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.
Clinical Trials 'To whom it may concern' letter
UMAL Clinical Trials-Questionnaire
Standard Operating Procedures - UK based (pdf)
Application Flow Chart - UK based (pdf)
Standard Operating Procedures - Overseas based (pdf)
Application Flow Chart - Overseas based (pdf)
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.