Insurance

It is extremely important that appropriate insurance is in place for each research project undertaken by an Imperial College Investigator whether it involves:

• Conducting surveys
• Using non-invasive imaging
• Inclusion in trials, drugs, devices, surgical procedures or other treatments

Insurance is needed to provide cover against harmful events which could potentially be experienced by a human subject as a result of their participation in research.

For NHS research you will be required to explain what arrangements are in place for negligent and/or non negligent harm in any IRAS ethics application. We can provide you with a standard statement if required.

The policy is arranged through our brokers and is renewable on 31 July of each year. Current Certificate of Insurance is available from the RGIT.

All studies need to be assessed individually by the RGIT and where necessary these need to be referred to the College’s Insurance Manager.

Trials which need to be referred to insurers include:

• Paper studies (studies not involving invasive procedures with people) only if they are being conducted overseas
• Trials involving medical devices/methods only (any trials) without drugs should be viewed the same as drug trials so only need referring if they meet the criteria below
• More than 5,000 participants
• Overseas
• Pregnant women
• Children under 5

You should not assume that the insurance will apply to your project until it has been confirmed to you in writing or email by one of our RGIT Research Governance Managers or Research Facilitators.

A Human Clinical Trial is defined as any investigational study conducted for the purposes of research and any research, data analysis, or other advice provided in relation to the study and its results.

The relevant policy sections are:

• Section 2 – Product Liability

Legal liability for damaged in respect of bodily injury or property damage caused by Products (goods or products made, sold, handled or distributed by the Imperial College).

• Section 3 -Legal Liability for Human Clinical Trials

Damages in respect of any bodily injury to a research subject provided that legal liability is caused by an occurrence within the Policy Territory (worldwide) and in connection with clinical trials.

• Section 4 - No Fault Compensation for Human Clinical Trials

Liability to pay compensation and claimants costs and expenses in respect of any bodily injury to a research subject providing the liability is caused in connection within the business and the clinical trial.

• Section 5 Errors and Omissions

Liability for damages in respect of any claim arising by reason of any negligent act, error or omission.

There are certain difficulties with arranging insurance for human clinical research to be conducted by Imperial College, outside the UK.

The insurance policies do provide global cover however because they are issued in the UK, they are governed by UK law.  Overseas countries even within the EU often have local laws that require insurance policies to be issued locally. These will attract additional premiums which must be met by each project.

Researchers are strongly advised to consider and discuss the insurance implications of a multi-centre overseas research with the RGI team prior to committing the College to overseas collaborations.

It is essential that Imperial College clinical research complies with local insurance and legal requirements.

List of countries requiring local policies.

In addition to Imperial's policies, any research occurring in an NHS organisation requires insurance for clinical negligence from the relevant NHS Trust(s). 

This insurance will apply to claims arising from negligence on the part of the NHS or persons acting in the course of their work with the NHS.

Where the research involves NHS patients under the care of NHS organisations, indemnity for harm to participants resulting from clinical negligence is provided through NHS indemnity schemes. No proof of indemnity is expected.

Please contact a relavant RGIT member if you need to discuss this in more detail.

An indemnity must be provided by the relevant pharmaceutical company where research involving human participants/direct human interactions is sponsored by a pharmaceutical company and involves the administration of pharmaceutical products to research subjects.

The pharmaceutical company should issue Imperial College with the standard Association of British Pharmaceutical Industry ("ABPI") indemnity, which, in effect, provides no-fault compensation in case of personal injury resulting from the use of the pharmaceutical product in the research.

If you are involved in research of this kind, you should check that this indemnity is in place. Research Services will be able to answer any questions you may have about ABPI type indemnities.

The following statements, depending on the type of study, can be included in participant information sheets after Imperial College negligent and non-negligent harm insurance have been confirmed for your trial by the RGI team:

1. Studies involving invasive clinical procedures on human participants, eg medicines, radiation, MRI, tissue or blood samples

Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.

If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Insert name and contact details). The normal National Health Service complaint mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College Research Governance and Integrity Team.

2. Studies involving invasive clinical procedures on human participants that are conducted on potentially excluded participants, ie HIV/AIDS, CJD, Hepatitis studies

Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault.

This provision does not apply to claims which arise as a result of Hepatitis, Creutzfeldt-Jakob Disease, HIV/AIDS or any related conditions.

This does not affect your legal rights to seek compensation. If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Insert name and contact details). The normal National Health Service complaint mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College Research Governance and Integrity Team.

3. Studies involving human participants, requiring ethics, which do not involve invasive clinical procedures, eg tissue bank studies, studies involving discarded excess tissue, questionnaires

If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Insert name and contact details). The normal National Health Service complaint mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College Research Governance and Integrity Team.