Navigating Ethics Approval in Research Projects: A Guide

How to… secure University research ethics approval for large and uncertain projects

While planning for ethics is a key part of project applications, the reality of a large project is that methods may change once you get going. Depending on how often your university Research Ethics Committee (REC) meets, it can be worth staging your ethics over 2-3 applications, rather than trying to get everything correct first time. Many university ethics systems are now online and so it is easier to track and make additional ‘notifications’, ‘adjustments’ or ‘follow-up applications’ to the main project.

Timing

This project started 1 November 2023 and I decided to focus on getting ethics approval at the January 2024 REC; ethics committees, at that point, were meeting every two months. My thinking was that it would be good to have approvals in place, ready for the team starting (I recruited through Jan-Feb 2024, to start in April-May 2024). This first application secured approval for the interviews and to approach relevant organisations as potential data-holders. The interview question schedules were structured by the research questions and the literature review undertaken to write the bid. In the event, the team spent the early months of the project doing a desk-based review of the literature and existing evidence, which helped provide context for the later interviews.

Forms

Normally, we would approach gatekeepers or potential participants with an information sheet and consent form. We instead asked the REC for permission to post these documents to our project website. In this way, we could signpost people direct and keep our approach emails more succinct.

Later approvals and amendments

We returned to the REC later in 2024 to seek approval for an anonymous online survey for those who had experienced or witnessed professional sexual misconduct, using the University-approved JISC platform ‘Online Surveys’. We also submitted a small number of amendments over 2024-2025, for example: clarifying that we could interview someone based overseas; or speak to them in-person, rather than just online. We also asked for permission to submit Freedom of Information requests, if that were required to secure sexual misconduct case data.

Interviewing in the context of sensitive research

A key issue arose, due to the sensitive nature of the project, where potential participants were happy to speak to us and:

Were willing to sign a consent form, but did not want to be recorded or directly quoted;.

Did not want to sign a consent form or want to be recorded, but were happy for us to quote them in a way that preserved their anonymity. Others preferred us to simply use what they said to inform our understanding for the project, rather than be quoted direct.

This created some discussion in the team as to how to treat these ‘interviews’. The starting point was that all participants had consented verbally to take part, and we had discussed with each participant how they would like the interview notes/recording to be treated. So we were confident on the ethical basis of their participation. We decided to label any interview without a signed consent form as an ‘off-the-record’ (OTR) meeting and we developed a key in the header of every transcript (both interview and OTR), which explained how the data could be used. We also flagged where the individual was a ‘single role holder’ which made their insight unique and therefore potentially identifiable, as a caution when writing up. We submitted a notification to our Research Ethics Application to document these decisions.

Ensuring anonymity

Another issue we faced was dealing with data in the public domain and involving named – sometimes high-profile – individuals. Our Research Ethics Committee were concerned that our data was anonymised for analysis and write-up. However, while preparing our first paper, we realised that while we could anonymise the individuals as case studies in the main body of the article, the weblinks to the data and evidence we were using inevitably identified them. Given the data is in the public domain, we are not breaching confidentiality, but we are mindful of the impact on those involved in the case. This issue will be diluted when we use a larger sample of cases, but is something we will continue to reflect on.

Additional approvals

In the second half of 2024, we started to plan our approach to finding interview participants and identifying data-holders – mapping out who held what; what data they published already, and what they did not. It was at this point that we realised that we might need a separate process for health professionals and for military. See separate blogs on NHS ethics and Ministry of Defence Research Ethics Committee.

Data Protection Impact Assessment

Since we are triaging data from a number of sources, we checked the guidance for Data Protection Impact Assessment. This is a concern for researchers who are collecting data relating to an identified or identifiable living individual. As mentioned, some of our open data searches, by definition, relate to named individuals. Open data searches include looking through media and legal case databases, for example. This processing fulfils two criteria under Section 8 of the Data Protection Act 2018 (DPA): “personal data already in the public domain (manifestly made public)” and “necessary for archiving, research or statistical purposes” (see: Conditions for sensitive processing | ICO).

The data we are requesting from data-holders is anonymised and we have negotiated formats to ensure this – for example: for quantitative data, we can ask for small numeric totals to be left blank (primary suppression) or for aggregated crosstabulation of categorical variables; for qualitative data, records can been redacted. Though unlikely, we are mindful that our knowledge of open data cases (i.e. those cases already in the public domain) could mean we can identify these individuals in anonymised data requests. However, we will be checking for this in analysis and write-up. In addition, final project datasets for analysis and archiving will be anonymised and collated in a way that protects identity.

Speak to your Research Governance team and keep records

In all cases, we recommend talking to your Research Governance team ongoing through your project and keeping a running log of every ethics decision (and rationale) as a team. This will be useful also in writing up the research for publication.