CIOMS cited

International ethics frameworks emphasize both the protection of vulnerable participants and the importance of equitable inclusion in research. In ultra-rare gene therapy trials, extensive safety monitoring, long-term follow-up requirements, and specialized treatment infrastructure are necessary to ensure participant protection and scientific validity. However, these requirements operate within healthcare systems characterized by geographic, financial, and social inequalities, raising concerns about whether all eligible patients have a fair opportunity to participate. Recent regulatory reforms in the European Union, United Kingdom and United States increasingly promote methodological flexibility for small patient populations through adaptive trial designs, risk proportionate oversight, and alternative evidentiary approaches.

Migraine is one of the most disabling neurological disorders worldwide and is a leading cause of years lived with disability. The introduction of calcitonin gene-related peptide (CGRP)-directed monoclonal antibodies and gepants has moved prevention from a largely empirical, symptom-management paradigm toward mechanism-based therapy that can plausibly alter disease trajectory. That therapeutic shift raises a decisive neuroethical question: can it still be ethically acceptable to randomize participants with frequent migraine to months of placebo when highly effective, migraine-specific preventive options exist?  

This response analyses the discussion by Parsa-Parsi et al on the 2024 revision of the Declaration of Helsinki (DoH). The author argues that they underestimate the conceptual and practical significance of the new approach to the concept of vulnerability and how this approach connects to the Council for International Organizations of Medical Sciences (CIOMS) 2016 Guidelines. Drawing on the idea of ‘layers of vulnerability’, the author highlights how vulnerability is often contextual, dynamic and cumulative, and how this view avoids essentialising entire groups (such as pregnant persons) while clarifying when and how people facing multiple vulnerabilities can be ethically included in research with appropriate protections. The author further argues that there are similarities between DoH and CIOMS and that a closer alignment with CIOMS in the interpretation of the DoH offers a more coherent and practically useful framework for research ethics committees and researchers.

The aim of this paper is to discuss the ethical and legal justification of the broadly accepted ethical principle that researchers may not include adults without decision-making capacity to consent to participating in research studies if there are potential research participants with capacity who could be included instead. From the perspective of disability rights, the paper argues that this ethical principle is overprotective in its current form as it gives insufficient consideration to providing persons with disabilities the opportunity to participate in research on an equal basis with others. Nonetheless, the paper also argues that rather than rejecting this ethical principle entirely, it should be qualified to strike a better balance between protecting people without decisional capacity to consent to research and including them.

Fluconazole is key for pulmonary cryptococcosis (PC), but its hepatotoxicity (HT) risk is unclear. This study characterized fluconazole-induced liver injury in HIV-neg ative PC patients and explored its mechanism.

While medicine regulation in many countries requires prescription drug labels to classify side effects based on their incidence, when eliciting preferences of patients, most discrete choice experiments (DCEs) group side effects by severity. This mismatch between the presentation of side-effect attribute labels in DCEs and real-world choice contexts may impact patients’ choices, bias risk preferences, and threaten external validity. This study investigated whether using incidence compared with severity labels impacts preferences and DCE reliability.

While medicine regulation in many countries requires prescription drug labels to classify side effects based on their incidence, when eliciting preferences of patients, most discrete choice experiments (DCEs) group side effects by severity. This mismatch between the presentation of side-effect attribute labels in DCEs and real-world choice contexts may impact patients’ choices, bias risk preferences, and threaten external validity. The authors investigate whether using incidence compared with severity labels impacts preferences and DCE reliability.