How are physicians practicing medicine in the context of an international clinical trial protected against malpractice law suits?
Your international colleagues will need to obtain approval from their institution’s IRB and send you a copy of the approval letter before you can submit your own application here. In some cases, the UCSD IRB will accept the use of indemnification clauses taken from the international site’s informed consent. In other cases, the standard UCSD harm clause language must be removed from the consent form, which means a statement cannot be added to release UCSD from malpractice lawsuits. In the event of injury or other adverse event, report the event to the UCSD IRB and international IRBs as soon as possible to ensure that treatment, and/or compensation for injury will be available if allowed and possible. If you are concerned about the possibility of malpractice suits, mention this issue in the cover letter to your initial UCSD IRB submission and wait for a response.
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