Insurance and indemnity requirements for clinical trials vary greatly across different countries, healthcare systems and institutions and are influenced by both clinical trial designs and interventions. It is beyond the scope of this Roadmap to inform all those involved in clinical research of the numerous considerations one must take into account, specific to their own situation when setting up professional or clinical trial-specific indemnity or institutional insurance in the preparation of conducting clinical trials. This section provides a brief overview of some of the general and human research-specific requirements but does not constitute insurance or legal advice.

NSW Health, through the Treasury Managed Fund (TMF), provides cover for the Sponsor-related liabilities of clinical trials initiated by NSW Health Staff and conducted at a site under the control of a PHO TMF provides products liability for trials initiated by NSW Health Staff for:

• Products still in development by a party that is not a NSW Health Staff investigator-initiator;
• Products still in development by a NSW Health Staff investigator initiator;
• An off-label use of a registered product.

Definitions:

Insurance: A policy taken out by an individual or individual organisation to cover their liabilities.

Indemnity: An indemnity is a promise by one party to another that it will cover a loss arising from an event that happens to the other party.

Indemnity Form Standard (AU): A form routinely used when the site (the Indemnified Party) is providing premises for the conduct of the study. It is to be regarded as the basis for agreements between biopharmaceutical companies sponsoring clinical studies and the institution that hosts the study to be conducted.

Indemnity Form HREC (AU): For use where the Indemnified Party is providing ethical review for a multicentre clinical study, where the ethical review will be adopted by hospitals, institutions or sites that are independent from the Indemnified Party, or, as a reviewing HREC for a single centre study at a hospital or institution that is independent from the Indemnified Party.

Insurance for Researchers

Indemnity and insurance arrangements are taken out to protect sites or parent organisations against liabilities that it may incur during its clinical trial activities. In the case of insurance, the insured is the site or parent organisation, its owners, and employees. Insurance and indemnity arrangements ensure that an institution or sponsor can compensate participants who are harmed in a trial. For this reason, evidence of appropriate insurance and indemnity arrangements must be provided as part of documentation submitted for ethics review and/ or the Site-Specific Application.

Indemnity for Researchers

A site requires its own insurance cover and an additional indemnity from a Sponsor to cover its liabilities. In general, the commercial Sponsor’s insurance or indemnity arrangements do not provide cover for the trial site’s liabilities and so a separate insurance policy or indemnity is required.