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7 Cards in this Set

  • Front
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IBC Membership
• No fewer than five members
• Collectively have experience and expertise in recombinant DNA technology and risk assessment
• At least two members shall not be affiliated with the institution
• At least one scientist with expertise in animal containment principles when experiments
When the institution conducts recombinant DNA research at BL3, BL4, or Large Scale (greater than 10 liters), a__________________ is mandatory and shall be a member of the Institutional Biosafety Committee
Biological safety officer
Office of Biotechnology Activities (OBA)
office within the NIH that is responsible for:
(i) reviewing and coordinating all activities relating to the NIH Guidelines, and
(ii) performing other duties as defined in Section IV-C-3, Office of Biotechnology Activities (OBA).
What is the "Recombinant DNA Advisory Committee"?
The "Recombinant DNA Advisory Committee" is the public advisory committee that advises the Department of Health and Human Services (DHHS) Secretary, the DHHS Assistant Secretary for Health, and the NIH Director concerning recombinant DNA research.
What does RAC stand for?
Recombinant DNA Advisory Committee
Define the 4 IBC risk groups
• Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.
• Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
• Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available.
• (4) Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available.
Factors to be considered in determining the
level of containment include agent factors such as:
• Virulence
• Pathogenicity
• Infectious dose
• Environmental
• Stability
• Route of spread
• Communicability
• Operations
• Quantity
• Availability of vaccine or treatment
• Gene product effects such as toxicity, physiological activity, and allergenicity.