Pros And Cons Of Indemnity

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Indemnity If a patient is injured or dies during the course of a clinical trial or due to any clinical trial related occurrences; the sponsor, the site and all related parties may be sued. An indemnity agreement provides legal protection to all participants of the trial for any unforeseen adverse event as a result of the trial. Indemnity is a contract between all liable parties to compensate any individual for any loss or damage incurred during or due to the clinical trial. Although a participant may have health insurance, clinical trials are considered as experimental or investigational. Due to this, many health insurance companies will not cover routine doctor visits, scans, tests etc. during the course of the trial. Therefore, clinical…show more content…
The market model – it states that if the trial provides little or no benefit; or the target population is difficult to reach, a large compensation would be provided. However, less compensation is provided in the case of trials that have great benefit. 2. The wage model – participants are compensated based on their skill or area of work. Participants with similar skillsets will be compensated similarly. 3. The reimbursement model – participants are compensated only for the costs incurred during the trial. Compensation will be on par to their earning capacity. 4. The appreciation model – compensation is provided as a token of gratitude and will be paid at the completion of the trial.² Although there are no guidelines indicating that compensation should be paid to all participants of the trial, there are guidelines on compensating participants for any trial related injury. ICH-GCP states that there should be an indemnity signed between the sponsor and the investigational site indicating the insurance coverage except in the case of any negligence on the part of the investigational site. References 1. Karlberg JPE, Speers MA. Reviewing Clinical Trials: A Guide for the Ethics Committee. 2010. Pfizer. Found at 2. Leibowitz K, Sheckler V. Negotiating Clinical Trial Agreements. 2006. Rajpharma. Found at

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