CIOMS cited

Social and scientific value is a sine qua non for the ethical justification of medical research involving human participants. A favorable balance of individual benefits and risks does not render clinical research ethically justifiable if it lacks the potential to generate new knowledge that may improve health or well-being. Additionally, the inclusion of collateral benefits in the evaluation of clinical research may lead to or aggravate therapeutic misconception, and be harmful to research participants and to the research community. Collateral benefits may motivate individuals to take part in clinical research, but should be treated with caution.

Adverse drug reactions (ADRs) have a significant impact on the healthcare system worldwide. Underreporting of ADRs is identified as a main issue in pharmacovigilance. Mobile applications(apps) have been introduced as a solution for the underreporting of ADRs. This systematic review was conducted to assess the efficacy of the mobile applications in enhancing ADR reporting.

The primary objective of this scoping review is to understand and evaluate the concept, implementation, frequency, and value of "follow-up" in the context of adverse event (AE) assessment. Secondary objectives include providing an overview of various definitions of "follow-up," describing the requirements and studies evaluating follow-up methods, and assessing how often follow-up is undertaken in assessing an AE, by whom, and its value.

Report of a case of carbamazepine-induced acute hepatocellular liver failure in a patient with trigeminal neuralgia and complete recovery after discontinuation of carbamazepine.

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.

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.

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.