We are interested to conduct research using the VR-Biopac system in human subjects in a medical school lab (non-hospital location). We intend to measure various parameters (RSP –measure abdominal or thoracic expansion and contraction while breathing, ECG –record electrical activity generated by the heart ECG, Photo Plethysmogram (PPG), Electrodermal Activity). Also, we can assess exercise testing (CPET/VO2peak), anaerobic-aerobic thresholds, resting metabolism, and substrate utilization using the COSMED device.
We need to know the standards, regulations, and legal frame to develop such a clinical project in a non-clinical location (university) in order to obtain the approval of the research ethical commission.
Dear Veronica,
it will be important to know the country you are conducting the study in. Is it EU-based? Data protection will have to be considered, as well as informed consent and potential risks of the intervention. Which is your ethical comission?
Best
Boris
Dear Boris,
I am working in Iasi, Romania (a European Union country). Our VR project has to be assessed and approved by the research ethics commission of the University of Medicine and Pharmacy from Iasi.
I much appreciate your help!
Dear Veronica Mocanu :
Does the EC provide any documents to guide you trough the process? Your study sound interesting and you should not experience any major problems with approval. However, you need to make sure your participants are properly informed also with regard to data storing and processing (EU GDPR will apply). Exercise testing could be the only hurdle you have to take (all other variable you record are non invasive). For exercise testing, certain criteria will apply including communication of risks to the participants and relative and absolute criteria for test termination.
Best Boris
Off course you need Ethics approval! This is also especially important if you want to report in a scientific journal your results
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