Download Research Protocol Registration at WUStL

Academic Research in the
New Millennium:
an EH&S Perspective
Institutional Biological and Chemical
Safety Committee/
Environmental Health and Safety
Joe Kanabrocki
Biological Safety Officer
747-0309
[email protected]
Biological & Chemical Safety
at WUSM
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Animal Studies
Reviewed
Grant Environmental
Approvals
Fume Hood
Certifications
Lab & Clinic
Inspections
Chemical/Odor
Emergencies
Recombinant DNA
Registrations
Respirator Fit Tests
Evolving Issues
•Biomedical technology.
Gene “therapy”; gene transfer.
Xenotransplantation.
•Emerging infectious diseases.
•Bioterrorism/biowarfare threat.
•Agricultural biotechnology.
Hilltop
Gene Transfer Technologies


First research subject admitted to NIH Clinic
for gene therapy approx. ten years ago.
Initial assumption: gene transfer to focus on
study & treatment of genetic deficiency
diseases: true gene therapy.

Gene transfer clinical trials to date:
Cancer (62%), monogenetic deficiency diseases
(13%),
AIDS (9%)

Patient dies at U. Penn.; gene trials/human
Gene Transfer Technologies
 Three
types of delivery vectors employed:
Viral vectors:
• retroviruses
• adenoviruses
• adeno-associated viruses
• vaccinia/fowlpox viruses
• Herpes virus
• Lentiviruses (HIV based vectors)
 Cationic liposomes
 Plasmids

Infection Control for Gene
Transfer Technologies
 Traditional
Infection Control
Prevent infection.
 Diagnosis and therapy known.
 Isolation to prevent transmission.

 Gene
transfer
Produce infection.
 Contain infection.
 Usually not treatable by conventional therapy.
 Isolation to prevent transmission.

Xenotransplantation
 Animal
organs used to “bridge” human
transplant patients.
 Transgenic animals produced to produce
organs recognized as human (MHC
genes).
 Presents infection control issues:
 zoonoses
(animal pathogens infecting
humans)
 novel pathogens able to cross species
Emerging Diseases
Examples of new and reemerging diseases.
Emerging Diseases
Response to H5N1 avian influenza outbreak in Hong Kong.
Emerging Diseases
Benefits of emerging diseases research.
Emerging Diseases
Emerging diseases funding (National Institute of Allergy and Infectious Diseases).
Threat of Biological
Terrorism and Warfare
Federal response to
terror attacks

Federal agencies have requested that
research institutions develop an inventory
describing the nature & use of research
materials associated with research activities.




Centers for Disease Control and Prevention (CDC)
Federal Bureau of Investigation (FBI)
Department of Justice-Office of Inspector General
(DOJ-OIG)
Mandate is forthcoming (December 2002?).
Regulatory Compliance:
Response to terror threats & attacks

Select Agent Transfer (SAT) Rule
Rule pertains to select bacteria, viruses, fungi and
toxins with potential for use as WMD.
 Purpose of SAT Rule is to ensure that:

• select infectious agents & toxins shipped only to
institutions/individuals equipped to handle appropriately.
• transfer of these agents is to those who have legitimate
reasons to use them.
• system is implemented whereby scientists and
researchers involved with legitimate research may
continue transferring these agents without undue burden.
Regulatory Compliance:
Response to terror threats & attacks

U.S. PATRIOT Act (Uniting and Strengthening
America by Providing Appropriate Tools Required to
Intercept and Obstruct Terrorism-2001)
 Extends limitations of the SAT Rule to use and
possession of Select Agents.
 Prohibits certain personnel from access to select
agents.
• Criminal records.
• Foreign nationals from certain countries.
• Drug abusers.
Research Protocol
Registration at WUStL





Why this request?
What does “research protocol registration” mean? What
types of research protocols must be registered?
Who should register their research? With whom is the
research registered?
How does a PI register his/her protocol?
When and how often are protocols registered?
Why this request?

Federal response to terror attacks.


FBI, CDC, DOJ, USDA
Regulatory compliance.
NIH (recombinant DNA)
 OSHA (BBP and Lab Standard)
 DOT/FAA

The “right” thing to do.
 Facilitate research activities

Regulatory Compliance:
Long-established requirements

National Institutes of Health:



OSHA:



Guidelines for Research Involving Recombinant
DNA Molecules (1976).
Guide for the Care and Use of Research Animals
(Occupational Health and Safety requirements for
workers and investigators)
Laboratory Standard (1990)
Bloodborne Pathogens Standard (1991)
Other funding agency requirements:

e.g. American Heart Association, DOD, etc.
The “Right” Thing To Do

Provides basis for assessment of research
associated risks:
• Primary function of Institutional Biological and
Chemical Safety Committee (IBC).
Allows for determination of appropriateness of
facilities and lab work practices.
 Provides basis for staff training needs.
 Provides EH&S with info on hazardous waste
disposal needs.

The “Right” Thing To Do

Provides mechanism for institutional and PI
accountability.
Public outcry for accountability.
 St. Louis Fire Department requirements
include the establishment of inventories of
research materials.
 Security

Inventory of
Biohazardous Materials
Inventory to be maintained in
Biohazardous Materials Database.
 Access database.
 Tracks research reagents, research
locations, personnel, training, grants
supporting research, lab audit data, fume
hood test data
 Component of Environmental
Management System (EPA initiative)

Biohazardous Materials
Database
Occupational & public health info for
exposure prophylaxis.
 Info for support personnel

(e.g. maintenance, custodial, etc.)
Info for lab decommissioning.
 Regulatory compliance records.
 Provides registry of WUStL research
resources for campus investigators.

What does “research protocol
registration” mean?
Completion of a registration form
describing research program elements
and protocols.
 Program-based research protocol
description, not grant-based.
 Graded approach-emphasis on risk


The greater the risk, the greater the
required detail.
Who should register their
research?
Investigators should register their research if:
they have Principal Investigator status;
 their research involves regulated or hazardous
biological agents and/or materials or select
chemical agents.

With whom is the
research registered?
Registration Program administered through
the Office of Biological and Chemical
Safety on behalf of the Institutional
Biological and Chemical Safety Committee
(IBC).
 Program of the Environmental Health and
Safety Department, FMD, School of
Medicine.

Institutional Biological & Chemical
Safety Committee (IBC)
Med
School & Hilltop representation
(CHAIR: Sam Stanley, M.D.).
Membership to reflect required
expertise.
Charge:
 Review
and assess risks associated with
research involving etiologic agents, biological or
chemical.
 Review and assess risks associated with
Draft IBC Policy:
Research Registration
The Institutional Biological and Chemical Safety
Committee (IBC) endorses registration with the IBC
of all research activities (in vitro and in vivo)
involving regulated and/or potentially hazardous
biological or select chemical research materials.
The bases for this endorsement include regulatory
compliance documentation, inventory assessment,
security and establishment of a registry of research
resources for the WUStL research community (24
April 2002).
What types of research protocols
must be registered?


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Recombinant DNA molecules and recombinant
DNA-containing organisms or cell cultures
which are subject to the NIH Guidelines for
Research Involving Recombinant DNA
Molecules, including human gene therapy trials.
Pathogenic microorganisms or agents
potentially infectious to humans and/or animals.
Human blood, tissues, and cell lines as well as
potentially infectious animal blood, tissues and
cell lines.
What types of research protocols
must be registered?

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
Carcinogens, mutagens, teratogens, drugs, and
toxins when administered in vivo to animals or in
vitro to cell or tissue cultures to induce a
biological outcome.
Animals for which a reasonable potential for
transmission of zoonotic agents exists, e.g., wildtrapped animals, sheep, & rhesus macaques.
Exotic plants, animals or microbes (e.g., nonindigenous plant or insect pathogen, or biological
control agent).
How does a PI register
his/her protocol?

Complete Recombinant DNA and
Hazardous Research Materials Protocol
form.

Available at: www.ehs.wustl.edu
Can be filed as e-mail attachment.


Requires printing of cover page only for
signatory purposes.
When and how often
are protocols registered?
Protocols are considered active for five
years.
 Amendments can be made in the interim
when novel (relative to the protocol) risks
or regulated materials are added to the
protocol.

EH&S Initiatives
IBC
administrative support.
Research materials and compliance
database.
Web-based on-line research
registration.
Coordinated
compliance effort.