human research ethics
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Author(s):  
Katherine Christian ◽  
Carolyn Johnstone ◽  
Jo-ann Larkins ◽  
Wendy Wright

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.


BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053646
Author(s):  
Carly R Luke ◽  
Katherine Benfer ◽  
Leeann Mick-Ramsamy ◽  
Robert S Ware ◽  
Natasha Reid ◽  
...  

IntroductionNeurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are ‘at risk’ of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants ‘at risk’ of a later diagnosis of adverse NDO or NDD will be determined.Methods and analysisAboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020–2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or ‘at risk’ of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.Ethics and disseminationEthics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children’s Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12619000969167.


2021 ◽  
Author(s):  
Adriaan Erasmus ◽  
Michael Melek ◽  
Malia Ho

Abstract Background Diabetic peripheral neuropathy is a common complication of diabetes mellitus. Neuropathy predisposes patients to diabetic foot ulcers (DFU) due to the loss of protective sensation and associated deformities. Management of foot ulcers are multifactorial, but pressure offloading can be considered as one of the most important aspects of management. According to IWGDF Guidelines, non-removable knee-high offloading devices are recommended as the 1st line of treatment for these ulcers. However, this is a very underutilised treatment modality. This study aimed to evaluate the practitioner preferred offloading modalities and reasons for their preference. Methods This project was approved by the university’s human research ethics committee. An online survey was distributed amongst Australian podiatrist via an industry related social media group. The survey collected simple demographical information, management strategies, preferred offloading modalities for the management of diabetic foot ulcers and reasons for their preferred method. Results Sixty-three podiatrists completed the survey with the majority practicing in private clinics. All practitioners treat diabetic foot ulcers regularly with most participants treating up to ten ulcer cases per week and 14% of participants treating more than 20 ulcers per week. Contrary to the IWGDF guidelines, standard therapeutic footwear was the most preferred method of management for the treatment of diabetic foot ulcers, with ease of use reported as the main reason for practitioners using this modality. Non-compliance to the use of non-removable knee-high offloading devices include perceived patient non-compliance and poor tolerance. Conclusion This study shows that practitioners’ offloading strategies do not adhere to the IWGDF guidelines. The reasons for not adhering to the guidelines seems to be a clinical practicality rather than evidence-based practice. Reasons for choosing a management strategy is multi-factorial (not just reducing plantar pressures). Further studies may be required to evaluate the effectiveness of therapeutic footwear in ulcer healing, taking into consideration other factors such as practitioner and patient preference, clinical practicality, and access to support. Based on the findings, this study provides suggestions on how to overcome the barriers that prevent podiatrist from adhering to the recommendations of the IWGDF when selecting offloading devices in general clinical practice.


2021 ◽  
Vol 1 (3) ◽  
pp. 220-227
Author(s):  
Ericka N. L’Abbé ◽  
Gabriele C. Krüger ◽  
Charlotte E. G. Theye ◽  
Alieske C. Hagg ◽  
Okuhle Sapo

The Pretoria Bone Collection (PBC) began in 1942 with the opening of a medical school at the University of Pretoria (UP) in Pretoria, South Africa, where this skeletal collection is housed in the Department of Anatomy. The purpose of this paper is to provide information on the national legislation associated with obtaining, curating and researching skeletal remains in South Africa, the demographic composition of the PBC, and the inclusion of a portion of these remains into a digital repository known as Bakeng se Afrika (BsA). The PBC comprises 873 complete skeletons, 344 complete postcrania without crania, and 308 complete crania without postcrania. Skeletal contents are reflective of the population statistics of South Africa, with a smaller proportion of White (32%) than Black (65%) South Africans. Unlike the population profile, males in the PBC are greater in number (75.5%) than females (24.5%), which may be explained by the number of migrant labourers traveling into a large city such as Pretoria. From this sample, crania (206), maxillae (141), mandibulae (408), femora (137), and radii (134), as well as several other skeletal elements were micro-XCT scanned and are available on the BsA server. A researcher needs to submit an online application to the Human Research Ethics Committee (HREC) of the Faculty of Health Sciences at the University of Pretoria for access to these collections.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e057021
Author(s):  
Claudia Ortoleva Bucher ◽  
Philippe Delmas ◽  
Annie Oulevey Bachmann ◽  
Ingrid Gilles

IntroductionThe COVID-19 pandemic was making a huge impact on Europe’s healthcare systems in the spring of 2020, and most predictive models concurred that pandemic waves were in the offing. Most studies adopted a pathogenic approach to the subject; few used a salutogenic approach. These showed, however, that nurses can retain their health despite a pandemic by mobilising generalised resistance resources. Our study aims to understand how nurses working in Switzerland’s hospitals protected their health and workplace well-being during the COVID-19 pandemic by investigating the moderating effects of the health resources they mobilised against the stressors inherent to the situation. The study aims to explore and describe the stressors and the resources nurses used to remain healthy during the COVID-19 pandemic.Method and analysisWe will use a concurrent mixed-methods panel design with qualitative analyses ancillary to quantitative analyses. Quantitative data will be collected using electronic questionnaires at four time points over 2 years. Qualitative data will be collected using focus groups. Nurses from Switzerland’s two main linguistic regions who had direct, indirect or no contact with patients with COVID-19 will be invited to participate. The a priori sample size will be at least 3631 participants at T0 and 1852 at T4. Longitudinal structural equation modelling and knowledge mapping will be used to analyse quantitative and qualitative data, respectively. The results derived from the two data types will then be compared and discussed using a side-by-side approach to determine whether they agree or disagree and how they complement each other to achieve our aims.Ethics and disseminationNurses will receive an electronic informed consent form. The data collected will be stored on a secure server at the authors’ institution. This research project was approved by the Human Research Ethics Committee of the Canton of Vaud (2020-02845).


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e049007
Author(s):  
Julie M Marchant ◽  
Anne B Chang ◽  
Kobi L Schutz ◽  
Lesley Versteegh ◽  
Anne Cook ◽  
...  

IntroductionBronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact on caregivers, especially during acute respiratory exacerbations. In other chronic respiratory diseases (eg, asthma), empowering consumers with an individualised plan for management of acute exacerbations improves clinical outcomes. However, in the absence of any such data specific to bronchiectasis, action management plans are rarely currently used in children or adults with bronchiectasis. We hypothesise that providing an individualised bronchiectasis action management plan (BAMP) to children with bronchiectasis reduces non-scheduled doctor consultations, compared with not having a BAMP.Methods and analysisThis multicentre, parallel, double-blind, randomised trial involving three urban Australian hospitals commenced in June 2018 and will include 198 children, aged <19 years with bronchiectasis who had 2 or more exacerbations in the previous 18 months. Children will be randomised to having an individualised BAMP or standard care (a decoy clinic letter). Primary caregivers will then be followed up monthly for 12 months. The primary outcome is the rate of acute non-scheduled doctor visits for respiratory exacerbations by 12 months. The main secondary outcomes are cough-specific quality of life scores at 6 and 12 months, overall exacerbation rate over 12 months, and proportion of children who received timely influenza vaccination by 30 May annually.Ethics and disseminationThe Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Heath Research and Queensland Children’s Hospital approved the study. The results of the trial will be submitted for publication and the BAMP made available free online.Trial registration numberAustralia and New Zealand Clinical Trials Register ACTRN12618000604202.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e049976
Author(s):  
Matthew P Simunovic ◽  
Emily H Shao ◽  
Perach Osaadon ◽  
Muhammad Bayu Sasongko ◽  
Lay Khoon Too

IntroductionThere is increasing interest in subretinal injections as a surgical procedure, largely as a result of emerging treatments for ocular diseases which necessitate this manoeuvre. However, surgical variables in the efficacy of such treatments have to date been largely overlooked and the proportion of drug which reaches the intended compartment of the subretinal space remains unknown. Our aims are twofold: first, to determine the proportion of subretinally injected medication retained following surgical delivery and second, to compare two different techniques of injection (‘1-step’ vs ‘2-step’).MethodsWe outline a randomised controlled trial of subretinal injection of alteplase following vitrectomy for the management of submacular haemorrhage secondary to age-related macular degeneration. Patients will be randomised to receive either 1-step injection, where the therapeutic solution simultaneously defines the surgical plane or 2-step injection, where the surgical plane is first identified with balanced salt solution prior to injection of subretinal alteplase, as outlined below. Sodium fluorescein will be used as an optical label to track drug reflux into the vitreous cavity using quantitative protocols established in our laboratory. All patients will undergo fluid air exchange at the completion of surgery, with injection of bevacizumab 1.25 mg and 20% sulfahexafluoride gas as the vitreous substitute (both of which may help improve outcomes). Alteplase, sodium fluorescein and bevacizumab will all be used for off-label indications in the trial.Ethics and disseminationEthical approval has been obtained from the South Eastern Sydney Local Health District’s Human Research Ethics Committee (HREC 17/092). The results of this trial will be disseminated in peer-reviewed proceedings (associated with conference presentation) and in scholarly journals.Trial registration numberACTRN12619001121156.


2021 ◽  
Vol 91 (11) ◽  
pp. 2545-2545
Author(s):  
Guy Henry Morton Stanley ◽  
Ryckie George Wade ◽  
Sara Potts ◽  
Nichola Wilson ◽  
Michael Findlay

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047887
Author(s):  
Kim A Vuong ◽  
Silvia Manzanero ◽  
Jacobus P J Ungerer ◽  
Gary Mitchell ◽  
Brett McWhinney ◽  
...  

IntroductionAlcohol use in patients presenting to the emergency department (ED) is a significant problem in many countries. There is a need for valid and reliable surveillance of the prevalence of alcohol use in patients presenting to the ED, to provide a more complete picture of the risk factors and inform targeted public health interventions. This PACE study will use two biomarkers, blood ethanol and phosphatidylethanol (PEth), to determine the patterns, presence and level of alcohol use in patients presenting to an Australian ED.Methods and analysisThis is an observational prevalence study involving the secondary use of routinely collected blood samples from patients presenting to the Royal Brisbane and Women’s Hospital (RBWH) Emergency and Trauma Centre (ETC). Samples will be tested for acute and medium-term alcohol intake using the two biomarkers blood ethanol and PEth respectively, over one collection period of 10–12 days. Descriptive statistics such as frequencies, percentages, means, SD, medians and IQRs, will be used to describe the prevalence, pattern and distribution of acute and medium-term alcohol intake in the study sample. The correlation between acute and medium-term alcohol intake levels will also be examined.Ethics and disseminationThis study has been approved by the RBWH Human Research Ethics Committee (reference, LNR/2019/QRBW/56859). Findings will be disseminated to key stakeholders such as RBWH ETC, Australasian College for Emergency Medicine, Royal Australasian College of Surgeons, Statewide Clinical Networks, and used to inform clinicians and hospital services. Findings will be submitted for publication in peer-reviewed journals and presentation at appropriate conferences.


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_5) ◽  
Author(s):  
Michael J Harrison ◽  
Nicola Brice ◽  
Waheba Slamang ◽  
Kate Webb ◽  
Christiaan Scott

Abstract Background Advanced HIV infection is associated with an inflammatory arthritis, however few reports have described this disorder in children. This study aimed to describe the clinical features of HIV arthropathy in a case series of children in South Africa and compare these with features of JIA. Methods Retrospective data were collected from HIV-infected children with HIV arthropathy enrolled in a Paediatric Rheumatology clinic in Cape Town, South Africa. Data from a recently described, published cohort of children with JIA enrolled in the same clinic were included for comparison. Ethical approval was granted by the Human Research Ethics Committee of the University of Cape Town, with a waiver for consent. Results Eleven cases of HIV arthropathy were identified. Cases predominantly affected boys (8/11), and the median age of onset was 10.3 years (IQR 6.9–11.6). Most cases presented in the setting of advanced immunosuppression, with a median absolute CD4+ count of 389 cells/uL (IQR 322–449) and median CD4+ proportion of 19.5% (IQR 14.8–25.0) at presentation. The clinical presentation was variable, with both oligoarthritis (6/11) and polyarthritis (5/11) being prevalent. All cases exhibited large joint involvement, which was usually asymmetrical. In addition, four children had asymmetrical small joint involvement. Associated features included enthesitis (4/11) and dactylitis (1/11). The most consistent laboratory feature was elevated acute phase reactants, and typical ultrasonographic findings were joint effusions and synovial hypertrophy. JIA and HIV arthropathy presented at a similar age, with median age at HIV arthritis onset of 10.3 years (IQR 6.9–11.6) versus 9.25 years (IQR 4.5–12.3) at arthritis onset in the JIA subgroup. HIV arthropathy cases were predominantly male (M/F ratio 3.0), whereas JIA cases had an equal sex distribution (M/F ratio 0.9). Oligo-articular disease was more frequently described in children with HIV arthropathy (55%), compared to those with JIA (38%). Conclusion In this series, most cases of HIV arthropathy exhibited asymmetrical large joint oligoarthritis or polyarthritis, and presented in older boys with advanced immunosuppression. HIV arthropathy appears to present at a similar age to JIA, with a comparable pattern of joint involvement to oligo-articular and poly-articular JIA subtypes. 


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