Is there an Affordable Clinical Research Liability Insurance Policy?

How do you provide proper insurance:  the right type of clinical research liability insurance for your clinical research organization? Doesn’t the Pharmaceutical or Manufacturer provide indemnification clauses that cover the research organizations?

What if you are a clinical research organization that employs three investigators: (each an M.D. or D.O.) and many independently contracted sub investigators; Some of these (a combination of mid levels  (NP’s, CNM’s and PA’s).

Yes, you  can purchase a policy for  the organization that includes everyone you need to implement your  sophisticated work of the FDA approved trial. 

The Doctors’ Insurance Agency provides single state, multi state national or even Tele Medical Clinical Research Liability Insurance Policies that are underwritten by companies that understand how to rate, underwrite, issue and manage these policies as your organization grows.  You might need a separate clinical trial organization liability insurance policy.  

Isn’t the policy at the organizational, site level unnecessary because of the indemnification or hold harmless of the sponsor: 

No, often the language indemnifying contract research organizations has holes in the language, leaving the investigators, research managers, and owners exposed.

Sponsors will often indemnify Contracting Research Organizations (CRO’s or SMO’s) or even seem to indemnify PI’s and SubI’s…

And, still if you want the certainty that your owners, and your contract healthcare providers working within your  research organization are properly named on the liability insurance policy, then a stand alone research liability policy is the answer. 

Stand alone, Clinical research organization liability insurance policies are often less than $ 6,000 (even less than $ 4,000 per  year)

And, they cover all of the personnel associated with the details of implementing the research:  The insured includes all of the the following:

Physicians, whether contracted or employed, for Professional Services on behalf of the Named Insured Clinical Research organization: 

a. Clinical Research Associates,

b. Clinical Research Monitors,

c. Clinical Research Coordinators,

d. Principal Investigators and Clinical Investigators, and

e. Bioethicists.

 Doesn’t my Investigator need to ask his/her own medical malpractice insurer to add clinical research to their own medical malpractice insurance policy

If you have Healthcare Providers (M.D.’s,  DPM’s, D.O.’s, D.C.’s) who are satisfied that their own institutional or private medical malpractice insurance policy can cover them for this clinical research work, then this policy will just respond as ‘primary’ ; often leaving their own med malpractice insurance as secondary to these clinical research organization liability policies. 

Insure all physicians and investigators, mid levels at the Clinical Research Organization/ Site Management Organization Policy  Level

(this includes tail)

Like with Locum Tenens case work, or  Medical Director contract work, or infrequent work with Telemedicine organizations, the best way to assure the providers, employed or contracted that the clinical trial work is covered (both at the entity level and for the investigators) is to insure them along with the organization.

 What is nice about the ‘organization level’ approach to claims made clinical research liability insurance policies is not only that these affordable One million/ three million per claim and aggregate policies will cover everyone, they will cover everyone Generally.  This ‘general’ organizational level professional liability insurance means, the workers, PhD’s, MD’s Medical Directors, Investigators, Sub Investigators, Research Associates,  Managers owners, officers.. they will all have tail (as long as the policy is active) the insurance will respond to any claims that name them even after they have dissociated or terminated from the trial work. 

The information needed to underwrite/ to develop the premium is the following: 

The details of the research:

That is: 

·         the number of investigators (actively working on each trial)

·         the number and type (pharmaceutical or medical equipment) of trials,

·         the number of participants and  

·         the annual revenues derived from the work.

 In addition to an endorsement that expands the definition of insured to include principal investigators and specific contract research organization personnel;  this policy includes a broad definition of insured which covers all employees who perform study procedures and services that don't fall into the scheduled titles and then to further broaden the definition they have  which covers independent contractors as well.

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