Download Institutional Biosafety Committee Member Training

Institutional Biosafety
Committee Member Training
October 2013
Background
Recombinant DNA work covered under NIH Office of
Biotechnology Activities (NIH OBA) in:
•NIH GUIDELINES FOR RESEARCH INVOLVING
•RECOMBINANT OR SYNTHETIC NUCLEIC ACID
MOLECULES(March 2013)
Purpose of Guidelines:
• specify the practices for constructing and handling:
• (i) recombinant nucleic acid molecules,
• (ii) synthetic nucleic acid molecules, including those
that are chemically or otherwise modified but can
base pair with naturally occurring nucleic acid
molecules,
• (iii) cells, organisms, and viruses containing such
molecules.
Why 2 Committees?
Institutional Biosafety Committee
UT System level committee that allows for the review of
rDNA related work and makes the minutes available to
the public (NIH) without being classified as “medical
committee”
Biological Safety Committee
UTHealth committee that discusses all other relevant
Biosafety issues, committee is considered a “medical
committee” therefore minutes are not available to public
BSC vs IBC
Biological Safety Committee (BSC)
•Reviews research involving the use of infectious agents NOT
rDNA
•Inclusive of subcommittees-needlestick and healthcare
•BMBL as a reference document
Institutional Biosafety Committee (IBC)
•Reviews all research that involves the use of rDNA
NIH/OBA rDNA Guidelines as reference document
Biosafety Levels
Biosafety levels are a combination of facilities,
equipment and practices.
Level 1: basic lab, good lab practices
Level 2: limited lab access, specific training and practices
Level 3: containment (biosafety cabinet), specific training
and practices
Level 4: full containment; specific facility, training and
practices
Risk Assessment Factors
•Pathogenicity
•Route of Transmission
•Agent Stability
•Infectious Dose
•Concentration
•Availability of effective prophylaxis, treatment
•Availability of medical surveillance
•Host susceptibility
Risk Assessment
Organism
Hosts
Vector
Expression of foreign gene
Protein produced
Containment
Facility
Laboratory-specific protocol
Training & expertise of personnel
History of the Guidelines
The NIH Guidelines were implemented
in response to public and scientific
concern over the emerging science of
rDNA technologies in the early 1970’s.
By 1976, NIH had published the first
set of guidelines which have been
amended over time to allow for greater
public access and a greater emphasis
on safety.
Section I: Scope and
Applicability
If your institution receives NIH funding for rDNA
research, then it must comply with the NIH Guidelines.
Even if a project is privately sponsored, that research
must still be conducted in accordance with the NIH
Guidelines if conducted at an institution subject to the
NIH Guidelines.
Section II: Safety
Considerations
Risk Assessment
Risk Group 1 (RG1) agents are not associated with
disease in healthy adult humans.
Risk Group 2 (RG2) agents are associated with human
disease which is rarely serious and for which preventive or
therapeutic interventions are often available.
Risk Group 3 (RG3) agents are associated with serious or
lethal human disease for which preventive or therapeutic
interventions may be available.
Risk Group 4 (RG4) agents are likely to cause serious or
lethal human disease for which preventive or therapeutic
interventions are not usually available .
Section II: Safety
Considerations
Containment
Containment should be a combination of standard
microbiology practices, engineering controls,
laboratory facilities and design.
Containment is defined in:
•Appendices G, P, & Q of the NIH Guidelines
•Laboratory Safety Monograph (historical document)
•Biosafety in Microbiological and Biomedical
Laboratories (BMBL)
Section III: Experiments
covered by the NIH Guidelines
III-A: transfer of drug resistance
III-B: cloning of lethal toxins
III-C: human gene transfer research
III-D: infectious agents as vectors & transgenic animals
III-E: generation of transgenic rodents
III-F: exemptions
Experiments Covered by the NIH
Level of Review
Section
Research Example
IBC, RAC review and NIH Director review
and approval
III-A
Cipro resistant Bacillus anthracis
IBC approval and NIH review for
containment determination
III-B
Cloning botulinum toxin expression into adenovirus
IBC and IRB approval and NIH review
before research particpant enrollment
III-C
Human gene transfer
III-D
Expression of a nonnative protein in Staphylococcus
aureus
IBC notification at initiation
III-E
Germline alteration of rodents which may be housed in
BL-1
Exempt
III-F
Purchased transgenic rodents
IBC approval before initiation
III-A: Major Actions
Requires: IBC Approval, RAC Review, NIH Director
Approval Before Initiation of Work
Transfer of therapeutically useful drug resistance to
organisms which may compromise human
health/agriculture/medicine
III-B: Toxin Transfer
Requires: NIH/OBA, IBC Review and Approval Before
Initiation of Work
Deliberate cloning of toxin molecules lethal to
vertebrates at an LD50 of less than 100 nanograms/Kg
of body weight (e.g., botulinum toxin)
Containment determined by NIH/OBA
III-C: (Deliberate Transfer of
rDNA into
Research Participants, ex. Gene Therapy)
Requires: RAC Review, IBC and IRB Approval Before
Participant Enrollment
Human gene transfer (HGT) protocols
•All HGT trials except those covered under vaccine
exemption require RAC registration.
•20-30% will be publicly reviewed and may require
public review prior to participant enrollment.
III-D: General Work
Requires: IBC Review and Approval Prior to the
Initiation of Work
•Involves RG 2-4 agents, host/vector system
•Cloned DNA from RG 2-4 agents into non-pathogenic
prokaryotes
•RG 2-4 agents into whole animals, usually transgenic
•Recombinant plants
•Large scale experiments greater than 10L
•Generation of any transgenic animal other than BSL-1
rodents
III-E: Less Restrictive Work
Requires: IBC Notification at the Initiation of Work
(BSL-1 Containment), and Subsequent IBC Review and
Approval
•rDNA molecules that contains less than 2/3 of any
eukaryotic viral genome
•Transgenic rodents with BSL-1 containment
•(crossbreeding of transgenics now exempt at BSL-1)
•Whole plants that require minimal containment
•Anything else NOT covered under sections III-A through IIID & III-F
III-F: Exemptions
Exempt from the NIH Guidelines and Does Not Require
IBC Review or Approval
rDNA molecules that are:
•Not in organisms or viruses
•Not a risk to health or the environment
-See Appendix C
•Note: exceptions to exemptions!
FAQ
Review process for human gene transfer protocols
http://oba.od.nih.gov/rdna/rdna_faq.html
Vaccine exemptions
http://oba.od.nih.gov/oba/ibc/FAQs/VaccineFAQs.pdf
Major actions under the guidelines
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Major_
Actions_Under_the_NIH_Guidelines.pdf
Transgenic animals
http://oba.od.nih.gov/oba/ibc/FAQs/TransgenicAnimalF
AQs-Aug2011.pdf
FAQ
IBC committee minutes
http://oba.od.nih.gov/oba/ibc/IBC_Minute_Q_A.pdf
Experiments that are exempt
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Experi
ments_that_are_Exempt_from_the_NIH_Guidelines.pdf
Section IV: Roles and
Responsibilities
Responsibilities of the Institution:
•Ensure compliance with NIH Guidelines
•Establish IBC
•Appoint a Biosafety Officer if conducting BSL-3, BSL-4,
or large-scale work
•Ensure IBC has expertise in the research that is
reviewed
•Establish a medical surveillance program as needed
•Report all incidents to the NIH OBA
Section IV: Roles and
Responsibilities
Responsibilities of the IBC:
•Review rDNA research, and approve those research projects that are found to conform
with the NIH Guidelines. This review shall include:
-(i) independent assessment of the containment levels required by the NIH
Guidelines for the proposed research; (ii) assessment of the facilities, procedures,
practices, and training and expertise of personnel involved in rDNA research; (iii)
ensuring that all aspects of Appendix M have been appropriately addressed by the
PI; (vii) ensuring compliance with all surveillance, data reporting, and adverse event
reporting requirements set forth in the NIH Guidelines.
•Notify the PI of the results of the IBC’s review and approval.
•Lower containment levels for certain experiments as specified in Section III-D-2-a,
Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or
Restricted Agents is Cloned into Nonpathogenic Prokaryotic or Lower Eukaryotic HostVector Systems.
•Set containment levels as specified in Sections III-D-4-b, Experiments Involving Whole
Animals.
Section IV: Roles and
Responsibilities
Responsibilities of the IBC:
•Periodically review rDNA research conducted at the institution
to ensure compliance with the NIH Guidelines.
•Adopt emergency plans covering accidental spills and
personnel contamination resulting from rDNA research.
•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.
•The IBC may not authorize initiation of experiments which are
not explicitly covered by the NIH Guidelines until NIH establishes
the containment requirement.
•Perform such other functions as may be delegated to the IBC.
Section IV: Roles and
Responsibilities
Responsibilities of the Biological Safety Officer (BSO)
•Periodic inspections to ensure that laboratory
standards are rigorously followed;
•Report to the IBC and the institution any significant
problems, violations of the NIH Guidelines, and any
significant research-related accidents or illnesses of
which the BSO becomes aware;
•Develop emergency plans for handling accidental spills
and personnel contamination and investigating
laboratory accidents involving rDNA research;
•Provide advice on laboratory security;
•Provide technical advice to PIs and the IBC on
research safety procedures.
Section IV: Roles and
Responsibilities
Responsibilities of the Principal Investigator (PI)
•Initiate or modify no recombinant DNA research which requires IBC approval prior to
initiation until that research or the proposed modification thereof has been approved by
the IBC and has met all other requirements of the NIH Guidelines;
•Determine whether experiments are covered by Section III-E, and ensure that the
appropriate procedures are followed;
•Report any significant problems, violations of the NIH Guidelines, or any significant
research-related accidents and illnesses to the BSO, Animal Facility Director (where
applicable), IBC, NIH/OBA, and other appropriate authorities (if applicable) within 30
days;
•Report any new information bearing on the NIH Guidelines to the Institutional
Biosafety Committee and to NIH/OBA
•Be adequately trained in good microbiological techniques;
•Adhere to IBC approved emergency plans for handling accidental spills and personnel
contamination;
•Comply with shipping requirements for rDNA molecules.
Section IV: Roles and
Responsibilities
Responsibilities of the PI:
•Responsible for full compliance with the NIH Guidelines in the
conduct of rDNA research.
•Responsible for ensuring that the reporting requirements are
fulfilled and will be held accountable for any reporting lapses.
•Prior to initiating research:
-Make available to all laboratory staff the protocols that
describe the potential biohazards and the precautions to
be taken;
-Instruct and train laboratory staff in: (i) the practices and
techniques required to ensure safety, and (ii) the
procedures for dealing with accidents; and
-Inform the laboratory staff of the reasons and provisions
for any precautionary medical practices advised or
requested (e.g., vaccinations).
Section IV: Roles and
Responsibilities
Responsibilities of the PI:
During conduct of research:
•Supervise the safety performance of the laboratory staff to ensure
that the required safety practices and techniques are employed;
•Investigate and report any significant problems pertaining to the
operation and implementation of containment practices and
procedures in writing to the BSO, Animal Facility Director (where
applicable), IBC, NIH/OBA, and other appropriate authorities (if
applicable)
•Correct work errors and conditions that may result in the release of
rDNA materials; and
•Ensure the integrity of the physical containment (e.g., biological
safety cabinets) and the biological containment (e.g., purity and
genotypic and phenotypic characteristics).
IBC Requirements
No fewer than 5 members who exhibit:
rDNA
Knowledge
Research
expertise
Community
interest
Required to annually submit IBC roster update including
curriculum vitae of new members, brief biographical sketch
and any significant updates of existing members to OBA
UTHealth IBC Membership
Full Members
Ex-Officio Members
Serve staggered two year terms
(FY 12-14)
Representative from Risk
Management/Legal Affairs
3+ faculty members with rDNA
experience and/or biological safety
and containment
Representative from Health
Services
2 individuals not associated with the
institution (community member)
At least 1 member from each school
At least 1 with animal containment
At least 1 with infectious disease
expertise
1 student member
Director, Environmental Health &
Safety
VP, SHERM
Executive Vice President for
Research
Representative from HCPC
Expectations: Members
Active participation on the Committee
Sharing expertise and experience
Question and scrutinize protocols
Ensure protocols meet requirements of NIH
Guidelines, BMBL and other biosafety guidelines
Participate as a member of a Subcommittee during
preliminary reviews
Timely response as a member of a Subcommittee
Participate in member training, at least annually
UTHealth Protocol Review
Submitted to Biosafety for assessment
Communication with PI to produce protocol
Submitted to Subcommittee for review
Submit protocol to IBC for full review
Protocol accepted
Protocol rejected,
tabled or pending
Approval Memos
Once a protocol is approved the appropriate memo is
sent out
•Approval memo
•Conditional approval memo
Conditionally Exempt Protocols
To be a conditionally exempt protocol, proposed work
must meet the following conditions:
• No work that falls under the NIH Guidelines
• Only involves the collection of human samples (i.e.
blood, urine, tissue, etc.)
• Sample processing limited to:
• Centrifugation
• Storage
• Biological safety office reviews and approves protocols
• Protocols appear in meeting packets
IBC Resources
NIH Guidelines for Research Involving
Recombinant DNA Molecules
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelin
es.pdf
Office of Biotechnology Activities
http://www4.od.nih.gov/oba/
CDC/NIH Biosafety in Microbiological
and Biomedical Laboratories (BMBL)
http://www.cdc.gov/biosafety/publications/bmbl5/BMB
L.pdf
Questions?