Universities and research institutions operate at the edge of what is and is not known. That might mean making, receiving, storing, testing and disposing of materials that are dangerous, toxic, infectious or just plain mysterious.
Particularly in relation to infectious or potentially infectious material, current and historical controversies, and movies, provide some good examples of relevant concerns, including:
If you have not already set up initial checks relating to materials as part of your project approval process, consider the following points:
Health and safety (general)
Materials, such as biocides and chemicals, pose safety risks to those that handle them. In addition, the systems and equipment needed to handle certain materials, or clean equipment, may also themselves pose a safety risk. Therefore, general health and safety should be high on the list of priorities when assessing a new project involving materials. The main legislation is the Health and Safety at Work, etc. Act 1974. Conducting a reasonable risk assessments for novel materials is easier said than done and may require external expert input.
Biosafety
A research project may involve microorganisms or animals, or animals infected with microorganisms. Containment is crucial and the risk of staff infections should be managed carefully. The Health and Safety Executive (HSE) has published detailed guidance on biosafety measures it expects organisations to implement. See, for example, the resources published by the HSE in relation to laboratories.
Animal pathogen licence
If any person (think broadly about the persons involved) will possess a sample of any animal pathogen (e.g. a virus like avian influenza) or an animal that they know or reasonably suspect contains an animal pathogen, that person may require a licence from the HSE. Specifically, they will need a 'SAPO licence' if the pathogen is specified in the Specified Animal Pathogens Order 2008 (or equivalent legislation applicable to Wales and Scotland). For that purpose, an animal pathogen includes attenuated or genetically modified versions and nucleic acid that could be used to produce the pathogen.
Genetically Modified Organisms (GMO)
If the material is biological and has had any of its genome modified in any way, then consider whether the project complies with the Genetically Modified Organisms (Contained Use) Regulations 2014. Risk assessments, notifications, approvals and the payment of fees may be required.
Radioactive material
This type of material is subject to strict controls. If a project involves using radioactive materials, it may be necessary to notify, register with, or seek the consent of the HSE under the Ionising Radiations Regulations 2017. In addition, an environmental permit may be required under the Environmental Permitting (England and Wales) Regulations 2016.
Goods subject to export restrictions
The UK has implemented a system of controls over UK exports. It is easy to overlook global trade compliance as a topic of concern in relation to a domestic research project. However, it is a worthy inclusion in the preliminary checks before a project. The consequences of breach are severe and research projects often involve cross-border collaboration. Does everyone in the team know not to send samples of research materials outside the UK? What about a specialist foreign contractor that is urgently required to provide some critical analysis of the material? Military and dual use items (including certain pathogens and genetic elements deriving from them) and radioactive materials, are on the UK export control list. Consult the list before the project starts.
Human tissue
If the material contains even a single human cell, then it is 'relevant material' for the purpose of the Human Tissue Act 2004 (HTA). As a general rule, if the material is of human origin then make sure to check the position under the HTA. Several important obligations apply if the material is in scope, including potentially (subject to various complicated carve outs and caveats) the need to obtain donor consent, storage licences and a positive opinion of a research ethics committee.
These are not all the things that should be on a list of preliminary legal checks before a research project involving materials (the intellectual property position should also be checked, for example). However, consider adding them to the current list or starting a list with them as the first checks.
Contracts relating to the project should refer accurately to the compliance requirements that apply to the material, including by specifying the applicable legislation and regulators and capturing subordinate legislation, regulatory guidance and changes that occur over time.