Healthy volunteers participating in biomedical research benefit from varying levels of protection in different parts of the world since they are too rarely identified as a specific subset of study participants with specific vulnerabilities and risks. These differences in protection can lead to unfair and ethically unacceptable situations. Healthy volunteers are subject to a number of risks, not only regarding the respect of their rights and of their health but they are also at risk of being exploited because of their financial situation, educational level and motivations. In the end, the scientific validity of the studies may also be called into question. Through its work, the VolREthics (Volunteers in Research and Ethics) initiative, set up by the Inserm ethics committee, outlines the ethical issues raised by the involvement of healthy volunteers in biomedical research, and highlights the need to improve their protection worldwide. Healthy volunteers are essential to scientific progress and society, and their potential vulnerabilities must be recognized and taken into account.
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http://dx.doi.org/10.1051/medsci/2023118 | DOI Listing |
Sensors (Basel)
December 2024
Abu Dhabi Maritime Academy, Abu Dhabi P.O. Box 54477, United Arab Emirates.
Electroencephalography (EEG) has emerged as a pivotal tool in both research and clinical practice due to its non-invasive nature, cost-effectiveness, and ability to provide real-time monitoring of brain activity. Wearable EEG technology opens new avenues for consumer applications, such as mental health monitoring, neurofeedback training, and brain-computer interfaces. However, there is still much to verify and re-examine regarding the functionality of these devices and the quality of the signal they capture, particularly as the field evolves rapidly.
View Article and Find Full Text PDFPharmaceutics
December 2024
Department of Psychiatry, Oxford University, Warneford Hospital, Oxford OX3 7JX, UK.
: Cannabidiol (CBD) is an approved treatment for childhood epilepsies and a candidate treatment for several other CNS disorders. However, it has poor oral bioavailability. We investigated the effect of a novel lipid formulation on its absorption in humans and on its tissue distribution in mice.
View Article and Find Full Text PDFNutrients
December 2024
Bionos Biotech SL, LabAnalysis Life Science, Biopolo Hospital La Fe, 46026 Valencia, Spain.
Background/objectives: Magnesium (Mg)-based food supplements contribute to the maintenance of adequate levels of Mg that are essential for overall health and well-being. The aim of this double-blind, randomized, cross-over clinical study was to assess the plasma Mg levels in volunteers following the oral administration of a magnesium-based nutraceutical ingredient, MAGSHAPE microcapsules (Mg-MS), in comparison to other commonly used magnesium sources, including the following: Mg Oxide (MgO), Mg Citrate (Mg-C), and Mg bisglycinate (Mg-BG).
Methods: A total of 40 healthy women and men were put on a low-Mg diet for 7 days, and after 8 h of fasting, a blood sample was taken from a digital puncture before (0 h) and 1 h, 4 h, and 6 h after the oral intake of each product.
Int J Mol Sci
December 2024
Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences, Zlotowski Center for Neuroscience and Zelman Center-The School of Brain Sciences and Cognition, Ben-Gurion University of the Negev, Beer-Sheva 8410501, Israel.
This narrative review examines lithium's effects on immune function, inflammation and cell survival, particularly in bipolar disorder (BD) in in vitro studies, animal models and clinical studies. In vitro studies show that high lithium concentrations (5 mM, beyond the therapeutic window) reduce interleukin (IL)-1β production in monocytes and enhance T-lymphocyte resistance, suggesting a protective role against cell death. Lithium modulates oxidative stress in lipopolysaccharide (LPS)-activated macrophages by inhibiting nuclear factor (NF)-ƙB activity and reducing nitric oxide production.
View Article and Find Full Text PDFMedicina (Kaunas)
December 2024
Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Rome Open University, 00166 Rome, Italy.
: In this study, the effects of an eight-week exercise and nutrition program on blood lipids, glucose, insulin, insulin resistance (HOMA-IR), leptin, ghrelin, irisin, malondialdehyde (MDA), and Growth Differentiation Factor 15 (GDF15) in overweight women were investigated. : A total of 48 women volunteers participated in this study. The participants were randomly divided into four groups: control (C), exercise (E), nutrition (N), exercise + nutrition (E + N).
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