This page explains why insurance must be arranged for your research project as part of the JRCO registration process.

Please complete the Sponsorship and Insurance Request Form and submit along with your ethics application. For clinical trials involving investigational medicinal products please also complete and submit the CTIMP Addendum.

Insurance

Why is insurance needed

It is extremely important that appropriate insurance is in place for each healthcare 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.

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.

Imperial College insurance policy

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

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

Policy detail

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.

Overseas research (including EU)

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 JRCO 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 pdf.

Clinical negligance

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.  It is usually applied as part of the NHS R&D confirmation for a project.

Please contact a relevant NHS Trust R&D office if you need to discuss this in more detail.

ABPI Indemnity

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.

Participant Information Sheets

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 JRCO:

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 mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College, Joint Research Compliance Office.

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 (DELETE AS APPROPRIATE) 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, Joint Research Compliance Office.

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 mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College, Joint Research Compliance Office.