I obtained ethical approval from the ethics committee of the mental health
service in which I conducted the interviews (See appendix 28). Five main ethical considerations were identified as follows:
2.19.1 Informed Consent
Informed consent is a basic requirement of key international codes of medical research ethics such as the Nuremberg Code, the Declaration of Helsinki and The Council of International Organisations of Medical Sciences (Kjellin, 2011). The process of informed consent includes informing patients who are invited to participate in research about “the nature of the study, its aims, risks,
advantages, alternatives, confidentiality and any other condition of relevance for an informed decision, and they should know that participation is voluntary” (Kjellin, 2011, p.274). To ensure that patients provided informed consent to participate in this research study, the clinical nurse manager, Kevin Madigan, reviewed the patient’s electronic record prior to making initial contact. If there were any indications from either the electronic record or from the initial
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to provide informed consent, we decided to exclude the patient from the recruitment process or contact a member of the multidisciplinary team of the patient to clarify if it would be appropriate to contact the patient to invite them to participate. Patients were also invited to ask any questions about the research study before conducting the interview and it was explained that they could stop the interview at any stage without giving a reason. In addition, patients were invited to sign two different consent forms (Appendix 25 and 26). The first indicated consent to participate in the research interview. The second indicated specific consent for the interview to be recorded. I believe the use of these two separate consent forms rather than one global consent form in combination with the information letter helped patients clearly understand my invitation.
2.19.2 Decisional Capacity
Key international codes of medical research ethics specify that a patient must ordinarily have decisional capacity in order to provide informed consent to participate in research unless there are exceptional circumstances. Decisional capacity has been defined as “capacity to make and express a choice,
understand the information, evaluate the situation and possible consequences and handle information rationally” (Kjellin, 2011, p.275). Roberts et al. (2002) concluded that a diagnosis of schizophrenia does not necessarily preclude a patient from providing informed consent as many patients in the study were able to make rational decisions about participation in research that were similar to psychiatrist’s decisions. Palmer et al. (2005) found that even though patients with a diagnosis of diabetes mellitus scored better on a standardised
competence assessment than patients with a diagnosis of schizophrenia, individualised consideration of capacity was warranted. This was due to the significant heterogeneity within diagnostic groups and the superior predictive utility of the Mini-Mental State Examination over diagnosis. Appelbaum et al. (1999) reported that in female psychiatric outpatients with a diagnosis of major depressive disorder, more depressive symptoms or less previous experience of research were not associated with impaired decisional capacity.
To ensure that all patients who provided informed consent had decisional capacity, patients were excluded from the recruitment process if there was any indication from the electronic record, from the initial conversation between Kevin
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Madigan and the patient or from communication between Kevin Madigan and the patient’s treating team that they were not suitable to participate in research.
2.19.3 Undue Influence
The declaration of Helsinki states that:
“When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an
appropriately qualified individual who is completely independent of this relationship.” (World Medical Association, 2010)
To ensure that patients did not consent under duress, none of the researchers who invited patients to participate in the research or conducted the interviews worked as a member of the patient’s treatment team. In addition, the
information letter provided to patients clarified the professional roles and affiliations of the researchers and that declining to participate would not affect their treatment in any way.
2.19.4 Anonymity
A condition of the ethical approval for this study granted by the mental health service was that the service must be anonymised. Accordingly, I am obliged to anonymise the mental health service in all aspects of dissemination of this research including this PhD thesis. I have anonymised the service in this thesis by withholding or redacting any information that would directly identify the service. I have also protected the anonymity of the patients by using codes to link quotes to the same patient in the results and redacting identifying
information from the quotes.
2.19.5 Protocol for Observed Distress
As I was interviewing patients who were attending a mental health service, part of the ethics application process involved development of a process for
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responding to distress that I observed in participants during the qualitative interview session. The ethics committee approved the following protocol:
Step 1: If the participant becomes distressed during interview, the
interviewer (Stephen Shannon) will seek permission for a clinician within the mental health service to contact the participant. In the mental health service, Kevin Madigan, is the named clinician who should be contacted in the event of a participant becoming distressed. If Kevin Madigan is not available then a member of the service users treating team should be contacted.
Step 2: The interviewer (S.S.) will report the distress and the participant’s contact details to Kevin Madigan or a member of the service user’s treating team.
Step 3: A clinician will contact the participant to assess their level of distress and ask the participant’s permission to contact their clinical team if
necessary.