Are All Types of Clinical Trials Covered by Clinical Research Insurance?
Precisely what an insurance policy covers is normally determined by that particular policy’s terms, conditions and exclusions, and clinical research policies aren’t an exception. Depending on a particular clinical research policy’s terms, it might cover a range of trials or only select ones.
Some clinical research policies will only cover federally approved research trials that have all the necessary paperwork filed. For instance, a trail may not be covered by a policy if the trials’ Investigational New Drug application or an exemption isn’t in place.
An insurance agent who’s familiar with these types of policies will be able to help organizations determine precisely what their clinical research policy covers and what requirements must be met so that coverage isn’t compromised.
What Protections Do Clinical Research Insurance Policies Make Available?
Clinical research insurance policies are usually underwritten as liability-only policies, which means they typically provide protection in covered situations where an organization is sued by another party. Like most liability policies, a clinical research policy will likely help with legal costs and settlements associated with covered claims.
The risks that these policies help protect against can often be categorized into two categories:
- Non-negligent harm caused to trial participants
- Negligent harm caused to trial participants
Coverage for the first risk category may be termed “no-fault compensation.”
In most situations, organizations that need this insurance will want coverage for both categories of risks. An insurance agent can help confirm that a policy offers both types of protection.
Do Clinical Trials Policies Cover Employee Injuries?
If a provider or other employee is injured during a clinical trial, their injury probably won’t be covered by a clinical trials policy. Even if the injury is directly related to administering a vaccine or medication, such an incident would normally be treated as a workplace injury.
Workplace injuries usually fall under the domain of workers compensation insurance, which organizations are likely required to have but typically is distinct from a clinical trials policy. Clinical trials policies are usually focused on the liability risks that enrolling subjects in presents.