Risk Assessment Breakout Session

1
Risk Assessment Breakout Session

• Southwest Regional Conference for IBC Best
  Practices
• Today and Tomorrow
• August 18, 2005

2
Overview

• Brief introductory remarks
• What are the risks associated with working with
  rDNA?
• What are the possible benefits?
• What is a risk assessment?
• What are the underlying factors that influence
  the risk?
• Once risks are identified, how are they managed?
• Three 5-7 minute presentations on specific risk
  management activities based on the type of work
  performed
• Open discussion, questions, comments

3
Introductions

• Bob Emery, UTHSC Houston
• Bruce Brown, UTHSC Houston
• Suzanne Rivera, UT Southwestern
• Stacy Berg, MD, Baylor College of Medicine/Texas
  Childrens Cancer Center

4
What are the risks?

• Possible infection resulting in disease or
  illness in workers, or release to population
  (people, plants, animals)
• Possible risk to patients involved in clinical
  trials
• Compliance risks OBA guidelines, OSHA General
  Duty Clause
• Reputational risk to institution

5
What are the benefits?

• rDNA represents an essential component of modern
  biomedical research
• Helps move promising treatments from benchtop to
  bedside
• Vaccines
• Treatments
• Agriculture

6
What is a risk assessment?

• A comprehensive evaluation of the potential
  hazards associated with an agent and its
  subsequent manipulation and use
• NIH acknowledges that risk assessments are
  ultimately, a subjective process

7
Typical Worksetting and Institutional Committee
Consideration of rDNA Activities by Risk Group
8
Main risk drivers

• Route of infection
• Virulence
• Pathogenicity
• Communicability
• Infectious dose
• Operations
• Environmental stability
• Quantity
• Vaccine and treatment availability
• Gene product effects

9
Risk mitigation

• Risk assessment
• Training/education
• Physical containment
• Laboratory practices
• Safety equipment
• Biological barriers

10
Panelist Remarks

• Bruce Brown lab benchtop
• Suzanne Rivera studies involving animal models
• Stacy Berg, MD studies involving human volunteers