George Mason University receives funding from the National Institutes of Health (NIH) for research involving recombinant or synthetic nucleic acid molecules, and therefore must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic nucleic Acid Molecules (NIH Guidelines). These requirements extend to all researchers at Mason, even if their own projects are not funded by NIH.
Per NIH Guidelines, Mason’s Institutional Biosafety Committee (IBC) is charged with review and oversight of research and instructional projects involving recombinant deoxyribonucleic acid (DNA), synthetic nucleic acids, and biohazardous materials.
Principal Investigators and Instructors must register and receive committee approval before beginning work involving microorganisms, recombinant or synthetic DNA, or human or non-human primate materials such as blood, body fluids, tissues, or cell lines, and Select Agents or Toxins. The committee review process helps ensure each project’s compliance with NIH Guidelines, university policies, regulatory requirements and industry best practices.
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Submitting a Protocol or Project for IBC Review
- Create a Safety Submission in RAMP Safety. Training on how to create a Safety Submission is available on MasonLEAPS.
- Submit the Safety Smartform in RAMP Safety 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 pre-review and review process.
- During pre-review, the Biosafety Officer will review the submission and reach out with any initial questions or concerns. The Biosafety Officer will determine whether the protocol must go through administrative review (BSL1) or full committee review (BSL2, BSL3). If full committee review is required, the Biosafety Officer will ensure that the protocol is ready to be brought before the committee.
- Once the Biosafety Officer deems the protocol ready for review, the protocol will be sent to committee members for review.
- Please note that review by full committee will be delayed if questions or concerns raised during the preliminary review are not addressed in a timely manner.
- The IBC will review the Safety Submission and notify the Principal Investigator/Course Instructor of the approval status.
IBC Meeting Schedule and Submission Deadlines
Safety Submissions submitted in RAMP Safety fifteen or more 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 Instructor via RAMP Safety with any questions or concerns about the submission.
Principal Investigators and Course Instructors are encouraged to submit their Safety Submission 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 noted during pre-review have been resolved.
IBC Approval and Other Determinations
- Full approval means the project may commence upon receipt of the approval letter from the IBC.
- Modifications required means the project may not commence until the specific conditions noted in the IBC determination letter are addressed. The conditions should be addressed within 30 days of receipt of the letter from the IBC. Once all conditions are met, full approval will be issued by the IBC Administrator. 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 edited and resubmitted to the committee for consideration at a future meeting.
- Approval withheld means that the protocol submission has significant deficiencies in accordance with IBC, regulatory or Mason policy, or safety requirements, or a protocol has been submitted to the IBC repeatedly without correction as requested by the IBC.
If the IBC determines anything other than full approval, the IBC Administrator will inform the Principal Investigator/Course Coordinator in writing of the items or changes necessary to receive full approval.
Protocol Amendment, Renewal, and Termination
Safety Submissions (approved protocols) must be renewed every three years from the most recent approval date. Prior to the protocol’s expiration, the listed Principal Investigator/Course Coordinator will receive an automated email from RAMP instructing them to initiate the renewal process. Active protocols that predate the implementation of RAMP Safety will continue to receive notifications from firstname.lastname@example.org to alert them of the approaching deadline.
Principal Investigators and Course Coordinators must notify the IBC when they cease work on an active registration. To terminate an active registration, select Request Closure in RAMP Safety.
Training and step-by-step instructions on how to initiate a protocol amendment, review, and termination in RAMP is available in MasonLEAPS.
- Recombinant and synthetic nucleic acid molecule research;
- Biosafety and physical containment;
- Institutional policies;
- Applicable laws;
- Standards of professional conduct and practice;
- Community attitudes;
- Environmental considerations;
- Assessing the safety of research and instructional projects involving recombinant and synthetic nucleic acid molecules and biohazardous material; and,
- Identifying potential risks to public health and safety.
If you are interested in serving on the IBC, please contact EHS.
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.
Protocols Involving Research Animals
Principal Investigator Responsibilities Under the NIH Guidelines
- 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 beginning 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; 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.
Transition to RAMP Safety: Frequently Asked Questions
Is the IBC process still the same?
The transition to RAMP changes how researchers complete and submit their research protocols for review to the biosafety committee, and how the protocol moves through the approval process. The biosafety policies, IBC process and submission deadlines remain the same. As always, an approved protocol is required for all BSL-1, 2 and 3 work. Protocols must be submitted 15 business days before the next scheduled meeting to be considered at that meeting.
Will the IBC still meet monthly?
Yes, the committee will continue to meet on the first Friday of every month to review and approve protocols, except for January and July, when meetings are held the second Friday of the month.
Who is required to submit an IBC protocol in RAMP?
There are no changes to who is required to submit an IBC protocol. All new protocols, renewal requests, and modification must now be submitted using RAMP.
Is training available on navigating and submitting an IBC protocol in RAMP Safety?
Training on RAMP’s safety module is available on MasonLEAPS.
What changes to the protocol forms can I expect? Are the questions and layout the same as the paper forms?
Many questions from the paper forms were transitioned to RAMP, but question order and form layout is different. In RAMP, many of the pages are responsive, meaning the questions you are required to answer depend on your responses to previous questions.
Who can see my protocol in RAMP?
Mason collaborators can view a protocol if they are designated as the Principal Investigator, Primary Contact, or Protocol team member on the protocol. If you would like additional Mason collaborators to be able to view the protocol, you can assign guest viewers to the protocol by clicking “Manage Guest List” on the left-hand navigation of the protocol main page. Only individuals with Mason login credentials can be granted access to view and/or edit the protocol. The IBC administrator, biosafety officer, and committee members will be able to review the protocol as it moves through the review process.
Who can edit my protocol?
A PI proxy can be assigned to view, edit and respond to committee inquiries on the PI/Course Coordinator’s. PI proxies can be assigned on the protocol landing page by clicking “Assign PI Proxy” on the Forms menu.
Can someone submit a protocol on my behalf?
Yes, if the individual has access to RAMP, they can generate a new protocol and assign you as the Principal Investigator on the “Basic Information” page.
If I have a protocol that was approved prior to the RAMP Safety migration, am I required to enter it into RAMP for continued approval?
No, your previously approved protocol will remain approved until its assigned expiration date. However, if you need to renew and/or modify your protocol, you will need to enter the protocol information into RAMP as if it were a new protocol and include the original protocol number in the Protocol Title field.
I need to modify a protocol that was previously approved on the paper (pdf) form. Do I submit a paper modification form or use RAMP Safety?
Protocol modifications will need to be entered into RAMP. Since you will not have a previously approved protocol in RAMP, you will need to submit the protocol as if it were a new protocol and include your proposed modifications. In the Protocol Title field, please include your previously approved protocol number.
If I have a previously approved/pre-RAMP protocol, will I be notified by EHS about an upcoming expiration?
Yes, you will receive a reminder of an upcoming protocol expiration via email from email@example.com. All protocols entered into RAMP Safety will receive reminders for upcoming protocol expiration via an automated email from the RAMP system.
Can I print my protocol from RAMP Safety?
Yes, you can print your protocol by clicking “Printer Version” on the protocol’s top left navigation menu.
Who do I contact if I have questions about submitting an IBC protocol in RAMP Safety?
Please reach out to firstname.lastname@example.org with any IBC protocol related questions.