CIOMS cited

This article maps the key legal and ethical challenges which will need to be addressed for a successful roll-out of digital twin models for children living with rare diseases, using the example of phenylketonuria (PKU) as model disease. The main legal challenges, which will arise in virtually all jurisdictions worldwide, have been analysed with a focus on European Union law: data protection, medical device regulation, AI regulation, intellectual property, and product liability. The main ethical challenges have been analyzed using research and digital ethics frameworks of the WHO, UNESCO, HLEG-AI, and CIOMS: autonomy, informed consent to research, trust, and the impact on interpersonal relations, identity and self-understanding. The shortcomings with respect to current laws, regulations, and ethics guidelines are identified. Clear legal and ethical guidance is, however, urgently needed to protect vulnerable groups of patients from harm, notably children living with rare diseases, and to help innovators navigate the complex legal and ethical issues the digital twin concept raises.

Current estimates suggest that Africa contains about 14% of the world’s population and accounts for 20% of the global burden of disease. Yet, it accounts for a mere 3% of clinical trials globally.The time is ripe—even overdue—for determining how best to direct future health research efforts. In response, a call has been heard for a continent-wide Africa-centric research ethics framework to redirect health research in Africa, as well as address the health research ethics malpractices that have violated the rights, dignity and well-being of participating African communities. Nevertheless, we should remain aware of what already exists and what continues to be of value.

The controversy over the use of unethically obtained specimens and data derived from them for research and education is not new to bioethics, but the US Public Health Service project, the Tuskegee Study of Untreated Syphilis (TS), has not been subjected to such scrutiny. A study identified 19 articles published under 13 different journal titles between 1936 and 1973 that detailed the results of TS. Examination of journal records showed that none of the 19 selected publications derived from TS ever received a retraction notice or expression of concern.

Research ethics frameworks used in South Africa view deafness from a biomedical perspective. This could hinder research access to deaf communities. Deaf-centric best practices draw from sociocultural perspectives instead. Motivated by this lack of deaf-centric provisions for research with deaf communities in the existing legal ethical frameworks in South Africa, this article examines best practices for gaining access to Deaf communities based on a broader study on South African Sign Language place names.

A systematic review of policy documents was carried out to provide a comprehensive overview of how vulnerability is conceptualized and operationalized in research ethics. The aim was to investigate the meaning and definition of vulnerability in research ethics, its normative justification, the comprehensive set of subjects it refers to, and consequent provisions.

Since 2016, Moroccan pharmaceutical companies have been required to report adverse effects linked to medicines. Initially, reports were submitted using the CIOMS form, sent by normal mail to le Centre Antipoison et de Pharmacovigilance du Maroc, then using XML files in ICH E2B format, sent electronically. In 2021, a “vigiflow e-reporting for industry” standardized online reporting system was implemented. The primary objective of this study was to evaluate the pharmaceutical companies' use of electronic reporting. Secondarily, the study aimed to assess the quality of adverse drug reaction reports by comparing completeness scores across the three reporting means.

This review aims to define the minimal data scope for association studies in vaccine safety, providing a reference framework for implementing active vaccine surveillance systems (AVSSs) worldwide, especially in low- and middle-income countries. PubMed, Embase and Web of Science were searched for cohort and case-control studies related to AVSS published between January 1, 2018, and September 7, 2022. Guided by the WHO and CIOMS guidelines, a 4D framework for Minimum Data Sets (MDSs), including “Vaccine,” “Outcome,” “Demographic Data,” and “Covariate”, was developed.