UPDATE 17 MAY 2021 - Ethical approval for research projects involving UK-based face-to-face participation - CORONAVIRUS PANDEMIC
The purpose of this document is to provide guidance to researchers about the ethical approval processes at the University during the easing of restrictions in response to the ongoing coronavirus pandemic.
Restarting research activities
In line with the latest Scottish Government guidance on lifting COVID-19 restrictions, and as we transition from protection level 3 to protection level 2, we are planning to allow UK-based activity which involves face-to-face interaction for the purpose of data collection to resume from Monday 17th May 2021.
Principles relating to restarting research
Below is a set of overarching principles which have been developed by the University to ensure that a consistent approach to restarting research is achieved across the University. This set of principles will be applied locally by Schools alongside specific guidance on the steps to be taken by PI’s or Research Students for recommencing research involving face-to-face interaction for the purpose of data collection. We will update this information as new Scottish Government social distancing measures emerge.
We require researchers to use these principles to think about how they would restart their research activities safely.
- Remote working will remain the default option for those who are able to do so.
- This guidance applies to UK based University staff and research students only. Research Staff and Students who are currently based overseas, should not recommence face-to-face research data collection for the time being, and should continue to adhere to their specific regional lockdown guidance. This position will be reviewed monthly.
- The health, safety & wellbeing of students and staff is very much the priority. No research staff and research students should be on-campus if they have COVID-19 symptoms. All research staff and research students must adhere to the enhanced safety procedures whilst on campus.
- All staff and students will adhere to government mandated health & safety / social distancing policies. These policies may adapt over time.
- All staff and students should be cognisant of any additional health and safety recommendations, including PPE.
- Staff and students should not feel obliged to return to campus if they feel it would be unsafe to do so, are self-isolating, in the vulnerable category etc.
- All researchers should ensure that a work plan has been drafted and agreed with their supervisor prior to any work being undertaken which involves face-to-face interaction for the purpose of data collection.
- In the case of research students, all supervisors should commit to identifying any training needs the student may have to enable the work to be carried out.
- All researchers and supervisors will ensure that planned activities are subjected to a new risk assessment prior to work commencing.
- Room risk assessments will be reviewed and amended, as appropriate, by the relevant staff member(s) in each area (for example, School Health & Safety Officer).
- Where clearly stated, all individuals entering rooms must adhere to the specific flow systems designed for each room, following a shared collegial approach. This could mean an altered flow of people in certain areas.
Ongoing current research projects with prior ethical approval
There are alternatives to face-to-face methods available to collect data from human participants, such as telephone/video interviews, online focus groups, online surveys and asynchronous data gathering methods.
If an ongoing remote research project is redesigned to adopt face-to-face data collection methods, you must update your recruitment documents to outline how you will interact with participants and use this version in future. Any already active participants must be informed of the switch to face-to-face interaction and be provided with the updated participant information sheet. It is important that you make clear to participants that if they no longer wish to participate owing to this change, or for any other reason, that they are free to withdraw at any point.
It is important to carefully consider if it is appropriate to approach your target sample during the ongoing pandemic.
- For example, it may not be appropriate to approach key workers who are involved in public health and safety at this time (for example health and social care, education and childcare, public services, government, etc).
- If your research involves recruitment of participants from the NHS please be aware that some NHS trusts have paused all recruitment and clinical studies due to the current situation.
- The vulnerability of research participants may have increased due to social isolation, ill health, lack of access to support (such as GP services) meaning the risk of harm to participants needs careful consideration.
If you decide that any paused research will resume, it is important to inform any participants already recruited to the study. It is important that you communicate how any actively enrolled participants will be managed, particularly concerning any safety monitoring / follow up etc. where applicable.
Applying for ethical approval for new projects
As the coronavirus pandemic continues it must be recognised that restrictions on daily life may be in place for some time, and researchers need to consider the design of their research in the current context. Researchers should consider if the research design needs to be revised before applying for ethical approval while the pandemic persists.
Working with patients, elderly and other vulnerable groups may continue to be challenging even if wider social distancing measures have been relaxed, and careful consideration of the risk of harm to participants and researchers is particularly important during the pandemic.
Any new clinical projects need to follow National Institute for Health Research (NIHR) guidance on research during the pandemic and will require a sponsorship review by Edinburgh Napier prior to approval. The commencement of new clinical studies must be commensurate with capacity and readiness in local health and care services, and researchers involved in Clinical studies should contact the SHSC Research Integrity Convenor for advice on this process.
Guidance on preparing a new application for ethical approval
1. My project can be completed fully remotely
If your research design allows appropriate use of remote research methods for its full duration you should submit your ethical application as normal – outlining the benefits of the research, its recruitment strategies, details of your remote research methods, consideration and mitigation of risk of harm to participants and researchers, how you will obtain informed consent from the participants, details on the information shared with participants (Participant Information Sheets, debriefing information etc.) and data management information.
School Research Integrity Committees will then consider the application for approval through the usual processes. You may be asked for further information, to make amendments, or be given approval to the project as proposed.
2. My project will start remotely but may move to face-to-face in the future
If your research project can start remotely, but you consider that it will be necessary to conduct face-to-face research at some point during the project, you are asked to highlight that this will be necessary in the initial application for ethical approval.
Such a situation may arise if the research project is over a longer timescale, involves a phase of research that would not be appropriate for remote data collection but could be delayed until social distancing restrictions are further relaxed, or may involve research participants who cannot engage with research during the current restrictions but may do so when the restrictions are fully removed (vulnerable groups, digitally excluded participants for example).
Approval may then be granted on a staged approach – researchers should submit an application outlining their plans for the first stage of the project using remote data collection for approval (stage 1). The researcher would then be required to submit an amendment to their ethical application before the School committee could approve any stage 2 research (any proposed return to face-to-face research).
This staged approach to ethical approvals allows the Schools to be aware of the types of research being carried out at different phases of the coronavirus pandemic rather than allowing a project to be approved that may not be suitable at this time, whilst allowing researchers to adapt their projects to the changing situation of the pandemic and associated social restrictions. Researchers should be aware that some restrictions may continue for some time or change quickly while designing their research project.
Remote data collection methods
There are a number of remote data collection methods that can substitute for face-to-face interactions. The fundamental ethical principles that apply to apply to all research continue to be applicable using these methods, and researchers are encouraged to particularly consider:
- The appropriateness / potential risk
- What different risks might be created using remote data collection methods?
- Is the topic appropriate for an online interview or survey? (for example, if an interview is about a sensitive or traumatic topic what are the implications for the wellbeing of a participant during and after the interview?)
- How will you approach gaining (and documenting) that informed consent has been given?
- Data management
- How will you deal with research data from remote methods? Where is it stored? How is it made secure?
Our Code of Practice for Research Integrity contains guidance about online surveys, working with vulnerable groups, and informed consent.
Other sources of guidance on remote data collection include:
Support for researchers
We advise in the first instance, that Research Students discuss their research data collection needs with their Director of Studies. Once this discussion has taken place, the Research Student should contact their School Health & Safety advisor to complete an individual risk assessment before recommencing research which involves face-to-face interaction for the purpose of data collection.
PI’s should contact their School Health & Safety advisor to complete an individual risk assessment before recommencing research which involves face-to-face interaction for the purpose of data collection.
Review of this guidance
The University Research Integrity committee will continue to review our guidance as the Scottish Government restrictions change, and we will update this guidance as needed.
University Research Integrity Committee