Providing appropriate insurance cover is an essential requirement in conducting clinical trials. Subjects participating in clinical trials and their families need reassurance that if something goes wrong, compensation will be available. Insurance provides financial protection for health or life against specified contingencies such as death, loss or damage.

It usually involves regular premiums being paid in return for a policy guaranteeing such protection. Insurance cover will take into account the therapeutic area, type of medication being tested - i.e. biologics, generics etc, planned enrolled patients and the countries where the trials will be conducted. Insurance cover should cover the duration of the trial but may require annual renewal in case there are any changes to any of the above parameters. 

The role of the Ethics Committee (EC) is to protect the patients enrolled in a clinical trial, therefore most ethics committees require that a valid insurance certificate be submitted as part of the review process. Though insurance cover is provided by the sponsor, it is incumbent upon the principal investigator and his research team to follow the protocol, because negligence could invalidate the insurance certificate. 

In addition some clinical trial insurance policies have a requirement that the investigators participating in clinical trials hold their own professional liability insurance, in the event of a claim for negligence. This liability insurance is usually provided by the employer or the institution where they practice. However, in many countries it is not normal or standard to have professional liability insurance and this can cause difficulties when sponsors request that such policies are put in place. For example in many African countries, doctors and nurses do not have professional liability insurance and in their contract it might state that the ministry of health will cover any legal costs and compensation claims in the event of any case involving professional liability.

In these cases it is often possible and perfectly acceptable for the employing hospital to provide a letter to the trial sponsor (or their insurance provider) that confirms that professional liability insurance is not typical in their country and the local arrangement is as follows (then describing what is put in place). The trial insurance providers need assurance that they will not be liable for a professional negligence claim. 

There have been incidents where external sponsors have insisted that a professional liability insurance policy is put in place for all clinical staff working on a trial in a country where this is not standard practice. This is unfortunate and brings increased cost to running clinical trials in these countries. The beneficiaries are the insurance companies that get this new business – who are usually located in the country of the sponsor and are very expensive. Here sensible pragmatism is needed or the insurance culture that exists elsewhere in the world will be passively exported to the countries who neither need it or can afford it, causing it to creep into practice and become a local requirement.

This would be a major issue as the increased cost of clinical trials will put off local researchers and inhibit trials where there are not profits. Research sites in developing countries should not automatically put these policies in place but should check back with the sponsor and see if alternative and locally appropriate solutions can be found. 

Sponsors may take out a separate clinical trial insurance policy or may include this into their product liability insurance. Many Universities, product development partnerships and pharmaceutical companies will elect to have global insurance in place to cover the majority of the countries where they run trials, and individual policies for new or less frequently used countries. Some countries such as Russia insist on having local insurance whilst others will want to know if the families of patients involved in trials are covered in case of death due to the study drug/device. It is important to understand the requirements of each country where the document is to be submitted.

References

Janice Hedgecock - Insurance in clinical trials Institute of Clinical Research Publishing version 1.0 2005