IBC
Authority & Responsibility
PI
Responsibilities
IBC Review Process
Renewals
Forms
Amendments
Committee
Membership
Schedule of IBC Meetings
Links
FAQs
Introduction
This is the web page for FIU's Institutional
Biosafety Committee (IBC). The purpose of the IBC is to ensure that
the NIH
Guidelines for Research Involving Recombinant DNA Molecules are
adhered to at FIU. Recombinant DNA molecules are defined by NIH
guidelines as either: (i) molecules that are constructed outside
living cells by joining natural or synthetic DNA segments to DNA
molecules that can replicate in a living cell, or (ii) molecules that
result from the replication of those described in (i) above. See the
section
"Definition
of Recombinant DNA Molecules" for further detail.
FIU requires
that all use of recombinant DNA at the University be
registered with the Institutional Biosafety Committee, even
if the use is as simple as the cloning of allelic PCR products prior
to sequencing. In many cases this process will be as simple as
filling out a form indicating that the type of recombinant work being
carried out in your lab is exempt from NIH guidelines.
IBC Authority and Responsibilities
All institutions that receive NIH funding for research involving recombinant DNA molecules must follow the NIH guidelines. Failure to adhere to these guidelines can result in suspension or termination of NIH funding, or to a requirement for NIH approval of any or all recombinant DNA projects at the institution. The IBC is therefore responsible for establishing and implementing policies that provide for the safe conduct of recombinant DNA research and that ensure compliance with NIH guidelines. IBC responsibilities are fully specified in Section IV-B-2-b of the NIH Guidelines.
The principal investigator is responsible for registering all recombinant DNA work ongoing in their laboratory and for ensuring proper laboratory techniques and practices are followed. In addition, it is the responsibility of the PI to ensure proper training for all laboratory staff, and to update the IBC whenever new recombinant DNA research projects are initiated, or recombinant DNA protocols are changed. PI/PD responsibilities are fully specified in Section IV-B-7 of the NIH Guidelines.
The IBC must be comprised of at least 5 members, at least two of which are not affiliated with FIU. Collectively the committee must possess experience with and expertise in recombinant DNA technology and animal containment principles. In addition, experience with plant pathogens or plant pest containment principles (Appendix P) or with recombinant DNA research involving human participants (Appendix M) is required if recombinant DNA research in these areas is planned or ongoing at the institution.
Meetings and Submission Deadlines: The IBC meeting schedule and submission deadlines are posted on this website. Complete files must be submitted by the deadline in order to be considered for the next meeting.
Required IBC review elements
In order to conform with section IV-B-2-b-(1) of the NIH guidelines, a full IBC review should include an
independent assessment of required containment levels for the
proposed research, an assessment of facilities, procedures,
practices, training and expertise of all personnel involved in
recombinant DNA research, assurance that all aspects of
Appendix
M have been appropriately addressed by the PI, as well as several
requirements concerning human gene transfer experiments and
coordination with the
RAC (Recombinant DNA Advisory Committee).
Additional IBC
responsibilities associated with the review process are specified in
sections IV-B-2-b-(2)
through IV-B-2-b-(7). These include the responsibility to notify
the PI of results of the IBC review and approval process, the
lowering of containment levels for certain experiments as specified
in section III-D-2-a,
periodic review of recombinant DNA research at FIU to ensure
compliance with NIH guidelines, and adopting emergency plans covering
accidental spills and personnel contamination resulting from
recombinant DNA research.
Finally, it is the duty of the
IBC to report any significant problems with or violations of
the NIH
Guidelines and any significant research-related
accidents, or illnesses to the appropriate institutional
official and NIH/OBA within 30 days, unless the IBC determines that a
report has already been filed by the PI.
Help with IBC Submission Forms, and Where to Submit
If you have questions after reading over the information and forms on this site, please contact the IBC committee member in your Department or College for assistance. The e-mail addresses and affiliations of current IBC members are listed in the Committee Membership and Contact Information section below. If there is not an IBC committee member in your Department or College, please contact the Chair of the IBC with your questions.
All IBC form submissions should be sent directly to the IBC Chairperson. After being logged in, the forms will be forwarded to the IBC committee member in your Department or College for evaluation. Once again, if there is not an IBC representative in your Department or College, your application will be handled by the Chair of the IBC.
Please note: If your project involves funding (e.g., you are applying for funding or have already been funded), you are required to include a copy of your research grant proposal with your IBC form submission.
Review Guidelines
Exemptions
FIU requires that all use of recombinant DNA at the University be registered with the Institutional Biosafety Committee. Many common uses of recombinant DNA, however, qualify for exemption under Section III-F of the NIH Guidelines. So, the first question to ask is "Is my use of recombinant DNA exempt from from the NIH guidelines?" The following recombinant DNA molecules are exempt:
- Recombinant molecules that are not in organisms or viruses (Section III-F-1).
- Recombinant molecules that consist entirely of DNA segments from a single non-chromosomal or viral DNA source (Section III-F-2).
- Recombinant molecules that consist entirely of DNA from a prokaryotic host when propagated in that host (Section III-F-3).
- Recombinant molecules that consist entirely of DNA from a eukaryotic host when propagated in that host (Section III-F-4).
- Recombinant molecules that consist of DNA from different species that exchange DNA through known physiologic processes (Section III-F-5). See Appendices A-I through A-VI for the lists of natural exchangers that are exempt.
- Recombinant molecules that do not present a risk
to health as determined by the NIH Director
(Section
III-F-6). Experiments which use
risk group 1 or 2 DNA/RNA inserted into E. coli K-12,
Saccharomyces, or Bacillus subtillus or Bacillus
lichenformis host-vector systems (E. coli BL21 does
not fall into this category), which do not involve the cloning
of toxin molecules or large-scale experiments (more than 10 liters
of culture). See
Appendix
C for exemptions under this section and for other classes of
experiments that are exempt under the NIH guidelines. For a
convenient risk group database which is searchable by organism click
here;
http://www.absa.org/riskgroups/index.html
If your use of recombinant DNA
qualifies for an exemption under these criteria, please fill out the Exemption
Request Form. After review, a copy of the approved application
for exemption will be sent to you. If any changes are made to
protocols for a study that has received an exemption from the IBC, a
new application must be submitted to the IBC.
If your
use of recombinant DNA does not meet any of the
exemption criteria above you must submit an application and undergo a
full review by the IBC.
Recombinant DNA research subject to NIH guidelines
If your use of recombinant DNA does not meet any of the exemption criteria specified in the Exemption section above, you must submit an application and undergo a full review by the IBC. Please fill out and submit the form entitled "Recombinant DNA and Gene Transfer Form." The majority of studies will fall under sections III-D and III-E.
Studies that require IBC notification simultaneous with initiation
Full IBC review is not required prior to initiation of all studies. For example, studies in which all components are derived from non-pathogenic prokaryotes and non-pathogenic lower eukaryotes may be initiated without full IBC review. Experiments that may be initiated simultaneously with IBC notification are specified in Section III-E of the NIH guidelines. This includes experiments involving the introduction of risk group 1 DNA/RNA into risk group 1 organisms such as E. coli BL21, or non-viral risk group 1 or 2 DNA/RNA propagated in tissue culture systems. For these studies, a registration document shall be dated and signed by the investigator and filed with the IBC at the time the experiment is initiated.
For a convenient risk group database which is searchable by organism click here: http://www.absa.org/riskgroups/index.html
If your study also requires IACUC approval, please note that IACUC approval must be sought separately, and is explicitly not covered by an IBC registration document.
Biosafety Level 1 (BL-1) and Biosafety Level 2 (BL-2) studies are renewed annually for up to three years. Duration of Biosafety Level 3 (BL-3) studies is one year. An annual update is required for all studies. The requirements for annual renewals are as follows:
- BL-3 studies: To renew
approval, submit a copy of the currently-approved protocol and the
annual
update form for IBC review. Renewals for BL-3 studies must be
submitted in time to be processed before expiration of current
approval. A study may not be continued if IBC approval
expires before the renewal process is completed.
-
Bl-1 and BL-2 studies: To renew approval for the second and third
years of the study, the PI must submit a completed
annual
update form to the IBC. Although it is the PI's responsibility to
renew in a timely fashion, you will receive notification of the need
to renew an approval, typically 1-2 months prior to your expiration date. If
you have not applied for renewal 30 days after expiration of an
approval, you will be sent a letter of termination, and data
collected during a lapse period may not be useable. Don't let this
happen to you!
Section IV-B-7-c-(3) of the NIH guidelines specifies that all changes to an approved protocol must be reported by the PI to the IBC. An amendment form and full documentation of the revised protocol must be submitted to the IBC for review and approval prior to initiation of the amended protocol.
Coordination with IACUC for research involving animals.
IACUC review can take place prior to, or concurrently with, IBC review. Both IACUC and IBC approval are required prior to initiation of a study, requiring coordination among these committees. The IBC chair will provide the IACUC committee with a copy of the IBC approval letter.
Committee Membership and Contact Information
If you have any questions concerning IBC policies or procedures, please e-mail us at the FIU IBC. You may also directly contact the IBC representative in your Department of College, using the e-mail addresses listed below.
The
current membership of the FIU IBC is:
Kelly Rein, IBC Chairperson, Dept. of Chemistry & Biochemistry,
FIU, reink@fiu.edu or (305) 348-6682
Tamece Knowles, Biosafety Officer, Environmental
Health and Safety, FIU, knowles@fiu.edu
Rita Mukhopadhyay, College of Medicine, FIU,
Rita.Mukhopadhyay@fiu.edu
Kenneth Murray, Department of Biological Sciences, FIU, kmurray@fiu.edu
Rene H. Fernandez , Animal Care Facility Coordinator, FIU, rfernan@fiu.edu
George
Duncan, Broward County Sheriff's Office (community member)
Ann Glasse (community Member)
Ex officio members (non-voting):
Christopher
Grayson, Office of Research Integrity, FIU
Jonathan Tubman, Office of Research Integrity, FIU
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Schedule of IBC Meetings
The meetings are tentatively scheduled to take place on the first
Wednesday of each month at 4:00 PM. The IBC will only meet if
there are applications to review. If there are no IBC applications
submitted within one week prior to the meeting date, the meeting will be
canceled.
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