Gender identity healthcare: evaluation of the impact of Scottish Government funding

Annex D: Ethical Sensitivities and Data Protection

Ethics have been given prime consideration in this evaluation work. Ensuring the confidentiality of participants is of the highest importance. The project team has followed the protocols of the Economic and Social Research Council (ESRC) Research Ethics Policy and the Ethics Guidance for SG Social Policy Researchers, with respect to handling sensitive information, consent and clarity of the uses and objectives of the research. The project team has complied with data protection regulations (GDPR and Data Protection Act 1998) with regard to the collection, processing, storage and destruction of data. Maximum effort has been made, through clear and open-ended communication, to ensure participants understand the purpose of the research and their role within it. For example, the surveys included a section on the use of the research and full consent has been sought for interviews.

As described earlier in the section on Ethical Approach and Clearances, we have gone through the necessary channels to ensure that this service evaluation complies with NHS Research Ethics requirements. We received confirmation from the NHS Research Ethics Committee that, as this project is a service evaluation, it does not require formal approval by the NHS REC. We were informed that this also held true were we to include service users/patients in our sampling strategy. We were also informed by the Research & Development teams at the NHS Health Boards that, as this is a service evaluation, it does not require R&D Management approval.

This project has aimed to actively involve service user voice within the evaluation. This comes with several ethical considerations and risks that have been managed and mitigated. The research team anticipated that service users may have an experience of trauma or other sources of previous emotional harm. Throughout the interview process, in order to create a safe space for discussion, all participants were reassured of their anonymity, their right to withdraw and that the interview would be conducted at their own pace. As mental health first aid-trained researchers, the evaluation team were cognisant of signs of potential distress, and how to support people experiencing distress and signpost them to further resources. The team were also cognisant of safeguarding protocols (see below) should there be a risk of harm. Finally, the research team were aware of the potential of consultation fatigue, and sought to offer flexibility should interviewees need to reschedule, clarity around how the information they shared would be used in the report, and a token of appreciation for their time (vouchers).

Informed Consent

Due to the nature of this evaluation project, it has been necessary to gain informed consent of each participant taking part in interviews for the project. During participant recruitment, participants were given an information pack, which was made available via email. Within this pack, the following documents were present:

• Information sheet
• Informed consent form

The information sheet (see Annex E) detailed the purpose, scope and nature of the proposed data collection activity. Signposting information was given, as well as a data storage and retention statement as set out in Horizons Research policy. The information sheet reminded participants of their right to withdraw from the study. After they received their information pack, they were then invited to complete the informed consent form, which included statements around understanding the study information, consenting to being a voluntary participant, understanding that data will be confidential, and that data can be withdrawn (see Annex F). Once a completed consent form was received by the team, scheduling and confirmation of the interviews took place, taking into account availability of participants and the need to maintain safe service delivery.

Impact of Research on Participants

Due to the nature of semi structured interviews, emotional distress is a possibility for both participants and the researchers involved. To minimise this risk, several steps will be implemented. Firstly, during the interviews and focus groups, participants will be reminded of their right to not answer any questions within the interview without providing reason. Our team of researchers are adept at conducting interviews sensitively and supportively. As qualitative researchers, the team follows university best practice guidelines, placing an emphasis on safety, accessibility and wellbeing, to ensure that emotional distress is reduced as far as possible, including taking breaks.

Secondly, some participants (notably, service users) were provided with an invitation to debrief following their interview. This debrief session was conducted with the researcher themselves, or via a Debrief Form (see Appendix D). Debrief information included clear signposting information to relevant organisations, including counselling, mental health support, and other appropriate services.

Third, to reduce any stresses related to privacy and confidentiality, we made clear to participants during the consent-obtaining phase and at the start of the interview that data would be anonymised, so that identifying information would be removed from interview transcripts and deliverables. Participants were also clearly reminded of their right to anonymity, and their right to withdraw from the project (with data deleted).

Protocols were in place on what to do should a participant be at risk of harm. Due to the nature of the topic, participants were not given promises of unconditional confidentiality if the researcher was concerned about their safety or the safety of others. If the participant disclosed information that raised concerns, the researcher would follow the safeguarding and reporting policy set out by the NHS and Horizons.