Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings.

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-06-18 DOI:10.1515/cclm-2024-0604
Julián Verona, Yilmaz Gülsen, Martina Zaninotto, Sody Munsaka, Nafija Serdarevic, Sudip K Datta, Joesph Wiencek, Nilda Fink
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Abstract

Objectives: To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals.

Methods: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature.

Results: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties.

Conclusions: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

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临床研究项目和实验室医学伦理核对表:评估不同环境下生物伦理原则遵守情况的两种工具。
目的制定两份伦理检查表,以评估(i)研究项目中伦理问题的管理和(ii)医疗实验室专业人员对伦理行为的认识:方法:IFCC 伦理学特别小组成员根据相关文献进行全面讨论:本临床研究项目核对表应有助于在向 IRB 或同等机构提交研究项目之前从伦理角度对其进行评估,从而降低拒绝率并提高项目的时间效率。为评估实验室医学伦理行为而设计的核对表可用于自我评估(内部审计)和第三方执行的认证/认可程序:这些核对表虽然简单,但却是指导专业人员在实践中遵守伦理原则的有力工具,尤其是在难以找到经认可的伦理委员会的发展中国家。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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