Institutional Biosafety Committee (IBC)

The Biosafety Committee is a sub-committee of the University Research Committee.

Much of the text below is drawn verbatim from a publication of the Medical Research Council (MRC) entitled Guidelines for Ethics on Medical Research: Use of Biohazards and Radiation. The University is grateful to the MRC for permission to reproduce the text. Copies are available on request from the Research Office (Ext 71231). Note that what follows below is a much abbreviated version of the full MRC text.

Introduction

This Committee works in conjunction with the Committees for Human Ethics Research Committee and the Animal Ethics Screening Committee. All research protocols involving microbiological, biomedical and genetic applications require approval from one, two or all of these Committees. The MRC requires such clearance before it will consider any application for research funding.

Biosafety is concerned with the containment methods required when managing parasites, infectious agents and infected or potentially infected animals, tissues or other materials. The purpose is to reduce exposure of laboratory workers, other persons and the outside environment, to potentially hazardous agents.

Four principles of biomedical ethics are generally recognised:

  • autonomy (respect for the person - a notion of human dignity
  • beneficence (benefit to the research participant)
  • non-maleficence (absence of harm to the participant)
  • justice (notably distributive justice - equal distribution of risks and benefits between communities


Worker and public safety is of paramount concern. Workers must be adequately trained and provided with a working environment in which the necessary facilities and equipment are available. If this is done and the guidelines below are observed, risk to the general public will be minimised.

When considering research protocols, the Biosafety Committee is involved in various processes, including risk assessment, which would include, but not be limited to:

i. concentration and quantity of organisms
ii. stability and viability of organism
iii. potential for transmission, by contact or aerosol
iv. nature of the work
v. specific risks associated with genetically-modified organisms (GMO s)
vi. risk of harmful bi-products
vii. risk of unknown contaminants

Biosafety Levels

 Four biosafety levels are defined and the required laboratory facilities must be available before approval of the protocol will be granted.

  1. Biosafety Level 1 (BL 1) 
    The standard laboratory practices, safety equipment and facilities appropriate for secondary educational and undergraduate training and teaching are required. Research involving defined and characterized strains of viable infectious agents not known to cause disease in healthy adults or to colonize in humans falls into this category.
    Requirements: A basic laboratory without safety equipment is needed. Primary containment must be practised by adhering to standard laboratory practices during open bench operations.


  2. Biosafety Level 2 (BL 2)
    Risk is associated with exposure by ingestion, inoculation or mucous membrane contamination, but not normally by exposure to aerosols.

    The standard microbiological practices plus the following are necessary: protective gloves and coats when conducting procedures with infective agents; decontamination of all waste; biohazard signs; and control of access. These precautions are applicable in clinical, diagnostic, teaching and other facilities when working with the broad spectrum of indigenous, moderate?risk agents present in the community and associated with human disease of varying severity. Activities with low aerosol potential using such agents can be conducted on the open bench, but using good microbiological techniques.

    Requirements: A containment laboratory with partial containment equipment (Class I or II biological safety cabinets) must be used to isolate mechanical and manipulative procedures that produce readily detectable aerosols. Sealed rotor centrifuges and an autoclave are required.

    BL 2 applies to an organism that may cause human disease and be a hazard to laboratory workers, but is unlikely to spread to the community. Laboratory exposure rarely produces infection and effective prophylaxis or effective treatment is usually available.

  3. Biosafety Level 3 (BL 3)
    Aerosol-borne disease is a primary concern at this level, which also implies high risk of life-threatening disease at low dosage.

    In addition to Biosafety Level 2 practices, the following are necessary: special laboratory clothing and controlled access. These precautions are appropriate in clinical, diagnostic, teaching, research or production facilities when working with indigenous or exotic agents, which may readily cause potentially fatal infections.

    Requirements: A containment laboratory with partial or total containment equipment (Class I, II or III biological safety cabinets) must be used to isolate all procedures that may produce aerosols.

    This includes the availability of respiratory protective equipment and air conditioning; HEPA filtered exhaust air; controlled access and training of all users of the facility. Regular monitoring of users is suggested and a medical consultant should be available for referral. Standard operating procedures should be adhered to and there should be ready access to appropriate medical treatment - for example, access to anti-retrovirals in the case of needle-stick injuries when working with HIV-containing material.

    BL 3 applies to organisms that may cause severe human disease and which present a serious hazard to laboratory workers. It may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available.

  4. Biosafety Level 4 (Bl 4)
    In this case, agents are readily transmissible, they produce very serious and often fatal disease and treatment is limited or unavailable. This category of biocontainment applies to work on parasites or infectious agents, such as exotic or eradicated agents, whose acquisition and maintenance is entirely proscribed, or is authorised only in exceptional circumstances by the authorities in charge of health, agriculture and the environment. Access to such a facility should be severely restricted and closely monitored and the unit should preferably be structurally independent. The unit must be sealed and airtight.

    In addition to Biosafety Level 3 practices, the following are necessary: entrance through a change room where street clothing is removed and laboratory clothing donned; shower on exit; all wastes are decontaminated on exit from the facility.

    Requirements: A maximum containment laboratory with total containment equipment (Class III biological safety cabinets), or full?body, air?supplied, positive?pressure, personnel suits for all procedures and activities. All effluents, including air, must be decontaminated.

    BL 4 applies to an organism that causes severe human disease and is a serious hazard to laboratory workers. It may present a high risk of spread to the community and there is usually no effective prophylaxis or treatment.

Genetically Modified Organisms  (GMOS)

What follows is a much condensed version of the MRC s guidelines and interested parties ought to What follows is a much condensed version of the MRC?s guidelines and interested parties ought to request the booklet.

Research using cultured organisms, such as prokaryotic or eukaryotic single cells (with the exception of fertilised ova) may be regarded as ethically acceptable, provided the necessary containment facilities are used.

Gene therapy by cell transplantation in animals is ethically acceptable, subject to the normal guidelines for animal ethics being observed as is manipulation of animal embryos or germ-line cells to create transgenic animals.

Risk in working with GMO s may be regarded as a function of:

i. access: the risk of infecting an animal or person exposed to a micro-organism containing recombinant DNA
ii. expression: the risk that polypeptides coded for by the recombinant DNA could be produced or expressed by the organism
iii. damage: the risk that polypeptides expressed by the organism might damage the host

What follows is a much condensed version of the MRC?s guidelines and interested parties ought to request the booklet.

Research using cultured organisms, such as prokaryotic or eukaryotic single cells (with the exception of fertilised ova) may be regarded as ethically acceptable, provided the necessary containment facilities are used.

Gene therapy by cell transplantation in animals is ethically acceptable, subject to the normal guidelines for animal ethics being observed as is manipulation of animal embryos or germ-line cells to create transgenic animals.

Total risk factor Containment
10-15 or less Good microbiological practice
10-12 or less Category 1
10-9 or less Category 2
10-6 or less Category 3
>10-6 Category 4


There are three different aspects of genetic engineering pertaining directly to humans:
i. determining genetic lesions in individuals has relevance to genetic counselling
ii. where patient health is likely to be improved by somatic gene therapy
iii. manipulation of human germ-lines, which is too complex to cover here

There are many other genetic engineering issues affecting humans and animals, some of which are listed in the MRC booklet, which also, lists a number of helpful websites where further information may be obtained.

Enquiries to:
The Research Office:
Ext. 71231 or Iain.Burns@wits.ac.za for procedural issues, or
Professor C. Tiemessen, on carolinet@nicd.ac.za for technical issues
Closing dates: applications may be submitted at any time

Radioactive-Isotopes

If radioactive materials are to be used on animals or humans, the research protocol must be submitted via the Director of the The Radiation and Health Physics Unit at the The Radiation and Health Physics Unit, Yale Road Entrance (Gate 6), for approval of the procedure involving ionising radiation. Details of the considerations in the application of ionising radiation to human or animal subjects are contained in the MRC booklet.

Enquiries to:
The Director
The Radiation and Health Physics Unit
Ext. 76931 or James.Larkin@wits.ac.za 

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