Research governance

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• Due diligence on overseas research partners

  When research funding is transferred into the control of an overseas partner.

  To transfer control of research grant funds to an overseas partner, the University must first undertake due diligence checks on the partner. This is required by UK Research and Innovation (UKRI), the main UK Government research funder. See the UKRI's current guidance on due diligence checks.

  The University's due diligence policy and process is currently a working draft and is still being finalised.

  If you are transferring funding to an overseas partner, the University's Finance unit will provide you with the relevant paperwork to complete.

• Export controls

  When any goods, software or information moves from the UK to outwith the UK.

  The UK Government controls the export of strategic goods, software and technology (whether through physical or digital means). These ‘Export Controls’ also cover university-based research.

  The most recent UK legislation on these controls is the Export Control Order 2008 and The Export Control (Amendment) Order 2022. The UK Government has issued guidance on export controls applying to academic research, and provided relevant case studies. The UK’s system of export controls is administered at a national level by the Export Control Joint Unit, and is enforced by HM Revenue and Customs.

  It is a criminal offence to break this law and could result in liability for both the University and the individual researcher.

  Follow the instructions below well ahead of starting any relevant activity (at least six weeks is recommended). This will allow enough time to determine whether your research requires an export licence, and, if required, obtain a licence.

  Within the University, you can get advice and support on complying with export controls from the research governance team within Research and Innovation Services.

  Do I need an export licence?

  1. Determine if your planned activity involves exporting goods, software or technology. Here are some useful definitions: 
     • ‘Exporting’ means transferring from the UK to a location outside the UK. For transferring software or technology digitally, it is considered exporting if the recipient is located outwith the UK (even if they are usually based in the UK and are only temporarily outwith the UK).
     • 'Goods’ means physical objects.
     • ‘Software’ means one or more programmes or microprogrammes fixed in any tangible medium of expression.
     • 'Technology’ means either information that is necessary for, or can be used in connection with, the development, production or use of goods or software.
     • ‘Information’ means blueprints, plans, diagrams, models, formulae, tables, source code, engineering designs and specifications, manuals and instructions written or recorded on other media or devices (e.g. emails, disk, tape, read-only memories).
     • ‘Source code’ (or source language) means a convenient expression of one or more processes which a programming system may turn into equipment executable form.
       
       
  2. Check whether any of the goods, software or technology you are exporting is something listed on the UK Government’s Goods Checker website:
     1. Go to the Goods Checker website. 
     2. Use a series of appropriate keywords to search in the ‘key terms’ box.
     3. If you find a listing that is, or relates to, what you are exporting, note the exact search term you used to locate that listing so that you have this ready when you contact research governance.
        
        
  3. If your planned activity involves exporting goods, software or technology and it is listed on the Goods Checker website, contact the research governance team at researchgovernance@st-andrews.ac.uk as soon as possible (and at least six weeks before you start research).

• Nagoya Protocol

  When projects involve non-human genetic material moving across borders.

  Universities and researchers are legally required to comply with the Nagoya Protocol, under the Nagoya Protocol (Compliance) Regulations 2015.

  Under the Nagoya Protocol, the UK Government requires that researchers demonstrate that they have, for every project involving the transfer of non-human genetic material across a border, proactively and explicitly checked whether any of that activity falls within scope of the Protocol. If their work does fall in scope, then the researchers must obtain all relevant paperwork before starting. They must then honour the conditions in the paperwork, including passing that paperwork and its conditions on to all future users of the material. See the UK Government Nagoya Protocol guidance web page for more information. 

  Failure to comply with this law can potentially constitute a criminal offence and could result in liability for both the University and the individual researcher.

  Follow the instructions below well ahead of any relevant activity (at least 12 weeks is recommended). This will allow enough time to determine whether your research requires any specific approvals or agreements relating to the Nagoya Protocol, and, if so, to obtain them.

  Steps to take

  For all projects involving the use of non-human genetic material, you must complete the Nagoya due diligence proforma (Word) and follow the instructions in the document.

• Projects involving the NHS, MoD or social care services

  All such projects, including using data or samples held by such organisations.

  Different types of approvals may be required for research involving the National Health Service (NHS), Ministry of Defence (MoD) or social care services. This includes research involving patients, service users or employees directly, or their samples or data (including data-only studies).

  Approvals can also be required for work that is not defined as ‘research’. For example, service evaluation, service improvement and audit.

  For information about gaining approval for this type of research, please go to the research involving the NHS, MOD or health and social care services web page.

• National Security and Investment Act (NSIA)

  When projects fall within the ambit of the NSIA.

  The National Security and Investment Act (NSIA) 2021 came into force on 4 January 2022 it gives the UK government powers to scrutinise and intervene in transactions to protect national security. The government has published guidance about the NSIA regime but there are broadly two strands:

  • acquisition of an entity which triggers a mandatory notification; and
  • acquisition of an asset (which includes IP rights) which has a voluntary notification process. Where no voluntary notification is made the transaction can go ahead but at any point the secretary of state can call in the transaction if they feel that it may pose risk to national security. If the transaction is called in after it completes then we could be required to unwind it which can have financial and reputational repercussions.

  It is for the acquirer to determine whether notification is required or should be made.

  Where an activity falls within the ambit of NSIA the government can:

  • approve the transaction
  • refuse approval, or
  • require alterations to the transaction before it goes ahead.

  If a transaction related to the activity has already occurred, the government can retrospectively block or unwind its terms.

  What action by a researcher ‘triggers’ the NSIA process?

  • For researchers the trigger is usually granting rights to IP (an asset) in one of the 17 fields.
  • Licensing IP is sufficient to trigger the process - it does not need to be transfer of ownership.
  • The legislation does not distinguish between the location of the entities - transactions between two British entities is also under the scope of the legislation and some universities are of the view that these transactions are in fact more of a risk as they won’t be subject to government approval under the separate export control regime.
  • Where a researcher has a spin out and another party is acquiring some or all of the spin out then this could lead to a mandatory notification.

  What does the process involve, and how long does it take?

  • If a voluntary notification is submitted:
    • 30 working days for government review – then either accepted or called in.
    • 30 working days for assessment after call-in (can be extended by up to a further 45 working days if required).
    • Government decides whether to approve the transaction, impose conditions, or block.
  • If no voluntary notification is submitted:
    • A call-in notified to the University after coming to the attention of the government through market monitoring. The government then has 30 working days (can be extended by up to 45 further working days) to review.
    • Government decides whether to approve the transaction, impose conditions, or block.
    • If transaction has already gone through and conditions imposed or blocked then the transaction needs to be unwound or amended.
  • If a mandatory notification has been made by the acquirer (for transactions in relation to entities not assets)
    • Approval must be given before the transaction can be completed, otherwise the transaction is void with civil and criminal penalties for proceeding without the necessary approval.
    • 30 working days for government review – then either accepted or called in.
    • 30 working days for assessment after call-in (can be extended by up to a further 45 working days).
    • Government decides whether to approve the transaction, impose conditions, or block.

  17 Sensitive Areas

  The 17 Sensitive Areas to which the NSIA applies are:

  ·       Advanced Materials ·       Advanced Robotics ·       Artificial Intelligence ·       Civil Nuclear ·       Communications ·       Computing Hardware ·       Critical Suppliers to Government ·       Cryptographic Authentication ·       Data Infrastructure

  ·       Defence ·       Energy ·       Military and Dual-Use ·       Quantum Technologies ·       Satellite and Space Technologies ·       Suppliers to the Emergency Services ·       Synthetic Biology ·       Transport

   Do I need to make notification?

  • Check if your activity relates to one of the 17 Sensitive Areas – if it does then consider the points below.

  • • Check if your activity relates to a qualifying acquisition being:
      • the acquisition is of a right or interest in, or in relation to, a qualifying asset or qualifying entity (these terms are explained below)
      • the entity or asset you are acquiring is from, in, or has a connection to the UK
      • the level of control you acquire over the qualifying entity or qualifying asset meets or passes a certain threshold (for example, your stake or voting rights in a qualifying entity becomes higher than 25%)

  • • Check if your activity relates to a qualifying asset or entity being:

  Qualifying assets include:

  • • • ideas, information or techniques which have industrial, commercial or other economic value (intellectual property)
      • tangible moveable property
      • land

  Qualifying entities include:

  • • • a company
      • a limited liability partnership
      • any other body corporate
      • a partnership
      • an unincorporated association
      • a trust

  • If your planned activity involves one or more of the 17 areas and involves a qualifying asset or entity then please contact the Chief Legal Officer at chieflegal@st-andrews.ac.uk as soon as possible to allow time for any notification that may be required.

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• Research involving animals, their samples or data

  All such research, including surveys, observation or secondary data.

  The University’s Animal Welfare and Ethics Review Body (AWERB) is responsible for overseeing, reviewing and approving research involving animals, their samples, or data.

  For more information, please go the research involving animals web page.

• Research involving humans, their samples or data

  All such research, including surveys, observation or secondary data.

  All research involving human participants, their samples or data requires University ethical review and approval. You may need additional approvals for work involving children, other vulnerable groups, or security-sensitive materials.

  For more information, please go to the research involving humans web page. In particular, review the 'what projects require ethical review and approval' section on the ethical review application page.

  If your research also involves the NHS, MoD or social care services, you may require ethical approval from those organisations in addition to University or third party governance approvals described above. For information, please go to the research involving the NHS web page.

• Ethical review of research funders

  For when research funding is to be transferred into the University.

  The University conducts ethical reviews for research grant funding (that is, funding for carrying out research and not for standalone events or training). The ethical review process seeks to ensure researchers are impartial and independent from their association with their research funder.

  You should keep approval letters for research funders as part of your project paperwork. Students should include these alongside other ethical approval documents in their final thesis submission.

  You can find the list of approved funders and more information on making an application on the ethical review of research funders page.