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Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness

 Consultant – Clinical Research and Drug Development, Mumbai, Maharashtra, India

Correspondence Address:
Arun Bhatt,
303-4, Dheeraj Valley 3/C, Mohan Gokhale Road, Goregaon East, Mumbai - 400 063, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_271_20

Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.

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