{"id":238,"date":"2022-05-18T13:35:18","date_gmt":"2022-05-18T11:35:18","guid":{"rendered":"https:\/\/wp.unil.ch\/hrp\/?page_id=238"},"modified":"2024-11-07T13:54:17","modified_gmt":"2024-11-07T12:54:17","slug":"lrh_oclin_orh","status":"publish","type":"page","link":"https:\/\/wp.unil.ch\/hrp\/en\/lrh_oclin_orh\/","title":{"rendered":"Design & categorisation"},"content":{"rendered":"
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TIPS! <\/span>Tips<\/span>1. Define the primary objective of the project (secondary and exploratory objectives, if applicable)
2. Define the primary endpoint (secondary and exploratory endpoints, if applicable)
3. Assess the sample size to meet the objective(s).<\/span><\/span><\/span><\/span>\n<\/div>\n<\/div>\n\n\n\n

Does my project fall within the scope of the Human Research Act (HRA<\/a>) or is it outside the HRA?<\/p>\n\n\n\n

This law aims to protect <\/strong>the dignity<\/strong>, la personality <\/strong>and health <\/strong>of the human being (Art. 1 HRA<\/a>)<\/p>\n\n\n

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My project is HRA<\/a><\/p>\n<\/div>\n\n\n\n

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I do not know<\/a><\/p>\n<\/div>\n\n\n\n

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My project is outside HRA<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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If my research project falls within the scope of the HRA, a submission to the ethics committee is required, so which ordinance should I refer to?<\/p>\n<\/div>\n\n\n\n

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The ordinance on clinical trials in human research (ClinO)<\/a> regulates human research projects classified as clinical trials.<\/p>\n\n\n\n

The ordinance on clinical trials with medical devices (ClinO-MD) <\/a>regulates in particular clinical trials with medical devices, with the exception of in vitro diagnostic devices, devices in accordance with Art. 2a, para. 2 TPA<\/a> and combinations of devices and medicinal products (in accordance with Art. 2, para. 1, let. f and g ClinO-MD<\/a>). These exceptions are governed by the ClinO.<\/p>\n\n\n\n

The ordinance on research involving human beings (HRO)<\/a> regulates all human research projects with the exception of clinical trials.<\/p>\n<\/div>\n<\/div>\n\n\n\n

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I do not know<\/a><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n

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