User research ethics guidance
In the following sections we will discuss what research ethics is and why it’s important. All user research that is conducted with people should comply with the following key principles:
- Need to ensure ethical participation
- Prioritise the avoidance of harm to any participants
- Research data will only be used for the purpose it was collected.
Recommendations are given about conducting research in an ethically sensitive way. We also include information on finding out if your proposed ‘user research’ is classified as ‘research’ or if it’s an ‘evaluation’. This is important as it impacts if you’ll need to obtain ethical approval from the Research Ethics Committee (REC) or not. Any research will also need to comply with Information Governance (IG) and with General Data Protection Regulations (GDPR).
Research ethics within the NHS and NES
All researchers and anyone else conducting research as part of their work for the NHS should follow the highest practical ethical standards in delivering this research. NHS research ethics information is mostly aimed at providing information and guidance around conducting clinical research. At NES, we conduct mostly 'social' or 'user' research which still involves human participants, but we are much more likely be asking them to evaluate a new website or application, rather than to take part in any clinical trial. For this reason, we need our own guidance around how to conduct this type of research in an ethical way.
For NHS clinical research, it’s likely that ethical consent via the Integrated Research Application System (IRAS) will be needed.IRAS is a lengthy and detailed process that is necessary for safely and ethically involving people in clinical research .At NES, our research usually won’t have any direct impact on our participants health, and therefore it’s very unlikely that an IRAS application will be required. To help people decide if their study is classed as ‘research’ the Health Research Authority (HRA) have produced a Decision support tool. Further information can also be found in the HRA Defining Research document.
Following discussions with NHS Tayside Research Ethics Committee, it seems that most NES ‘user research’ falls under the category of ‘service evaluation/ improvement/ development’. We will continue to use the term ‘research or research activity’ to describe our user research activities throughout the rest of this document, but as far as the NHS ethics boards are concerned, it’s probably not classified as ‘research’. More details on research governance and definitions of research can be found in the NES Research Governance Policy. There is another HRA tool that can be used to work out if an NHS REC review is needed
For the purpose of NES research activities, under the Governance Arrangements for Research Ethics Committees (GAfREC) arrangements, then NHS REC review for research is required for health and social care projects involving the following groups:
i. service users and/or carers (past and present)
ii. adults (age 16 or over) who lack capacity to consent for themselves
iii. prisoners
iv. practising midwives conducting a clinical trial
v. processing of confidential patient information
vi. adults who are cared for in private, voluntary, or council nursing homes
vii. social and health research in children
In these cases, then an application should be made via the IRAS system.
Why do we need to consider research ethics?
For research involving people, we need to carefully consider the ethics of the research project. The principles that apply to health and social care research can be found in the UK policy framework for health and social care research.
We need to consider the ethics of any planned research, both for moral reasons and to ensure we do no harm. It’s especially important if the research touches on sensitive topics, such as illness, bereavement, chronic health conditions (which is quite likely given we are a health organisation). Research activities involving vulnerable groups (eg children, frail older people, people with cognitive impairments) will also require careful consideration of the rights, dignity and wellbeing of the people involved. It’s also important to maintain the reputational integrity of NES and the wider NHS. When Meta conducted covert research without the knowledge of Facebook users, they suffered reputational damage and lost the trust of many people.
The user experience research that we carry out is not usually classed as research by the decision support tool or by the table in the Defining research document. Research carried out at NES therefore may not require approval by an institutional research ethics committee (REC) if it’s classed as a ‘service evaluation’ or ‘improvement’ a formal approval procedure is unlikely to be required.
Regardless of whether we need to submit an ethical approval application, we still need to consider research ethics, and the associated data protection issues, in planning any new research project. Where an IRAS application will not be needed, the full user research proposal should still be carefully considered, and preferably shared with other team members (of the Experience team) to get feedback on any ethical issues that perhaps haven’t been identified.
Good practice recommendations
- Informed consent: Researchers should obtain informed consent from participants before they take part in the study. Participants should be fully informed about the study's purpose, procedures, and risks, this information should ideally be provided in a clearly written information sheet. Vulnerable groups may not be able to give informed consent, more details on this are detailed in the section below. Be honest with participants about why you are doing the research, how you’ll use the results and what the expected impact will be. They should also have the opportunity to ask questions and withdraw from the study at any time, it’s a good idea to include contact details for any queries on the consent form. Include the NES privacy information on the information sheet and/or consent form. For more information see the following Nielsen Norman article on informed consent. Here is an example of a NES informed consent form and info sheet .
- Confidentiality and anonymity: Researchers should protect the privacy of study participants. The identities of participants should not be disclosed in any publications or presentations that result from the study, and any personal information disclosed should be treated as confidential. Anonymity should be used in cases where participants may be at risk if their identity is revealed. Where quotes from participants are required in presentations or publications, a pseudonym can be assigned. For more information see the following Neilsen Norman article on privacy and security.
- Data Protection/GDPR:
It is important to comply with EU General Data Protection Regulation (GDPR). More information on data protection and GDPR can be found on the NES information governance and security hub and the Information Commissioner’s Office (ICO) Guide to the UK GDPR. Only collect personal data where necessary (for example, if running a survey, do you really need any personal information? If not, it’s better to keep it anonymous, and not collect any sensitive data) Wherever possible, anonymise recorded data (you may want to keep a key or codes in a separate document).
Ensure any form of recorded personal data is safe, and only keep raw data as long as necessary. The UK GDPR came into effect on 01 January 2021, and sets out the key principles, rights and obligations for the processing of personal data with some changes aligned to a UK context. Safeguards and processes are in place within NES to ensure we are fully compliant whenever we are dealing with personal data. More details can be found on the NES information governance and security hub and the Information Commissioner’s Office (ICO) Guide to the UK GDPR
At the start of any new project, or when a researcher comes into an existing project to carry out a new research activity, then data protection issues should be considered if the activity involves the processing of personal data; or if personal data already collected will be used for a different purpose to which it was originally collected. More guidance on this can be found in the NES Data Protection Impact Assessment Guidelines.
- Risk management: Researchers should carefully assess the potential risks and benefits of their study and take steps to minimise any risks to participants. Avoid asking sensitive questions or collecting sensitive information that could harm participants' psychological or emotional well-being. Consider indirect harm, and make sure that any risks for participants don’t outweigh any benefits. Also be very careful with any sensitive information that may be revealed in a study that perhaps can’t be fully anonymised.
- Respect for participants: Researchers should treat study participants with respect and dignity and avoid any actions or behaviours that could harm or exploit them. In user testing, for example, it’s important to let them know that we are testing the technology and not them, and that they can’t do anything ‘wrong’. Researchers should also be sensitive to cultural and other differences among participants and ensure that they are not marginalized or discriminated against in any way. Being respectful of participants time is also important, make sure you do not keep them waiting in any study they may participate in, and keep the session as concise as possible. In the NHS, most research participants are giving us their time for no extra reward/incentive so ensure they are made aware that this is appreciated by sending appropriate thanks, after any research session.
- Transparency and accountability: Researchers should be transparent about their study methods and findings and make their data and analysis available to others for independent review and replication. Research results should be reported accurately to ensure that the research findings are reliable, valid and are not biased. If research is to be published, then the FAIR principles should be followed as closely as possible which allows for the more effective reuse of research material.
- Participant selection: Participants should be selected based on their ability to provide useful insights, rather than for reasons such as gender, race, or ethnicity. In some cases, we may need to select participants to investigate specific accessibility issues, for example, to check our sites are accessible for people with a visual impairment, or for people who use screen readers.
- Institutional review: If your study has been classified as ‘Research’ then researchers should obtain institutional review board approval before starting their study to ensure that it is ethical, and that it meets the necessary ethical standards and regulations. Further details on NHS Research Ethics Committees in Scotland.