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Use of Master Indemnity Agreement in research: updated DH guidance

Published on 18 July 2017

In June 2017 The Department of Health published updated guidance notes on the Master Indemnity Agreement (MIA), particularly in relation to its use within clinical research projects.

The MIA is an agreement between NHS organisations in England and suppliers that provide equipment free of charge, either on loan or on a permanent basis. Registration of a supplier with the MIA provides NHS organisations with assurance that the supplier has public and product liability insurance to cover their liabilities for the supply of their equipment.  NHS organisations may enter into call-off agreements with suppliers registered on the MIA, thereby affording both parties the protections offered under the scheme.

The recent update confirms that the MIA is not appropriate where the equipment is the subject of a clinical investigation (where insurance and indemnity arrangements should be agreed under the model Clinical Investigation Agreement (mCIA)).  It provides new clarification that the MIA may be suitable for use when equipment is provided for a research project, where that equipment is not the subject of the research.  This allows the sponsor to choose to use the MIA scheme in place of agreeing the insurance and indemnity arrangements for the equipment within the site agreement (e.g. model Clinical Trial Agreement (mCTA), model Agreement for Non-Commercial Research (mNCA), etc.).

The HRA will continue to use the Initial Assessment Letter and HRA Approval Letter to provide clarity to participating NHS organisations on the stated intention of the sponsor with regards to use of the MIA, or inclusion of the equipment indemnity within the site agreement.

Published in News, Statements