HWS-REC 3.2
HEALTH AND WELLNESS SCIENCES ETHICS PROTOCOL
CODE OF ETHICS FOR BIOSAFETY
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.
All research protocols involving microbiological, biomedical and genetic applications
require biosafety approval from the Health and Wellness Sciences Research Ethics
Committee (HWS-REC).
1. Biosafety Levels
Five biosafety levels are defined and the required laboratory facilities must be
available before approval of the protocol will be granted.
1.1 Biosafety Level 1
Standard microbiological practices, safety equipment and facilities appropriate for
undergraduate training and teaching are required. Research in this category involves
defined and characterised strains of viable infectious agents not known to cause
disease in healthy adults or to colonise in humans.
Requirements:
A basic laboratory without safety equipment is needed. Primary containment must be
practised by adhering to standard laboratory practices during open bench operations.
1.2 Biosafety Level 2
The standard microbiological practices plus the following are necessary: protective
gloves and coats when conducting procedures with ineffective agents;
decontamination of all infectious waste; biohazard signs; and limited 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.
2.3 Biosafety Level 3
HWS-REC 3.2
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 serious and potentially lethal
infections.
Requirements: A high 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.
2.4 Biosafety Level 4
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. Such
precautions are necessary when working with dangerous and exotic agents which
pose a high individual risk of life-threatening disease, or which are potentially of great
veterinary or agricultural significance.
Requirements: A maximum containment laboratory with total containment equipment
(Class III biological safety cabinets) is used to isolate all procedures and operations
involving infectious materials or partial containment equipment is used in combination
with full-body, air-supplied, positive-pressure, personnel suits for all procedures and
activities.
2.5 Biosafety Level 5
This category of parasite or infectious agent refers to certain exotic or eradicated
parasites or infectious agents whose acquisition and maintenance is entirely
proscribed or authorised in exceptional circumstances only.
Requirements: Special permission based on the correct facilities and practices of a
laboratory can only be obtained from the Department of Health.
3. Radioactive-Isotopes
If radioactive materials are to be used, the research protocol must have approval of
the procedure involving ionising radiation from an appropriate institution in addition to
the Cape Peninsula University of Technology.
4. Recombinant DNA
Recombinant DNA research is defined in terms of four classes of experiment:
4.1 Class A Experiments
The following experiments fall into this class and require clearance from the HASREC prior to commencement:
a) Deliberate formation of recombinant DNAs containing genes for the biosynthesis
of toxic molecules lethal for vertebrates at an LD50 of less than 100 nanograms
per kg body weight.
b) Deliberate release into the environment of any organism containing recombinant
DNA.
c) Deliberate transfer of a drug resistant trait to microorganisms that are not known
to acquire it naturally, if such acquisition could compromise the use of the drug to
control disease agents in human or veterinary medicine or agriculture.
d) Deliberate transfer of recombinant DNA or DNA derived from recombinant DNA
into human subjects.
HWS-REC 3.2
4.2 Class B Experiments
The following experiments fall into this class and require clearance from the HASREC prior to commencement:
a) Experiments using human or animal pathogens as host-vector systems.
b) Experiments in which DNA from human or animal pathogens is cloned in nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
c) Experiments involving the use of infectious animal or plant viruses or defective
animal or plant viruses in the presence of helper virus in tissue culture systems.
d) Recombinant DNA experiments involving whole animals or plants.
e) Experiments involving more than 10 litres of culture (organisms or materials as
defined in the second paragraph of Point 1: Information, above).
4.3 Class C Experiments
Experiments in this class require notification to be sent to the HAS-REC when the
experiment commences. The class comprises all experiments using material (as
defined in the second paragraph of Point 1: Introduction, above) which do not fall
within Classes A, B or D.
4.4 Class D Experiments
The following recombinant DNA molecules are exempted from controls:
a) Those that are not organisms or viruses.
b) Those that consist entirely of DNA segments from a single nonchromosomal or
viral DNA source though one or more of the segments may be a synthetic
equivalent.
c) Those that consist entirely of DNA from a prokaryotic host including its
indigenous plasmids or viruses when propagated only in that host or a closely
related strain of the same species) or when transferred to another host by well
established physiological means; also, those that consist entirely of DNA from a
eukaryotic host including its chloroplasts, mitochondria, or plasmids (but
excluding viruses) when propagated only in that host (or a closely related strain
of the same species).
d) Certain specified recombinant DNA molecules that consist entirely of DNA
segments from different species that exchange DNA by known physiological
processes though one or more of the segments may be a synthetic equivalent.
Guidance in this regard can be obtained from the list published by the NIH in
the USA from time to time.
Document reviewed annually
Last reviewed: April 2008
Bibliography
This document is largely adapted from Wits University’s Ethics Policy