ethics committees
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Animals ◽  
2022 ◽  
Vol 12 (2) ◽  
pp. 190
Jacques Cabaret ◽  
Ludivine Fortin

The attitude towards animals in research depends on both the role of the stakeholder and their personal characteristics. Most studies on the subject have been carried out on stakeholders from biomedical research institutes with comparatively few sociological studies on stakeholders from agricultural research centers. Previous findings suggest that animal caretakers at agricultural research centers felt undervalued by the hierarchy, and that animal reification was present in the sector. This may indicate that a lack of consideration for the animal subjects correlates with an inadequate sensitivity towards humans. Since these findings were published twenty years ago, there has been an increasing emphasis on the importance and actions of ethics committees in research, animal welfare bodies, and public concern for animals, which may have impacted the current perspective. To better understand current degrees of animal reification amongst stakeholders of agricultural research, we conducted semi-directive interviews at a leading agricultural research institute in France (INRAE). The interviews targeted both animal caretakers and researchers who were involved in the study of infectious diseases in livestock, or the behavior of horses and quails. After having transcribed the recorded interviews into text, semi-automatized analyses were carried out to categorize them into distinct groups, from which the most characteristic words and sentences were extracted. Three groups of stakeholders were identified: (i) animal caretakers involved in invasive infectious disease research; (ii) animal caretakers involved in behavioral research; and (iii) researchers. The findings show that animal caretakers felt acknowledged by their hierarchy. It is possible the increased skill criteria for people recruited into this position over the years, combined with greater prospects for continuous learning and development in the profession, may have fostered a more respectful regard across the hierarchy. The animal caretakers clearly expressed that their primary objective was to successfully execute the research protocols and that the animals were viewed as prototypes for research, with which they could, on occasion, develop a bond with. The bond was more important for animal caretakers involved in behavioral studies than for those involved in the study of infectious diseases, where invasive biological sampling and restraining of the animals is required. Researchers prioritized the procurement of robust data to test hypotheses, analyze phenomena, and publish their results. Their concern for the animals rather reflected the views of the general public opposed to thought-out personal opinions on the matter; this is possibly due to their comparatively limited interaction with the animals. They considered the animals in abstract terms that were indicative of reification. This study concludes that animal reification is still present, albeit to varying degrees amongst the stakeholders.

Cao Huanhuan ◽  
Ming Li ◽  
Mingxu Wang ◽  
David Roder ◽  
Ian Olver

 In this paper, the evolution of the ethics committees for health research, their history, membership, and function in China and Australia is described. Investigators in each country compared the history and governance of their ethical systems based on the published evidence rather than personal opinions. Similarly, examples of challenges were selected from the literature. In both countries, the aim was to maximize the social benefits of research and minimize the risk imposed on the participants. Common challenges include maintaining independence, funding and delivering timely ethical reviews of the research projects. These challenges can be difficult where research ethics committees rely on voluntary contributions and lack a strong resource base. They must adapt to the increasingly rapid pace of research as well as the technological sophistication.  Population health research can challenge the conventional views of consent and privacy. The principles of the sound ethical review are common in both countries; governance arrangements and operational procedures, however, can differ, reflecting the cultural values and norms of their host countries and in respect of legal environments. By studying the evolution and function of ethics committees in the two countries, we established the differences in the governance and health systems, while similar ethical objectives helped sustain collaborative research.

Samira Raoofi ◽  
Seddighe Arefi ◽  
Rahim Khodayari-Zarnaq ◽  
Bashir Azimi-Nayebi ◽  
Mir Sajjad Seyyed Mousavi

Medical ethics committees play an important role in examining and resolving ethical problems in hospitals by developing ethical guidelines and making ethical decisions. This study aimed at investigating the challenges that these committees typically face. This qualitative phenomenological study was conducted in 2020. Data was collected through semi-structured interviews with purposive sampling and participation of 19 ethics committees’ members in Tehran hospitals. Then, data were analyzed by the content analysis method using MAXQDA-10 software. Challenges of hospital ethics committees were classified into three main themes including external factors, intra-organizational factors, and ethics committee structure, in addition to six sub-themes including inadequate supervision, lack of instructions, organizational culture, human resources, nature of the committee, and ineffectiveness of committees’ decisions. Since many challenges are faced by ethics committees, plans should be developed and implemented to fulfill the following purposes: (i) strengthen the position of these committees in hospitals, (ii) continuous supervision over the formation and holding of the committees, (iii) their operation process, (iv) their decision-making process, and (v) process of sharing committees’ decisions with all hospital stakeholders and staff.

2022 ◽  
Na Wang ◽  
Jenny Gamble ◽  
Qiuxiang Zhang ◽  
Elizabeth Elder ◽  
Jyai Allen ◽  

Abstract Background:Undergoing an abortion is stressful. This protocol aims to assess the feasibility, acceptability, and primary effects of a complex intervention to promote positive coping behaviors and alleviating depression symptoms among Chinese women undergo abortion.Methods:A two-arm randomized controlled trial design will be used. Participants will be recruited at their first appointment with the abortion clinic, those who consent to participate will be randomly allocated to receive either the START intervention (in addition to standard abortion care) or standard care only. All participants will receive survey follow-up until six weeks post-abortion. Ethical has been granted by local and university ethics committees. This research was supported by an Australian Government Research Training Program (RTP) Scholarship Discussion:Results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the literature evidence on improving women’s psychological well-being following abortion in ChinaTrial registration: Registered at the Chinese Clinical ChiCTR2100046101. Date of registration: May 4, 2021

Daniele Romanin Da Silva Cunha ◽  
André Aroldo Freitas De Moura ◽  
Poliano Bastos da Cruz

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e050413
Ning Sun ◽  
Dong-Mei He ◽  
Xiangyin Ye ◽  
Lei Bin ◽  
Yuanfang Zhou ◽  

IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients’ BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral–cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People’s Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

2022 ◽  
Vol 0 (0) ◽  
pp. 0
Shatavisa Mukherjee ◽  
ShamboSamrat Samajdar ◽  
Rohan Tripathi ◽  
SantanuKumar Tripathi

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e059527
G Andre Ng ◽  
Amar Mistry ◽  
Michelle Newton ◽  
Fernando Soares Schlindwein ◽  
Craig Barr ◽  

IntroductionThe purpose of this study is to assess the ability of two new ECG markers (Regional Repolarisation Instability Index (R2I2) and Peak Electrical Restitution Slope) to predict sudden cardiac death (SCD) or ventricular arrhythmia (VA) events in patients with ischaemic cardiomyopathy undergoing implantation of an implantable cardioverter defibrillator for primary prevention indication.Methods and analysisMulticentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction is a prospective, open label, single blinded, multicentre observational study to establish the efficacy of two ECG biomarkers in predicting VA risk. 440 participants with ischaemic cardiomyopathy undergoing routine first time implantable cardioverter-defibrillator (ICD) implantation for primary prevention indication are currently being recruited. An electrophysiological (EP) study is performed using a non-invasive programmed electrical stimulation protocol via the implanted device. All participants will undergo the EP study hence no randomisation is required. Participants will be followed up over a minimum of 18 months and up to 3 years. The first patient was recruited in August 2016 and the study will be completed at the final participant follow-up visit. The primary endpoint is ventricular fibrillation or sustained ventricular tachycardia >200 beats/min as recorded by the ICD. The secondary endpoint is SCD. Analysis of the ECG data obtained during the EP study will be performed by the core lab where blinding of patient health status and endpoints will be maintained.Ethics and disseminationEthical approval has been granted by Research Ethics Committees Northern Ireland (reference no. 16/NI/0069). The results will inform the design of a definitive Randomised Controlled Trial (RCT). Dissemination will include peer reviewed journal articles reporting the qualitative and quantitative results, as well as presentations at conferences and lay summaries.Trial registration numberNCT03022487.

2022 ◽  
Vol 7 (1) ◽  
pp. e007466
Caesar Alimisnya Atuire ◽  
Sofía P Salas ◽  
Katharine Wright ◽  
J Radeino Ambe ◽  
Jantina de Vries

As healthcare authorities around the world strive to get as many citizens as possible vaccinated against the SAR-CoV-2 virus, many countries have begun including children in the population groups to be vaccinated. Properly designed clinical trials involving children are important to ensure safety, efficacy, and dosage of therapies in (developing) children. Within the complex health, social, and political scenario of the ongoing pandemic, ethics committees and policy makers in low-income and middle-income settings need to consider additional ethical questions when called on to review phase III COVID-19 vaccine trials involving in children. We set out some of the ethical questions to keep in mind before, during, and after the implementation of phase III COVID-19 vaccine trials in limited resource settings. Specifically, we discuss and offer succinct answers to the following questions: How relevant will the trial vaccine be for the population participating in the trial? Should vaccines that have not been approved for use among adults be approved for use in trials with children? Which children should be involved in COVID-19 vaccine trials? What criteria of informed consent are to be adopted with minors? Placebo versus an existing already approved vaccine? What specific duties of ancillary care should be taken into consideration for COVID-19 vaccines especially in low-income and middle-income countries? The answers we offer are considerations that can serve as ‘things to think about’ when reviewing or implementing COVID-19 trials involving children in low-income settings.

2022 ◽  
Vol 75 (3) ◽  
Larissa Viana Ues ◽  
Leticia Helbingen Pereira ◽  
Rayssa Maria de Araújo Ferreira Paula Bastos ◽  
Luana Cássia Miranda Ribeiro ◽  
George Oliveira Silva ◽  

ABSTRACT Objectives: to categorize factual elements of ethical-disciplinary nursing lawsuits in the state of Goiás. Methods: cross-sectional, retrospective study, based on secondary data obtained from ethical-disciplinary lawsuits filed at the Regional Nursing Council of Goiás (Coren-Goiás) between the years 2010 and 2019. Results: the highest number of lawsuits filed was in 2013 and 2014, with a greater frequency in the state capital. The majority came from the Nursing Ethics Committees and ex-officio complaints. The professional with most complaints was the nursing technician, aged between 31 and 40 years old, at the beginning of their career. The most common type of complaints referred to performing attributions that were not within the nursing competences. Conclusions: as a highlight are the contributions of this study to professional ethics in nursing and the clear need to consolidate these skills in nurses who are in training and in the continuous education for those already in the profession.

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