Research Governance Approval Research Articles

Challenges and opportunities of translating animal research into human trials in Ethiopia

Background and objectivesAlthough the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented in different countries. Therefore, the aim of this study was to investigate the challenges and opportunities of translating animal research into human trials in Ethiopia.MethodsA descriptive qualitative study, using in-depth interviews, was conducted in which preclinical and clinical trial researchers who have been involved in animal research or clinical trials as principal investigator were involved. Data were analyzed using inductive thematic process.ResultsSix themes were emerged for challenges: lack of financial and human capacity, inadequate infrastructure, operational obstacles and poor research governance, lack of collaboration, lack of reproducibility of results and prolonged ethical and regulatory approval processes. Furthermore, three themes were synthesized for opportunities: growing infrastructure and resources, improved human capacity and better administrative processes and initiatives for collaboration.Conclusion and recommendationsThe study found that the identified characteristics/features are of high importance either to hurdle or enable the practice of translating animal research into human trials. The study suggests that there should be adequate infrastructure and finance, human capacity building, good research governance, improved ethical and regulatory approval process, multidisciplinary collaboration, and incentives and recognition for researchers to overcome the identified challenges and allow translating of animal research into human trials to proceed more efficiently.

Multidisciplinary care of older adults in the emergency department to influence deprescribing in older adults: a cohort study

AbstractBackgroundInappropriate polypharmacy in older adults is a major health problem associated with poor clinical and health service outcomes.AimWe aimed to evaluate the effectiveness of a geriatric pharmacist service in the emergency department (ED) identifying potentially inappropriate prescribing (PIP).MethodBetween 1 June 2018–31 May 2019, adults ≥70 years of age presenting to ED were reviewed by the Geriatric Emergency Department Intervention (GEDI) pharmacist. The intervention consisted of pharmacist‐led medication review using Screening Tool of Older Person’s Prescriptions (STOPP) and Screening Tool to Alert doctors to Right Treatment (START) criteria, patient education on recommendations, an updated medication list, and a letter sent to their general practitioner (GP) electronically. For eligible consenting older adults, telephone calls were made at least 28 days post‐discharge to assess the effectiveness of the intervention. A survey with GPs after 6 months determined how recommendations were perceived. Ethics approval was granted by the Metro North Health B Human Research Ethics Committee (reference no: HREC/18QCH/69–1245) and research governance approval was granted by the study site (Cairns Hinterland Hospital and Health Service, reference no: SSA/Q12345/40673). Informed consent was obtained from all participants via a project information sheet and either the completion of a written consent form (patient participants), verbal consent before interview (GP participants), or implied consent via email responses (GP participants). Routinely collected health data obtained for this study were de‐identified and data included in the follow‐up study was de‐identified.ResultsThe GEDI pharmacist reviewed 1214 older adults with an average age of 81 years. The median number of prescribed medications was 10 and 36.8% of older adults had STOPP recommendations. When contacted (n = 35), of those enrolled in the follow‐up study, 71% had stated their medications changed, 40% reported all STOPP medications had ceased, and 69% had START medications commenced, suggesting the recommendations provided were clinically appropriate and readily accepted by their GPs.ConclusionIntegration of a geriatric pharmacist demonstrated ample opportunities to address PIP in targeted older adults presenting to ED. This study shows that the pharmacist was able to promote appropriate prescribing through patient education and recommendations communicated to the GP on discharge.

Clinical practice guideline adherence in oncology: A qualitative study of insights from clinicians in Australia.

The burden of cancer is large in Australia, and rates of cancer Clinical Practice Guideline (CPG) adherence is suboptimal across various cancers. The objective of this study is to characterise clinician-perceived barriers and facilitators to cancer CPG adherence in Australia. Semi-structured interviews were conducted to collect data from 33 oncology-focused clinicians (surgeons, radiation oncologists, medical oncologists and haematologists). Clinicians were recruited in 2019 and 2020 through purposive and snowball sampling from 7 hospitals across Sydney, Australia, and interviewed either face-to-face in hospitals or by phone. Audio recordings were transcribed verbatim, and qualitative thematic analysis of the interview data was undertaken. Human research ethics committee approval and governance approval was granted (2019/ETH11722, #52019568810127). Five broad themes and subthemes of key barriers and facilitators to cancer treatment CPG adherence were identified: Theme 1: CPG content; Theme 2: Individual clinician and patient factors; Theme 3: Access to, awareness of and availability of CPGs; Theme 4: Organisational and cultural factors; and Theme 5: Development and implementation factors. The most frequently reported barriers to adherence were CPGs not catering for patient complexities, being slow to be updated, patient treatment preferences, geographical challenges for patients who travel large distances to access cancer services and limited funding of CPG recommended drugs. The most frequently reported facilitators to adherence were easy accessibility, peer review, multidisciplinary engagement or MDT attendance, and transparent CPG development by trusted, multidisciplinary experts. CPGs provide a reassuring framework for clinicians to check their treatment plans against. Clinicians want cancer CPGs to be frequently updated utilising a wiki-like process, and easily accessible online via a comprehensive database, coordinated by a well-trusted development body. Future implementation strategies of cancer CPGs in Australia should be tailored to consider these context-specific barriers and facilitators, taking into account both the content of CPGs and the communication of that content. The establishment of a centralised, comprehensive, online database, with living wiki-style cancer CPGs, coordinated by a well-funded development body, along with incorporation of recommendations into point-of-care decision support would potentially address many of the issues identified.

Progressive resistance training in young people with Prader-Willi syndrome: protocol for a randomised trial (PRESTO)

IntroductionPreliminary evidence suggests that progressive resistance training may be beneficial for people with Prader-Willi Syndrome (PWS), a rare genetic condition that results in muscle weakness and low muscle tone.To establish...

Subgroup effects of non-surgical and non-pharmacological treatment of patients with hand osteoarthritis: a protocol for an individual patient data meta-analysis

IntroductionHand osteoarthritis (OA) is a common joint disorder in the adult population. No cure for hand OA is known yet, but treatment aims to reduce symptoms. Non-surgical and non-pharmacological therapy...

Effectiveness–implementation hybrid type 2 study evaluating an intervention to support ‘information work’ in dementia care: an implementation study protocol

IntroductionPatients with long-term conditions consistently report a lack of information around services and support available to them. This unmet need for information is significant among people with dementia and family...

Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa

IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An ‘underfeeding syndrome’ can...

Ethical and research governance approval across Europe: Experiences from three European palliative care studies

Background: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products. Aim: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. Design: An online survey analysed using descriptive statistics. Setting/participants: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. Results: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. Conclusion: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations.

Challenges in obtaining research ethics and governance approvals for an Australian national intersector, multisite audit study.

Objective The aim of this study was to describe timelines and challenges encountered in obtaining ethics and governance approvals for an Australian multicentre audit study involving 100 public (n=22) and private (n=78) sites from three health sectors and all eight Australian states and territories. Methods We determined and compared the processes, documentation and number of business days required to prepare applications and obtain research ethics and governance approvals. Results In total, the full ethics and governance process (calculated from the date the first application was started to the date the final approval was granted) took 203 business days (79% of the study timeline). Standard risk ethics applications (n=4) took a median of 17 business days (range 3-35 days) to prepare and 32 business days (range 17-67 days) to be approved; expedited ethics applications (n=4) took a median of 5 business days (range 1-20 days) to prepare and 10 business days (range 1-44 days) to be approved. Governance approvals (n=23) took a median of 27 business days (range 4-63 days) to prepare and 20 business days (range 4-61 days) to be approved. Challenges included the lack of a nationwide single-site ethical review process, the extensive time required to duplicate content across applications, variability in application requirements and submission systems, and contract negotiations. Conclusion Further improvements are needed to reduce duplication and increase the efficiency of Australian ethics and governance review processes. What is known about the topic? The process for obtaining ethics approval for multicentre research has been streamlined through the introduction of single-site ethics review. However, the process of gaining ethics and governance approvals for national multicentre research continues to be time-consuming, resource-intensive and duplicative. What does this paper add? This is the first study to examine the challenges of obtaining ethics and governance approvals for a non-interventional multicentre study involving three health sectors (hospital, aged care, general practice), both private and public services and all eight Australian jurisdictions. Previous examinations of Australian multicentre studies have considered only one health sector, focused on the public system and/or were not national in scope. What are the implications for practitioners? Researchers and funders need to be aware of the considerable time, resources and costs involved in gaining research ethics and governance approvals for multicentre studies and include this in budgets and study timelines. Policy makers and administrators of ethics and governance review processes must address barriers to conducting multicentre research in Australia.

Challenges in Obtaining Research Ethics and Governance Approvals for an Australian National Intersector, Multisite Audit Study

Objective: To describe timelines and challenges encountered in obtaining ethics and governance approvals for an Australian multi-centre audit study involving 100 public (n=22) and private (n=78) sites from three health sectors and all eight Australian states and territories. Methods: We determined and compared the processes, documentation and number of business days required to prepare applications and obtain research ethics and governance approvals. Results: In total, the full ethics and governance process (calculated from the date the first application was started to the date the final approval was granted) took 203 business days (79% of the study timeline). Standard risk ethics applications (n=4) took a median of 17 business days (range 3-35) to prepare and 32 business days (range 17-67) to be approved; expedited ethics applications (n=4) a median of 5 business days (range 1-20) to prepare and 10 business days (range 1-44) to be approved. Governance approvals (n=23) took a median of 27 business days (range 4-63) to prepare and 20 business days (range 4-61) to be approved. Challenges included the lack of a nationwide single-site ethical review process, the extensive time required to duplicate content across applications, variability in application requirements and submission systems, and contract negotiations. Conclusion: Further improvements are needed to reduce duplication and increase the efficiency of Australian ethics and governance review processes.

Research approvals iceberg: how a \u2018low-key\u2019 study in England needed 89 professionals to approve it and how we can do better

BackgroundThe red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change.Main textWe have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies.ConclusionEthics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

Video clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: study protocol for a pragmatic randomised evaluation of myVideoClinic

BackgroundVideo clinics, where patients can have a hospital appointment with their clinician from home, are emerging in practice, but their effectiveness is unclear. This study will evaluate whether a video clinic implemented at the University Hospitals Birmingham (UHB) NHS Foundation Trust improves patient satisfaction compared to standard face-to-face appointments for liver transplant patients.MethodsThis will be a parallel, two-arm, statistician-blinded, randomised evaluation. Clinically stable liver patients at 1 to 5 years post-transplant (n = 180) will be randomised in equal numbers to video clinic appointments (intervention) or standard face-to-face appointments (control). The intervention group will have outpatient appointments from home via a secure video link accessed through the UHB patient portal. All patients will complete baseline questionnaires before randomisation and electronic follow-up questionnaires after each follow-up appointment during the subsequent 12 months. The primary outcome is the difference in scores between groups for three domains of patient satisfaction, namely ‘convenience of location’, ‘getting through to the office by phone’ and ‘length of time waiting’ (modified Visit-Specific Satisfaction Instrument). Secondary outcomes include quality of life (EQ-5D-5 L), costs, clinical contacts and user experience. Statistical analysis will be descriptive and performed on an intention-to-treat basis. The primary outcome will be analysed using baseline and 3-, 6-, 9- and 12-month questionnaires (according to patient follow-up appointment frequency) and comparisons made between study arms. A within-trial cost consequences analysis will be undertaken on the economic data. Patients (n = 8), carers/family members (n = 6) and health professionals (n = 14) will be interviewed about the experience of video clinics and the interviews will be analysed using thematic analysis.DiscussionThis study will allow an in depth understanding of whether video clinics can improve patient satisfaction with their care. In addition, the intervention could save patients time and costs, removing the need to travel long distances for outpatient appointments. Video clinics may be applicable to a wide range of other clinical settings and health conditions. The study has been approved by the NHS Health Research Authority and a National Research Ethics Committee (Ref: 17/WM/0338) and research governance approval has been obtained from UHB (Ref: RRK6080).Trial registrationISRCTN: 14093266 (25/03/2018; retrospectively registered).

The PodPAD project: a podiatry-led integrated pathway for people with peripheral arterial disease in the UK \u2013 a pilot study

BackgroundPeripheral arterial disease affects the lower limb and is associated with diabetes, high cholesterol, smoking and obesity. It increases the risk of cardiovascular morbidity and mortality. It can be symptomatic causing intermittent claudication, but often there are few clinical signs. Podiatrists are able to detect the presence of peripheral arterial disease as part of their lower limb assessment and are well placed to give advice on lifestyle changes to help reduce disease progression. This is important to improve health outcomes and is offered as a prevention/public health intervention.MethodWe describe the clinical and patient-centred outcomes of patients attending a podiatry-led integrated care pathway in a multi-use clinic situated in a venue supported by the National Centre for Sports and Exercise Medicine in the UK. At the baseline appointment, patients were given a full assessment where symptoms of intermittent claudication using the Edinburgh Intermittent Claudication Questionnaire, foot pulses, Doppler sounds, Ankle Brachial Pressure Indices, glycated haemoglobin (HbA1c) and cholesterol levels, and smoking status were recorded. A tailored treatment plan was devised, including referral to an exercise referral service, smoking cessation programmes (if applicable) and each participant was also seen by a dietician for nutritional advice. Participants were followed up at 3 and 6 months to assess any improvement in vascular status and with each completing the EQ-5D quality of life questionnaire and a simple satisfaction questionnaire at the end of the study. As this was a complex intervention a pilot study design was adopted to evaluate if the method and outcomes were suitable and acceptable to participants the results of which will then inform the design of a larger study.ResultsData was collected on 21 individuals; 15 men (71.4%) and 6 women (28.6%) across the 6-month study period. Eleven participants were referred onto the exercise referral service; 16 participants saw the dietician for nutritional advice at baseline and had one-to-one or telephone follow-up at 3 months. Five out of 14 participants had reduced scores from baseline of intermittent claudication during the study period. No evidence for substantive changes in Doppler sounds or ABPI measurements was revealed. Quality of life scores with the EQ-5D improved in 15 participants; this was statistically significant (p = 0.007) with 14 participants who completed the simple satisfaction questionnaire expressing a positive view of the programme. Of the four people who were smokers, two stopped smoking cigarettes and moved to e-cigarettes as part of smoking cessation advice.ConclusionAs this was a pilot study the sample size was low, but some statistically significant improvements with some measures were observed over the 6-month study. Podiatrists are able to provide a comprehensive vascular assessment of the lower limb and accompanying tailored advice on lifestyle changes including smoking cessation and exercise. Locating clinics in National Centres for Sports and Exercise Medicine enables easy access to exercise facilities to encourage the adoption of increased activity levels, though the long term sustainability of exercise programmes still requires evaluation.This study was reviewed and approved by London Brent Ethics Committee IRAS ID 204611 and received research governance approval from the sponsor, Sheffield Teaching Hospitals NHS Foundation Trust Research and Innovation Office STH19410.

Protocol: A grounded theory of ‘recovery’—perspectives of adolescent users of mental health services

IntroductionPolicies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental...

Patient-level data linkage across ambulance services and acute trusts: assessing the potential for improving patient care

ABSTRACT
 ObjectivesThe potential of linked healthcare data to support improvements to the care quality, efficiency and service planning is recognised by the Department of Health and NHS England. UK ambulance services however, have little information regarding the outcome of patients as there is no routine data sharing. An urban ambulance service has previously piloted linked data with one acute trust. The Pre-Hospital Emergency Department Data Linking Project (PHED Data) aims to assess the potential opportunities for and challenges to routinely linking data for several sites. It aims to define what indicator sets can be developed from these linked data, with a view to informing commissioning and improvement of healthcare delivery.
 ApproachThe project is a two-year mixed-methods observational study, funded by the Health Foundation, working with six acute trusts of various size and CQC-derived performance, to carry out six work packages.
 Work package one uses liaison activities with trust senior staff to negotiate information sharing agreements, and a learning log to enable an economic assessment of the set-up costs.
 Work packages two to five analyse ambulance response time, referrals from healthcare professionals, ED mortality, and frequent ED diagnoses, respectively, exploring relationships with ED outcomes, quantitatively. Qualitative analysis will explore, with staff groups, how the findings might influence commissioning and pre-hospital care.
 Work package six will examine commissioning decisions and patient care, through interviews with commissioners and performance managers.
 ResultsIn work package one, we have successfully negotiated overall research ethics and governance approval, involving in-depth discussion about definitions of identifiable patient data, and protecting against potential re-identification. We have recruited six acute trusts, comprising 13 hospital sites, for whom equivalent data is available. We have been working for six months in liaison with these Trusts to deliver information sharing agreements (three are currently approved) and data transfer, working with research governance, information governance and clinical staff. The processes have varied, with intra-Trust co-dependencies introducing delays and non-linear processes being common.
 For work packages two to five, some data analysis will be available for presentation at the conference.
 ConclusionThis project has the potential to shed light on the practicalities of data linkage for health service providers who face similar challenges with patient data held in multiple organisations.
 The study also anticipates being able to recommend quality improvement to support the development of new pathways in pre-hospital care.

Supporting activity engagement by family carers at home: maintenance of agency and personhood in dementia

ABSTRACTAn explorative paper to describe how family carers, through the caregiving journey, reaffirm and promote the agency of people with dementia. Agency is an important concept in dementia care and is crucial to the promotion of wellbeing and the delivery of person-centred care. This article is based on one of the key findings of a study that explored family carers’ experiences of engaging their relatives in daily activities in domestic settings. Following research governance and ethical approval, 30 in-depth interviews (initial and follow-up) were carried out with 15 resident-carers of people with dementia who were recruited via local community mental health teams. Then five focus groups were conducted with 21 participants accessed through carers support groups. Interviews and focus groups were transcribed, coded and analysed using a grounded theory method. Findings showed the process in which family carers encouraged and sustained a sense of autonomy and control (agency) in their relative’s daily activities. Key strategies used by carers included: being non-judgemental; facilitating a sense of worth; taking calculated risks; maintaining the continuity of their relative’s identity; enhancing a sense of connection with their relative’s role and identity using enjoyable activities; preventing inactivity and attending to the bodily source of the agency. Lack of support for carers could ultimately pose a risk to the maintenance of the agency of people with dementia. This study provides a deeper insight into the process used by home carers to support the agency of people with dementia. This is essential if practitioners are to identify and develop more realistic intervention strategies and to work in effective partnership with family carers. The implications for the creation of dementia-friendly communities are discussed.

Understanding and evaluating the effects of implementing an electronic paediatric prescribing system on care provision and hospital work in paediatric hospital ward settings: a qualitatively driven mixed-method study protocol

IntroductionElectronic prescribing systems can improve the quality and safety of healthcare services, but their implementation is not straightforward and may create unexpected change. However, the added complexity of paediatric prescribing...

Planning a research project.

The planning stage of any research project is one of the most important stages in the research process. This article offers insight into the important issues a researcher needs to consider when planning his or her research, including how to develop a research protocol, obtaining research funding, seeking academic, peer and social support, gaining research ethics and governance approval and planning a research schedule. Careful planning ensures that the research project is achievable and can be completed on time, with the funding available.

Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

BackgroundThere is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD).MethodsTwo trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis.ResultsWe obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration.ConclusionsCluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for research governance approval and intervention implementation. Pretrial data analyses should inform trial design and analysis plans.Trial registrationCurrent Controlled Trials ISRCTN 47558792 and ISRCTN 35701810 (both registered on 17 March 2010).

G430(P) Research and development approval timelines for an NIHR portfolio adopted multicentre observational study in England and Wales

Over the last 15 years the processes for obtaining research and development (R&D) approval for conducting multicentre medical research in England have undergone some changes. The introduction of participant identification...