Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators

Background During the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called ‘fast-track-review-procedures’ (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs). Methods and findings An explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats. Conclusions This study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.

Military Medical Research Ethics

Military medicine presents unique challenges for medical research. Landing in Iraq, Coalition forces required investigational drugs to combat the threat of poison gas. As the fighting progressed, battlefield conditions necessitated rapid innovation to control bleeding, manage fluid resuscitation and transfusion, conduct field surgery, treat traumatic brain injury, develop limb prosthetics, and enhance performance. While clinicians delivered high-quality retrospective and survey studies, conditions unique to the military made it difficult to obtain informed consent and conduct controlled clinical trials of emerging therapies and medical devices. The result was a dearth of sufficient studies. Remedying the situation requires reformulating the rules of informed consent for military medical research and enlisting civilian subjects while protecting the rights and privileges of each group.

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

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.

The Association Between the Pattern of Electronic Cigarette Smoking and Gastroesophageal Reflux

Background: This study was aimed to investigate the proportion of gastroesophageal reflux (GER) among electronic cigarette (e-cig) smokers and its association with the pattern of e-cig smoking.Method: This cross-sectional study underwent among e-cig smokers community in Cirebon City, Jawa Barat, ranged from March to August 2020. Subjects were enrolled through consecutive sampling method. The data collection used survey containing the pattern of e-cig smoking and GER. The pattern of e-cig smoking included the duration of e-cig smoking and the amount of e-cig smoking. Gastroesophageal reflux consisted of GER-related symptoms (heartburn, regurgitation, and nocturnal symptom) and gastroesophageal reflux disease (GERD). GERD was defined as GERD questionnaire score cut-off 8. Data analysis used chi square test. This study has been approved by The Medical Research Ethics Committee, Faculty of Medicine, Universitas Swadaya Gunung Jati.Results: There were 273 respondents in this study. The proportion of heartburn was 6.6%, 10.3% for regurgitation, 3.7% for nocturnal symptom, and 5.5% for GERD. There was no association between duration of e-cig smoking and heartburn (p 0.681), regurgitation (p 0.568), nocturnal symptom (p 0.764), and GERD (p 0.113). There was no association between amount of e-cig smoking and heartburn (p 0.062), regurgitation (p 0.770), nocturnal symptom (p 0.985), and GERD (p 0.605).Conclusion: There was relatively low proportion of GER among e-cig smokers. There was no association between the pattern of e-cig smoking and GER in this study.

Can we decrease the duration of basal thumb joint distraction for early osteoarthritis from 8 to 6 weeks? Study protocol for a non-inferiority randomized controlled trial

Background To our knowledge, to date, 52 patients with thumb carpometacarpal osteoarthritis (CMC1 OA) were treated with joint distraction. So far, most patients experienced improved physical function and less pain. After 2 years, only 1 patient proceeded to trapeziectomy. This study assesses if we can safely lower the distraction duration from 8 to 6 weeks for CMC1 joint distraction, maintaining the improvement in physical function and pain. Methods This is a monocenter randomized controlled non-inferiority trial that includes patients younger than 65 years of age with ongoing symptoms of CMC1 OA and an established indication for surgery. All patients will be treated with CMC1 joint distraction. The primary outcome is to assess whether 6 weeks of joint distraction is not inferior to 8 weeks in terms of physical function at 1 year after surgery. Secondary outcomes will identify differences between groups at 1 year in pain intensity, patient satisfaction, hand health status, adverse event rates, treatment failure, differences in thumb strength and range of motion, and radiographic changes. Discussion If safe, the duration of basal thumb joint distraction can be reduced to 6 weeks, reducing patient burden. Because this is a relatively new treatment, this trial will provide greater knowledge of potential adverse events. This knowledge allows for more informed decision making for patients considering CMC1 distraction treatment. Future studies can directly compare joint distraction to other treatments of CMC1 joint arthritis like splinting and trapeziectomy. Trial registration Central Committee on Research Involving Human Subjects (CCMO), NL68225.100.18; registered on 9 August 2019. Medical Research Ethics Committees United (MEC-U), R19.003; registered on 9 August 2019. Netherlands Trial Register, NL8016; registered on 15 September 2019.

Characteristics of Inflammatory Storm in BALF of Severe Pneumonia in Children

Background: There are few studies on inflammatory storms in bronchoalveolar lavage fluid (BALF) of children with pneumonia. Therefore, we will retrospectively investigate characteristics of inflammatory storms in BALF of children with pneumonia in our hospital.Methods: 161 children with pneumonia were retrospectively divided into two groups: mild and severe pneumonia, according to the clinic diagnosis. Flow cytometry was performed to detect the levels of cytokines, including IL-2, IL-4, IL-6, IL-10, IL-17A, TNF-α and IFN-γ. We performed receiver operator characteristic curve (ROC) and spearman correlation to evaluate the role of BALF inflammatory cytokines and cells in pneumonia.Results: 1) The levels of IL-6, IL-10, IL-17A, and TNF-α, and ratios of IL-6 to IL-10 and TNF-α to IL-10 in BALF of severe pneumonia group were higher than those of mild pneumonia group. 2) The number of inflammatory cells and the percentage of neutrophils in BALF of severe pneumonia group increased, and the percentage of macrophages decreased, compared with the mild pneumonia group. 3) ROC analysis showed that both the increase of the levels of IL-6, IL-10 and TNF-α, and ratios of IL-6 to IL-10 and TNF-α to IL-10, number of inflammatory cells and neutrophils, percentage of neutrophils, and the decrease of the percentage of macrophages exceeding the cut-off value could be used to distinguish children with severe pneumonia from mild pneumonia. Conclusion: In severe pediatric pneumonia, BALF inflammatory cytokines and inflammatory cell infiltration are more intense. And these inflammatory signals are important biomarkers for reflecting the severity of pediatric pneumonia.Trial registration: This study approved by the Medical Research Ethics Committee of Children’s Hospital of Chongqing Medical University, registered in http://www.chictr.org.cn/, No. ChiCTR2000034048(registration date, June 22, 2020).

Covid-19, the WHO, and the apparent collapse of traditional medical research ethics

On January 14, 2021, a WHO Ad Hoc expert group published an article in the highly influential The New England Journal of Medicine, titled: “Placebo-Controlled Trials of Covid-19 Vaccines – Why We Still Need Them” justifying the use of placebo in further trials of Covid-19 vaccines, even after purported efficacious vaccines have become available. Medical research involving human beings ought to conform strictly to principles, rules and procedures established since the Nuremberg Code (1947), especially as elaborated in the Declaration of Helsinki (2013) and the WHO/CIOMS Guidelines (2016). The NEJM article forms part of an observable trend of moral backsliding that needs to be recorded. In this paper, considering traditional medical research ethics under the impact of the Covid-19 pandemic and its ramifications and effects, and with a particular focus on the highly vulnerable populations and countries of sub-Saharan Africa, I make some relevant remarks. My arguments here are anchored in my observations as a moral philosopher though limited by my lack of expertise in any of the branches of medical science.

Engaging Research Participants with Results: A Rights Informed Approach

IntroductionSharing findings with research participants is gaining attention as an ethical imperative for the research community. However, current discussions on this topic typically take a paternalistic approach to the issue, with the research team having the power to decide whether or not the sharing of results should be carried out and how this is done. In this paper we propose an alternative approach to engaging participants with the findings from the research to which they have contributed.MethodsThe ethnographic fieldwork for our study was carried out in multiple phases from August 2018 to January 2019 and again from August 2019 to December 2019 among two vulnerable communities in the south Indian state of Kerala. Engagement of research participants with findings was integrated into the research protocol and various strategies including forming partnerships with participants and identifying appropriate forms of dissemination among the different categories of participants were carried out during fieldwork. The format and mode of dissemination varied depending on the participant category and was tailored to ensure that each participant was able to engage actively with the findings as opposed to merely passively receiving the results from our study,ResultsPrevious research studies that had been undertaken among our participants had not shared research results with them and were interpreted by the communities that researchers were not interested in making any difference to their situation. Building reciprocal relationships in a way that minimised power disparities and tailoring outputs to forms that promoted active engagement were key factors that helped participants to engage with our results. Such engagement added value to our research by enabling us to jointly evolve the recommendations from our study.Conclusion Participants contribute to the success of research by providing information that is sought by researchers. Compared to the dominant bio-medical research ethics framework, a rights informed approach to sharing research results with participants acknowledges this and recognises their agency to engage with research findings. Such an approach is not only socially responsible and ethical, but also improves the impact and legitimacy of research among the participants and the larger population that they represent.

Exploring Pictorial Health Education Tools for Long-Term Home Care: A Qualitative Perspective

Regarding long-term home care needs, nurses need to communicate effectively and reasonably when teaching home caregivers. Designers can assist medical staff and develop pictorial tools to enhance communication. The purpose of this study is to explore a theoretical basis from the perspective of designers, patients’ home caregivers, and medical staff to construct a theoretical framework that can jointly develop pictorial health education tools and healthcare system. The qualitative methods, including in-depth interview and observation, are applied to this study; ground theory sets out to construct a framework from the verbatim transcript of the interviews. Based on interview results, six axial codes were extracted: (1) the method of interdisciplinary cooperation; (2) medical research ethics; (3) communication methods; (4) forms of health education tools; (5) development of health education tools; (6) home care intubation procedure. Eight groups of home caregivers offered suggestions from their experiences. The designers need to assist medical staff to solve real problems, pay attention to professional norms, and forms of cooperation. Health education tools need to meet the needs of medical staff and home caregivers and designers should pay attention to the processes of communication. This study can also assist in interdisciplinary cooperation to explore the theoretical basis of pictorial health education tools for nurses in the context of long-term care at home.