Who Insures a Clinical Trials Investigator Doctor and How?

May 22, 2021

Clinical Research Investigator Liability Insurance 

Insurance agents and brokers of Medical Malpractice Insurance policies are often asked if we can ensure the doctor for their work as investigators in clinical trials.

A growing area in the vast healthcare niche it is at once productive and beneficial to building a better society and profitable an opportunity for physicians to work independent of large healthcare organizations as independent contractors

 The Doctors Insurance Agency now has agents throughout California, as well as partners in Washington and Arizona.

 We work with a lot of clinical research organizations, sponsors and medical doctors who are asked to work in clinical trials as investigators.

 The question is who insures these investigator doctors and how?


One position is that the sponsors will cover them: sponsor contracts include indemnification of physicians through their liability policies.

If they do, then the coverage is limited to the clinical trial work. The limitation with these sponsor policies is the confusing language stating that it does not extend coverage in case of negligence committed by the investigator or any of their staff. How else could the investigator be involved in a claim if not for a negligent allegation in implementation of that trial?

Some sponsor executives will then say that investigators should find liability protection under their own medical malpractice policies.

 That very well could be the case if the investigator already happens to be a private practitioner who carries their own individual policy,  rather than encumbered by being blended or integrated with a group. If the sponsor indemnification clause excludes investigator liability for negligent allegations, and the investigator physician is not able to include the trial work under their own medical malpractice policy, then they have one of two choices.

 They can work with the clinical research organization to purchase a comprehensive policy that includes all investigators and sub-investigators for negligent claims connected to the trial work, or they can purchase their own individual investigator liability policy.

 The Doctors Insurance Agency specializes in Clinical Research Organization Policies with an expanded definition of insured, relieving the physicians of this responsibility.

 We also underwrite competitive and sustainable limited part-time investigator liability policies.