2: Review by the full committee or administrative review
Review by full committee will be delayed if questions and concerns raised during the preliminary review are not addressed in a timely manner.
The IBC will review the submittal and notify the Principal Investigator/ Course Instructor of the approval status.
IBC Registration Approval
- Full approval means the project may commence upon receipt of an approval letter from the IBC.
- Prerequisite approval means the project may not commence until specific conditions are addressed. The special conditions are noted in the letter from the IBC. The conditions must be addressed within 30 days of receipt of the letter from the IBC. Once all special conditions are met, full approval will be issued. The committee does not need to review the project again before full approval is issued.
- Deferred approval means that the submission requires significant revision and must be resubmitted to the committee for consideration at a later date.
Updates and Modifications
Changes in personnel, working material, or the scope of a project must be submitted for review by the IBC. To submit modifications and updates, complete the modification form and submit it electronically to email@example.com.
Minor changes, such as the addition or removal of personnel, do not require full committee review. Changes in material and scope will be reviewed by full committee.
IBC registration must be renewed every three years. The IBC will notify Principal Investigators and Course Instructor 2 months before the registration is set to expire to initiate the renewal process.
Notification of Termination
Principal Investigators and Course Instructors must notify the IBC when they cease work on an active registration. To terminate an active registration, contact the IBC at firstname.lastname@example.org.
Report all laboratory incidents to EHS. Incident reports should include sufficient information to allow for an understanding of the nature and consequences of the incident, as well as its cause. The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) states that “…any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses” must be reported to NIH Office of Science Policy (OSP) within 30 days. Certain types of accidents must be reported on a more expedited basis. Spills or accidents in BSL2 laboratories resulting in an exposure must be immediately reported to NIH OSP. Spills or accidents occurring in high containment laboratories resulting in an overt or potential exposure must be immediately reported to NIH OSP.
Any spill or accident involving recombinant DNA research of the nature described above or that otherwise leads to personal injury or illness or to a breach of containment must be reported to OSP. These kinds of events might include skin punctures with needles containing recombinant DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials occurring outside of a biosafety cabinet. Failure to adhere to the containment and biosafety practices articulated in the NIH Guidelines must also be reported to OSP.
Review of Protocols Involving Research Animals
Animal research involving biohazardous agents, recombinant DNA or synthetic nucleic acid molecules must be reviewed and approved by the IBC and Institutional Animal Care and Use Committee (IACUC). An IBC registration and IACUC registration must be submitted separately to the respective committees. Please note that the IACUC will not approve a registration of involving biohazardous agents, recombinant DNA or synthetic nucleic acid molecules unless full or prerequisite approval has been issued by the IBC.
Principal Investigator Responsibilities under the NIH Guidelines
Principal Investigators are responsible for full compliance with the NIH Guidelines during the conduct of research involving recombinant or synthetic nucleic acid molecules. As part of this general responsibility, the Principal Investigator should:
- Be adequately trained in good microbiological techniques;
- Provide laboratory research staff with protocols describing potential biohazards and necessary precautions;
- Instruct and train laboratory staff in the practices and techniques required to ensure safety and the procedures for dealing with accidents;
- Inform laboratory staff or the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations);
- Supervise laboratory staff to ensure that the required safety practices and techniques are employed;
- Correct work errors and conditions that may result in the release of recombinant or synthetic nucleic acid materials;
- Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., host-vector systems that preclude survival of the agent outside the laboratory);
- Comply with permit and shipping requirements for recombinant or synthetic nucleic acid molecules; and,
- Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination.
Before initiating research subject to NIH Guidelines, the Principal Investigator must:
- Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines;
- Propose physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC;
- Submit a research protocol to the IBC for review and approval;
- Seek NIH OBA’s determination regarding containment for experiments that require case-by-case review;
- Petition NIH OBA, with notice to the IBC, for proposed exemptions from the NIH Guidelines;
- Obtain IBC approval before initiating any research subject to the NIH Guidelines; and,
- Seek NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A, and III-B of the NIH Guidelines.
While conducting research subject to the NIH Guidelines, the Principal Investigator must:
- Determine the need for IBC review before modifying recombinant or synthetic nucleic acid research already approved by the IBC;
- Submit any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review;
- Remain in communication with the IBC throughout the duration of the project; and,
- Report any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the IBC, NIH OBA, and, as applicable, other appropriate authorities.
Principal Investigators conducting human gene transfer research subject to Section III-C of the NIH Guidelines must:
Human gene transfer is the deliberate transfer into human research participants of either:
- Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or
- Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria: contain more than 100 nucleotides; or possess biological properties that enable integration into the genome (e.g., cis elements involved in integration); or have the potential to replicate in a cell; or can be translated or transcribed.
An oversight body (e.g., Institutional Biosafety Committee (IBC) or Institutional Review Board (IRB)) determines that a human gene transfer protocol submitted to it for approval would significantly benefit from Recombinant DND Advisory Committee (RAC) review.
One or more of the criteria below are satisfied:
- The protocol uses a new vector, genetic material, or delivery methodology that represents a first-in-human experience, thus presenting an unknown risk.
- The protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
- The proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for oversight bodies to evaluate the protocol rigorously.
For more information about the registration and review process for human gene transfer trials under the NIH Guidelines, please email OSP at HGTprotocols@mail.nih.gov or call 301-496- 9838.