Bibliometric analysis of publications that cited the CIOMS 2016 “International ethical guidelines for health-related research involving humans”

The CIOMS book "International Ethical Guidelines for Health-related Research Involving Humans", published in 2016 (IEG2016), provides information to assist research ethics committee members and research practitioners with pragmatically implementing ethical considerations while planning and conducting their research. To identify which aspects of research IEG2016 has had the greatest impact since its publication, we analyzed metadata from 942 papers that cited IEG2016 (English language title only) from Web of Science (WoS, Clarivate). Using VOSviewer, we mapped the co-occurrence of keywords to derive the network of all keywords that co-occurred at least five times in the set of citing papers. We found that the keywords <i>ethics</i>, <i>research ethics</i>, <i>informed consent</i>, and <i>clinical trials</i> had high co-occurrence scores in this set of publications. Strong links were also observed between <i>ethics</i>, <i>research ethics</i>, and <i>informed consent</i>. We identified fifteen human-related (HR) keyword nodes in this keyword network. Analysis of the subset of 273 IEG2016-citing articles containing these fifteen HR keywords showed later-date publications were focused on the youngest humans (<i>children</i>, <i>adolescents</i>, <i>young people</i>, <i>minors</i>) and the humans typically responsible for those youngest humans, namely <i>women</i> and <i>parents</i>. Seventy-nine of the 110 networked countries/regions associated with IEG2016-citing articles were home to HR keyword articles. We conclude that IEG2016 has had significant impact in health and medical science literature and has served as a foundation for health-related research around the world in the areas of <i>ethics</i>, <i>informed consent</i>, and <i>research ethics</i> and the linkage of these topics to under-represented populations in such research.