Reporting ethical approval in case reports and case series in 12 consecutive years: A systematic review

作     者：Linh Tran Vuong Thanh Huan Luu Lam Thang Tai Adnan Safi Moustafa ElBadry Ahmed Mohamed Osman Algazar Sedighe Karimzadeh Nguyen Vinh Khang Nguyen Hai Nam Zaheer Ahmad Qureshi Nguyen Lam Vuong Le Huu Nhat Minh Nguyen Tien Huy 

作者机构：University of Health SciencesVietnam National University Ho Chi Minh CityHo Chi Minh CityVietnam Department of Sport MedicinePham Ngoc Thach University of MedicineHo Chi Minh CityVietnam Department of CardiologyCity Children HospitalHo Chi Minh CityVietnam Department of MedicineLahore General HospitalLahorePakistan Faculty of MedicineSohag UniversitySohagEgypt Neurology DepartmentAlharam HospitalGizaEgypt Department of Pharmaceutical SciencesSchool of Pharmacy and Pharmaceutical SciencesUniversity of California IrvineIrvineCaliforniaUSA Department of NeurologyUniversity Medical CenterHo Chi Minh CityVietnam Department of Liver TumorCancer CenterCho Ray HospitalHo Chi Minh CityVietnam Liver Transplant UnitCancer CenterCho Ray HospitalHo Chi Minh CityVietnam The Frank H.Netter M.D School of Medicine at Quinnipiac UniversityBridgeportUSA Department of Medical Statistics and InformaticsFaculty of Public HealthUniversity of Medicine and Pharmacy at Ho Chi Minh CityHo Chi Minh CityVietnam International Ph.D.Program in MedicineCollege of MedicineTaipei Medical UniversityTaipeiTaiwanChina Global Clinical Scholars Research Training ProgramHarvard Medical SchoolBostonMassachusettsUSA Institute of Research and DevelopmentDuy Tan UniversityDa NangVietnam School of Medicine and PharmacyDuy Tan UniversityDa NangVietnam School of Tropical Medicine and Global Health(TMGH)Nagasaki UniversityNagasakiJapan 

出 版 物：《Health Care Science》 (科学医疗(英文))

年 卷 期：2024年第3卷第5期

页      面：298-311页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Imperial College London, London, United Kingdom Department of Medical Laboratory Science, College of Health Sciences, University of Human Development 

主　　题：case report case series ethical approval declaration of Helsinki institutional review board informed consent 

摘      要：Our study describes the reported rate of the Institutional Review Board(IRB)approval,declaration of Helsinki(DoH),and informed consent in the case reports and case series and investigates factors associated with the ethical approval *** searched PubMed for case reports and case series from 2006 to ***,we obtained the first 20 articles of a case report cluster from 20 distinct *** analysis initially contained at least 2400 papers,with 100 papers each study design and *** 26(5.4%)of 480 included studies reported IRB approval,DoH approval,and participant informed consent;58(12.1%)reported two out of three ethical statements(DoH,informed consent,IRB);and 151(31.5%)reported only one,leading to nearly 245 studies(51.0%)did not report any ethical approval *** clusters mentioned the DoH the *** years,ages,ethical item types,and cluster types were associated with ethical reporting *** study found the serious under‐reporting of ethical practices in both case reports and case series.