About the IBCC
About the Protocol Registration and Approval process
- Where can I find all of the IBCC forms?
- Why do protocols need to be registered?
- Who has to register with the IBCC?
- Do I still have to get protocol approval if my rDNA work is considered Exempt by NIH?
- How do I register my protocols?
- I have completed the registration form, now what?
- How does the review process work?
- When will I know if my protocol has been approved?
- When can I begin work?
- How long is my protocol good for?
Protocol Renewals, Amendments and Terminations
- How do I renew my protocol for continued approval?
- My protocol is going to expire soon, when should I re-register with the IBCC?
- Oh no! My protocol approval has lapsed and I still need to conduct work on it. What should I do?
- What type of protocol changes am I required to notify the IBCC about?
- How do I report changes or modifications to my protocol?
About the IBCC
What is it?
In accordance with the NIH Guidelines, which require all institutions receiving any NIH funding to establish and implement policies that provide for the safe conduct of research, the University of Texas at Dallas has formed the Institutional Biosafety and Chemical Safety Committee, or IBCC. The IBCC is a University-wide standing committee charged with oversight, administration, and review of all UTD Laboratory policies and projects involving teaching or research with recombinant or synthetic nucleic acid molecules and other hazardous biological and chemical materials that may pose safety, health, or environmental risks. and chemical materials.
Who is it?
IBCC is composed of faculty and research staff appointed to the committee by the President, plus members of the community surrounding the UTD Campus, as well as ex-officio members from Research and Academic Safety and the Office of Research and Innovation. The full roster may be found (this is in the works)
When is it?
The Committee meets regularly (typically monthly during the long semesters) to review protocols and safety policies. The IBCC calendar of upcoming meetings and protocol application deadlines may be found here.
About the Protocol Registration and Approval process
Where can I find all of the IBCC forms?
All of the IBCC forms may be found here.
Why do protocols need to be registered?
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. Failure to do so could result in the loss of all NIH funding; not just funding for the Principle Investigator found to be in violation of the NIH Guidelines, but for the entire University. This applies to teaching laboratories as well.
Who needs to register with the IBCC?;
Any PI conducting research involving recombinant DNA (rDNA), pathogens, select agents, biological material from human or non-human primates, or particularly hazardous chemicals MUST register each individual protocol with the IBCC before any work may begin.
rDNA – molecules that are constructed outside living cells 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.
Pathogens – or infectious agents are any agent associated with disease in healthy human adults. Biological agents classified as Risk Group-2 (RG2) or Biosafety Level -2 (BSL2) and above require review by the IBCC.
Select Agents and Toxins -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. Toxins are any proteinaceous compounds that pose a severe risk to human life or health in low concentrations.
Biological material from humans and non-human primates – 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. These materials are automatically classified as RG2/BSL2 and as such must be registered with the IBCC.
Do I still have to get protocol approval if my rDNA work is considered Exempt by NIH?
ANY protocol that involves rDNA must be registered with the IBCC.
How do I register my protocols?
New protocols or ongoing protocols approaching expiration may be registered online using the Protocol Registration Form. Protocols submitted by the application deadline will be reviewed at the next regularly scheduled IBCC meeting. Protocols submitted after the deadline will be tabled until the following meeting.
I have completed the registration form, now what?
After submitting the completed form to the Committee, the PI should ensure the laboratory personnel on the protocol are properly trained to avoid any potential delays in their work. Prior to authorization of the protocol, the Biosafety Officer (BSO) will verify the Site-Specific Safety Training has been properly documented and signed by all lab personnel working on the protocol, as well as verification of all required online training and proper biosafety containment levels are present in the lab. The protocol will not be approved by the IBCC until these requirements have been fulfilled.
How does the review process work?
Once the protocol has been submitted, the BSO will verify proper documentation of training requirements and laboratory facilities are appropriate for the work to be conducted. The committee will then convene and review the protocol. The PI is welcome to attend the meeting, 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 the decision.
What is the decision process entail?
Based on the provisions presented in the protocol, the committee will assign one of four possible outcomes:
Approved as written – the committee had no concerns with the safety practices presented and all requirements have been met. Work may begin immediately.
Tabled pending modifications and designated member review – the committee has some minor issues with the protocol and/or personnel training requirements have not been met. Once these issues have been corrected, a member designated by the Committee Chair shall review, and if appropriate, recommend the protocol to the Chair for approval, without the need to wait for the next meeting.
Tabled pending modifications and re-review by full IBCC at next convened meeting – the committee has found some issues of moderate concern. Once the PI has addressed all issues outlined by the committee and submitted the revised protocol registration document, the committee will re-review the protocol at the next meeting, provided the protocol was resubmitted by the application deadline.
Declined – the committee found a number of significant concerns with key components of the proposed research that are in violation of the NIH Guidelines, UTD safety policies, or both.
When will I know if my protocol has been approved?
You will be notified of the committee’s decision typically within 48 hours of meeting.
When may I begin work?
You may begin work immediately after receiving notice that the committee has deemed your protocol Approved as written. You may not begin work until the protocol has been signed and approved by the appropriate parties; doing so without proper authorization will result in a violation of the NIH Guidelines and must be reported to the NIH Office of Biotechnology Activities (OBA).
How long is my protocol good for?
The maximum period of approval for an application is 3 years with a required review annually. All protocols expire annually on the anniversary of IBCC approval (the date referenced in the notification of approval). To keep a protocol active, you must submit an Annual Renewal Form within the 30 day period prior to the anniversary of approval, each year for the life of the protocol. Once the approval period has expired, you must submit a new protocol if you wish to continue working on the project.
Protocol Renewals and Amendments
How do I renew my protocol for continued approval?
After receiving initial approval, you must complete and submit the Annual Renewal Form each year BEFORE the anniversary of initial approval for the protocol. For example, if you submitted a new protocol that was approved by the Committee in October 2015, you must submit the Annual Protocol Renewal form by the protocol submission deadline for the October 2016 and October 2017 meetings. In October 2018, if work is still being conducted on the project, you must submit a new Protocol Registration Form to remain compliant with the NIH Guidelines and University Policy.
My 3-year protocol approval is going to expire soon, when should I re-register with the IBCC?
We recommend that you re-register a month in advance in order to account for any issues that may arise with the new protocol to avoid any lapse in IBCC approval. A courtesy reminder will be sent to you 6-8 weeks before the submission deadline; however it is still the responsibility of the PI to submit the appropriate documentation in a timely manner to avoid any interruptions of research.
Oh no! My protocol approval has lapsed and I still need to conduct work on it. What should I do?
Once protocol approval has expired, all work on the project must cease immediately. You will need to submit a new Protocol Registration Form as soon as possible so that it may be reviewed by the IBCC at the next meeting.
I am changing some items in my protocol, do I need to notify the IBCC?
Any significant changes to the protocol must be approved by the IBCC before said changes may be implemented. This includes a change in laboratory personnel working on the project, project location, or any change in biological materials, in addition to procedural changes.
How do I report changes or modifications to my protocol?
Complete and submit a Protocol Amendment Form. Only complete the sections of the protocol that are changing. Sections of the protocol that will not be changing should be left blank.