National Health Service Ethics Approval Research Articles

Epidemiology of hospitalisations due to chickenpox and quality of life lost in community and hospital settings: protocol for a prospective cohort study across two countries

IntroductionWhile still a ubiquitous disease of childhood, chickenpox has been effectively controlled in many countries through the use of vaccination. Previous health economic assessment of the use of these vaccines...

Managing Unusual Sensory Experiences in People with First-Episode Psychosis (MUSE FEP): a study protocol for a single-blind parallel-group randomised controlled feasibility trial

IntroductionHallucinations (hearing or seeing things that others do not) are a common feature of psychosis, causing significant distress and disability. Existing treatments such as cognitive–behavioural therapy for psychosis (CBTp) have...

Study protocol for the antidepressant advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care: a feasibility study

IntroductionThe Antidepressant Advisor Study is a feasibility trial of a computerised decision-support tool which uses an algorithm to provide antidepressant treatment guidance for general practitioners (GPs) in the UK primary...

The only way is ethics? Applying for National Health Service ethical approval and governance for research with children

ABSTRACTIn this Viewpoints piece, we reflect on the process of applying for National Health Service (NHS) ethical approval and governance for research with children in England. We present a case study of our experiences of navigating the Integrated Research Application System (IRAS) for one study, The Hair Study. We argue that, for children’s geographers, getting to grips with the complex processes of applying for NHS ethical approval and governance is important when considering the move towards interdisciplinary working, and engagement with children in underexplored spaces and places, such as: doctors surgeries; hospitals; dentists; and other services commissioned by the NHS.

High-Resolution Contrast-Enhanced Micro-Computed Tomography to Identify the Cardiac Conduction System in Congenitally Malformed Hearts: Valuable Insight From a Hospital Archive

We obtained National Health Service ethical approval to image congenitally malformed hearts from the Alder Hey archive, Liverpool, United Kingdom. Consented samples that were archived in the 1970s were scanned by Iodine-enhanced micro-computed tomography (micro-CT) [(1)][1], producing 3-dimensional

Use of patient-held information about medication (PHIMed) to support medicines optimisation: protocol for a mixed-methods descriptive study

IntroductionRisks of poor information transfer across health settings are well documented, particularly for medication. There is also increasing awareness of the importance of greater patient activation. Patients may use various...

Experiences of a patient-initiated self-monitoring service in inflammatory arthritis: A qualitative exploration.

The aim of the present study was to explore patients' experience of a patient-initiated self-monitoring service for people with rheumatoid or psoriatic arthritis who are on methotrexate. The study took the form of qualitative semi-structured interviews, embedded within a randomized controlled trial. Twelve participants who were randomly assigned to the intervention arm were interviewed. Interviews digitally, transcribed verbatim and analysed using inductive thematic analysis. The study received full National Health Service ethics approval from Camden and Islington Community Local Research Ethics Committee (Ref. 09/H0722/91). Analysis revealed five key themes. Participants described usual care as burdensome and an inefficient use of time, particularly those in employment. Being able to self-monitor and initiate their own care increased patients' knowledge about their illness and its treatment, and enabled them to gain a sense of control and ownership over their arthritis. They appreciated the personalized nature of the new service, which allowed them to be seen at a time and by a method more appropriate to their needs. There were, however, some concerns about fidelity to the service protocol, confusion about the lack of consistency between symptoms and laboratory results, and anxiety about self-monitoring. Overall, participants were positive about the new service, in comparison with usual care, valuing its tailored approach and empowering effects. Further work is needed to ensure adherence to the service protocol and address anxieties around self-monitoring prior to any widespread implementation of the service.

Safety of human olfactory mucosal biopsy for the purpose of olfactory ensheathing cell harvest and nerve repair: a prospective controlled study in patients undergoing endoscopic sinus surgery

Nasal olfactory mucosa is an accessible source of olfactory ensheathing cells for spinal cord regeneration. However, safety of the biopsy technique and the effects on sense of smell and nasal function have not been robustly assessed in the form of a prospective controlled study. National Health Service ethical approval was granted for this study of 131 patients. The primary outcome measure was olfactory function and the secondary outcomes included postoperative complication rates as well as the SNOT 22, NOSE scale scores and surgeon reported (Lund-Kennedy score) nasal function outcomes. 65 patients underwent functional endoscopic sinus surgery (FESS) and superior turbinate biopsy, and 66 patients underwent FESS only as the control group. There was no significant difference in complication rates between the two groups. All Olfactory function outcomes were unaffected following olfactory biopsy. We demonstrated that the patients quality of life and nasal patency as well as surgeon reported outcome measurements remain unaffected following olfactory harvesting. We have uniquely provided level 2a evidence for the safety of endoscopic biopsy of olfactory mucosa, which does not affect nasal function or the sense of smell compared to standard FESS without biopsy.

Ethics, publication andThe Clinical Teacher

Ethics, publication and<i>The Clinical Teacher</i>

The BodyMind Approach (BMA) to psychotherapeutic groupwork with patients with medically unexplained symptoms (MUS): A review of the literature, description of approach and methodology for a pilot study

This paper presents a literature review of research into interventions with people with medically unexplained symptoms (MUS). The review forms the basis for the research questions, provides a rationale for an innovative approach (The BodyMind Approach/BMA) to intervention for patients with anxiety/depression with MUS and justification for the most suitable methodology for the pilot study. An overview of the problem is provided as backdrop to the rationale. Patients with MUS make up a substantial percentage of all primary care (PC) consultations, are notoriously difficult to treat and make huge demands on resources. A pilot study took place in the National Health Service (NHS) in the UK between 2004 and 2007 receiving full NHS ethical approval for delivery in PC. Following on from the systematic search of the literature the argument for, and description of, the BMA (based on the discipline Authentic Movement from within the field of Dance Movement Psychotherapy) to group psychotherapy is presented. The intervention emphasises learning in a verbal and non-verbal-integrated approach, encouraging an awareness of the inter-relationship between body, self and mind. It uses meditative, mindful movement deriving from natural body gestures and posture, relaxation, massage promoting movement metaphor to change beliefs and to understand the meaning of the symptoms within a self-managing framework. The symptom is seen as a metaphor for connections between body, self and mind. It is founded on the principle that bodily experience can be an avenue for meaning-making in personal development leading to increased well-being; better coping strategies; changes in perception of the body-felt sense and improved lifestyle choices and behaviours. The research sought to answer a number of questions concerning the intervention such as benefits, process and outcomes from the perspective of participants and the facilitator. The methodology selected was mixed, using both qualitative (analysis of pre, post and follow-up interviews with participants and facilitator's process recordings); and quantitative whereby standardised outcome measures were completed by patients pre/during/post intervention and at follow-up. Medication, secondary referral and GP visits were also quantified pre/post-intervention and at follow-up. Findings supported the hypothesis, and went beyond it, revealing a reduction in, and disappearance of, symptoms to a significant effect.

A researcher's journey for clarity: clarifying liability and indemnity issues when carers take on a role in medicines management

A client attending a depot clinic in a mental health setting requested that her husband be enabled to give her injection. This request was followed up in a practice development project. Following the success of the project, the local National Health Service (NHS) Mental Health Trust supported a research project to explore the issues raised further. The Local Research Ethics Committee raised a question around carer liability. This question led to a 2-year liaison with the NHS Litigation Authority, the local NHS Trust's legal team, Royal College of Nursing and others. The journey clarified that liability for a carer was covered under the Third Party Liability Scheme, where the carer came under the umbrella of being an 'authorised voluntary worker'. While the experience delayed the research project, it was a significant learning opportunity in the NHS ethical approval system.