Why Do Clinical Trial Sites Require Insurance And/Or An Indemnity

Clinical Trials insurance provides protection for those who sponsor and conduct clinical trials, arising from claims made against them by the trial participants. Cover can be provided on a No Fault Compensation basis to meet Australian Guidelines, including that of the Human Research Ethics Committee.

In additional the above, a legal liability extension can be added, as well as a medical malpractice extension if the trials medical practitioners own defence cover excludes trial work.

Cover can also be provided for:

  • Pre-clinical research
  • Bioequivalence testing
  • Medical devices
  • All phases of drug trial from Phases I to IV

Organisations that conduct clinical trials are often exposed to risks such as condemnation of undamaged stock, property at unspecified locations, spoilage, contamination, crisis response, product recall and regulatory inquiries. Covers are available to develop bespoke policies for these risks.

We have clients based both nationally and worldwide and we can arrange cover either on a per protocol or on an annual declaration basis.

McKenzie Ross can structure a robust, single policy solution that encompasses the multi-facets of exposure, including:

  • Errors and omissions insurance for consequential damages arising from negligent performance or non-performance of any aspect of a trial. Policies generally can cover the costs of repeating a portion or a whole phase of a clinical trial.
  • Medical malpractice coverage for bodily injury claims by subjects arising from medical services or during the course of medical services.
  • Products liability insurance for liability arising out of the handling, distribution, or manufacturing of drugs/medical devices during the pre-clinical and clinical phases, in Phase IV post-marketing surveillance, and thereafter.
  • Clinical trial medical expense coverage, sub-limited to respond to out-of-pocket medical expenses required of trial participants. This coverage can support the insured’s timely response to acute medical needs arising from products administered or services rendered during the trial
  • General liability for premises-related bodily injury/personal injury, property damage and advertising liability claims.
Why do clinical trial sites require insurance and/or an indemnity?

Indemnity and insurance arrangements are taken out to protect the clinical trial site against liabilities that it may incur in the course of its clinical trial activities. In the case of insurance, the insured will typically be the institution, its directors and employees (including researchers).

Although clinical trial participants are neither indemnified or insured parties, insurance and indemnity arrangements ensure that an institution or sponsor is able to 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.

If cover is provided by way of an indemnity or managed fund or scheme arrangement, the relevant State or Territory underwrites the risks, however, unlike insurance arrangements, the cover provided under an indemnity or managed fund arrangement may be discretionary leaving your trial exposed to severe losses

Clinical trial researchers who are employees of the relevant private sector entity may be covered under the entity’s clinical trials insurance arrangements. However, many clinicians conducting clinical trials in a private sector entity will not be employees of that entity. Researchers that are not employees are required to have in place professional indemnity or medical indemnity insurance that includes coverage for clinical trials as a condition to participate in the conduct of a clinical trial.

Find out more

As an experienced clinical liability trials insurance broker, our relationships with specialist local clinical trials underwriting agencies ensure we are able to offer a suitable solution for this unique risk.

Contact Luke Lalor on (03) 9691 2222 or luke@mckenzieross.com.au to discuss your clinical trials insurance needs.

Clinical Liability Trial Insurance FAQ’s

Why Do Clinical Trial Sites Require Insurance And/Or An Indemnity?

Insurance and indemnity arrangements are necessary to protect the clinical trial site against liabilities that it may occur during and as a result of clinical trial activities. This ensures that the institution or sponsor is able to compensate participants who may be harmed during a clinical trial.

What Is The Difference Between Insurance And Indemnity Cover?

An individual or institution typically obtains an insurance policy to protect them from their liabilities and risks. An indemnity is a promise by one party to another that it will cover a loss that arises from an event that happens to the other party.

Does Insurance Pay For Clinical Trials?

Clinical liability trial insurance does not pay for clinical trials, but it does protect those who sponsor and conduct clinical trials from claims made against them by the trial participants. An expert insurance broker can clarify what type of coverage you require when conducting clinical trials.

Does Product Liability Insurance Cover Clinical Trials?

Clinical liability trial insurance can include products liability insurance. It can also include errors and omissions insurance, medical malpractice coverage, products liability insurance, clinical trial medical expense coverage, and general liability.

Who Provides Insurance And Indemnity Cover For Clinical Trials?

Indemnity or insurance coverage for clinical trial activities in the public sector are provided by each State and Territory. The Unimutual scheme covers trials conducted by university researchers in the university sector. Sites that conduct clinical trials in the private sector will usually obtain clinical liability trial insurance from a commercial insurance broker.

Need guidance on the type of commercial insurance product or service that’s best for you? Talk to our broking teams today – Call us on (03) 9691 2222

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