CHARTER
INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
The University of Denver is responsible for ensuring that activities involving recombinant DNA
or select agents and other biological hazards at the University of Denver are in compliance with
established National Institutes of Health (NIH) Guidelines for research involving recombinant
DNA molecules or select agents and other biological hazards. General recognition of
institutional authority and responsibility properly establishes accountability for safe conduct of
the research. This authority is placed with the Institutional Biosafety Committee
(Committee/IBC), which acts on behalf of the Vice Provost for Graduate Studies and Research.
In overseeing the conduct of research involving recombinant DNA or select agents and other
biological hazards, the IBC is charged with the following responsibilities:
I. Responsibilities
A. Review all University proposals which anticipate use of recombinant DNA or
select agents and other biological hazards. The Committee approves/denies
conduct of those proposal programs in accord with the NIH Guidelines. The
review shall include the following:
1. An independent assessment of the containment levels required by those
Guidelines for the proposed research.
2. An assessment of the facilities, procedures, and practices and of the
training and expertise of recombinant DNA and biological hazard
personnel.
3. An assessment of research facilities, procedures, and practices in
conjunction with the Environmental Health & Safety Manager and the ERI
Safety Officer. At least one meeting per year will be held at the Eleanor
Roosevelt Institute (ERI) to assess the conditions in the BSL2/ABSL2
laboratory. Site visits of any laboratory using recombinant DNA or select
agents or carrying out research involving other biological hazards may
occur at any time.
B. Set containment levels for certain specified experiments.
C. Notify investigators of the results of Committee reviews.
D. Periodically review research involving recombinant DNA and select agents and
other biological hazards being conducted at the University to ensure that the
requirements of the Guidelines are being fulfilled.
E. Develop emergency plans covering accidental spills and personnel contamination
resulting from such research.
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INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
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F. Report within 30 days to the Vice Provost for Graduate Studies and Research and
to NIH any significant problems resulting from violations of the Guidelines and
any significant research-related accidents or illnesses.
G. Prohibit initiation of experiments not explicitly covered by the Guidelines until
NIH establishes the containment requirement.
H. Provide consultation to principal investigators handling biological hazards.
I. Advise and make recommendations to the Vice Provost for Graduate Studies and
Research on all issues relating to biological hazards and research.
J. Perform such other functions as may be delegated to the Committee by the NIH
Guidelines.
II. Containment
A. Class A experiments require review by the NIH and the University IBC before
initiation (investigators should submit the Cover Sheet for Review by Institutional
Biosafety Committee with supporting documentation). Included are:
1. Deliberate formation of recombinant DNAs containing genes for the
biosynthesis of toxic molecules lethal for vertebrates at an LD50 of less
than 100 nanograms per kilogram body weight.
2. Deliberate release into the environment of any organism containing
recombinant DNA, except certain plants as described in the NIH
Guidelines.
3. Deliberate transfer of a drug-resistant trait to microorganisms that are not
known to acquire it naturally, if such acquisition could compromise the
use of the drug to control disease agents in human or veterinary medicine
or agriculture.
4. Deliberate transfer of recombinant DNA or RNA derived from
recombinant DNA into human subjects.
B. Class B experiments require IBC approval before initiation. Investigators must
submit proposed work to the IBC for review (investigators should submit the
Cover Sheet for Review by Institutional Biosafety Committee with supporting
documentation).
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INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
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1. Experiments using human or animal pathogens (CDC Class 2, Class 3,
Class 4, or Class 5 agents) as host-vector systems.
2. Experiments in which DNA from human or animal pathogens (CDC Class
2, Class 3, Class 4, or Class 5 agents) are used as host-vector systems.
3. Experiments involving the use of infectious animal or plant viruses or
defective animal or plant viruses in the presence of helper virus in tissue
culture systems.
4. Recombinant DNA experiments involving whole animals and plants.
5. Experiments involving more than 10 liters of culture.
C. Class C experiments require IBC notice simultaneously with initiation
(investigators should submit the Cover Sheet for Review by Institutional Biosafety
Committee with supporting documentation). For example, experiments in which
all components derive from non-pathogenic prokaryotes and non-pathogenic
lower eukaryotes are included in this class. All such experiments can be carried
out at BSL1 containment. The IBC will review all such proposals, but review
prior to initiation is not required.
D. Class D experiments are exempt from the NIH Guidelines. These experiments
still require IBC approval, but may commence prior to review (investigators
should submit the Cover Sheet for Review by Institutional Biosafety Committee
with supporting documentation). These experiments include:
1. Those that are not in organisms or viruses.
2. Those that consist entirely of DNA segments from a single non-
chromosomal or viral DNA source, though one or more of the
segments may be a synthetic equivalent.
3. Those that consist entirely of DNA from prokaryotic host,
including its indigenous plasmids or viruses, when propagated
only in that host (or a closely related strain of the same species)
or when transferred to another host by well established
physiological means. Also, those that consist entirely of DNA
from a eukaryotic host, including its chloroplasts, mitochondria,
or plasmids (but excluding viruses), when propagated only in
that host (or a closely related strain of the same species.)
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4. Certain specified recombinant DNA molecules that consist
entirely of DNA segments from different species that exchange
DNA by known physiological processes, though one or more of
the segments may be a synthetic equivalent. A list of such
exchanges will be prepared and periodically revised by NIH.
5. Other classes of recombinant DNA molecules to be determined
by NIH if they do not present a significant risk to health or the
environment.
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Cover Sheet for Review by Institutional Biosafety Committee
Principal Investigator: Department/Unit:
Phone: E-mail:
Project Title:
Indicate the Biosafety Level of the proposed work.
(See http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3.htm for descriptions.)
BSL1 [ ] BSL2 [ ] BSL3 [ ] BSL4 [ ]
I. Biological Materials Used in the Project.
1. Describe the recombinant DNAs used in the proposed work (cloned gene(s), vectors used --
give both name and type of each vector).
2. Which of the genes described above will be expressed?
3. What organism(s) or cell lines are used in the proposed work?
4. Describe any infectious or pathogenic agents used in the proposed work.
5. List any materials of human or mammalian origin (blood, etc.). Indicate whether each
material is certified pathogen free.
II. Methods Used to Contain Biohazardous Materials.
1. Describe methods for containment of and disposal of biohazardous materials. (For
BSL2 work and above, append SOPs, which should include information on health
surveillance, if recommended.)
III. Specific Aims of Project and Protocols Used.
1. Provide the research plan from the proposal sent to granting agency.
2. If no proposal is available (or it does not outline pertinent experimental procedures), provide:
a. A synopsis of the specific aims of the project (maximum one page).
b. Protocols for recombinant DNA work and other biohazardous work, in outline format.
IV. Review Timeline. The IBC meets quarterly in March, June, September, and December.
This form, and all appendices (proposal, SOPs, etc.) should be submitted
electronically to Malcolm Woolum, mwoolum@du.edu.
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IBC Annual Report for Approved Projects
(Please type directly into the document using as much space as needed.)
Principal Investigator: Department/Unit:
Phone: Email:
Project Title:
Indicate the biosafety level of the IBC-approved project.
(See http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s3.htm for descriptions.)
BSL1 [ ] BSL2 [ ] BSL3 [ ] BSL4 [ ]
Is the project funded by a granting agency?
If yes, provide the following information:
Funding agency and grant number:
Duration of funding:
If no, provide the following information:
Is the project still active?
Has or will a grant proposal be resubmitted?
Agency:
Submission date:
Proposed project period:
Address the following issues in a concise narrative:
1. Are there any changes, or do you expect there to be changes, in the biological materials
used as outlined on the IBC Cover Sheet (Section I) since this project was approved (or
since your last annual report)?
2. If so, provide SOPs, as necessary (BSL2 or higher), which cover the changes or explain
how the SOPs originally submitted will be adapted for the changes in the project.
3. Also, provide the following information on changes to the project:
a. A brief synopsis of the specific aims of the changes to the project.
b. Protocols relevant to the changes in recombinant DNA work and other biohazardous
work, in outline format.
4. Have there been any accidental breaches of containment in the last year? How were
these breaches handled?
Submit this form and any appendices (SOPs, etc.) electronically to the Research
Compliance Coordinator in the Office of Sponsored Programs:
Malcolm Woolum, mwoolum@du.edu.
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IBC Internal Operating Procedures
1. All materials for review of research proposals involving recombinant DNA work and
other biohazardous procedures will be submitted electronically to the Research
Compliance Coordinator in the Office of Sponsored Programs.
2. Materials for IBC review of a research proposal will initially be forwarded to the Chair of
the IBC, who will make a preliminary assessment as to whether a review is required. If a
review is necessary, the Chair will assign primary and secondary reviewers based on the
expertise of the committee members. Primary and secondary reviewers will be expected
to carefully evaluate the biological hazards of their assigned proposals. Every effort will
be made to distribute work load evenly. Community members will not routinely be
assigned as primary and secondary reviewers--only when expertise is lacking among
DU/ERI members.
3. Once primary and secondary reviewers have been assigned, all members will receive an
e-mail notifying them that a proposal has been submitted for IBC review and indicating
who the primary and secondary reviewers are. Review materials will be made available
on a password-accessible website so that all IBC members have access to each proposal
submitted for review.
4. The IBC will meet quarterly (March, June, September, and December) to discuss and
approve/recommend revision of proposals submitted for review. At the end of a meeting,
the date and time for the subsequent meeting will be decided.
5. At each quarterly meeting the primary reviewer will be expected to lead discussion and
make recommendations for approval (or needed revision) for each proposal they have
been assigned. Approval will be by a vote of the committee at the meeting. If the
primary reviewer of a proposal is unable to attend a meeting, they will convey their
comments and recommendations in writing (by e-mail) to the Chair of the IBC at least 48
hours in advance of the meeting. Proposals that require remediation will generally be
delegated to the primary and secondary reviewers and the Chair for final approval after
the PI has responded to the committee’s concerns. Proposals requiring remediation will
be handled in a timely manner so as not to prevent research progress on the part of the
Principal Investigator (PI) while ensuring that the research is carried out safely.
6. Committee members will not be involved in review of their own proposals and will be
excused from the meeting during discussion of their proposal.
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7. If the primary and secondary reviewers have questions or concerns about a proposal in
advance of a meeting, they will e-mail their concerns to the Chair of the IBC, who will
convey them anonymously to the PI, to give the PI the opportunity to respond prior to the
meeting date. Any response from the PI will be e-mailed to the primary and secondary
reviewers by the Chair of the IBC or will be made available on the IBC members’
website, so that these materials can be considered at the quarterly IBC meeting.
8. All communication with PIs will be through the Chair of the IBC or the OSP Research
Compliance Coordinator, so as to maintain the anonymity of the primary and secondary
reviewers. Communications will be by e-mail whenever possible to provide
documentation of the review process.
9. The Office of Sponsored Programs will send a letter to the PI and the proposed sponsor
notifying them of the committee’s final decision, the biosafety level of the project, and
the term of the approval: for BSL1 projects, for the duration of the project; and for BSL2
and higher projects, until funding for the project comes up for renewal. For projects at
all BSL levels, approval letters will state (a) that it is the PI’s responsibility, prior to
instituting any changes in the biological materials used in the project as described in
Section I of the approved Cover Sheet, to submit to the IBC an amended Cover Sheet for
IBC approval; (b) that an IBC Annual Report for Approved Projects must be submitted
each year for approval; (c) that biological hazard spills must be immediately reported to
the appropriate institutional authority; (d) that the PI is responsible for training project
personnel involved in work using biological hazards above the BSL1 level, and that
written documentation that the training has been approved by the Safety Officer must be
kept in the PI’s laboratory.
10. Six weeks prior to a project’s approval anniversary date, the OSP Research Compliance
Coordinator will notify the PI of the need to submit an IBC Annual Report for Approved
Projects, due two weeks before the next scheduled IBC meeting. If the Annual Report
contains no changes to the project, the review will be conducted by the IBC Chair. If the
Annual Report contains changes, the review will be conducted by the IBC Chair and the
original primary and secondary reviewers, with unanimous approval among them
required for continuance of the project.
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