Empowering local research ethics review of antibacterial mass administration research

作     者：Nelson K.Sewankambo Paul Kutyabami Nelson K. Sewankambo;Paul Kutyabami

作者机构：Department of MedicineSchool of MedicineCollege of Health SciencesMakerere UniversityP.O.Box 7072KampalaUganda Department of PharmacySchool of Health SciencesCollege of Health SciencesMakerere UniversityP.O.Box 7072KampalaUganda 

出 版 物：《Infectious Diseases of Poverty》 (贫困所致传染病（英文）)

年 卷 期：2022年第11卷第5期

页      面：1-13页

核心收录：

学科分类：01[哲学] 0101[哲学-哲学] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 010105[哲学-伦理学] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 

基　　金：This work was supported under a Greenwall Foundation (G# 134972) grant on the "Mass Administration of Antibiotics: Reaching Clinical and Community Equipoise" as part of the Making a Difference in Real-World Bioethics Dilemmas program. The Greenwall Foundation did not have a role in the design of the study  collection  analysis  and interpretation of data or in writing the manuscript. 

主　　题：Antibiotic Mass drug administration Ethics Review Committee Ethics Review Institutional Review Board Empowerment Guidance Trials 

摘      要：Background::Recent studies using mass drug administration(MDA)of antibiotics to entire communities have focused global attention on the unique ethical challenges of MDA of antibiotics in research and public health interventions.However,there is no specific guidance for Research Ethics Committees(RECs)or Institutional Review Boards(IRBs)to review such trials.We surveyed the literature to identify the unique ethical challenges and to strengthen the competencies of RECs or IRBs in low-and middle-income countries(LMICs)in their ethical reviews of these trials.Methods::We employed a desk review.We searched PubMed,Web of Science,and Google Scholar,combining terms formass drug administrationwith terms forresearch ethics committees,institutional review boards,andethics.We reviewed citations of search results to retrieve additional articles.Only articles published and indexed in the above databases up to 6 January 2022 in English were included.Abstracts(without full articles),books and articles that had exclusive veterinary and environmental focus were excluded.We synthesized the literature to identify particularly challenging ethical issues relevant to antibacterial MDA trials in LMICs.Results::The most challenging ethical issues can be categorised into four broad domains:determining the social value of MDA,assessing risks and benefits,engaging all stakeholders meaningfully,and study design-related ethical challenges.These four domains interact and impact each other.Together,they reveal the need for RECs/IRBs to review MDA studies through a broader lens than that of clinical trials per se.From our findings,we propose a framework to guide the RECs and IRBs in LMICs to perform the initial and continuing review of antibiotic MDA trials.We also recommend strengthening the competencies of LMIC RECs or IRBs through ongoing training and collaboration with RECs or IRBs from high-income countries.Conclusions::REC/IRB review of research using MDA of antibiotics plays a critical role in assuring the ethical conduct of MDA studies.Local RECs/IRBs should be empowered to review MDA studies comprehensively and competently in order to advance scientific knowledge about MDA and promote improved global health.