Safety Review and Approval Process for Research Proposals

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Safety Review and Approval Process for Research
Proposals

• Bob Emery, Dr.P.H.
• Safety, Health, Environment Risk Management

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Objectives

• Summarize the general classes of potentially
  hazardous agents that might be used in research
• Provide an brief overview of the UTHSCH safety
  committee structure in place to oversee the use
  of these agents
• Describe how the process for protocol review and
  approval works
• Identify common pitfalls and how to avoid them

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Main Possible Hazard Classes in Research
Activities

• Radiation
• Radiation producing devices or radioactive
  materials
• Biological agents
• Human specimens, rDNA, select agents
• Hazardous chemicals
• Toxics, ignitables, reactives, explosives, select
  agents

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Typical Span of Protocol Reviews, Driven by
Licensing, Registration, Possession Controls
Radiation
Select agent chemicals
Chemicals
Select agent biologicals, rDNA
Biologicals
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What Might You Be Missing?

• Acutely hazardous chemicals
• Explosives?
• OSHA targeted chemicals, e.g. benzene
• Infectious agents
• OSHA targeted activities involving human blood,
  body fluids, TB
• Also note In many cases, funding agency
  requirements include attesting to compliance with
  these sorts of issues

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UTHSCH Safety Committees

• Committee structure mimics hazard classes
• Radiation Safety (meets 12/yr)
• Biological Safety (meets 12/yr)
• Chemical Safety (meets 6/yr)
• Safety Council (meets 4/yr)
• (broad overarching committee, includes facility
  safety as well as research)
• Membership consists mainly of faculty peers, with
  support provided by EHS

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Main Safety Committee Concerns

• What is the hazard?
• How will it be handled?
• Are the people aware of the hazard (trained) and
  afforded protection (protective equipment,
  vaccines, etc)?
• Emergency response?
• What about waste products?

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Application Process

• The key question Does the research involve the
  use of
• Radiation?
• Potentially infectious biological agents?
• Hazardous chemicals?
• Items 9, 10, 11 on UTHSCH Review and Approval Form

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If Yes.

• Access appropriate forms on EHS or Research
  Administration website
• If assistance is needed at any point in the
  process, contact EHS at 8100
• Submit completed forms to EHS for committee
  review (OCB 1.330)
• EHS conducts preliminary review and is
  authorized to provide provisional approvals for
  most applications
• Applications placed on agenda appropriate
  committee review
• No set deadline for submission (typically agendas
  set 1 week prior to meeting)

10
Radiation

• Radiation producing device (e.g. x-ray machine or
  laser)
• Unit must be registered with state, operators
  trained, protected
• Issues addressed on application form
• Radioactive materials (e.g. radioisotope tracers)
• Must be licensed (actually sublicensed), workers
  trained, protected
• Issues addressed on application form

11
Biological Agents

• BSL1 rDNA
• Simple registration with EHS
• BSL2 agents
• application, EHS review and approval, subsequent
  submission to committee
• BSL3 agents
• requires full application and committee review
• Agents classifications can be viewed at
• http//www.absa.org/resriskgroup.html

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Hazardous Chemicals

• Access UTHSCH list of designated acutely
  hazardous chemicals and carcinogens on website
• http//www.uth.tmc.edu/ut_general/research_acad_af
  f/safety/chemsafe/protocol/protocol.htm
• If on list, complete application
• Submit for committee review

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Disconnects to Look For

• What safety committees actually exist?
• What is the membership? Peers?
• How is the committee supported?
• Are they responsive to faculty needs, inquiries?
• What is the turn around time?
• What do the applications require need to know or
  academic curiosity?
• Is there communication across committees?
• IRB, IACUC, various safety committees, etc.

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Also, Look Into

• Inquire about a routine safety surveillance
  program processes are not stagnant
• Do results go back to committees?
• Is EHS perceived as
• Supporting the research enterprise?
• Tolerant of the research enterprise?
• Completely ignorant of the research enterprise?

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Measuring Faculty EHS Expectations versus
Service Delivery
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Measuring Faculty EHS Expectations versus
Service Delivery
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But Sometimes Things Can Go Wrong
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Common Difficulties

• Need for approvals last minute
• Documented worker safety training
• Inventories and labels
• Blocked pathways (and hallways)
• Materials stacked too high in lab
• Despite these difficulties EHS remembers that
  were all in the same pool so lets enjoy the
  water!