Clinical Research Liability Insurance

October 10, 2017

The Doctors Insurance Agency has been providing Clinical Trial Medical Malpractice Insurance for clinical principal investigators and sub investigators for over 15 years.

As investments have flowed into clinical research, the FDA continues to work hard to fast track some drugs to market. The need for clinical research organization liability insurance, site management organization liability insurance, sponsor liability insurance and principal investigator liability insurance has grown concurrently.

Many of our medical malpractice insurance policies already include an endorsement to protect our doctors who work with clinical research sponsors and organizations. Specialists ranging from psychiatry to internal medicine are involved in behavioral health research and are very likely to have coverage via your medical malpractice policy. It is important to work with an agent or underwriter that understands your policy and that can explain this to the organizations doing the research.

Behavioral and Social Sciences Research

Behavioral and social sciences research is an area where our insurance agency is seeing some growth. Behavioral and Social Sciences Research is a large, multifaceted field, encompassing a wide array of disciplines.

The field of research uses surveys, questionnaires, interviews, randomized clinical trials, direct observation, physiological manipulations, recording, descriptive methods, laboratory and field experiments, standardized tests, economic analyses, statistical modeling, ethnography, and evaluation.

We have found that it is important to work with insurance carriers with an active and experienced life sciences division – clinical research professional liability insurance is affordable, especially for start up organizations. You can find that rates reflect size and the experience of the organization. Often premium is not much more than $3500 to $5000 annually and as the organization grows, and you add research technicians, PhDs and medical doctors Investigators and sub investigators, the policy can include them. These policies are written with a broad definition of insured, including independent contractor or employee investigator physicians. These research liability policies allow you to add doctors easily.

Behavioral and social sciences research is not restricted to a set of disciplines or methodological approaches. The field is defined by several key themes including an emphasis on theory-driven research;
the search for general principles of behavioral and social functioning; an emphasis on individual variation, and variation across categories such as gender, age, and sociocultural status; and a focus on both the social and biological contexts of behavior.

The growth in behavioral and social sciences research obviously involves highly trained/credentialed and licensed clinicians that understand skated nuances; can observe and report the findings that benefit sponsor organizations. The Doctors Insurance Agency can make sure your Researchers are included in the coverage

Behavioral and social sciences are not the only growth area . Pharmaceutical development continues at a rapid pace. There are national programs that support training clinicians, mid-level providers, other medical personnel to participate (even to moonlight as researchers). Practitioners participating in research can obtain coverage for their work often for less than $ 2,000 per year in professional liability premium covering their clinical research work.

The question that many practitioners face is when do they draw a line between their own medical professional liability policy which covers them in their clinic, and a new separate organizational policy with broad definitions to include site managers, recruiters administrators medical directors and the investigators.

In the last three years we've seen a pain manager( an individual solo anesthesiologist) start his own clinical research organization policy that now covers four principal investigators, two sub investigators, half a dozen clinical research technicians and generates over $500,000 in annual revenue. His premium is just about $10,000 per year to support this entire team.

We have also see internal medicine doctors, groups of six opening a separate division that provides clinical research organization insurance for less than $ 7,000 per year.
We have a podiatrist in Las Vegas; Her practice and her clinical Research growth are on par both generating accessible revenue. She has two policies one covering her practice one covering her clinical research organization. These policies provide risk management assistance, underwriting expertise and of course important specific and unique claims service.

We have psychiatrists, participating in telemedicine that have decided to start a separate research organization so they can conduct behavioral social science research and start up research professional liability policies that are less than $5000..

The process is easy to start; complete the clinical research liability application include all of the investigators, researchers technicians involved, provide carefully discrete information about protocol type of research. Describe the number of participants, annual revenue, expected duration and the type (whether it is pharmaceutical or behavioral). With this the underwriters will generally have enough to offer a firm bind-able quote