Research
With respect to industry sponsored research, the updated mCTA 2021 and mCIA 2021 includes an Appendix (Appendix 7) which should be completed by sponsors and NHS/HSC organisations for clinical trials where the sponsor provides equipment to the NHS/HSC organisation for the purposes of conducting the clinical research trial. Relevant excerpts from both the mCTA guidance and the updated mCTA 2021 are included below for ease of reference.
Liability and indemnity are covered in this Appendix 7 with respect to the equipment provided by the sponsor for a clinical research study. When completing this Appendix 7, all HSC Trusts in Northern Ireland should select “Alternative #1 – indemnity provided by this Appendix 7”. This “Alternative #1 – indemnity provided by this Appendix 7” only applies to equipment provided by a sponsor to a NHS/HSC organisation for the purposes of conducting research, and it cannot be used for any equipment provided to the NHS/HSC Trusts for the purposes or service development/improvement.
mCTA
7.2 Liability: Equipment and Resources Only.
Alternative #1 – indemnity provided by this Appendix 7
The Sponsor has no liability for damages of any sort, including personal injury or property damage resulting from the use of [Sponsor Equipment], [Sponsor Resources] [or] [Vendor Property] except to the extent that:
a) such damages were caused by the wilful misconduct, negligent acts or omissions of Sponsor or the Vendor; or
b) a personal injury to a Clinical Trial Subject is one covered by the indemnity detailed in Appendix 3 of this Agreement.
Sponsor shall be responsible for organising and ensuring payment for all costs associated with the routine maintenance of the [Sponsor Equipment], [Sponsor Resources] [and] [Vendor Property] and will replace the same at no cost to the Participating Organisation in the event replacement of the foregoing is deemed required as a result of equipment failure or routine maintenance.
Subject to Clause 5.4 of the Agreement, the Participating Organisation shall be liable for any damage, loss or destruction of the [Sponsor Equipment], [Sponsor Resources] or [Vendor Property] and for any losses attributable to the [Sponsor Equipment], [Sponsor Material] [or] [Vendor Property] caused by the Participating Organisation’s wilful misconduct, negligent acts or omissions. Under no circumstances shall the Participating Organisation be liable for any damage caused as a result of using the equipment per instructions or due to normal wear and tear. To avoid doubt, the Participating Organisation shall not insure the [Sponsor Equipment], [Sponsor Material] or [Vendor Property].
Alternative #2 – Equipment is supplied under an MIA
The [Sponsor] [Vendor] is providing the [Sponsor Equipment] [Vendor Property] to the Participating Organisation pursuant to the terms of an MIA. The MIA that shall apply to the provided [Sponsor Equipment] [Vendor Property] is the MIA applicable to the place where the Participating Organisation is constituted.
mCTA and CRO mCTA Guidance – Pg18
2.32 Appendix 7: Equipment and Resources Where no Equipment/Resources are being provided Appendix 7 should be omitted from the final clinical trial agreement. Appendix 7 includes tables where equipment and resources that are provided by Sponsors (and/or CROs, as applicable) for the clinical trial should be listed. These tables include a column where the depreciated value of the equipment/resources can be detailed. It is noted that there is no standard method for determining depreciation and therefore, this must be discussed and agreed between Sponsor and Participating Organisation (and CRO, as applicable). The Sponsor (or CRO, as applicable) should indicate whether alternative 1 or 2 should be used with respect to liability in Clause 7.2 of Appendix 7. The selection should be clearly indicated in the agreement. It is noted that Northern Ireland does not have any MIA arrangements and that the MIA in England is not applicable to equipment loaned or gifted for the purpose of clinical trials. Alternative #1 must be used where the Participating Organisation is constituted in England or Northern Ireland.
Service Development/Improvement
As there is no MIA in place in Northern Ireland to cover the provision of equipment to HSC Trusts for service development/improvement, separate arrangements need to be in place for each piece of equipment that has been provided to a HSC Trust when receiving equipment for service development/improvement. Trusts must follow their procedures for managing such loaned medical equipment being put in to use, and/or ensure that indemnity arrangements, servicing, training, and appropriate safety checks/tests are in place before first use. Regional Medical Physics (medical.physics@belfasttrust.hscni.net) service can advise on the latter safety checks/tests.
To read more see the guidance for information that needs to be included in the mCTA.