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Shamsi-Gooshki E, Parsapoor A, Moosavi S. Ethical challenges in conducting research in low and middle income setting during public health emergencies: a qualitative evidence of a COVID-19 pandemic: the experience of Iran. BMC Med Ethics 2025; 26:38. [PMID: 40098165 PMCID: PMC11912589 DOI: 10.1186/s12910-025-01193-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2024] [Accepted: 03/06/2025] [Indexed: 03/19/2025] Open
Abstract
BACKGROUND Every minute during an epidemic is important and research in such conditions is for the benefit of the society. Considering that identifying experiences is a way to prevent repeated mistakes and prepare people to face crisis situations, this study aimed to explain participants' experiences of ethical challenges encountered in conducting research related to Covid-19 in Iran. METHOD This qualitative study was carried out using conventional content analysis for 2 years from March 2020 to March 2022 in Tehran, Iran. A number of 30 people were selected in a purposeful method and information was obtained through semi-structured interviews. The participants in the study were people with positions including members of institutional and national research ethics committees, researchers, clinicians, university hospitals managers during the COVID-19 pandemic. The method of data analysis in this study was conventional content analysis using the Graneheim and Lundman method. RESULTS Participants' experiences on ethical challenges were explained through three themes: "substantive ethical values principles", "the Research Environment", "Research Governance and Management". CONCLUSION This study examines ethical challenges in COVID-19 research across three domains: values, environment, and research governance. The results suggest the need to develop crisis-specific ethical frameworks, strengthen research ethics infrastructure and training, and establish more transparent standards and oversight systems. These findings could be useful in refining ethical policies and managing future crises.
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Affiliation(s)
- Ehsan Shamsi-Gooshki
- Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran
- Monash Bioethics Center, Monash University, Melbourne, Australia
| | - Alireza Parsapoor
- Medical Ethics and History of Medicine Research Center, Department of Medical Ethics, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran
| | - Soolmaz Moosavi
- Department of Medical Surgical Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, P.O.Box: 1996835119, Intersection of Valiasr St. and Niayesh Highway, in Front of Rajaei Hospital, Tehran, Iran.
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Shandera WX. COVID-19 ethics: unique aspects and a review as of early 2024. Monash Bioeth Rev 2024; 42:55-86. [PMID: 39003388 PMCID: PMC11368997 DOI: 10.1007/s40592-024-00199-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/11/2024] [Indexed: 07/15/2024]
Abstract
COVID-19 presents a variety of ethical challenges in a set of arenas, arenas not always considered in past pandemics. These challenges include issues related to autonomy, distributive ethics, and the establishment of policies of equity and justice. Methods are a literature review based on regular editing of an online textbook during the COVID-19 outbreak and a literature review using key ethical terms. Patients are confronted with new issues related to autonomy. Providers need to expand their concepts of ethical issues to include decisions based on proportionality and public health ethics. The public health sector needs to assess the beneficence of alternative modes of disease control. The research community needs to redefine the concept of informed consent in emergent conditions. All elements of the medical spectrum-physicians, scientists, and the community-at-large including the pharmaceutical industry-need to consider the multifaceted methods for preventing future pandemics. This will require giving particular emphasis to public health funding and ending the documented discrimination that exists in the provision of proven therapies. The developing world is especially at risk for most of the ethical issues, especially those related to equity and justice. The ethical issues associated with the COVID-19 outbreak are not unique but provide a diverse set of issues that apply to patients, providers, social groups, and investigators. The further study of such issues can help with preventing future outbreaks.
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Orievulu K, Hinga A, Nkosi B, Ngwenya N, Seeley J, Akanlu A, Tindana P, Molyneux S, Kinyanjui S, Kamuya D. A scoping review of ethics review processes during public health emergencies in Africa. BMC Med Ethics 2024; 25:63. [PMID: 38778293 PMCID: PMC11110293 DOI: 10.1186/s12910-024-01054-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2023] [Accepted: 05/06/2024] [Indexed: 05/25/2024] Open
Abstract
BACKGROUND The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.
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Affiliation(s)
- Kingsley Orievulu
- Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa.
- School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.
- Centre for Africa China Studies, University of Johannesburg, Johannesburg, South Africa.
| | - Alex Hinga
- KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
| | - Busisiwe Nkosi
- Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa
- University of Toledo, Ohio, Toledo, USA
| | - Nothando Ngwenya
- Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa
- School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa
| | - Janet Seeley
- Africa Health Research Institute, KwaZulu-Natal, Durban, South Africa
- School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa
- Global Health and Development Department, London School of Hygiene and Tropical Medicine, London, UK
| | - Anthony Akanlu
- West Africa Centre for Cell Biology and Infectious Pathogens, University of Ghana, Accra, Ghana
| | - Paulina Tindana
- Department of Health Policy, Planning and Management, School of Public Health, College of Health Sciences, University of Ghana, Accra, Ghana
| | - Sassy Molyneux
- KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
- Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK
| | - Samson Kinyanjui
- KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
- Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK
| | - Dorcas Kamuya
- KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
- Centre for Tropical Medicine and Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK
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4
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Park YS, Kim OJ. Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea. J Korean Med Sci 2024; 39:e116. [PMID: 38565174 PMCID: PMC10985498 DOI: 10.3346/jkms.2024.39.e116] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/26/2023] [Accepted: 03/04/2024] [Indexed: 04/04/2024] Open
Abstract
BACKGROUND Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. METHODS We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness. RESULTS The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). CONCLUSION As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.
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Affiliation(s)
- Young Su Park
- Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine, Seoul, Korea
| | - Ock-Joo Kim
- Department of the History of Medicine and Medical Humanities, Seoul National University College of Medicine, Seoul, Korea.
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Shetty YC, Thatte UM, Pal A, Katkar J. Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study. Perspect Clin Res 2024; 15:31-37. [PMID: 38282627 PMCID: PMC10810054 DOI: 10.4103/picr.picr_79_23] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2023] [Revised: 07/06/2023] [Accepted: 07/07/2023] [Indexed: 01/30/2024] Open
Abstract
Purpose and Aim In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann-Whitney U-test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results Constitution changed , more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.
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Affiliation(s)
- Yashashri Chandrakant Shetty
- Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
| | - Urmila Mukund Thatte
- Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
| | - Amitrajit Pal
- Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
| | - Janhavi Katkar
- Department of Institutional Ethics Committee, Seth GSMC and KEM Hospital, Mumbai, Maharashtra, India
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6
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Nomali M, Mehrdad N, Heidari ME, Ayati A, Yadegar A, Payab M, Olyaeemanesh A, Larijani B. Challenges and solutions in clinical research during the COVID-19 pandemic: A narrative review. Health Sci Rep 2023; 6:e1482. [PMID: 37554954 PMCID: PMC10404843 DOI: 10.1002/hsr2.1482] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2023] [Revised: 07/15/2023] [Accepted: 07/25/2023] [Indexed: 08/10/2023] Open
Abstract
Background and Aims The COVID-19 pandemic has presented significant challenges to clinical research, necessitating the adoption of innovative and remote methods to conduct studies. This study aimed to investigate these challenges and propose solutions for conducting clinical research during the pandemic. Methods A narrative review was conducted (approval ID: IR.AMS.REC.1401.029), utilizing keyword searches in PubMed and Web of Science (WOS) citation index expanded (SCI-EXPANDED) from January 2020 to January 2023. Keywords included COVID-19, clinical research, barriers, obstacles, facilitators and enablers. Results Out of 2508 records retrieved, 43 studies were reviewed, providing valuable insights into the challenges and corresponding solutions for conducting clinical research during the COVID-19 pandemic. The identified challenges were categorized into four main groups: issues related to researchers or investigators, issues related to participants and ethical concerns, administrative issues, and issues related to research implementation. To address these challenges, multiple strategies were proposed, including remote monitoring through phone or video visits, online data collection and interviews to minimize in-person contact, development of virtual platforms for participant interaction and questionnaire completion, consideration of financial incentives, adherence to essential criteria such as inclusion and exclusion parameters, participant compensation, and risk assessment for vulnerable patients. Conclusion The COVID-19 pandemic has significantly impacted clinical research, requiring the adaptation and enhancement of existing research structures. Although remote methods and electronic equipment have limitations, they hold promise as effective solutions during this challenging period.
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Affiliation(s)
- Mahin Nomali
- Department of Epidemiology and Biostatistics, School of Public HealthTehran University of Medical SciencesTehranIran
| | - Neda Mehrdad
- Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences InstituteTehran University of Medical SciencesTehranIran
- Nursing and Midwifery Care Research Center, Health Management Research InstituteIran University of Medical SciencesTehranIran
| | - Mohammad Eghbal Heidari
- Students' Scientific Research Center, School of Nursing and MidwiferyTehran University of Medical SciencesTehranIran
| | - Aryan Ayati
- Tehran Heart Center, Cardiovascular Diseases Research InstituteTehran University of Medical SciencesTehranIran
| | - Amirhossein Yadegar
- Endocrinology and Metabolism Research Center (EMRC), Vali‐Asr HospitalTehran University of Medical SciencesTehranIran
| | - Moloud Payab
- Non‐Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences InstituteTehran University of Medical SciencesTehranIran
| | - Alireza Olyaeemanesh
- National Institute of Health ResearchTehran University of Medical SciencesTehranIran
- Health Equity Research Center (HERC)Tehran University of Medical Sciences (TUMS)TehranIran
| | - Bagher Larijani
- Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences InstituteTehran University of Medical SciencesTehranIran
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Parkinson B. We need to talk about research ethics committees (RECs). Evid Based Nurs 2023; 26:85-86. [PMID: 37137674 DOI: 10.1136/ebnurs-2023-103748] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/21/2023] [Indexed: 05/05/2023]
Affiliation(s)
- Ben Parkinson
- Nursing and Community Health, Glasgow Caledonian University, Glasgow, UK
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8
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Wilmes N, Hendriks CWE, Viets CTA, Cornelissen SJWM, van Mook WNKA, Cox-Brinkman J, Celi LA, Martinez-Martin N, Gichoya JW, Watkins C, Bakhshi-Raiez F, Wynants L, van der Horst ICC, van Bussel BCT. Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review. BMJ Glob Health 2023; 8:e012007. [PMID: 37257937 PMCID: PMC10254958 DOI: 10.1136/bmjgh-2023-012007] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2023] [Accepted: 04/13/2023] [Indexed: 06/02/2023] Open
Abstract
BACKGROUND The COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct. METHODS A systematic scoping review was performed by searching PubMed and Embase. The search was performed on November 8th, 2020. Studies with hospitalised patients diagnosed with COVID-19 over 18 years old were eligible for inclusion. With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. For reasons of comparison, data regarding country income level, study location and journal impact factor were also collected. RESULTS 972 studies were included. 21.3% of studies reported informed consent, 42.6% reported waivers of consent, 31.4% did not report consent information and 4.7% mentioned other types of consent. Informed consent reporting was highest in clinical trials (94.6%) and lowest in retrospective cohort studies (15.0%). The reporting of consent versus no consent did not differ significantly by journal impact factor (p=0.159). 16.8% of studies reported a prestudy protocol registration or design. Ethical approval was described in 90.9% of studies. Information on anonymisation was provided in 17.0% of studies. In 257 multicentre studies, 1.2% reported on data sharing agreements, and none reported on Findable, Accessible, Interoperable and Reusable data principles. 1.2% reported on open data. Consent was most often reported in the Middle East (42.4%) and least often in North America (4.7%). Only one report originated from a low-income country. DISCUSSION Informed consent and aspects of data handling and sharing were under-reported in publications concerning COVID-19 and differed between countries, which strains study quality conduct when in dire need of answers.
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Affiliation(s)
- Nick Wilmes
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
- Cardiovascular research institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands
| | - Charlotte W E Hendriks
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Caspar T A Viets
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Simon J W M Cornelissen
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Walther N K A van Mook
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
- Academy for Postgraduate Medical Training, Maastricht University Medical Center, Maastricht, The Netherlands
- School of Health Professions Education, Maastricht University, Maastricht, The Netherlands
| | - Josanne Cox-Brinkman
- Department of Health Law, Maastricht University Medical Centre, Maastricht, The Netherlands
| | - Leo A Celi
- Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Centre, Boston, Massachusetts, USA
- Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA
- Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
| | - Nicole Martinez-Martin
- Department of Pediatrics, Stanford Center for Biomedical Ethics, Stanford University, San Jose, California, USA
| | - Judy W Gichoya
- Department of Radiology and Imaging Sciences, Emory University School of Medicine, Emory University, Atlanta, Florida, USA
| | - Craig Watkins
- School of Journalism and Media, University of Texas, Austin, Texas, USA
| | - Ferishta Bakhshi-Raiez
- Department of Medical Informatics, Amsterdam University Medical Centre, Amsterdam and Amsterdam Public Health, Quality of care The Netherlands, Amsterdam, The Netherlands
| | - Laure Wynants
- Department of Development and Regeneration, KU Leuven, Leuven, Belgium
- Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Iwan C C van der Horst
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
- Cardiovascular research institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands
| | - Bas C T van Bussel
- Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands
- Cardiovascular research institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands
- Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
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Johnson AN, Clockston RLM, Fremling L, Clark E, Lundeberg P, Mueller M, Graham DJ. Changes in Adults' Eating Behaviors During the Initial Months of the COVID-19 Pandemic: A Narrative Review. J Acad Nutr Diet 2023; 123:144-194.e30. [PMID: 36075551 PMCID: PMC9444582 DOI: 10.1016/j.jand.2022.08.132] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Revised: 08/20/2022] [Accepted: 08/31/2022] [Indexed: 11/18/2022]
Abstract
Factors such as regulations and health concerns shifted daily habits, including eating behaviors, during the early months of the coronavirus disease 2019 (COVID-19) pandemic. This comprehensive narrative review synthesizes research on eating behavior changes during the early months of the pandemic (February to June 2020), including changes in amount, rate, and timing of food consumption, types and healthfulness of foods consumed, the occurrence of other specified eating behaviors (eg, restrained eating or binging), and reasons for eating (eg, stress or cravings), among adults. A literature search using three EBSCOhost databases and Google Scholar was conducted to identify relevant articles made available in 2020. A total of 71 articles representing 250,715 individuals from more than 30 countries were reviewed. Findings show eating behaviors changed little during the early COVID-19 pandemic for most participants. Among those whose eating behaviors changed, increases in both intake and frequency of eating meals and snacks were more common than decreases. Findings on timing of eating and healthfulness of food consumed showed mixed results. However, when changes occurred in the type of food consumed, increases were more common for snacks, homemade pastries, white bread/pasta, legumes, and fruits/vegetables; decreases were more common for meats, seafood/fish, frozen foods, fast food, dark breads/grains, and dark leafy green vegetables. During the pandemic, binging, uncontrolled eating, and overeating increased, meal skipping decreased, and restrictive eating had mixed findings. Changes in factors such as emotions and mood (eg, depression), cravings, and environmental factors (eg, food insecurity) were related to changes in eating behaviors. Findings can inform clinical practitioners in efforts to mitigate disruptions to normal, healthy eating patterns among adults both in and outside of global health catastrophes.
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Affiliation(s)
- Ashlie N Johnson
- Department of Psychology, Linfield University, McMinnville, Oregon.
| | | | - Lindsey Fremling
- Department of Psychology, Colorado State University, Fort Collins, Colorado
| | - Emma Clark
- Department of Human Development and Family Studies, Colorado State University, Fort Collins, Colorado
| | - Pamela Lundeberg
- Department of Psychology, Colorado State University, Fort Collins, Colorado
| | - Megan Mueller
- Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado
| | - Dan J Graham
- Department of Psychology, Colorado State University, Fort Collins, Colorado
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10
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Paucsik M, Leys C, Marais G, Baeyens C, Shankland R. Self‐compassion and savouring buffer the impact of the first year of the COVID‐19 on PhD students' mental health. Stress Health 2022; 38:891-901. [PMID: 35286765 PMCID: PMC9111133 DOI: 10.1002/smi.3142] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2021] [Revised: 03/07/2022] [Accepted: 03/08/2022] [Indexed: 12/16/2022]
Abstract
Doctoral students face many challenges that were reinforced by COVID-19-related lockdowns. We assessed this impact over 1 year on doctoral students' depression, anxiety, stress, well-being, and doctoral engagement. We also investigated the potential protective role of self-compassion and savouring on mental health, well-being, and doctoral engagement. A total of 134 PhD students from several French universities responded to the three-time points of this longitudinal study. The results showed a significant increase in depression, anxiety and stress and a significant decrease in well-being and doctoral engagement during the first year of the pandemic. Self-compassion and savouring predicted lower levels of depression, anxiety, and stress, and higher levels of well-being over time. Savouring alone predicted higher doctoral engagement over time. This study reveals the significant impact of the pandemic year on the mental health of doctoral students, and the relevance of self-compassion and savouring as psychological resources to cope with adversity.
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Affiliation(s)
- Marine Paucsik
- Univ. Grenoble Alpes, Univ. Savoie Mont Blanc, LIP/PC2SGrenobleFrance
| | | | - Gabriel Marais
- Univ. Lyon 1CNRSLaboratoire de Biométrie et Biologie EvolutiveVilleurbanneFrance
| | - Céline Baeyens
- Univ. Grenoble Alpes, Univ. Savoie Mont Blanc, LIP/PC2SGrenobleFrance
| | - Rebecca Shankland
- Grenoble Ecole de ManagementGrenobleFrance,Univ. Lumière Lyon 2, Laboratory DIPHE (Development, Individual, Processes, Handicap, Education)BronFrance
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11
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Mat Rifin H, Danaee M. Association between Burnout, Job Dissatisfaction and Intention to Leave among Medical Researchers in a Research Organisation in Malaysia during the COVID-19 Pandemic. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:10017. [PMID: 36011652 PMCID: PMC9407700 DOI: 10.3390/ijerph191610017] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/10/2022] [Revised: 08/07/2022] [Accepted: 08/11/2022] [Indexed: 06/15/2023]
Abstract
Employee turnover could affect the organisation's performance. Job dissatisfaction and burnout have been identified as factors influencing the intention to leave. Thus, this study aimed to determine the level of intent to leave, and predictors associated with intention to leave among medical researchers in Malaysia. A cross-sectional, stratified random sampling study was conducted among researchers in a research organisation under the Ministry of Health. Respondents answered an online questionnaire that included sociodemographic information, job dissatisfaction, burnout, and intention to leave. A total of 133 researchers participated. More than one-third (41.4%) of the researchers had a moderate and high level of intention to leave. Burnout and job dissatisfaction were identified as significant predictors. Burnout was noted to have a positive relationship with the intent to leave (β = 0.289, 95% CI (B): 0.287, 1.096). Meanwhile, job satisfaction was found to have a negative relationship with the intention to leave (β = -0.348, 95% CI (B): -0.768, -0.273). Burnout among researchers is quite worrisome as more than two-thirds of the researchers experienced moderate to high burnout. Reducing burnout and job dissatisfaction would increase work performance and produce high-quality research output, hence decreasing the turnover rate.
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Affiliation(s)
- Halizah Mat Rifin
- Institute for Public Health, National Institutes of Health, Ministry of Health Malaysia, Shah Alam 40170, Malaysia
| | - Mahmoud Danaee
- Department of Social and Preventive Medicine, Faculty of Medicine, University Malaya, Kuala Lumpur 50603, Malaysia;
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Yogendrakumar V, Dewar B, McGuinty M, Dowlatshahi D, Dyason C, Kwok ES, Ramsay T, Lund H, Shamy M. Many trials of hydroxychloroquine for SARS-CoV-2 were redundant and potentially unethical: an analysis of the NIH clinical trials registry. J Clin Epidemiol 2022; 143:73-80. [PMID: 34780978 PMCID: PMC8590481 DOI: 10.1016/j.jclinepi.2021.11.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2021] [Revised: 10/29/2021] [Accepted: 11/06/2021] [Indexed: 11/21/2022]
Abstract
OBJECTIVE We sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. STUDY DESIGN AND SETTING We identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020. RESULTS Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10). CONCLUSION Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.
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Affiliation(s)
- Vignan Yogendrakumar
- Department of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
| | - Brian Dewar
- Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada.
| | - Michaeline McGuinty
- Department of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
| | - Dar Dowlatshahi
- Department of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
| | - Claire Dyason
- Department of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada
| | - Edmond Sh Kwok
- Department of Emergency Medicine, The Ottawa Hospital, Ontario, Canada
| | - Tim Ramsay
- Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada; Ottawa Methods Center, University of Ottawa, Ontario, Canada
| | - Hans Lund
- Section of Evidence-Based Practice, Western Norway University of Applied Sciences, Bergen, Norway
| | - Michel Shamy
- Department of Medicine, The Ottawa Hospital, University of Ottawa, Ontario, Canada; Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
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13
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Vinceti SR, Filippini T. Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency. ACTA BIO-MEDICA : ATENEI PARMENSIS 2022; 93:e2021579. [PMID: 35546005 PMCID: PMC9171886 DOI: 10.23750/abm.v93i2.12582] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Subscribe] [Scholar Register] [Received: 11/16/2021] [Accepted: 11/17/2021] [Indexed: 11/23/2022]
Abstract
As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications' review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it).
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Affiliation(s)
| | - Tommaso Filippini
- Environmental, Genetic and Nutritional Epidemiology Research Center (CREAGEN), Section of Public Health, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy
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14
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Kadam AV, Patil S, Sane S, Shahabuddin S, Panda S. Challenges faced by ethics committee members in India during COVID-19 pandemic: A mixed-methods exploration. Indian J Med Res 2022; 155:461-471. [PMID: 36348593 PMCID: PMC9807194 DOI: 10.4103/ijmr.ijmr_1095_22] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/07/2023] Open
Abstract
Background & objectives The COVID-19 pandemic had a distinct impact on scientific research and Ethics Committees (ECs). We conducted a mixed-methods investigation to understand the issues faced and solutions identified by ECs during this pandemic in India. Methods A quantitative online survey form (30 members) and qualitative in-depth interviews (10 members) from various ECs were conducted. Thematic content analysis for qualitative and proportion analysis for quantitative data was carried out. Results During the online survey, an average difficulty score, which was measured using the Visual Analogue Scale, was 5.3 (SD 2.1). Pressure for expedited approvals was felt by EC members with a drastic increase in the number of submission of research projects. The scarcity of information on investigational products (IPs) and requisite consent process posed major hurdles. Ongoing non-COVID studies and post-graduate dissertations were badly hit due to the shift in attention towards COVID-related research. Non-familiarity with virtual technology and lack of face-to-face interactions were highlighted as demerits. However, a few of the EC members welcomed newer methods, being time-saving, convenient and reducing travel hassles. Site monitoring and severe adverse event-related analyses were also negatively impacted upon. Solutions included the alternate methods of consenting (virtual, abbreviated), a detailed explanation of the protocol and IPs and benefits versus risk assessment. Interpretation & conclusions Despite various challenges posed by the COVID-19 pandemic, the ECs in India steered well through the hurdles. Moreover, adapting a hybrid mode, technical training and updating guidelines were perceived as urgent by EC members.
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Affiliation(s)
- Abhijit Vasantrao Kadam
- Division of Clinical Sciences, ICMR-National AIDS Research Institute, Pune, Maharashtra, India
| | - Sandip Patil
- Division of Clinical Sciences, ICMR-National AIDS Research Institute, Pune, Maharashtra, India
| | - Suvarna Sane
- Division of Epidemiology, ICMR-National AIDS Research Institute, Pune, Maharashtra, India
| | - S.M. Shahabuddin
- Division of Library, ICMR-National AIDS Research Institute, Pune, Maharashtra, India
| | - Samiran Panda
- Division of Epidemiology and Communicable Diseases, Indian Council of Medical Research, New Delhi, India,For correspondence: Dr Samiran Panda, Indian Council of Medical Research, V Ramalingaswamy Bhavan, Ansari Nagar, New Delhi 110 029, India e-mail:
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15
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Neira-Fernández KD, Gaitán-Lee L, Gómez-Ramírez OJ. Health science research barriers and facilitators in the midst of the COVID-19 crisis: scoping review. REVISTA COLOMBIANA DE OBSTETRICIA Y GINECOLOGIA 2021; 72:377-395. [PMID: 35134285 PMCID: PMC8833242 DOI: 10.18597/rcog.3788] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/18/2021] [Accepted: 12/15/2021] [Indexed: 11/29/2022]
Abstract
Objective The COVID-19 pandemic has imposed a great challenge on health research because of the pressing need to respond promptly and effectively to this crisis situation. It is important to offer a high level perspective of the main barriers and facilitators found when conducting health science studies during the COVID-19 crisis and to discuss the research initiatives suggested by global, regional or local health research authorities. Materials and methods A systematic scoping review was carried out. A literature search was conducted in the Medline, Cochrane Library, Lilacs and Google Scholar databases. Original research studies, review and opinion articles and editorials available in full text published in Spanish, English or Portuguese between January 2020 and May 2021 were included. Two authors working independently selected the papers and collected the data. The barriers and facilitators identified were described and organized in four categories according to the literature: sociocultural, administrative, organizational and methodological. Official documents and communications from global, regional and local health and research authorities were also included. Results are presented in narrative and table form. Results Overall, 26 documents were selected for data analysis and synthesis. The barriers most frequently mentioned in the literature include issues with access to participants, ethics committees paperwork, biological risk for the researchers, and lack of inter and intra-institutional coordination. On the other hand, the facilitators identified include the adoption of on-line solutions, cooperative work among research actors, and a more flexible informed consent process. Regarding the initiatives disseminated by health and research authorities, four strategies were identified: prioritization of research questions, cooperation and inclusion promotion, fight against infodemia, and strengthening of the methodological quality of the studies. Conclusions Continued cooperation and interoperability among institutions, countries and disciplines to facilitate future research processes is a challenge in the context of the pandemic; similarly, it is now important to maintain open science and funding of cooperative studies when other priorities emerge. Likewise, there is an evident need to develop and sustain efficient information management systems to help with decision-making. Ongoing review of the effects of the pandemic on health research practice is needed in order to gain comprehensive insights of what we need to learn as a society from this crisis.
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Affiliation(s)
| | - Laura Gaitán-Lee
- Investigadora asociada Instituto de Investigaciones Clínicas, Universidad Nacional de Colombia, Bogotá (Colombia)..
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16
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Wang L, Zhang Y, Wang D, Tong X, Liu T, Zhang S, Huang J, Zhang L, Chen L, Fan H, Clarke M. Artificial Intelligence for COVID-19: A Systematic Review. Front Med (Lausanne) 2021; 8:704256. [PMID: 34660623 PMCID: PMC8514781 DOI: 10.3389/fmed.2021.704256] [Citation(s) in RCA: 41] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2021] [Accepted: 08/09/2021] [Indexed: 02/05/2023] Open
Abstract
Background: Recently, Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory syndrome virus 2 (SARS-CoV-2), has affected more than 200 countries and lead to enormous losses. This study systematically reviews the application of Artificial Intelligence (AI) techniques in COVID-19, especially for diagnosis, estimation of epidemic trends, prognosis, and exploration of effective and safe drugs and vaccines; and discusses the potential limitations. Methods: We report this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed, Embase and the Cochrane Library from inception to 19 September 2020 for published studies of AI applications in COVID-19. We used PROBAST (prediction model risk of bias assessment tool) to assess the quality of literature related to the diagnosis and prognosis of COVID-19. We registered the protocol (PROSPERO CRD42020211555). Results: We included 78 studies: 46 articles discussed AI-assisted diagnosis for COVID-19 with total accuracy of 70.00 to 99.92%, sensitivity of 73.00 to 100.00%, specificity of 25 to 100.00%, and area under the curve of 0.732 to 1.000. Fourteen articles evaluated prognosis based on clinical characteristics at hospital admission, such as clinical, laboratory and radiological characteristics, reaching accuracy of 74.4 to 95.20%, sensitivity of 72.8 to 98.00%, specificity of 55 to 96.87% and AUC of 0.66 to 0.997 in predicting critical COVID-19. Nine articles used AI models to predict the epidemic of the COVID-19, such as epidemic peak, infection rate, number of infected cases, transmission laws, and development trend. Eight articles used AI to explore potential effective drugs, primarily through drug repurposing and drug development. Finally, 1 article predicted vaccine targets that have the potential to develop COVID-19 vaccines. Conclusions: In this review, we have shown that AI achieved high performance in diagnosis, prognosis evaluation, epidemic prediction and drug discovery for COVID-19. AI has the potential to enhance significantly existing medical and healthcare system efficiency during the COVID-19 pandemic.
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Affiliation(s)
- Lian Wang
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Yonggang Zhang
- Department of Periodical Press and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.,Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
| | - Dongguang Wang
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Xiang Tong
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Tao Liu
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Shijie Zhang
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Jizhen Huang
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Li Zhang
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Lingmin Chen
- Department of Anesthesiology and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University and The Research Units of West China, Chinese Academy of Medical Sciences, Chengdu, China
| | - Hong Fan
- Department of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China
| | - Mike Clarke
- Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, United Kingdom
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17
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Saleh BM, Aly EM, Hafiz M, Abdel Gawad RM, El Kheir-Mataria WA, Salama M. Ethical Dimensions of Public Health Actions and Policies With Special Focus on COVID-19. Front Public Health 2021; 9:649918. [PMID: 34409003 PMCID: PMC8365183 DOI: 10.3389/fpubh.2021.649918] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2021] [Accepted: 06/24/2021] [Indexed: 01/10/2023] Open
Abstract
During pandemics, the ethicists, public health professionals, and human rights advocates raise a red flag about different public health actions that should, at best, be addressed through integrated, global policies. How to rationalize the healthcare resources and prioritize the cases is not a recent challenge but the serious concern about that is how to achieve this while not increasing the vulnerability of the disadvantaged population. Healthcare professionals use different scoring systems as a part of their decision-making so the medical teams and triage committees can allocate resources for predictable health outcomes and prognosis as well as to appropriately triage the patients accordingly. However, the value of the existing scoring systems to manage COVID-19 cases is not well-established yet. Part of this problem includes managing non-COVID patients with chronic medical conditions like non-communicable diseases and addressing their medical needs during the pandemic complex context in a way to avoid worsening their conditions and, on the other hand, avoid hindering the establishment of comprehensive standards for dealing with COVID-19. In this article, we discuss this dilemma as well as how preexisting ethical standards were challenged by COVID-19. We also discuss how monitoring the consistent application of ethical standards during the medical trials of new medications, vaccines, or unproven medical interventions is also a critical issue.
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Affiliation(s)
- Basma M. Saleh
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
| | - Eman Mohamed Aly
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
| | - Marwa Hafiz
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
| | - Rana M. Abdel Gawad
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
| | - Wafa Abu El Kheir-Mataria
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
| | - Mohamed Salama
- Institute of Global Health and Human Ecology, School of Science and Engineering, The American University in Cairo, Cairo, Egypt
- Faculty of Medicine, Mansoura University, Mansoura, Egypt
- Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland
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18
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Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators. PLoS One 2021; 16:e0255040. [PMID: 34297752 PMCID: PMC8301608 DOI: 10.1371/journal.pone.0255040] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2021] [Accepted: 07/09/2021] [Indexed: 11/19/2022] Open
Abstract
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.
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19
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Gill SV, Shin D, Ayoub M, Keegan L, Desrochers PC, Helfrich CA. Pivoting in Context: Using the Forging Alliances in Interdisciplinary Rehabilitation Research Model to Collaborate During COVID-19. Am J Phys Med Rehabil 2021; 100:519-525. [PMID: 33782276 PMCID: PMC8131232 DOI: 10.1097/phm.0000000000001749] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
ABSTRACT With the onset of the COVID-19 pandemic, researchers have been faced with challenges in maintaining interdisciplinary research collaborations. The purpose of this article is to apply and expand a previously introduced model to sustaining new interdisciplinary research collaborations: Forging Alliances in Interdisciplinary Rehabilitation Research (FAIRR). FAIRR is a logic model that can be used as a guide to create interdisciplinary rehabilitation research teams. In this article, the authors propose expanding FAIRR by including strategies for sustaining interdisciplinary rehabilitation research collaborations: modifying inputs (resources needed to assemble a team and to conduct research activities), shifting activities (steps taken to move the interdisciplinary collaboration forward), and examining what impacts the fit between inputs and activities. Two examples are used to highlight the application of the FAIRR model to interdisciplinary collaborations during COVID-19.
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Affiliation(s)
- Simone V. Gill
- College of Health and Rehabilitation Science: Sargent College, 677 Beacon Street, Boston University, Boston, MA 02215, USA
| | - Danny Shin
- College of Health and Rehabilitation Science: Sargent College, 677 Beacon Street, Boston University, Boston, MA 02215, USA
| | - Maria Ayoub
- College of Health and Rehabilitation Science: Sargent College, 677 Beacon Street, Boston University, Boston, MA 02215, USA
| | - Laura Keegan
- College of Health and Rehabilitation Science: Sargent College, 677 Beacon Street, Boston University, Boston, MA 02215, USA
| | - Phillip C. Desrochers
- College of Health and Rehabilitation Science: Sargent College, 677 Beacon Street, Boston University, Boston, MA 02215, USA
| | - Christine A. Helfrich
- American International College, Division of Occupational Therapy, 1000 State Street, Springfield, MA 01109
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20
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Nichol AA, Mwaka ES, Luyckx VA. Ethics in Research: Relevance for Nephrology. Semin Nephrol 2021; 41:272-281. [PMID: 34330367 DOI: 10.1016/j.semnephrol.2021.05.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
Abstract
Research is crucial to progress in nephrology. It is important that studies are conducted rigorously from the scientific perspective, as well as in adherence to ethical standards. Traditional clinical research places a high value on individual research subject autonomy. Research questions often include the clinical effectiveness of new interventions studied under highly controlled conditions. Such research has brought the promise of new game-changers in nephrology, such as the sodium-glucose cotransporter 2 inhibitors. Implementation research takes such knowledge further and investigates how to translate it into broader-scale policy and practice, to achieve swift and global uptake, with a focus on justice and equity. Newer challenges arising globally in research ethics include those relating to oversight of innovation, biobanking and big data, human-challenge studies, and research during emergencies. This article details the history of clinical research ethics and the role of research ethics committees, describes the evolving spectrum of biomedical research in human medicine, and presents emerging clinical research ethics issues using illustrative examples and a hypothetical case study. It is imperative that researchers and research ethics committees are well versed in the ethical principles of all forms of human research such that research is conducted to the highest standards and that effective interventions can be implemented at scale as rapidly as possible.
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Affiliation(s)
- Ariadne A Nichol
- Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA
| | - Erisa S Mwaka
- Department of Anatomy, College of Health Sciences, Makerere University, Kampala, Uganda
| | - Valerie A Luyckx
- Renal Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
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21
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El-Menyar A, Mekkodathil A, Asim M, Consunji R, Rizoli S, Abdel-Aziz Bahey A, Al-Thani H. Publications and retracted articles of COVID-19 pharmacotherapy-related research: A systematic review. Sci Prog 2021; 104:368504211016936. [PMID: 33989091 PMCID: PMC10454799 DOI: 10.1177/00368504211016936] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
The current COVID-19 pandemic situation has stimulated an unplanned clinical research paradigm which is evident from the surge of clinical trial registrations and the increasing number of COVID-related publications. We aimed to explore the standards for research conduction, publications and retraction of articles related to COVID-19 pharmacotherapy research during the pandemic. We analysed data from the contemporary literatures on studies reporting pharmacological agents for COVID-19 using MEDLINE, PubMed, WHO database and Google Scholar between January 01, 2020 and March 20, 2021. The initial search revealed a total of 61,801 articles. Based on the inclusion criteria, a total of 124 studies related to various pharmacological agents were included in the final analysis. Most of the studies were reported from the United States (n = 30, 24%). Of the 124 studies, 50 (40%) were randomized controlled trials (RCTs). Immunomodulatory drugs-related (n = 17, 34%) and COVID-19 vaccine-related studies (n = 14, 28%) were the main topics in the relevant RCTs. The median days for dissemination of findings in journals were 114 days (IQR 61-189). A comparative analysis revealed that RCTs were disseminated earlier (median 79 days; IQR 52-131) when compared to observational studies (median = 144 days; IQR 69-206) (p = 0.003). Six papers were retracted from high impact journals; in which the average period till publication was 33 days. Retraction of papers occurred within 10-48 days. Expedited reviews, research approval and early publications of COVID-19 related pharmaceutical studies could have an impact on the quality of publications. However, the huge number of publications in short time creates confusion for readers during the early phases of the pandemic. Retraction of papers is alarming but ensures research integrity and correctness of scientific information. These abbreviated processes could affect patient care and public awareness. It is imperative to follow rapid but rigours ethical standards for research approval and peer-review process for publications during health pandemics.
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Affiliation(s)
- Ayman El-Menyar
- Clinical Medicine, Weill Cornell Medical College, Doha, Qatar
- Clinical Research, Trauma Surgery, Hamad General Hospital, Doha, Qatar
| | | | - Mohammad Asim
- Clinical Research, Trauma Surgery, Hamad General Hospital, Doha, Qatar
| | - Rafael Consunji
- Injury Prevention Program, Trauma Surgery, Hamad General Hospital, Doha, Qatar
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22
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Chen Y, Cheng L, Lian R, Song Z, Tian J. COVID-19 vaccine research focusses on safety, efficacy, immunoinformatics, and vaccine production and delivery: a bibliometric analysis based on VOSviewer. Biosci Trends 2021; 15:64-73. [PMID: 33746182 DOI: 10.5582/bst.2021.01061] [Citation(s) in RCA: 32] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
Coronavirus Disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has affected tens of millions of people globally since it was declared a pandemic by the World Health Organization (WHO) on March 11, 2020. There is an urgent need for safe and effective preventive vaccines to curb this pandemic. A growing amount of related research has been published. This study aimed to provide the current status of COVID-19 vaccine using bibliometric analysis. We searched Embase.com and MEDLINE comprehensively and included articles, articles in press, reviews, short surveys, conference abstracts and conference papers about COVID-19 vaccine. VOSviewer1.6.11 (Leiden University, Leiden, Netherlands) was applied to perform the bibliometric analysis of these papers. A total of 1,312 papers were finally included. The BMJ has been the most popular journal in this field. The United States maintained a top position worldwide and has provided a pivotal influence, followed by China, India and United Kingdom. Among all the institutions, Harvard University was regarded as a leader for research collaboration. We analyzed the keywords and identified seven COVID-19 vaccine research hotspot clusters. COVID-19 vaccine research hotspots focus on clinical trials on vaccine safety and efficacy, research on vaccine immunology and immunoinformatics, and vaccine hesitancy. Our analysis results demonstrated that cooperation between countries, institutions, and authors were insufficient. The results suggested that clinical trials on vaccine safety, efficacy, immunology, immunoinformatics, production and delivery are research hotspots. Furthermore, we can predict that there will be a lot of research focusing on vaccine adverse reactions.
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Affiliation(s)
- Yamin Chen
- Key Laboratory of Evidence-based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China.,Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou, China
| | - Luying Cheng
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou, China
| | - Rongna Lian
- The First Clinical Medical College, Lanzhou University, Lanzhou, China
| | - Ziwei Song
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou, China
| | - Jinhui Tian
- Key Laboratory of Evidence-based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou, China.,Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China
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23
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Lam G, Zhou Y, Wang JX, Tsui YP. Targeting mesenchymal stem cell therapy for severe pneumonia patients. World J Stem Cells 2021; 13:139-154. [PMID: 33708343 PMCID: PMC7933990 DOI: 10.4252/wjsc.v13.i2.139] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2020] [Revised: 12/03/2020] [Accepted: 12/27/2020] [Indexed: 02/06/2023] Open
Abstract
Pneumonia is the inflammation of the lungs and it is the world's leading cause of death for children under 5 years of age. The latest coronavirus disease 2019 (COVID-19) virus is a prominent culprit to severe pneumonia. With the pandemic running rampant for the past year, more than 1590000 deaths has occurred worldwide up to December 2020 and are substantially attributable to severe pneumonia and induced cytokine storm. Effective therapeutic approaches in addition to the vaccines and drugs under development are hence greatly sought after. Therapies harnessing stem cells and their derivatives have been established by basic research for their versatile capacity to specifically inhibit inflammation due to pneumonia and prevent alveolar/pulmonary fibrosis while enhancing antibacterial/antiviral immunity, thus significantly alleviating the severe clinical conditions of pneumonia. In recent clinical trials, mesenchymal stem cells have shown effectiveness in reducing COVID-19-associated pneumonia morbidity and mortality; positioning these cells as worthy candidates for combating one of the greatest challenges of our time and shedding light on their prospects as a next-generation therapy to counter future challenges.
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Affiliation(s)
- Guy Lam
- School of Biomedical Sciences, University of Hong Kong, Hong Kong 999077, China
| | - Yuan Zhou
- Research and Development, Help Therapeutics Co. Ltd., Nanjing 211100, Jiangsu Province, China
| | - Jia-Xian Wang
- Research and Development, Help Therapeutics Co. Ltd., Nanjing 211100, Jiangsu Province, China
| | - Yat-Ping Tsui
- Research and Development, Help Therapeutics Co. Ltd., Nanjing 211100, Jiangsu Province, China.
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24
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Hashem H, Abufaraj M, Tbakhi A, Sultan I. Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic. Front Med (Lausanne) 2020; 7:598038. [PMID: 33425945 PMCID: PMC7785796 DOI: 10.3389/fmed.2020.598038] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2020] [Accepted: 11/24/2020] [Indexed: 12/14/2022] Open
Abstract
The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.
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Affiliation(s)
- Hasan Hashem
- Division of Pediatric Hematology Oncology, Department of Pediatrics, King Hussein Cancer Center (KHCC), Amman, Jordan
| | - Mohammad Abufaraj
- Division of Urology, Department of Special Surgery, Jordan University Hospital, Amman, Jordan
| | - Abdelghani Tbakhi
- Department of Cellular Therapy and Applied Genomics, King Hussein Cancer Center (KHCC), Amman, Jordan
| | - Iyad Sultan
- Division of Pediatric Hematology Oncology, Department of Pediatrics, King Hussein Cancer Center (KHCC), Amman, Jordan
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25
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Sahebi A, Moayedi S, Golitaleb M. COVID-19 pandemic and the ethical challenges in patient care. J Med Ethics Hist Med 2020; 13:24. [PMID: 34055240 PMCID: PMC8141212 DOI: 10.18502/jmehm.v13i24.4955] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2020] [Accepted: 12/01/2020] [Indexed: 11/24/2022] Open
Affiliation(s)
- Ali Sahebi
- PhD Candidate in Health in Emergencies and Disasters, Department of Health in Emergencies and Disasters, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Siamak Moayedi
- Assistant Professor, Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore, USA
| | - Mohamad Golitaleb
- Instructor, Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran
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26
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Sharma MK, Anand N, Singh P, Vishwakarma A, Mondal I, Thakur PC, Kohli T. Researcher burnout: An overlooked aspect in mental health research in times of COVID-19. Asian J Psychiatr 2020; 54:102367. [PMID: 33271688 PMCID: PMC7446612 DOI: 10.1016/j.ajp.2020.102367] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/07/2020] [Revised: 08/02/2020] [Accepted: 08/24/2020] [Indexed: 12/31/2022]
Affiliation(s)
- Manoj Kumar Sharma
- SHUT Clinic (Service for Healthy Use of Technology), Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
| | - Nitin Anand
- Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
| | - Priya Singh
- SHUT Clinic, Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
| | - Akash Vishwakarma
- SHUT Clinic, Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
| | - Ishita Mondal
- Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
| | | | - Tavleen Kohli
- Department of Clinical Psychology, NIMHANS, Bangalore, Karnataka, India.
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27
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Magaço A, Munguambe K, Nhacolo A, Ambrósio C, Nhacolo F, Cossa S, Macete E, Mandomando I. Challenges and needs for social behavioural research and community engagement activities during the COVID-19 pandemic in rural Mozambique. Glob Public Health 2020; 16:153-157. [PMID: 33125306 DOI: 10.1080/17441692.2020.1839933] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
After the Ebola outbreaks the world is again facing a challenge in which human behaviours and contact history play crucial roles in determining the trends in disease spreading within and across communities. With the onset of the recent coronavirus disease (COVID-19) pandemic, several issues related to conducting social behavioural sciences research and related community engagement activities arise, especially in rural areas of low-income countries, where the coverage of information and communication technologies (ICTs) is limited and their application on field-based research would imply a biased selection of relatively more privileged minorities with access to on-line and other communication platforms not requiring physical contact. This article enumerates and discusses the different technical challenges that social behavioural sciences research and community engagement activities face in times of public health emergencies caused by pandemics such as COVID-19. It also highlights the possibility of using alternative approaches to maintain the engagement with members of rural communities in research and social action activities, as well as the ethical challenges arising from such approaches.
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Affiliation(s)
- Amílcar Magaço
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
| | - Khátia Munguambe
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.,Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique
| | - Ariel Nhacolo
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
| | - Contardo Ambrósio
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
| | - Felizarda Nhacolo
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
| | - Saquina Cossa
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique
| | - Eusébio Macete
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.,National Directorate of Public Health, Maputo, Mozambique
| | - Inácio Mandomando
- Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique.,Instituto Nacional de Saúde (INS), Maputo, Mozambique
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28
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Du L, Chen YM, Li Y, Yuan W, Wang JS. Prevalence of depression during the SARS, MERS, and COVID-19 pandemics: A protocol for overview of systematic reviews. Medicine (Baltimore) 2020; 99:e22235. [PMID: 32957366 PMCID: PMC7505281 DOI: 10.1097/md.0000000000022235] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
BACKGROUND The outbreak of the novel coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has emerged to be the biggest global health threat worldwide. COVID-19 marks the emergence of the third large-scale epidemic related to the coronavirus, after SARS-CoV in 2002 and Middle-East respiratory syndrome coronavirus (MERSCoV) in 2012. The pandemic has had a harmful effect on the public mental health, especially on depression. Increasing systematic reviews (SRs) of coronavirus were focusing on depression. However, the methodological quality of these SRs is unclear. Therefore, to evaluate and compare the normativity of report of SR, we conducted a comprehensive overview of depression during the SARS, MERS, and COVID-19 pandemics. METHODS Two independent reviewers will conduct comprehensively searches in PubMed, EMBASE.com, Web of Science, the Cochrane Library, Chinese biomedical literature database (CBM), Chinese National Knowledge Infrastructure (CNKI), Wan fang Database, Chongqing VIP (CQVIP). Reference lists of articles, gray literature, and conference proceedings will also be searched. We will extract the data and assess the methodological quality using the Assessment of Multiple Systematic Reviews-2 (AMSTAR-2) measurement tool and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. General characteristics of the eligible SRs will be summarized and described. We will provide AMSTAR-2 and PRISMA assessments in tabular form for each review, the total percentage of each item will be calculated. Endnote X8 and EXCEL will be used. RESULTS Using the draft search strategy of databases, 8 SRs met the a priori criteria and were included. The overview of SRs will be published in a peer-reviewed journal. CONCLUSION Our overview will be a comprehensive synthesis of the existing systemic review on depression with SARS, MERS, and COVID-19. PROTOCOL REGISTRATION INPLASY202080003.
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Affiliation(s)
- Li Du
- The Third People's Hospital of Lanzhou City
| | - Ya-Min Chen
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University
| | - Ying Li
- Department of Obstetrics, the First Hospital of Lanzhou University
| | - Wei Yuan
- Department of Cardiovascular Medicine, the First Hospital of Lanzhou University
| | - Jian-Shu Wang
- Department of bone and soft tissue oncology, Gansu Provincial Cancer Hospital, Lanzhou, China
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29
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Matsui K, Yamamoto K, Inoue Y. Professional Commitment to Ethical Discussions Needed From Epidemiologists in the COVID-19 Pandemic. J Epidemiol 2020; 30:375-376. [PMID: 32624521 PMCID: PMC7429145 DOI: 10.2188/jea.je20200278] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022] Open
Affiliation(s)
- Kenji Matsui
- Division of Bioethics and Healthcare Law, the National Cancer Center Japan
| | - Keiichiro Yamamoto
- Department of Biomedical Ethics, University of Tokyo Graduate School of Medicine.,Clinical Research Center, the National Center for Global Health and Medicine
| | - Yusuke Inoue
- Department of Public Policy, University of Tokyo Institute of Medical Science
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30
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Ma X, Wang Y, Gao T, He Q, He Y, Yue R, You F, Tang J. Challenges and strategies to research ethics in conducting COVID-19 research. J Evid Based Med 2020; 13:173-177. [PMID: 32445288 PMCID: PMC7280675 DOI: 10.1111/jebm.12388] [Citation(s) in RCA: 29] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/19/2020] [Accepted: 03/27/2020] [Indexed: 12/13/2022]
Abstract
The number of research involving human subjects on coronavirus disease 2019 (COVID-19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review-related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity-improving and efficiency-improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.
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Affiliation(s)
- Xitao Ma
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Yanqiao Wang
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Tian Gao
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Qing He
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Yan He
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Rensong Yue
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Fengming You
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
| | - Jianyuan Tang
- Hospital of Chengdu University of Traditional Chinese MedicineChengduP.R. China
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