The University purchases Clinical Trials cover which provides automatic cover for all Clinical Trials including those where the University accepts responsibility as sponsor, except those specifically excluded.
The limit of indemnity is now £30 million.
The automatic cover is for injuries from negligent harm only. Cover provides an indemnity to:-
- the University
- its Employees
- its Students
- the Ethics Committee
There are exclusions within the Clinical Trial Legal Liability cover these are on what insurers call a Referral List:-Coverage must be confirmed BEFORE trial recruitment commences.
- Trials outside the UK
- drug and surgery trials
- research subjects known to be pregnant at the time of the trial
- research subjects under 5 years of age
- in respect of any Clinical Trial where Medicinal Purpose is
- assisting with or altering in any way the process of conception
- investigating or participation in methods of contraception
- in respect of any Clinical Trial involving genetic engineering (other than a Clinical Trial in which Medicinal Purpose is treating, preventing and diagnosing disease)
- in respect of any Clinical Trial where the substance under investigation has been designed, altered or manufactured by the University
- over 250 patients participating in a trial.
- Investigators are required, in their applications to Research Ethics Committee, to answer two questions regarding indemnity cover for the study.
The questions are (numbers refer to the number of the question on the NRES (National Research Ethics Service)/IRAS System (Integrated Research Application System).
IRAS Question A76-1
This relates to the legal liability of the Sponsor for harm arising from the management of the research. Where the University is the Sponsor then the tab “Other insurance or indemnity arrangements will apply” should be selected.
A statement of university having insurance cover for negligence in the design of the research may be included. If the project is a Research Project which is covered automatically, a suggest answer is:
"The University has in force a Public Liability Policy and/or Clinical Trials policy which provides cover for claims for "negligent harm" and the activities here are included within that coverage.”
Where the study is sponsored by an NHS organisation, then the “NHS indemnity scheme will apply” tab should be selected.
IRAS Question A76-2
This concerns the legal liability of sponsors or employers for harm arising from the design of the research.
NHS indemnity for harm arising from the design of the research is applicable if the design if the design has been developed by PI as part of their NHS work. If the design has been carried out by PI outside their NHS remit or as part of their University work, then NHS indemnity is not appropriate and the “Other insurance or indemnity arrangements will apply” tab should be selected.
IRAS Question A76-3
This relates to the legal liability of investigators/collaborators and Site management organisations for harm arising from the conduct of the research.
If all the research participants are NHS patients or will be recruited at NHS sites then the NHS indemnity scheme will apply. Where participants include non-NHS patients or will be recruited other than at NHS sites then the “Research includes non-NHS sites” must be selected.
IRAS Question A77
A77 asks whether the Sponsor has made arrangements for payment of compensation in the event of harm where no legal liability arises. This will be specifically relevant for commercially sponsored trails of medicines and clinical investigations of medical devices. The suggested response is that "No provision has been made for indemnity in the event of a claim for non-negligent harm".
Should the Research Ethics Committee make approval conditional on obtaining coverage for non-negligent harm, the University would refer this to UMAL for specific coverage.
Further information can be found on the Research and Commercial Services website.
Important Documents
Insurers Definition of a Clinical Trial is as follows:
Insurers define a Clinical Trial as an investigation or a series of investigations conducted on any person for Medicinal Purpose, which is now defined as:
- a) treating or preventing disease
- b) diagnosing disease or ascertaining the existence, degree of or extent of a physiological condition
- c) assisting with or altering in any way the process of conception or investigating or participating in methods of conception or contraception
- d) inducing anaesthesia
- e) otherwise preventing or interfering with the normal operation of a physiological function.
Procedures for obtaining Insurers Agreement for Clinical Trials/Research on Human Volunteers
For a decision on whether or not the University insurance covers a particular project that an investigator intends getting involved with, it is vital that certain information is sent to the Insurance Officer as soon as possible. Information required is as follows:
- The application/protocol detailing the work to be performed
- The completed Clinical Trial Questionnaire (CT2006)
- The Patient Information Sheet
- The Patient Consent Form
- If the work is to be Sponsored by the University there are procedures in force using the Research and Commercial Services website at www.rcs.bham.ac.uk and you need to look at the section on Governance and Sponsorship to ensure compliance.
- If an outside body is Sponsoring the work then details of who the Sponsor is, should also be sent to the Insurance Officer, together with a copy of any document where an indemnity is being offered.
- Full titles of projects rather than numbers which have no relevance to the Insurance Office, are more helpful in tracking a decision on cover.
Provision of the above will greatly assist the process of obtaining an insurance opinion and specific cover where referrals have to be made to UMAL and also where any decisions can be made ‘in house’.
International Clinical Trials
The University insurers will consider providing insurance for International Trials on a ‘case by case’ basis.
The reason these have to be considered in this way is because different countries have:
- Different legislative requirements
- Compulsory insurance requirements
- Limits of indemnity
- Different insurance certificates
- Insurers may ask about the ethical issues in the proposed country
- Conduct of a study and how this is to be done – use of local labour?
- Management of the data being collected – locally or within the UK?
- They will ask has a risk assessment been prepared for the work?
UMAL will refer to the specific country we may be considering to establish what the requirements are.
If the work is proposed outside of an EU country it is possible that UMAL have to go to the Lloyds market to obtain cover with a specialist broker because of the complexity of work and the local legislation.
The monitoring process of the work on a proposed international trial is part of the Research Governance process and any Sponsor will also have to be assured that the work can be monitored effectively from the Governance Compliance point of view because there are legal responsibilities/duties attached to being a Sponsor which will be covered within the Universities Governance procedures.
The information required for International Trials is the same information that would be required for the Governance processes anyway within the UK
- A protocol/application for the work still needs to be sent to the Insurance Office
- Where applicable Patient Information Sheet
- Patient Consent Forms
- The Clinical Trial Questionnaire.
- Risk Assessment for the country where the trial is to be conducted.
This is all key information to assist insurers in the considering cover requirements for an International Trial.
Insurance and Indemnity and Negligence and Non-Negligence coverage
- the Research Governance Framework makes it mandatory that EITHER insurance or indemnity be in place for any research project involving Health and Social Care
indemnity can be provided by the ABPI cover supplied by Pharmaceutical Companies
- insurance can be provided by Insurance Companies in one of two ways the provision of negligence or non-negligence coverage EITHER should be provided not both
- the Ethics Committees are charged with the task of deciding which should apply but they usually request negligence cover as that is the basis of the NHS Indemnity funded by Government
- negligence cover refers to a fault based system of indemnity whereby any person alleging they have suffered harm as a direct result of the research activity MUST prove negligence upon those involved if no negligence is proven then no claim results and no compensation is payable
non-negligence or no-fault is a different system whereby negligence or fault is in effect assumed and the person alleging harm is compensated for their injuries the amount of compensation is assessed and should equate to that which would be normally payable in the light of the circumstance and degree of harm caused
- regardless as to what cover may be provided by others it is necessary for the University to protect itself and its own employees against claims from participants and this can result in additional coverage being purchased by the University for specific Clinical Trials.