Insurance and Indemnity
Reaching agreement on insurance and indemnity is a key step in the trial approval pathway. Many regulators require insurance and indemnity to cover the liability of the sponsor and researchers in relation to a trial to be in place before providing approval. Generally, the Sponsor will be required to indemnify the investigator(s) against any loss incurred by the investigator as a result of the study.
Insurance: a policy taken out by an individual or an individual organisation to cover their liabilities.
General or public liability insurance covers risks that occur on an institution’s property or during activities organised by the institution. Product liability insurance covers risks that arise from giving or providing a professional service such as medical advice or treatment.
Indemnity: a promise made by one party to another that it will cover any loss suffered by the other party.
Clinical trials sites take out insurance or indemnity arrangements to protect them against liabilities that may arise of part of their clinical trials activities. The ‘insured’ are typically the institution, directors or staff carrying out research.
Although clinical trial participants are neither indemnified or insured parties, insurance and indemnity arrangements should ensure that an institution or sponsor would be able to compensate participants who are harmed in a trial.
As insurance and indemnity requirements vary between jurisdictions and with the status of the study sponsors and investigators, it is recommended that advice on insurance and indemnity requirements is obtained from a researcher’s organization (or an independent legal expert) prior to initiating any interventional clinical research.
Insurance for participants
If you are a patient, it is important to recognise that trial participation may influence your insurance, including travel insurance, life insurance, income protection and private medical insurance.