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Clinical trials have an integral role in medical research, but they come with inherent potential risk. Should something go wrong during a trial, whether as a result of negligence or not, the organization running the trial may be held financially responsible for any negative consequences that develop. Clinical trials insurance policies help organizations that run trials in Massachusetts shield themselves from many of the liability risks they face.
Clinical trials insurance policies are highly specialized commercial policies that normally offer protection against specific trial-related liability risks. Because these policies are so highly specialized, organizations that need this insurance should seek the expertise of an insurance agent who focuses on these types of policies. A knowledgeable agent will be able to explain the nuances of these policies’ protections and help organizations find a policy that suits their needs well.
The vast majority of organizations that run clinical trials in Massachusetts should probably have a clinical research insurance policy in place, and many may find that they’re required to procure coverage before trials begin. Some organizations that might find they need coverage are:
What clinical trials are covered by a clinical research insurance policy are determined by the terms and conditions of that particular policy. In some situations, a policy may only cover certain types of trials and it might also require that certain paperwork be properly filed.
For instance, some policies may only extend coverage to clinical trials that either have filed an Investigational New Drug application or obtained an exemption for the application. Not filing such paperwork could jeopardize a policy’s protections if the policy has this sort of requirement.
In many cases, only federally approved trials are covered by a policy. Non-approved trials are unlikely to be covered.
While every policy has its own coverages and terms, most of the protections offered in a clinical research policy can be separated into one of two categories:
Any protection offered for non-negligent harm might be phrased as “no-fault compensation.”
Clinical research policies can be substantial, but they’re affordable considering the potential risks and benefits of conducting trials. Premiums certainly are often much less than what a major liability lawsuit could cost if something went wrong during a trial. Even merely defending an organization against a single claim can be costly, and that doesn’t necessarily include the additional potential costs of a settlement or class action suit.
To find out exactly how much coverage for a trial would cost, organizations should speak with a knowledgeable and independent insurance agent. An independent insurance agent will be able to secure quotes for policies from different insurers in the state, and these quotes are the most accurate way to find out what a particular trial’s or organization’s coverage will cost.
If you oversee an organization that conducts clinical trials within Massachusetts, contact the independent insurance agents at Haberman Insurance Group. Our agents have the expertise necessary to help you select coverages for your organization, and they can show you multiple clinical trials insurance policy options that meet those coverage needs. With our assistance, you can be confident that your organization is well-protected when administering clinical trials.