Advice on research ethics and gatekeeper permissions for international researchers
Advice on research ethics and gatekeeper permissions for international researchers wishing to undertake research in the UK
This guidance is aimed at researchers based in a research organisation in a country other than the UK who have obtained or will be obtaining a favourable ethics opinion (sometimes referred to as an ‘approval’) in their home country, before undertaking their research in the UK. It is important to note that the research organisation must have agreed to sponsor the research and will be responsible for its governance.
For a definition of the role of a Sponsor, please see the appendix at the end of this document.
UKRIO’s general advice to researchers intending to carry out research in a country other than their own can be found in this section of our Code of Practice for Research.
Specifically, it states:
3.7.2 When conducting, or collaborating in, research in other countries, organisations and researchers based in the UK should comply with the legal and ethical requirements existing in the UK and in the countries where the research is conducted. Similarly, organisations and researchers based abroad who participate in UK hosted research projects should comply with the legal and ethical requirements existing in the UK as well as those of their own country.
That includes compliance with the requirements of the General Data Protection Regulations on data processing and protection.
It also includes research involving human participants, using animals in research and research that raises any other ethical issues.
It will be helpful to review the Code of Practice in full, to check that the ethics favourable opinion you have been granted covers the areas referenced in the Code, including those relating to consent and information provision. (Please note that whilst many universities in the UK are subscribed to UKRIO, it is a voluntary organisation, and the Code is not mandatory.)
You may also like to review the Concordat to Support Research Integrity, with which all research and higher education institutions in the UK are required to comply.
Research Ethics
A favourable ethics opinion from within the UK is needed if the research relates to National Health Service and Social Care patients/clients and/or their relatives or carers, please see this link. This covers all areas under the UK Framework for Health and Social Care research.
Gatekeeper permission
Gatekeepers have a variety of roles and responsibilities:
- a gatekeeper could be a person who is willing to help with recruitment of research participants where the researcher has no direct access to potential participants. They might be willing, for example, to pass on recruitment material within their organisations. Some might be willing to pass on contact details of potential participants having gained consent to do so.
- gatekeepers can also include the leaders of organisations; for example, a Headteacher, whose permission would be required in order to conduct research in a school. A comparable situation applies in universities where permission and support of the research governance department will be required. The gatekeeper’s permission is quite distinct from the consent of participants.
- in some cases, a gatekeeper’s permission is required as part of the ethics review of a study. Examples include the HRA for any studies aiming to recruit NHS patients or their carers and people (and their carers) in receipt of state funded social care. A further example includes research aimed at prisoners and the prison service; an application has to be made to His Majesty’s Prison and Probation Service in order to access its National Research Committee. These applications are made via Integrated Research Application System (IRAS).
- a gatekeeper could also be a webmaster or a leader of a social media group even if it’s possible to access members of that group directly.
Please also review UKRIO resources pages on research ethics.
Research using animals
Research using animals is also subject to regulation and may not be undertaken without the appropriate licences and approvals from within the UK. Please see further information available on our website here.
This information is not exhaustive but should form a helpful starting point for those wishing to undertake research in the UK.
Summary
This guidance applies to researchers with a clear affiliation to a research organisation, where that organisation is prepared to act as Sponsor of the research. In these circumstances, the expectation is that the Sponsor would have provided an ethics review, concluding in a favourable ethics opinion / approval.
Appendix 1 – Role of Sponsor
Sponsorship, governance and permission to proceed
The sponsorship of research would normally cover the following areas (this is not an exhaustive list):
Resources to conduct the study – do you have all the resources to carry out the study from start to finish?
Ensuring that all approvals are in place – there may be approvals other than ethics needed.
Ensuring that the study is managed and conducted according to all relevant local, national and international law and good practice guidance – you will be responsible for ensuring you operate in accordance with all relevant laws such as on data protection.
Responding to complaints etc in conduct of the study – what arrangements are in place to resolve complaints about the study or researcher; this needs to be independent of the researcher. Mistakes and difficulties can arise in the most rigorously conducted research and you will need to consider how you manage such difficulties.
Indemnity arrangements in the event of harm to researchers or participants – a sponsor would normally have this in place. Is there insurance cover for any issues relating to the conduct of research?
Management of the risks involved in the research. You will need to consider the impact of risks/problems on yourself as researcher, both whilst undertaking the research and subsequently. Where there is no sponsor other than the researcher, is there any surety that the risks of the project are fully assessed, for example to yourself as possible sole researcher?
Responding to, dealing with, managing and keeping records of adverse events that may occur.
Record keeping and data storage – are appropriate and legally compliant arrangements in place to store the data gathered safely and securely? Have you considered GDPR and data protection law (you will be liable for any breaches).
Quality assurance and accountability – ensuring that the research is conducted in accordance with the ethical opinion and that arrangements are in place for dealing with any necessary amendments. How do you make sure that you do what you say you are going to do and what are the consequences if you don’t do what you say you are going to do?
Dissemination – ensuring that the findings are appropriately disseminated. With publishing – how will you ensure that there is an appropriate and permanent contact to be responsible for queries and difficulties? This also applies to data storage. You may have provided contact information, but these may change over time.
The definition of sponsorship in the Framework for Health and Social Care research may also be of interest.
Written by Nicola Sainsbury, Research Integrity Manager, UKRIO, and David Carpenter, Independent Consultant and Trainer in Research Ethics -HRA, ARMA, UKRIO.
Thanks to expert UKRIO volunteers for reviewing this guide.
April 2023