Hot Topics in Research Ethics: Ethics of Decentralized Clinical Trials
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Decentralized clinical trials involve an array of digital tools to facilitate research without physical contact among research teams and participants such as recruitment, enrollment, informed consent, administering study interventions, obtaining patient reported outcome measures, and safety monitoring. These approaches can provide ways of ensuring participant safety and research integrity while sometimes reducing participant burden and trial cost. At the same time these novel designs also raise ethical issues in relation to participants’ safety and rights, the scientific validity of the study and ethics oversight. In this talk, Professor Vayena will describe these issues and offer suggestions of how they could be addressed.
This programme is organised by the Master of Health Research Ethics (MOHRE) programme at Universiti Malaya (http://www.mohre.um.edu.my). It is supported by the Fogarty International Center of the United States, National Institutes of Health (Grant R25TW010891) in collaboration with the Berman Institute of Bioethics, Johns Hopkins University.