Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic

Zhang, Hui; Shao, Fengmin; Gu, Jianqin; Li, Li; Wang, Yuming

doi:10.1001/jama.2020.4362

Cited by 40 publications

(44 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…An outbreak imposes new challenges to the process of ethical approval [31]. Most importantly, the instant reaction of both the researchers and the ethical committees is essential, while preserving the validity of scientific content [32].…”

Section: Discussionmentioning

confidence: 99%

Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial

Erőss

Molnár

Szakács

et al. 2020

Trials

View full text Add to dashboard Cite

Background Early reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5–26% and overall mortality can rise to 11% of the recognised cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for its prevention and treatment. We aim to compare the effects of a World Health Organization recommendation-based education and a personalised complex preventive lifestyle intervention package (based on the same WHO recommendation) on the outcomes of the COVID-19. Methods PROACTIVE-19 is a pragmatic, randomised controlled clinical trial with adaptive “sample size re-estimation” design. Hungarian population over the age of 60 years without confirmed COVID-19 will be approached to participate in a telephone health assessment and lifestyle counselling voluntarily. Volunteers will be randomised into two groups: (A) general health education and (B) personalised health education. Participants will go through questioning and recommendation in 5 fields: (1) mental health, (2) smoking habits, (3) physical activity, (4) dietary habits, and (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. Assessment will be done weekly during the first month, every second week in the second month, then monthly. The composite primary endpoint will include the rate of ICU admission, hospital admission (longer than 48 h), and mortality in COVID-19-positive cases. The estimated sample size is 3788 subjects per study arm. The planned duration of the follow-up is a minimum of 1 year. Discussion These interventions may boost the body’s cardiovascular and pulmonary reserve capacities, leading to improved resistance against the damage caused by COVID-19. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older population. Trial registration The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428- 2 /2020/EKU) and has been registered at clinicaltrials.gov (NCT04321928) on 25 March 2020.

show abstract

Section: Discussionmentioning

confidence: 99%

Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial

Erőss

Molnár

Szakács

et al. 2020

Trials

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Personalised health education against health damage of COVID-19 epidemic in the elderly hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial.

Erőss

Molnár

Zádori

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Early reports indicate that COVID-19 may require intensive care unit (ICU) admission in 5-26% and overall mortality can rise to 11% of the recognized cases, particularly affecting the elderly. There is a lack of evidence-based targeted pharmacological therapy for prevention and treatment alike. We aim to compare the effects of a World Health Organisation (WHO) recommendations’ based education and a personalised complex preventive lifestyle intervention package (based on the same WHO recommendation) on the outcomes of the COVID-19. Methods: PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive “sample size re-estimation” design. Hungarian population over the age of 60 years without confirmed COVID-19 will be approached to participate in a telephone health assessment and lifestyle counselling voluntarily. Volunteers will be randomized into two groups: (A) general health education; (B) personalized health education. Participants will go through questioning and recommendation in 5 fields: (1) mental health, (2) smoking habits, (3) physical activity, (4) dietary habits, (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. Assessment will be done weekly during the first month, every second week in the second month, then monthly. The composite primary endpoint will include the rate of ICU admission, hospital admission (longer han 48 hours) and mortality in COVID-19 positive cases. The estimated sample size is 3788 subjects per study arm. The planned duration of the follow-up is a minimum of one year. Discussion: These interventions may boost the body’s cardiovascular and pulmonary reserve capacities, leading to improved resistance against the damage caused by COVID-19. Consequently, lifestyle changes can reduce the incidence of life-threatening conditions and attenuate the detrimental effects of the pandemic seriously affecting the older population. Trial registration: The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (IV/2428- 2 /2020/EKU) and has been registered at clinicaltrials.gov (NCT04321928) on 25 March, 2020.

show abstract

“…Particularly, in 2016, the WHO published the "guidance for managing ethical issues in infectious disease" [109] to ensure the scientific validity of studies conducted during outbreaks as well as participants' rights and safety in these studies. The climate of fear may predispose patients to agree to participate in research where experimental drugs are being used and inclusion and exclusion criteria are not being properly documented [110]. An interesting viewpoint aiming to assure clinical trial integrity during COVID-19 pandemic was recently presented [111].…”

Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

COVID-19 research: pandemic versus “paperdemic”, integrity, values and risks of the “speed science”

Dinis-Oliveira

2020

Forensic Sciences Research

View full text Add to dashboard Cite

show abstract

Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic

Abstract: This study reviews research ethics committee applications for COVID-19–related research at a Chinese hospital in February 2020 to characterize study type, approval rate and review time, reason for revision or denial, and issues with informed consent.

Cited by 40 publications

References 2 publications

Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial

Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial

Personalised health education against health damage of COVID-19 epidemic in the elderly hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial.

COVID-19 research: pandemic versus “paperdemic”, integrity, values and risks of the “speed science”

Contact Info

Product

Resources

About