CIOMS cited

During the 2014–2016 Ebola epidemic in West Africa and the Ebola outbreaks between 2018 and 2020 in the Democratic Republic of Congo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes. Members of ethics committees, health authorities, health professionals, and political authorities were interviewed in the Democratic Republic of Congo and a workshop held with ethics committee members and regulatory authorities from Sierra Leone and Guinea, in order to document their experiences of reviewing, approving, and regulating current and new studies during epidemics and outbreaks, and to document lessons learnt and their recommendations for the rapid review of clinical trial protocols during public health emergencies.

Real-world data and real-world Evidence in regulatory decision making: report summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.

This study addresses these bioethical implications in the use of digital technologies to conduct mental health research, as noted by the Research Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry during the social distancing measures during the COVID-19 pandemic in Mexico. The increased use of digital tools abruptly transformed the manner in which studies were conducted, especially for those not familiar with this modality. The transition to these new digital technologies must include consideration of the bioethical implications of these strategies, and ethics committees must work with researchers to identify the best ways to safeguard the dignity, autonomy, and rights of participants.

The 8th European Pharmacovigilance Congress: speaker abstracts.

Aggregation of adverse event terms for signal detection and labeling in clinical trials. (Requires subscription). See also the CIOMS report on MedDRA Labeling Grouping (reference 40 in the publication)