scholarly journals A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

2021 ◽  
Vol 43 (5) ◽  
pp. 42-44
Author(s):  
Leonardo Tamariz ◽  
Fred J. Hendler ◽  
John M. Wells ◽  
Annette Anderson ◽  
Stephen Bartlett
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

scholarly journals Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  
Keyword(s):  
At Risk ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
National Implementation ◽  
General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

scholarly journals Implementation of the StandingTall programme to prevent falls in older people: a process evaluation protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e048395
Author(s):  
Morag E Taylor ◽  
Chris Todd ◽  
Sandra O'Rourke ◽  
Lindy M Clemson ◽  
Jacqueline CT Close ◽  
...  
Keyword(s):  
Older People ◽  
Research Ethics ◽  
Process Evaluation ◽  
Ethics Committee ◽  
Community Dwelling ◽  
Innovative Technology ◽  
Local Health ◽  
Research Ethics Committee ◽  
Personal Impact ◽  
The Uk

IntroductionOne in three people aged 65 years and over fall each year. The health, economic and personal impact of falls will grow substantially in the coming years due to population ageing. Developing and implementing cost-effective strategies to prevent falls and mobility problems among older people is therefore an urgent public health challenge. StandingTall is a low-cost, unsupervised, home-based balance exercise programme delivered through a computer or tablet. StandingTall has a simple user-interface that incorporates physical and behavioural elements designed to promote compliance. A large randomised controlled trial in 503 community-dwelling older people has shown that StandingTall is safe, has high adherence rates and is effective in improving balance and reducing falls. The current project targets a major need for older people and will address the final steps needed to scale this innovative technology for widespread use by older people across Australia and internationally.Methods and analysisThis project will endeavour to recruit 300 participants across three sites in Australia and 100 participants in the UK. The aim of the study is to evaluate the implementation of StandingTall into the community and health service settings in Australia and the UK. The nested process evaluation will use both quantitative and qualitative methods to explore uptake and acceptability of the StandingTall programme and associated resources. The primary outcome is participant adherence to the StandingTall programme over 6 months.Ethics and disseminationEthical approval has been obtained from the South East Sydney Local Health District Human Research Ethics Committee (HREC reference 18/288) in Australia and the North West- Greater Manchester South Research Ethics Committee (IRAS ID: 268954) in the UK. Dissemination will be via publications, conferences, newsletter articles, social media, talks to clinicians and consumers and meetings with health departments/managers.Trial registration numberACTRN12619001329156.

Research ethics committee approval as reported for abstracts submitted to the annual Euroanaesthesia meeting

2017 ◽  
Vol 34 (12) ◽  
pp. 824-830 ◽  
Author(s):  
Paul McConnell ◽  
Nechama Kaufman ◽  
Stefan De Hert ◽  
Charles Marc Samama ◽  
Zsolt Molnar ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

scholarly journals Better evidence for earlier assessment and surgical intervention for refractory epilepsy (The BEST study): a mixed methods study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017148 ◽  
Author(s):  
Frances Rapport ◽  
Patti Shih ◽  
Rebecca Mitchell ◽  
Armin Nikpour ◽  
Andrew Bleasel ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Health Services ◽  
Research Ethics ◽  
Surgical Intervention ◽  
Refractory Epilepsy ◽  
Ethics Committee ◽  
Local Health ◽  
Health Services Use ◽  
Research Ethics Committee ◽  
Resective Surgery

IntroductionOne-third of patients with refractory epilepsy may be candidates for resective surgery, which can lead to positive clinical outcomes if efficiently managed. In Australia, there is currently between a 6-month and 2-year delay for patients who are candidates for respective epilepsy surgery from the point of referral for surgical assessment to the eventual surgical intervention. This is a major challenge for implementation of effective treatment for individuals who could potentially benefit from surgery. This study examines implications of delays following the point of eligibility for surgery, in the assessment and treatment of patients, and the factors causing treatment delays.Methods and analysisMixed methods design: Observations of qualitative consultations, patient and healthcare professional interviews, and health-related quality of life assessments for a group of 10 patients and six healthcare professionals (group 1); quantitative retrospective medical records’ reviews examining longitudinal outcomes for 50 patients assessed for, or undergoing, resective surgery between 2014 and 2016 (group 2); retrospective epidemiological study of all individuals hospitalised with a diagnosis of epilepsy in New South Wales (NSW) in the last 5 years (2012–2016; approximately 11 000 hospitalisations per year, total 55 000), examining health services’ use and treatment for individuals with epilepsy, including refractory surgery outcomes (group 3).Ethics and disseminationEthical approval has been granted by the North Sydney Local Health District Human Research Ethics Committee (HREC/17/HAWKE/22) and the NSW Population & Health Services Research Ethics Committee (HREC/16/CIPHS/1). Results will be disseminated through publications, reports and conference presentations to patients and families, health professionals and researchers.

scholarly journals Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial

10.2196/18690 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18690 ◽  
Author(s):  
Lauren Bell ◽  
Claire Garnett ◽  
Tianchen Qian ◽  
Olga Perski ◽  
Henry W W Potts ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Behavior Change ◽  
Randomized Trial ◽  
Research Ethics ◽  
Adult Population ◽  
Ethics Committee ◽  
Perceived Usefulness ◽  
Self Report ◽  
London School ◽  
Research Ethics Committee

Background Drink Less is a behavior change app that aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11 am, asking users to “Please complete your mood and drinking diaries.” Previous analysis of Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour. To exploit a potential increase of vulnerability of excess drinking and opportunity to engage with the app in the evenings, we changed the delivery time from 11 am to 8 pm. We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user’s perceived usefulness of the app. Objective The primary objective is to assess whether sending a notification at 8 pm increases behavioral engagement (opening the app) in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth, and frequency of engagement with Drink Less over the first 30 days after download. Methods This is a protocol for a micro-randomized trial with two additional parallel arms. Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol. In the micro-randomized trial, participants will be randomized daily at 8 pm to receive no notification, a notification with text from the new message bank, or the standard message. The primary outcome is the time-varying, binary outcome of “Did the user open the app in the hour from 8 pm to 9 pm?”. The primary analysis will estimate the marginal relative risk for the notifications using an estimator developed for micro-randomized trials with binary outcomes. Participants randomized to the parallel arms will receive no notifications (Secondary Arm A), or the standard notification delivered daily at 11 am (Secondary Arm B) over 30 days, allowing the comparison of overall engagement between different notification delivery strategies. Results Approval was granted by the University College of London’s Departmental Research Ethics Committee (CEHP/2016/556) on October 11, 2019, and The London School of Hygiene and Tropical Medicine Interventions Research Ethics Committee (17929) on November 27, 2019. Recruitment began on January 2, 2020, and is ongoing. Conclusions Understanding how push notifications may impact engagement with a behavior change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalizable to other apps that target a variety of behavior changes. International Registered Report Identifier (IRRID) DERR1-10.2196/18690

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