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

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.”

Questions?Questions?

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

Questions?Questions?

Policies and ProceduresThe University of Texas at Austin

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

Questions?Questions?

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: oba@od.nih.gov

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