MyAV范

What is covered?

There are 2 insurance policies (with corresponding policy notes) associated with MyAV范 sponsored clinical research:

MyAV范 Clinical Trial Insurance Policy

The MyAV范 clinical trial insurance policy provides indemnity to MyAV范, its staff and students who are conducting MyAV范 sponsored interventional clinical research and includes two types of cover:

• Cover for negligent claims made by research participants and others (Legal Liability)
• Cover for non-negligent harm to study participants or others, that is compensation to participants where negligence cannot, or is not proven (no-fault compensation).

The policy includes cover for members (both internal and external to MyAV范) of IDMC, TSC or other committees where members are working on behalf of MyAV范 or at its direction.

MyAV范 Combined Liability Policy (incorporates Public and Product Liability Insurance Policies)

The MyAV范 Combined Liability Policy (covering both Public and Product Liability) provides indemnity to MyAV范, its staff and students who are conducting MyAV范 sponsored non-interventional, non-statutory, non-invasive trials/ research projects听which do not fall under the Clinical Trials Regulations or Medical Device Regulations.

The MyAV范 combined liability policy (Public and Products Liability) provides cover for claims made by research participants and others for

a) accidental Bodily Injury*

b) accidental property damage

c) Other 鈥渓egal liability鈥� contingencies neither expected nor intended from the standpoint of the Insured

* 鈥橞odily Injury鈥� means accidental a) injury b) sickness c) disease d) death including but not by way of limitation mental injury and shock

Whilst most clinical research studies will be automatically covered by either policy, there are some policy exclusions that will require referral to the insurer and may require additional cover. In these instances, a referral must be made to the insurer and alternative options will be sought for consideration by the Chief Investigator or Sponsor Representative

For all research involving Products manufactured by MyAV范, it is essential that a referral is made to the broker via the MyAV范 Insurance Manager to confirm the Product is automatically covered. Appropriate insurance policies must be in place for the research project and the product.

The definition of Products does not extend to include Apps / Software (Medical or otherwise) therefore separate insurance cover (and associated additional premium) will be required for any studies involving such apps/software.

For a study obtaining MyAV范 sponsorship via the JRO to be covered under MyAV范's insurance an Insurance Registration Form(s) must be completed. If appropriate registration and review of a study is not undertaken researchers may be personally liable for any claims:

• a MyAV范 Insurance Registration Form -听Interventional Clinical Studies is completed for every MyAV范 sponsored interventional study.
• a MyAV范 Insurance Registration Form - Public Liability is completed for every MyAV范 sponsored non-interventional, non-statutory, non-invasive trials/ research projects which do not fall under the Clinical Trials Regulations or Medical Device Regulations.
• a MyAV范 Insurance Registration form - Product Liability is completed in addition to the insurance registration forms detailed above for every MyAV范 sponsored trial involving a product manufactured by MyAV范 (i.e. 鈥楶roduct鈥� 鈥� see definition above). It should also be completed for any study involving a commercially sourced product which MyAV范 is manipulating or if MyAV范 have outsourced the manufacturing to an external organisation. If a commercial manufacturer has provided the drug or device and MyAV范 has not altered it this form does not need completing.

MyAV范 insurance policy is re-negotiated each year. The policy runs from 1 August听with cover notes issued for one year. Yearly renewal ensures that appropriate clinical trials insurance provisions are continuously in place for the research portfolio.

A note summarising the terms and conditions of the policy and a听cover note is available from听jro.sponsorship@ucl.ac.uk.

Who to contact

The MyAV范 and MyAV范H Joint Research Office administers the insurance form on behalf of MyAV范 for all MyAV范 sponsored clinical research studies managed by the JRO.