Detailed Outline – Ethical Approval Application

Detailed Outline – Ethical Approval Application

Exploring Nurses’ Perceptions and Experiences of Using Professional Management of Complex
Behaviour (PMCB) Disengagement Techniques in Managing Aggression among Dementia
Patients in Irish Mental Health Settings
1. Introduction and Overview
 Introduce ethical review purpose — ensuring that the research aligns with HSE ethical
standards, GDPR (2018), NMBI (2021), and the Belmont Report (1979) principles of
respect, beneficence, and justice.
 State that this ethical submission supports the MSc research project approved under
Dundalk Institute of Technology (DKIT) and HSE Cork/Kerry governance frameworks.
 Mention that the study does not involve patients, biological samples, or clinical
interventions, but focuses on staff perspectives.
2. Section A – General Information
 Principal Investigator: MSc Nursing student, DKIT.
 Supervisor: Dr [Name], DKIT Department of Nursing and Midwifery.
 Site: HSE Cork/Kerry Community Healthcare dementia/mental health unit.
 Purpose: Qualitative descriptive study exploring nurses’ experiences using PMCB
techniques to manage dementia-related aggression.
 Academic Qualification: Master’s Degree in Nursing (Level 9).
 Ensure institutional contact details and research credentials are listed.
3. Section B – Study Descriptors
3.1 Study Background
 Aggression and agitation are common in dementia (Cloak, Schoo & Khalili, 2024).

 Irish policy frameworks such as the HSE National Dementia Strategy (2014) and MHC
(2023) promote person-centred, non-restrictive care.
 Evidence shows nurses often feel unprepared to handle aggressive behaviours (Copeland
et al. 2025, p. 85).
 The PMCB programme trains staff to use safe de-escalation and physical disengagement
(de la Fuente et al. 2019, p. 76).
 Despite widespread training, little qualitative research explores nursnurses’ediences
of PMCB use in Irish practice (Theodoula Adamakidou et al. 2023, p. 3071).
 Aligns with NMBI (2021) ethics on dignity and respect and Belmont principles.
3.2 Aims and Objectives
 Aim: To explore nursnunursnurses’ceptionsxperiences of PMCB disengagement
techniques in dementia care.
 Objectives:
1. Examine understanding and application of PMCB techniques.
2. Identify barriers/facilitators to safe PMCB use.
3. Explore organisational influences on nursnunursnurses’fidenceafety.
4. Recommend training and policy improvements for HSE and NMBI frameworks.

3.3 Design and Methodology
 Design: Qualitative, descriptive, exploratory (Doi et al. 2024, p. 106).
 Sampling: Purposive; 10–12 registered nurses with ≥1 year dementia experience (Jang et
al. 2024, p. 378).
 Data Collection: Semi-structured interviews (30–45 min) via Teams or in person.

 Analysis: Thematic, using Braun & Clarke’s phase approach (Brailas 2025, p. 78); software.
 Ethics: Voluntary informed consent; GDPR-compliant confidentiality (Chhetri et al.
2022, p. 2763).
 Sample Justification: Data saturation expected with 10–12 participants (Busetto et al.).
2020).
3.4 Anticipated Outcomes
 Thematic insights into nurses’ biographies.
 Identification of training and organisational gaps.
 Recommendations for dementia-care improvement in HSE policy.
4. Section C – Study Participants
4.1 Selection and Recruitment
 Registered nurses in HSE Cork/Kerry dementia units (Calsolaro et al. 2021).
 Recruitment via gatekeepers (nurse managers/educators).
 Ensures voluntariness and prevents coercion.
4.2 Inclusion/Exclusion
 Include: NMBI-registered nurses with ≥1 year dementia care, PMCB trained.
 Exclude: agency/probationary staff, non-nurses, or those under investigation.
4.3 Informed Consent Process
 48-hour reflection period before signing (Cuddihy et al. 2024).
 Consent covers participation, audio recording, anonymisation, and data use.
4.4 Vulnerability and Safeguards
 Recognises workplace power dynamics.

 Confidential recruitment, anonymised transcripts, and voluntary withdrawal rights ensure
justice (Belmont Report).
5. Section D – Research Procedures
5.1 Participant Activities
 Single semi-structured interview (30–45 min).
 Conducted privately or online; recorded with consent (Aidana Karibayeva et al. 2025, p.
813).
 Questions focus on PMCB, organisational support, and safety (Alruwaili et al. 2025, p. 90).
5.2 Risks and Safeguards
 Possible emotional distress (Pachi et al. 2023, p. 2031).
 Mitigation: voluntary withdrawal, confidentiality, EAP support (Lynch et al. 2025, p.
529).
 Adheres to beneficence and non-maleficence.
5.3 Benefits
 Reflective professional insight, staff empowerment, enhanced policy alignment (MHC
2023).
5.4 Monitoring
 Researcher monitors emotional wellbeing (Ghimire 2025, p. 312).
 Post-interview debrief; EAP information provided.
5.5 Data Dissemination
 Aggregate thematic presentation only; shared via MSc thesis, conferences, and journals.
6. Section E – Data Protection
6.1 Governance

 Data Controllers: DKIT (primary) and HSE Cork/Kerry (joint).
 Processor: PI (student).
 Lawful, transparent processing per GDPR (2018).
6.2 Security Measures
 Encrypted laptop; locked cabinet for consent forms; no cloud storage.
 Pseudonymised transcripts (Hernandez et al. 2024, p. 55).
6.3 Retention
 Secure retention for five years; destruction thereafter (Adnan et al. 2025, p. 1139).
6.4 Confidentiality
 Use of pseudonyms; compliance with HSE Confidentiality Policy (Adil Hussain Seh et al.)
al. 2020, p. 133).
7. Section J – Indemnity and Insurance
 DKIT provides institutional indemnity for postgraduate research.
 HSE site indemnity applies under the HSE Research Governance Framework (2018).
 Public liability and professional indemnity cover both the researcher and the participants.
 No external funding or sponsor influence.
8. Section K – Cost, Resources, and Funding
 Estimated total cost: ~€125 (self-funded).
 Supported by DKIT access to NVivo and academic resources.
 No external or commercial funding.
 No payments to participants or investigators.
 Transparent financial disclosure (HSE 2018 governance).
9. Section L – Additional Ethical Issues

9.1 Emotional Distress
 Acknowledges possible psychological discomfort, mitigated by trauma-informed
interviewing and EAP referral.
9.2 Power Dynamics
 Recruitment via gatekeepers; anonymity preserved.
9.3 Confidentiality Risks
 Small-unit anonymity is protected through generalisation.
9.4 Researcher Reflexivity
 Reflexive journaling and supervisory debriefs to limit bias.
9.5 Dissemination Ethics
 Findings presented constructively, avoiding institutional blame.
9.6 Ethical Framework Alignment
 Compliant with Belmont Report, NMBI (2021), MHC (2023), HSE (2018), and Data
Protection (2018) standards.

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