What is my liability if a subject is injured or feels they have not received a benefit?
During contract negotiations, you should request formal indemnification in writing from the sponsor if it is not offered. This will outline the conditions under which each party will be responsible for patient injury. In general, if you did not contribute to a patient’s injury through your own negligence or willful actions – for example, if a patient has a bad reaction to a study drug and sues you – then if the sponsor has provided you with a formal indemnification, the sponsor will assume your liabilities and pay your defense costs, if any. If you do not get a formal indemnification, you will not be liable for injuries if you are not found to be at fault, but you generally will have to pay your own defense costs. Each patient will have signed an informed consent form that describes possible risks and possible benefits of taking part in the study, including that the patient may not see any improvement in his/her condition. It is important that you make sure patients understand what the
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