Introduction to Research Ethics, Biosafety and Biosecurity oversight at UCT
 Legislative Framework
 Biosafety and laboratory biosecurity
Principles of Biosafety
Biosafety and Biosecurity Resources

Introduction to Research Ethics, Biosafety and Biosecurity oversight at UCT

Research staff, postdoctoral fellows, and students at UCT are responsible for the ethical and safe conduct of their research projects. In compliance with national biosafety, biosecurity and research ethics-related legislation and institutional policies and regulations, all UCT research projects that involve human participants, animals, and potentially hazardous biological agents (pHBAs) such as human, animal or plant pathogens, toxins, recombinant or synthetic DNA/RNA, etc.must be reviewed by the institutional research ethics and biosafety committees. 

UCT has established research ethics committees to review, provide ethics approval and monitor research involving human participants (Human Research Ethics Committee: HREC) and animals (Animal Research Ethics Committee: AEC). The UCT Institutional Biosafety Committee (IBC) provides review and oversight of research protocols and related activities involving pHBAs and recombinant or synthetic nucleic acid molecules. The IBC has oversight over the three UCT Faculty-level Biosafety Committees (FBCs): Faculty of Health Sciences, the Faculty of Science and for Engineering and the Built Environment. If a project or protocol involves the use of human participants and/or animals and pHBAs, approval by the appropriate Ethics and Biosafety Committees will be required. 

The institution and laboratory managers must regularly evaluate and ensure the effectiveness of the Biosafety and Biosecurity programme, the proficiency of the workers, compliance with South African and international legislation, and the capability of equipment, facilities, and management practices to provide containment and security of pHBAs. Similarly, researchers and staff who handle pHBAs must understand the containment conditions and specific requirements under which these organisms and materials should be safely handled, stored and secured. Regular Biosafety and Biosecurity compliance audits and internal facility inspections are therefore performed. OHSE will liaise with lab managers and health and safety officers before an audit is conducted.


South Africa’s Biosafety and Biosecurity Legislative Framework

South Africa has a comprehensive and robust legislative framework governing biosafety and biosecurity, consisting of a broad range of acts/statutes, regulations, guidelines, standards and ethical requirements across various national government departments and sectors. In addition, South Africa is a signatory to or member of a number of international conventions and commissions that are pertinent to biosafety and biosecurity. The current legal framework covers research involving humans, animals, the environment, biodiversity, genetically modified organisms (GMOs) and biosecurity. A guideline document that maps out the current legal framework including links to government departments’ documents and application forms is available to assist researchers and ensure compliance (Groenewald, 2021).


The importance of Biosafety and Biosecurity in research environments

Life sciences research and innovation offer endless opportunities to improve human health, increase crop yields and food safety, and contribute to environmental sustainability. There are, however, risks involved in working in life sciences research laboratories. These work environments may pose infectious disease risks to persons that work in and near them. The knowledge, information, products, technologies, and equipment in these laboratories may also be deliberately misapplied (e.g., dual-use research) to pose a significant bioterrorism threat with broad potential consequences to public health and safety, agricultural crops, animals and the environment. The implementation of an integrated biorisk management system and a safety culture that promotes safe, secure, ethical and responsible practices are therefore essential.

Biosafety and laboratory biosecurity are the two main elements of an integrated biorisk management system. The WHO recently added a third element, namely the oversight of dual-use research (WHO, 2022). 

  • Biosafety includes the containment principles, technologies and practices that are implemented to prevent unintentional exposure or release of potentially hazardous biological materials such as human, animal or plant pathogens and toxins, genetically modified organisms (GMOs) and human and animal biological samples. 
  • The term “laboratory biosecurity” is used to describe the principles, technologies and practices that are implemented for the protection, control and accountability of specific biological agents and toxins and/or the equipment, skills and data related to their handling within facilities. The aim of biosecurity measures is to prevent the unauthorised access, loss, theft, misuse, diversion or intentional unauthorised release of these pathogens and/or toxins (adapted from WHO, 2020).Important biosecurity requirements include physical security (access control and monitoring), personnel management, inventory and material accountability tracking, information or data security, material transport policies and accident, injury and incident response plans.


Principles of Biosafety

The two principles of biosafety practice/management are containment and risk assessment within a risk analysis framework.

1. Containment includes the microbiological practices, safety- and personal protective equipment, and facility and infrastructural safeguards that protect laboratory workers, the environment, and the public from exposure to infectious microorganisms, toxins and biological materials (biorisks) that are handled and stored in the laboratory.

Four ascending risk categories or levels of containment, referred to as Biosafety Levels 1 through 4, are defined by the primary risk criteria of infectivity, severity of disease, transmissibility, and the nature of the work being conducted (CDC). Each Biosafety level describes the containment measures for the corresponding level of risk associated with handling a specific biological agent.

2. Risk analysis

The risk analysis framework includes risk assessment, risk management and risk communication.

  • Risk assessment is a systematic process – quantitative or qualitative – of gathering information and evaluating the nature and characteristics of the hazard (infectious or potentially infectious biological agent), determining the probability of exposure to the hazard (considering the specific laboratory procedures/ activities) and the magnitude of potential harm (consequences) caused by exposure to the hazard. 
  • Risk management is the identification and implementation of technologies, biosafety measures or practices that should be used or followed to avoid or minimise the likelihood or impact of the exposure (risk mitigation).The outcome of the risk assessment will assign an appropriate biosafety level for the work, including physical barriers, biosafety cabinets, appropriate personal protective equipment and response to accidents or spills. The monitoring of risks, reporting of incidents and laboratory-acquired infections, and updating risk management strategies are of utmost importance.
  • Risk communication includes the training of researchers, the development of standard operating procedures (SOPs) to guide the safe handling and disposal of the specific biological agent, signage (OH&S aspects), reporting of incidents, etc.

                   - ​​​​​​​Biosafety and biosecurity training, including occupational health and safety.

An important requirement of biosafety and biosecurity management is the provision of training and education to all individuals involved in activities with biological materials. Training programmes must be designed to provide the necessary knowledge and skills for the safe handling, storage and transport of biological materials, treatment of biological waste, correct operation of equipment, and the prevention of accidents and incidents. 


Biosafety and Biosecurity Resources

UCT research staff and students can access the following relevant Biosafety and Biosecurity resources:

 Click here for resources that will be updated as and when required.