Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study

ABSTRACTObjective: to know the nursing care to the patients with death encephalic, potential donors of multiples organs. Methods: this is a descriptive study, from qualitative approach, performed in a hospital of reference in Urgency and Emergency from Goiás state. Data were collected in September 2008, by means interviews semi-structured with 34 employees from nursing team. Data have been analyzed according to Bardin’s methodology. The study was approved by the Research Ethics Committee of the Hospital de Urgências de Goiânia (protocol number 027/08). Results: the survey showed that the majority from the interviewers no has knowledge on the death encephalic physiopathology. The cautions about they perform in most from the turns do not have difference regarding to another patients, the furtherance isn't optimize should and sometimes occur negligent into the care. Another factors influence into the care: lack of working conditions and education continued one’s. The majority from the interviewers care with a thought of humanizing, but does not appear compromised with the possibility of donation. Conclusion: the nursing team is critical to servicing and maintenance of the potential donor. Therefore, it’s necessary to direct more attention to the care, increasing the chances of success in transplantation. Descriptors: death encephalic; cautions of sicken; donation of organs. RESUMO Objetivo: conhecer a assistência de enfermagem a pacientes em morte encefálica, potenciais doadores de múltiplos órgãos. Métodos: estudo descritivo de abordagem qualitativa, realizado em um hospital referência em atendimento de Urgência e Emergência em uma cidade de Goiás. Os dados foram coletados em setembro de 2008, por meio de entrevistas semi-estruturadas com 34 funcionários da equipe de enfermagem, que se adequaram nos critérios de inclusão. Os dados foram analisados de acordo com Bardin. O projeto de pesquisa foi aprovado pelo Comitê de Ética do Hospital de Urgências de Goiânia (número de protocolo 027/08). Resultados: o estudo mostrou que a maioria dos entrevistados não possui conhecimento sobre a fisiopatologia da morte encefálica. Os cuidados que realizam, na maioria das vezes, não tem diferença quanto a outros pacientes. A assistência não é otimizada como deveria, e, por vezes, ocorre negligência no cuidado. Outros fatores influenciam no cuidado como: falta de condições de trabalho e educação continuada. A maioria dos entrevistados cuida com um pensamento de humanização, mas não se mostra comprometida com a possibilidade de doação. Conclusão: a equipe de enfermagem é fundamental para assistência e manutenção do potencial doador. Portanto, há necessidade de voltar uma atenção maior para o cuidado, aumentando as chances e sucesso nos transplantes. Descritores: morte encefálica; cuidados de enfermagem; doação de órgãos. RESUMEN Objetivo: conocer los cuidados de enfermería a los pacientes en muerte cerebral, potenciales donantes de órganos múltiples. Métodos: estudio descriptivo de enfoque cualitativo, realizado en un hospital de referencia en situaciones de emergencia y atención de emergencia en una ciudad de Goiás. Los datos fueron recolectados en septiembre de 2008, con entrevistas semi-estructuradas con 34 funcionarios del equipo de enfermería, que adapten los criterios de inclusión. Los datos fueron analizados de acordo con Bardin. El estudio fue aprobado por el Comité de Ética del Hospital de Urgências de Goiânia (número de registro 027/08). Resultados: el estudio demostró que la mayoría de los encuestados no tienen conocimiento sobre la fisiopatología de la muerte cerebral. El cuidado que realizan la mayor parte del tiempo no se diferencia de otros pacientes, la asistencia no es como debería ser optimizado y, a veces, se produce el abandono en la atención. Otros factores que influyen en la atención como: la falta de condiciones de trabajo y la educación continua. La mayoria Los correspondientes se ocupó con humanization pensar, pero no compromete a mostrar la posibilidad de la donación. Conclusión: el equipo de enfermería es esencial para el cuidado y mantenimiento de potenciales donantes, por eso que no necesita devolver una mayor atención a la atención y aumentar las posibilidades de éxito del trasplante. Descriptores: muerte cerebral; cuidado de enfermería; donación de órganos.

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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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264621992214 ◽

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.

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

BMJ Open ◽

10.1136/bmjopen-2020-044628 ◽

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.

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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 ◽

10.1136/bmjopen-2020-041695 ◽

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.

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

Ethics & Human Research ◽

10.1002/eahr.500104 ◽

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

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

BMJ Open ◽

10.1136/bmjopen-2020-048395 ◽

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.

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