CIOMS cited

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.

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.

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.

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.

This study explores stakeholders’ perspectives on post-trial access (PTA) in clinical trials and its feasibility in Ethiopia. Research participants considered that trial participants and communities should benefit from clinical trials and that multi-stakeholder collaboration was key in PTA planning and arrangements. However, they were uncertain of PTA feasibility in Ethiopia mostly due to a lack of legislation, regulations and guidelines on PTA and fear of losing sponsors because of increased costs resulting from them being obligated to provide PTA. It was recommended that Ethiopia establishes legislation and guidelines to govern PTA.

Based on a 2018 study to assess training needs of research ethics committees (RECs) in Colombia,Costa Rica, Guatemala, and Mexico, this paper describes information on RECs operating procedures related to biobank research reported by 55 participants. The study concluded that RECs in Mesoamerican countries lack clear policies on biobanks and have deficiencies in informed consent and governance. Regulatory advances and ongoing training are needed to protect participants’ rights.

This study explores the perspectives of researchers and research ethics committee (REC) members in Tanzania regarding post-trial obligations and their alignment with key ethical frameworks such as the Belmont Report, CIOMS guidelines and the Declaration of Helsinki. Findings revealed significant gaps in post-trial care, particularly in maintaining access to interventions. RECs and researchers face challenges in fulfilling post-trial responsibilities, calling for clear guidelines and sustainable post-trial mechanisms in resource poor settings.