principal investigator rdna/gene transfer training on nih guidelines office of research support and...
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Principal Investigator rDNA/Gene Transfer Training on NIH Guidelines
Office of Research Support and CompliancePat Levin
IBC Program Coordinator
Environmental Health and Safety Rachel LeBansky
Safety Specialist IV
The University of Texas at Austin
Recombinant DNA ProgramRecombinant DNA Program
• The office of Biotechnology Activities at the NIH oversees rDNA research, including human gene transfer
• Manages the rDNA Advisory Committee (RAC)
• Administers the NIH Guidelines for Research Involving Recombinant DNA Molecules
• Partners with Institutional Biosafety Committees (IBC) in the oversight of rDNA research
Definitions
• Recombinant DNA-(i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that are replicated in a living cell or (ii) molecules that result from the replication of those described in (i) above.
(www4.od.nih.gov/oba/Rdna.htm)
• Select Agents – specific microbiological agents and toxins of biological origin that have the potential to be weaponized and are regulated by the CDC/USDA.
(www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm)
Why is Training Required for PI’s and lab personnel?
• NIH Guidelines requires training for all PI’s and their lab personnel conducting recombinant DNA (rDNA) research
Regardless of source of funding.
• Noncompliance can result in suspension, limitation, or termination of NIH funds for rDNA research for the entire institution.
NIH GuidelinesNIH Guidelines ContentContent
• Section I – Scope
• Section II – Safety Considerations
• Section III – Types of Experiments Covered
• Section IV – Roles and Responsibilities
• Appendices
NIH GuidelinesNIH Guidelines Section I Section I
Scope of the NIH Guidelines
• Purpose• Definition of rDNA Molecules• General Applicability• Compliance with NIH Guidelines• General Definitions
The The NIH Guidelines NIH Guidelines Apply to…Apply to…
• rDNA research that is° Funded by the NIH° Performed at or sponsored by an institution that
receives any NIH funding for recombinant DNA research
• Rationale: For biosafety to be meaningful, it has to be observed by all investigators at an institution
Are the Are the NIH Guidelines NIH Guidelines optional?optional?
What are potential consequences of noncompliance with the NIH Guidelines?
• Suspension, limitation, or termination of NIH funds for recombinant DNA research at the institution
• Additional requirement for prior NIH approval of any or all recombinant DNA projects at the institution
The Advent of Recombinant DNA The Advent of Recombinant DNA TechnologyTechnology
Emergence of recombinant DNA technology (mid- 1970’s)
Concerns among both scientific community and general public
Public health and safety
Environmental impact
Potential ethical and social implications
The First The First NIH GuidelinesNIH Guidelines
• Published in July 1976
• Established responsibilities of investigators and institutions
PUBLIC CONCERNPUBLIC CONCERN
Public concerns about the potential public health and environmental consequences of rDNA and gene transfer research such as:• Expanding programs of biodefense research• Emerging infectious disease threats (SARS, Avian flu)• Human gene transfer continues to raise many safety,
ethical, and scientific issues in need of public discussion and analysis
• Advances in technology which enable unprecedented research • Reverse engineering of 1918 flu virus• Synthesis of the polio virus
NIH Guidelines for Research Involving NIH Guidelines for Research Involving Recombinant DNA MoleculesRecombinant DNA Molecules
A scientifically-responsive document that will continue to evolve
• Has undergone multiple revisions since 1976
• Latest version -April 2002
http://www.utexas.edu/research/rsc/ibc/links.php
Specifics vs. IntentSpecifics vs. Intent
“The NIH Guidelines will never be complete or final since all conceivable experiments involving recombinant DNA cannot be foreseen. Therefore, it is the responsibility of the institution and those associated with it to adhere to the intent of the NIH Guidelines as well as to the specifics.”
Good judgment is key UT IBC can help
NIH GuidelinesNIH Guidelines
Section II Section II
• Safety Considerations• Risk assessments: (Appendix B)
RG 1 RG 2 RG 3 RG 4Agents that are not associated with disease in healthy adult humans
Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available
Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)
Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)
NIH GuidelinesNIH Guidelines Section IISection II
BSL4
BSL3
BSL2
BSL1
Containment•Physical (Appendix G Practices•Equipment/Facilities
Criteria of Biological Agents
•Biological (Appendix I)•Survival/Transmission
It is the PI’s Responsibility to It is the PI’s Responsibility to determine Risk Group determine Risk Group
Examples of the four Risk Groups:
Risk Group 1: Klebsiella oxytoca, asporogenic B.subtilis
Risk Group 2: Bortedella pertussis, Chlamydia trachomastis, E. coli, C. diphtheriae, Shigella, Vibrio cholerae, Yersinia entercolitica, all human adenovirus types, Grp A Arboviruses, hepatitis A-E virus, Herpes viruses, Influenza Types A, B,& C, all human papilloma viruses, retroviruses HIV, SIV, HTLV, VSV
Risk Group 3: Brucella abortus, Coxiella burnetii, Francisella tularensis, M. tuberculosis, R. Typhi, Yersinia pestis, Coccidioides immitis, Histoplasma capsulatum, Lassa virus, Ebola & Marburg viruses
Risk Group 4: There is no RG4 work done at UT
NIH GuidelinesNIH Guidelines – Section III – Section III
IBC, RAC, NIH Director
IBC, OBA (in consult with experts)
IBC, IRB, RAC
IBC
IBC (notification)
Exempt
Level of review Example of rDNA
research involving animals
Relevant section(s) of the NIH
Guidelines
IBC, RAC review, and NIH Director review and approval
Experiments that compromise the control of disease agents in medicine through deliberate transfer of a drug resistance trait
III-A
IBC approval and NIH review for containment determinations
Experiments conducted with a recombinant DNA modified restricted agent in a whole animal
III-B
IBC and IRB approval and NIH review before research participant enrollment
Not applicable III-C
IBC approval before initiation Creating stable germline alterations of an animal’s genome, or testing viable rDNA modified microorganisms on whole animals, where BL-2 containment or greater is necessary
III-D
IBC notice at initiation Creating stable germline alterations of rodents using recombinant DNA when these experiments require only BL-1 containment
III-E
Exempt from the NIH Guidelines. IBC registration not required if experiment not covered by Sections III-A, III-B, or III-C
Purchase or transfer of transgenic rodents III-F
NIH GuidelinesNIH Guidelines Section III - Levels of ReviewSection III - Levels of Review
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Section III-D-4 Experiments Involving Whole Animals – IBC Approval Before Initiation
Experiments in which:
the animal’s genome has been altered by stable introduction of rDNA into germline, or
rDNA modified microorganisms are tested on whole animals
BL2 or BL2-N or greater containment
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Section III-D-5 Experiments Involving Whole Plants – IBC Approval Before Initiation
Experiments in which:
Plants genetically engineered by rDNA methods, or
Plants are used with recombinant DNA-modified insects
Generally BL2-P through BL4-P, depending on risk
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Section III-E-3 Experiments Involving the Generation of Transgenic Rodents – IBC Notice at Initiation Experiments in which:
Rodent’s genome has been altered by stable introduction of rDNA into germline
BL1 containment is appropriate
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Section III-F (and Appendix C-VI) - Exempt Experiments
The purchase or transfer of rodents for experiments that require BL-1 containment
Further manipulations of these animals with recombinant DNA are not necessarily exempt from the NIH Guidelines
NIH GuidelinesNIH Guidelines Section IVSection IV
Roles and Responsibilities
• Principal Investigator (PI)• Biological Safety Officer (BSO) • Institutional Biosafety Committee (IBC) • Institutional Officer (IO) • NIH• This is the reporting order for incidents,
accidents, or spills
PI ResponsibilitiesPI Responsibilities
• IBC approval approval must be granted prior to initiating or modifying any recombinant DNA research covered under sections III-A to III-D.
• Determine whether experiments are covered under NIH Guidelines and notify the IBC as appropriate.
• *Be adequately trained in good microbiological techniques*.
• Adhere to IBC emergency plans for spills and personnel contamination.
• Report any incidents, accidents, or spills to BSO and IBC..
NIH GuidelinesNIH Guidelines
NIH GuidelinesNIH Guidelines
UT- Austin ResponsibilitiesUT- Austin Responsibilities
• Establish and implement policies for the safe conduct of recombinant DNA research.
• Establish an Institutional Biosafety Committee.
• Assist and ensure compliance with the NIH Guidelines by investigators.
• Ensure appropriate training for IBC Members and PI’s
• PI’s are responsible for the actions of their lab and compliance with the guidelines
• Determine necessity for health surveillance of personnel.
• PI’s work with IBC in reporting any significant incidents to NIH-OBA.
NIH GuidelinesNIH Guidelines AppendicesAppendices
• Appendix A – Exemptions: Natural Exchangers• Appendix B – Classification of Etiologic Agents• Appendix C – Exemptions under III-F• Appendix D – Major Actions• Appendix E – Certified Host-Vector Systems• Appendix F – Biosynthesis of Toxic Molecules• Appendix G – Physical Containment• Appendix H – Shipment• Appendix I – Biological Containment
NIH GuidelinesNIH Guidelines AppendicesAppendices
• Appendix J – Biotechnology Research Subcommittee• Appendix K – Large Scale Physical Containment• Appendix L – Gene Therapy Policy Conferences• Appendix M– Points to Consider in Human Gene
Transfer Research• Appendix P– Physical and Biological Containment:
Plants• Appendix Q– Physical and Biological
Containment: Animals
Key Portions of the Key Portions of the NIH GuidelinesNIH GuidelinesAppendix BAppendix B
Appendix B
Classification of human etiologic agents on the basis of hazard
Bacterial Fungal Virus Prion Parasites
Brucella abortus RG3
Microsporum RG2
Ebola virus RG4
Epstein Barr RG2
Fasciola hepatica RG2
Key Portions of the Key Portions of the NIH GuidelinesNIH GuidelinesAppendix GAppendix G
Appendix G
Specifies details of containment and confinement for standard laboratory practices
Defines Biosafety Level 1 through Biosafety Level 4
Appropriate for animals that are worked with in a laboratory setting
Key Portions of the Key Portions of the NIH GuidelinesNIH GuidelinesAppendix IAppendix I
Appendix I
Biological containment barriers Limit the infectivity of a vector or vehicle
(plasmid or virus) for specific hosts Limit dissemination and survival of a vector in
the environment
Vectors can be genetically designed to decrease, by many orders of magnitude, the probability of dissemination of recombinant DNA outside the laboratory
Key Portions of the Key Portions of the NIH GuidelinesNIH GuidelinesAppendix QAppendix Q
Appendix Q
Applies when research animals are of a size or have growth requirements that preclude laboratory containment
For example, cattle, swine, sheep, goats, horses, poultry, etc.
Addresses containment and confinement practices in animal facilities (BL1-N to BL4-N)
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Primates - Appendix G or Q? Depends on the conditions under which the
primates are being housed and used in experimentation
Primates used in high-level, laboratory containment conditions; Appendix G applies
In other settings, primates may be worked with in settings akin to those described in Appendix Q
Professional judgment is key - IBC/IACUC can help!
Key Portions of the Key Portions of the NIH GuidelinesNIH GuidelinesAppendix MAppendix M
Appendix M
Points to Consider in the design and submission of protocols for the transfer of recombinant DNA Molecules into one or more human research participants.
Requirements for Protocol Submission, Review, and Reporting
Key Portions of the Key Portions of the NIH GuidelinesNIH Guidelines for Animal Researchfor Animal Research
Appendix M
Applies to human gene transfer experiments
Includes many considerations related to preclinical studies with animals
Expedited safety reporting requirements amended to include specifically the reporting of animal data “that suggest a significant risk for human research participants.”
Institutional Biosafety Institutional Biosafety Committees: The Linchpin Committees: The Linchpin
of Local Oversightof Local Oversight
InstitutionalInstitutional Biosafety CommitteeBiosafety Committee
• IBCs were originally established specifically for the review of rDNA research, but includes more oversight now
• Reviews research with biohazardous risks◦ Infectious agents◦ Highly toxic chemicals◦ Biological toxins
IBC MembershipIBC Membership
• No fewer than 5 individuals
• Appropriate rDNA expertise collectively
• Plant and animal experts, biosafety officer as appropriate
• Expertise in assessment of risk to environment and public health
• At least two public/community members not affiliated with the institution
• Appointed by Institutional Official (VP for Research)
Biological Safety OfficerBiological Safety Officer
• BSO must be appointed and made a member of the IBC if research is:
◦ Large scale (>10 L) ◦ BL-3
• The BSO’s duties include:◦ Periodic inspection of labs◦ Reporting to the IBC and institution of any problems,
violations, research-related accidents or illnesses◦ Developing emergency plans for handling accidental
spills and personnel contamination◦ Advice on lab security◦ Technical advice to PIs and IBCs on research safety
procedures
IBC ResponsibilitiesIBC Responsibilities
• Recombinant DNA research for conformity with the NIH Guidelines
• Minimize potential risk to environment and public health
◦ Containment levels per NIH Guidelines◦ Adequacy of facilities, SOPs, PI and lab
personnel training◦ Institutional and investigator compliance; e.g.,
adverse event reports
IBC ResponsibilitiesIBC Responsibilities
In basic and preclinical research, IBCs have the authority to:
• Lower containment levels for certain experiments in which DNA from Risk Group 2-4 is cloned in non-pathogenic organisms
• Set containment levels for experiments involving whole plants and animals
• Periodically review institutional compliance with NIH Guidelines
• Adopt emergency plans covering spills, contamination, other accidents
The Importance of IBCs and BSOs to Investigators
• The IBC and BSO can help you to:
– Ensure that you are working with recombinant DNA safely
– Meet all compliance requirements associated with NIH funding for research involving recombinant DNA
– Avoid preventable accidents and incidents that might cause harm or undermine public confidence in your research activities
– Obtain biosafety advice on an ongoing basis
IBCs and Other IBCs and Other Institutional Oversight CommitteesInstitutional Oversight Committees
IBCIRB
IACUC
IBC Review
• Risks to human health
Transfer of genetically altered material, viral vectors etc.
• Risks to the environment◦ Escape and establishment
in the wild◦ Interbreeding with wild
stock◦ Consumption by other
animals
IBC and IACUC Review of Animal IBC and IACUC Review of Animal Research Utilizing Recombinant DNAResearch Utilizing Recombinant DNA
IACUC Review
Animal welfare
• Pain and distress from adverse phenotypes (behavioral, anatomical and physiological abnormalities)
• Risks to other animals in the facility from the inadvertent spread of vectors
IBCs and IACUCsIBCs and IACUCsAnimal ResearchAnimal Research
Joint purview, and ideally collaborative review, over certain types of research
Transgenic or cloned animals
Use of recombinant DNA molecules in animals
Pre-clinical studies and data assessment for human gene transfer protocols
Animal Research with rDNA: Animal Research with rDNA: Points to ConsiderPoints to Consider
Containment procedures (SOP’s) Physical and biological Plans for recapture of escapees Consequences should containment fail
Procedures for transfer of animals Transportation procedures Disposal and destruction methods Breeding SOP’s Occupational biosafety concerns
Personal protective equipment Decontamination
IRB Review IBC Review• Conducts risk/benefit assessment relative to
individual research participants (physical, psychological, social harms)
• Selection of subjects and the informed consent process
• Data monitoring provisions to ensure the safety of subjects
• Provisions to protect subject privacy and confidentiality of data
• Injuries or any other unanticipated problems
• Compliance with regulations
• rDNA research for conformity with the NIH Guidelines
• Potential risk to environment and public health (risks to close contacts, HCWs, and the community, as well as to individual research participants
• Containment levels per NIH Guidelines
• Adequacy of facilities, SOPs, PI and other personnel training
• Institutional and investigator compliance (e.g., adverse event reports) Reviews trial design, biosafety and containment, and compliance with NIH Guidelines
IRB and IBC IRB and IBC Human Gene Transfer ResearchHuman Gene Transfer Research
IBC MeetingsIBC Meetings
• Frequency
Required to meet least quarterly, currently scheduled as bi-monthly.
IBC meeting dates are posted on the web
• Open MeetingsIBC meetings are open to the public
Heightened Institutional Heightened Institutional Responsibility forResponsibility for SecuritySecurity
Select Agent RuleAgents and toxins as listed by CDC/USDA/HHS
• Must be registered with agency
• Must develop written security plans
• Federal agencies may not release information about the location of Select Agents.
Training, Professional Training, Professional Development, and OutreachDevelopment, and Outreach
The NIH Guidelines emphasize the importance of training and place responsibility on:
• Institutions to train IBC Members, BSO, PI, and laboratory staff
• NIH also conducts and support training programs at local institutions
NIH OBA:
Conducts proactive not-for-cause site visits • Educate about IBC requirements• Provide on-site advice• Identify opportunities for improvement • Develop a body of information for the
development of “best practices”
May also conduct for cause site visits.
Enhancing the Quality of IBCEnhancing the Quality of IBC
UT Austin IBC Policies and Procedures Use of rDNA/Biohazardous Material
Covers:
• All relevant research sponsored by the university, conducted by university personnel, using university property or stored at university facilities
• This includes all faculty, staff, students, visitors, and agents and their employees engaged in activities and/or research involving rDNA and/or biohazardous materials
IBC Policies and Procedures
Use of rDNA/Biohazardous Materials
• Outlines the processes that must be followed when obtaining, using, storing, transferring, or destroying rDNA/biohazardous material
• Ensures compliance with relevant laws, regulations pertaining to receipt, using, storing, or transferring of rDNA/biohazardous material
• Minimizes risks to researchers, staff, students, facilities, the community, and environment while using biohazardous materials and recombinant DNA during teaching and research
IBC Policies & Procedures are
Based On:
• NIH Guidelines for Research Involving Recombinant DNA Molecules
• Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th ed., published by the CDC and NIH
• Select Agents and Select Toxins- HHS and CDC regulations- 42 CFR Part 73, and USDA regulations- 9 CFR Part 121
IBC
Responsible Parties
• PI’s who obtain, possess, or use rDNA and/or biohazardous material.
• The Biological Safety Officer (BSO) who is a member of the IBC
• Institutional Biosafety Committee (IBC)
• Vice President for Research is the Institutional Officer (IO)
Protocols Responsibilities of the PI
• Not initiate or modify any research involving rDNA/biohazardous materials subject to IBC approval under these IBC Policies or NIH Guidelines until the research or proposed modification has been approved by the IBC
• Make initial risk assessment of the rDNA and/or biohazardous material
• Identify proposed biosafety level of the rDNA and/or biohazardous material
• Determine whether experiments are covered by any section of the NIH Guidelines, and ensure that the appropriate procedures are followed
Training Responsibilities of the PI
• Complete mandatory training modules prior to receiving approval for the research protocol
• Provide training to staff on hazard risks, SOP’s, Personal Protective Equipment (PPE), occupational health and emergency procedures
• All training should be documented and will be periodically reviewed
Safety Responsibilities of the PI
• Develop and follow laboratory specific safety SOP• Provide personal protective equipment to staff• Provide occupational health as needed
(i.e. immunizations, base line serums)• Limit access and ensure material is physically
secured• Have available an IBC-approved emergency plan
available to all staff in lab (can be part of safety SOP). This must include current list of contact phone numbers in case an incident occurs
Reportable violations and incidents Responsibilities of the PI
• Investigate and report any significant research related incident to the BSO and IBC.
• Correct work errors and conditions. • Ensure integrity of physical and biological containment
• Comply with all reporting requirements for spills or accidents resulting in an overt exposure in > BL2 or potential exposure in BL3 or BL4
Reportable violations and incidents Responsibilities of the PI
• Any spill or accident involving rDNA/biohazardous material that leads to personal injury or illness.
-or-
• a breach of containment ie: direct contact with agent, needle stick, escape of transgenic animal, improper disposition of a transgenic animal,
-or-
• spills of high-risk recombinant/biohazardous material occurring outside of a biosafety cabinet.
Reportable incidentsReportable incidents
What do you doWhat do you doIf such an event occurs then the following must take place:
1. Isolate area and if possible contain spill.
2. Contact the Biosafety Officer at EHS Immediately
Mr Dennis Nolan Ph# 232-4999 or EHS 471-3511
If Mr Nolan is not on campus or you are unable to reach him, his alternate is
IBC Chair, Dr Woody Davis at Ph# 471-4003 or 450-4453
3.Once containment is established and BSO contacted, the PI is responsible for conducting and recording an internal investigation of his/her laboratory incident. A copy of the findings to be submitted to IBC Chair as soon as possible.
Experiments that Require IBC Review
• Transfer of drug resistance to microorganisms that are not known to acquire the trait naturally
• The deliberate transfer of rDNA/DNA/RNA derived from rDNA into human research participants (human gene transfer)
• The deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 ng/kg
• Using Risk Group 2/3 agents as host-vector systems
• The cloning of DNA from Risk Group 2/3 agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems
• Any work with recombinant infectious viruses, not just > RG 2
Experiments that Require IBC Review continued
• Whole animals in which the animal's genome has been altered by stable introduction of rDNA or DNA derived into the germ-line (transgenic animal)
• Viable rDNA-modified microorganisms tested on whole animals
• Genetically engineered plants by rDNA methods
• Protocols involving more than 10 liters of culture
• The formation of rDNA molecules containing no more than 2/3 of the genome of a eukaryotic virus
IBC Review of rDNA/Biohazardous Protocols
• Experiments using BL-2 or BL-3 containment must be reviewed and approved prior to the initiation of experiments.
• Experiments using BL-1 containment must also
undergo IBC review.
• Experiments requiring BL-4 containment will not be approved at UT-Austin at this time
IBC Submission Process
• Protocols must be submitted electronically
• Additional documents may be required◦ Lab safety and specific emergency plans◦ Certification letters◦ Risk assessments◦ Emergency plans
• See ORSC website for details
IBCProtocol Information to be Included on Form
Electronic application form (e-protocol)
• Agent characteristics (e.g., virulence, pathogenicity, environmental stability).
• Types of manipulations planned. (sonication, centrifugation)
• Source(s) of the inserted DNA sequences (e.g., species).
• Nature of the inserted DNA sequences (e.g., structural gene, oncogene).
• Host(s) and vector(s) to be used.
• Whether an attempt will be made to obtain expression of a foreign gene, and if so, the protein that will be produced.
• Containment conditions to be implemented.
• Applicable section of the NIH Guidelines (e.g., Section III-D-1, Section III-E-1, etc.).
IBC Inspections
• Laboratories will be inspected at least bi-annually by the IBC
• May be more frequent depending on risk or funding source requirements
IBC Inspections
• Laboratories will be inspected at least bi-annually by the IBC
• May be more frequent depending on risk or funding source requirements
IBC Inspections
Inspection will include:Periodic review of protocol registration for any changes in
personnel, agents, or manipulation
Rigorous lab inspections at frequency commensurate with risk.
Review of documentation for personnel training, lab safety inspections, safety equipment, biohazardous material inventory and storage
Review of SOP, emergency lab plans, and incident reporting
IBCCompliance Oversight and
Corrective Action • The IBC has authority to address non-compliance with these
procedures, NIH Guidelines, BMBL, or other regulatory requirements.
• Non-compliance can result in the IBC taking one or more of the following actions:
◦ Suspending use of the rDNA/biohazardous material
◦ Termination of the approval for the rDNA/biohazardous material
◦ Confiscation of the rDNA/biohazardous material
◦ Destruction of the rDNA/biohazardous material
◦ Any other action necessary to protect the public and/or the university
◦ Reporting to the NIH
Need more information?Need more information?
Institutional Biosafety Officer Institutional Biosafety Committee
Lab Safety Issues
Personal protective equipment for personnel Disposal of waste Decontamination of laboratory and equipment Containment facilities Accidents (emergency plans and response)
IBC
Training Acknowledgment• I agree to comply with the NIH Guidelines pertaining
to the shipment and transfer of recombinant materials. I acknowledge my responsibility for the conduct of this research in accordance with Section IV-B-7 of the NIH Guidelines. In addition, I agree to comply with the registration and guidelines for the use of select agents and toxins as described in the CDC’s BMBL, 5th ed., and the USDA/HHS Federal Register for select agents and toxins.
• Any modifications to rDNA/biohazardous protocols need to be submitted for IBC review and approval
Contact InformationContact Information
6705 Rockledge Drive, Suite 750Bethesda, Maryland 20892-7985
Phone (301) 496-9838Fax (301) 496-9839
http://www4.od.nih.gov/oba/e-mail: [email protected]
IBC
Resources
• Office of Research Support and Compliance(512) 471-8871http://www.utexas.edu/research/rsc/
• Environmental Health and Safety(512) 471-3511
http://www.utexas.edu/safety/ehs/index.php