As far as possible, distress to any participant should be prevented. However, the sensitive nature of the subject matter, involving depression, may lead to participants thinking about issues that may cause them distress. This policy outlines the strategies that are in place in case of participant or researcher distress.
As far as possible, distress to any participant should be prevented. However, the sensitive nature of the subject matter, involving depression, may lead to participants thinking about issues that may cause them distress. This policy outlines the strategies that are in place in case of participant or researcher distress.
Participant Distress
Vulnerable Adults
Edge Hill University (2019) inform that vulnerable adults are not just those who lack capacity but people who are more susceptible to potential distress or harm arising from their participation in a particular research procedure. This may include; frail older people, people with dementia, those with mind or brain impairments or learning disabilities as well as those with mental health problems, the homeless, travelling communities, asylum seekers, drug users, family carers and the bereaved or victims of abuse (The Care Act, 2014). As the research will be recruiting people with mental health problems (depression) the researcher has developed this policy to reduce the risk of potential distress or harm.
Research Design
The research is designed to encourage participants to recall sensitive information which may be distressing; however, the researcher is a registered mental health nurse and health visitor and is experienced in working with people suffering emotional distress.
A participant may become distressed when recalling information related to their perinatal depression. In which the lead researcher (EH) will understand that it is important to:
- listen, and allow the participant time and space to express their feelings
- respond with empathy
- help the individual feel more comfortable and safe
- ask the person how they think the issue could be supported best
- refer the individual to an appropriate helpful service.
Sign posting
EH has provided a list of helpful services (the participant information page will inform the participant that this information is available should they need it). This information can be re-presented at any point in the research process should a participant become distressed.
Crisis management
The mental health charity Mind (2020) report that a mental health crisis is when a person feels at breaking point and needs urgent help. This may include:
- feeling extremely anxious and having panic attacks or flashbacks
- feeling suicidal or self-harming
- having an episode of mania or psychosis.
The contact details of a trusted person will be collected prior to interview in case of emergency. If at any point it appears that a participant is in crisis in relation to their mental health, the researcher will ask the participant if they may contact a next of kin or a trusted person. It may be necessary to contact the emergency services if a person is threatening to take their own life or if they report that they are injured.
Researcher and distress
The researcher may need support related to this research. In addition to the supervisory team, wider support services are available.
- The Supervisory team have experience of supporting those in distressed situations, one is a midwife (LB), and (SS) and (AK) are experienced in leading research and supporting post-graduate research students, therefore support for the lead researcher can be provided
- The University counselling/staff support service
- Any other counselling service available through your volunteer work.
- GP.
Data Management Plan
What data will you collect or create?
- Participant contact details
- Online digital consent forms will be downloaded from the website
- Demographic information will be collected at the time of consent via an online form. This will include details of a next of kin/emergency contact. (Please see Appendix 7 for information regarding the collection of demographic information).
- Data from interviews will consist of digital recordings from telephone or WhatsApp video call interviews, downloaded WhatsApp text messaging transcripts and field notes. WhatsApp video call interviews will be audio recorded using a digital recorder placed next to the computer speaker, video content will not be recorded or used for analysis.
- Interview audio recordings will be transcribed
How will the data be collected or created?
Digital audio recordings will be made during telephone/video call interviews. Transcripts of WhatsApp instant messaging interviews will be downloaded. This data will be transcribed (telephone and video interviews, WhatsApp instant messaging is already in text form) and stored in Edge Hill University OneDrive through the lead researcher’s password protected login. The data will be structured into files and in identifiable folders that can be easily accessed. Written field notes will be transcribed or scanned and stored on OneDrive before being destroyed. Audio recordings will be deleted once interviews have been transcribed.
What documentation and metadata will accompany the data?
Demographic information (including emergency contact details) will be collected and kept separately from the transcripts.
How will you manage any ethical issues?
All data will only be reviewed by the lead researcher and the supervisory team in order to keep confidentiality a primary emphasis. Personal data will be destroyed when the study ends, and anonymised data will be stored for 10 years as per the University of Edge Hill’s ethics procedures.
Ethical review will be undertaken during monthly supervision sessions.
How will you manage copyright and Intellectual Property Rights (IPR) issues?
The intellectual property rights will remain the property of Edge Hill University.
How will the data be stored and backed up during the research?
The data will be stored in OneDrive via Edge Hill University upon the advice of Edge Hill University research office. OneDrive is double encrypted, and password protected. The password will be changed at regular intervals throughout the study. The director of studies will act as a data guardian for all data following the lead researcher leaving the university at the end of her contract, therefore, OneDrive will be shared with the data guardian who is the Director of Studies (DOS).
Paper documentation such as field notes will be transcribed or scanned into OneDrive before being destroyed.
How will you manage access and security?
Throughout the data collection process all data will be kept in secure databases. Electronic data will always be password protected and will be backed up with password protected secure hard drives. The electronically stored anonymised data will be kept for ten years in accordance with the Edge Hill policy on data.
Which data are of long-term value and should be retained, shared, and/or preserved?
The data will be kept for a minimum of 10 years and will be preserved and shared via electronic means. Once the primary researcher (EH) leaves the University, data will remain within the university and past to the director of studies (LB) to retain the data for the remainder of the years.
What is the long-term preservation plan for the dataset?
Data will be kept for a minimum of 10 years in line with University’s Research Data Management Policy. It will be kept electronically. All data will be accompanied by metadata to assist interpretation if data is ever questioned or requested at a later stage.
How will you share the data?
Data will be shared with the supervisory team through OneDrive. Data will not be shared through unsecure email or phone. The data collection procedure will inform participants that anonymised data may be used at a later date for a follow up study or as part of other studies.
Are any restrictions on data sharing required?
The data will be stored by the researcher in an accessible manner within the institute.
Before consenting to participate in the research, participants will be informed of the limits of confidentiality and that if they disclose information which indicates illegal activity, potential risk of harm to self or others, the researcher is obliged to inform the relevant authorities.
Digital recordings will be stored separately from transcribed data on a password protected computer to ensure confidentiality. In keeping with ethical requirements, data will be retained securely for 10 years before being securely disposed of. Only the researcher will have access to personal details such as names of research participants. The process for GDPR (2018) will be adhered to which states that any breach of confidentiality will be declared within 72 hours of first having become aware of that breach.
Who will be responsible for data management?
The primary researcher Emma Humes will be responsible for the data management. She will be overseen by the research team: DOS: Dr Lesley Briscoe, Prof. Sally Spencer and Dr. Axel Kaehne.
What resources will you require to deliver your plan?
Access to Edge Hill’s University facilities, a computer, hard drive, OneDrive and the university research repository.