TY - JOUR
T1 - Why We Need Stricter Oversight of Research Involving Human Subjects Affected by Conflict
AU - Ataullahjan, Anushka
AU - Lo, Samantha
AU - Aziz, Mohammad Haaris
AU - Somani, Nadia Amin
AU - Bhutta, Zulfiqar A.
N1 - Funding Information:
Acknowledgements This work was supported in part by the SickKids Centre for Global Child Health, which, as coordinator of the Bridging Research and Action in Conflict Settings for the Health of Women and Children (BRANCH), has received funding for BRANCH research activities, including from the International Development Research Centre (108416-002 and 108640-001), the Norwegian Agency for Development Cooperation (QZA-16/0395), the Bill and Melinda Gates Foundation (OPP1171560), and UNICEF (PCA 20181204).
Funding Information:
Methods Data sources. Using targeted Google searches and search functions on agency websites, we found national research guidelines for 17 humanitarian donor countries and unions (Australia, Belgium, Canada, Denmark, the European Union, France, Germany, Ireland, Italy, Japan, the Netherlands, Norway, Sweden, Switzerland, the United Kingdom, Spain, and the United States) that were drawn from the list of top 20 countries contributing to humanitarian assistance as identified in the 2018 Global Humanitarian Assistance Report.24 Furthermore, using targeted Google searches and search functions on government websites, we found national guidelines from 8 conflict-affected countries (Bangladesh, Lebanon, Liberia, Nigeria, Pakistan, the Democratic Republic of Congo, Mali, Ukraine) of 20 identified. Sixteen conflict-affected countries were identified using the 2018 Harmonized List of Fragile Situations,25 and 4 were identified by other means. Two guidelines from humanitarian donor countries (Spain, Germany) and 3 guidelines from conflict-affected countries (Democratic Republic of Congo, Mali, Ukraine) were not extracted because they were not in English. Using similar searches, research guidelines were included in the analysis from 3 UN agencies—the UN Office for the Coordination of Humanitarian Affairs, the World Health Organization (WHO), and UNICEF—of the 9 such agencies active in conflict settings that were identified from the 2018 Global Humanitarian Assistance Report,24 and granting regulations were included in the analysis from 9 donor agencies (the Bill and Melinda Gates Foundation, the Wellcome Trust, the Medical Research Council, the National Institutes of Health, the North American Aerospace Defense Command, the Swedish International Development Cooperation Agency, GAVI, the Global Fund, and the International Development Research Centre) (see Supplementary Appendix) from a list of 10 of the major research funding bodies and national funders (the Global Financing Facility was excluded).
Publisher Copyright:
Copyright © 2022 American Medical Association. All rights reserved.
PY - 2022/6
Y1 - 2022/6
N2 - Background: Despite the potential for ethical violations when research is conducted with conflict-affected populations, there is limited information on how and the extent to which ethical considerations specific to doing research with these populations are integrated into national and international ethics guidelines and, in turn, how these guidelines translate into practice. This study aims to fill this gap by systematically analyzing the existing research ethics guidance of humanitarian donor countries, conflict-affected countries, United Nations (UN) agencies, and funding agencies, as well as ethics reporting in research articles on conflict-affected populations published in peer-reviewed journals. Methods: A review of 32 research ethics guidelines and granting regulations from UN agencies, donor agencies, and governments was conducted, and the reporting of ethics procedures and practices of 498 articles published in peer-reviewed journals was analyzed. Results: Of the reviewed guidelines and regulations, 87.5% did not mention conflict-affected populations, and only one guideline (3.1%) catalogued any of the complexities of conducting research with conflict-affected populations. Among the reviewed published research articles on conflict-affected populations, obtaining ethics approval or a waiver was reported in only 48.2% of articles, and obtaining informed consent was reported in only 46.6% of studies. In the subset of articles that did not report receiving ethics approval, 88.5% were published in journals that required reporting of ethics approval. Conclusions: This study highlighted a gap in current research guidelines and granting regulations on the ethical conduct of research with conflict-affected populations and illustrated the need for such guidance to be integrated into governing documents and research practices. Moreover, this study demonstrated that there is a need for stricter enforcement of reporting requirements by journals to ensure that research with conflict-affected populations meets the required ethical standard. Partnerships among institutional ethics committees, donor agencies, and journals can ensure that the rights of conflict-affected populations are protected.
AB - Background: Despite the potential for ethical violations when research is conducted with conflict-affected populations, there is limited information on how and the extent to which ethical considerations specific to doing research with these populations are integrated into national and international ethics guidelines and, in turn, how these guidelines translate into practice. This study aims to fill this gap by systematically analyzing the existing research ethics guidance of humanitarian donor countries, conflict-affected countries, United Nations (UN) agencies, and funding agencies, as well as ethics reporting in research articles on conflict-affected populations published in peer-reviewed journals. Methods: A review of 32 research ethics guidelines and granting regulations from UN agencies, donor agencies, and governments was conducted, and the reporting of ethics procedures and practices of 498 articles published in peer-reviewed journals was analyzed. Results: Of the reviewed guidelines and regulations, 87.5% did not mention conflict-affected populations, and only one guideline (3.1%) catalogued any of the complexities of conducting research with conflict-affected populations. Among the reviewed published research articles on conflict-affected populations, obtaining ethics approval or a waiver was reported in only 48.2% of articles, and obtaining informed consent was reported in only 46.6% of studies. In the subset of articles that did not report receiving ethics approval, 88.5% were published in journals that required reporting of ethics approval. Conclusions: This study highlighted a gap in current research guidelines and granting regulations on the ethical conduct of research with conflict-affected populations and illustrated the need for such guidance to be integrated into governing documents and research practices. Moreover, this study demonstrated that there is a need for stricter enforcement of reporting requirements by journals to ensure that research with conflict-affected populations meets the required ethical standard. Partnerships among institutional ethics committees, donor agencies, and journals can ensure that the rights of conflict-affected populations are protected.
UR - http://www.scopus.com/inward/record.url?scp=85133445682&partnerID=8YFLogxK
U2 - 10.1001/amajethics.2022.518
DO - 10.1001/amajethics.2022.518
M3 - Review article
AN - SCOPUS:85133445682
SN - 2376-6980
VL - 24
SP - E518-E529
JO - AMA journal of ethics
JF - AMA journal of ethics
IS - 6
ER -