Book 4: Worker safety

All research protocols involving genetic manipulation should be considered by Research Ethics Committees and safety committees. Biosafety¹⁰ is chiefly concerned with the biohazards that may result from manipulating harmful organisms. After thorough risk analysis, all relevant protocols should be designed to reduce hazards to laboratory workers and the environment. Workers must be adequately trained before embarking on any work, and the necessary containment facilities and equipment must be installed before permission will be granted in respect of the relevant biosafety levels of experiments.

It is the duty of the host institution to ensure that adequate facilities are present and that control is exercised over the researchers and workers who are to be involved. The host institution should have a committee, which may be a Research Ethics Committee, concerned with biosafety and containment, but not necessarily limited to such considerations. All relevant experiments to be conducted in the institution must be approved by this authority, which will be responsible for monitoring the procedures in the host institution.

Book 4: Risk assessment

Risk assessment is the activity concerned with the decision to approve activities associated with a biohazard. Apart from biohazards associated with any given organism, additional factors need to be considered. These may include, but not be limited to, the following:

1. the concentration and quantity (number) of organisms concerned;
2. the stability and viability of the organism;
3. the potential for transmission, whether by contact or aerosol;
4. the nature of the work envisaged (whether liquid culture or aerosol challenge);
5. specific risks associated with GMOs (genetically modified organisms);
6. risk of by-products, such as spores, toxins, virulence factors;
7. risk of unknown contaminants such as cells or cell lines with latent oncogenic viruses or other associated viruses.

Some considerations are listed below.

4.1 Prokaryotes (including microbes, viruses)
There is a wealth of knowledge concerning the pathogenic potential of most microbes and viruses. This information is readily available, even at textbook level.

4.2 Eukaryotes

1. Parasites: There is a considerable body of information concerning most parasites. There may be different risks associated with parasites, depending on whether the project involves in vivo work (animal model) or in vitro (cultured) organisms. Furthermore, the risk may differ according to the stage of development. The host range is a further consideration for risk assessment.
2. Intact organisms: These may be pathogenic, such as protozoans, or they may pose handling risks in general, like venomous animals. Alternatively, the closer the organism is to humans phylogenetically, the greater the potential risk from zoonoses (see also (c) and (d) below).
3. Cells, cell lines or body fluids: Tissue samples or body fluids present high risks and should be treated with extreme care. The risk originates not from the cells themselves, but from their potential to harbour pathogenic organisms or agents, including prions. The risk is assessed at the level of the agent of highest possible risk. (d) Cultured material: There is a risk that cultured cells or tissue samples may contain pathogens, as in (b) and (c) above.