By Rachel Mead
and Alastair
Nicholson
On 28 April 2026, new regulations for Clinical Trials will come
into effect - the most significant updates in two decades. To
support a smooth transition, the Medicines and Healthcare
products Regulatory Agency (MHRA) and the Health Research
Authority (HRA) are working together to provide updated guidance
and information about key changes for industry.
In this joint blog, we set out to clarify the insurance
requirements for Phase 1 clinical trials.
Sponsors' liability
For Clinical Trials of
Investigational Medicinal Products (CTIMPs), in accordance
with Part 2 (14) of Schedule 1 to UK Statutory Instrument
2004/1031, The Medicines for Human Use (Clinical Trials)
Regulations and its subsequent amendments, the following
condition applies:
‘Provision has been made for insurance or indemnity to cover the
liability of the investigator and sponsor which may arise in
relation to the clinical trial' (and Part 2 (4) of Schedule 1 of UK
Statutory Instrument 2025/5 which comes into effect on 28
April 2026. It is a requirement, that ‘any document providing
evidence of insurance to cover liability of the sponsor or
investigator' be included with the Research Ethics Committee
(REC) application, to comply with Regulation 15 (5 J) of SI
2004/1031 (and Part A1 (f) of Schedule 3 of UK Statutory
Instrument 2025/538 which comes into effect on 28 April 2026 will
include ‘proof of insurance, a guarantee, or any other similar
arrangement').
Responsibilities
The sponsor is responsible for ensuring that it
has in place adequate insurance or indemnity to cover its
potential liabilities arising from the design and management of
the clinical trial.
The REC is informed of the nature of this cover
and is provided with evidence of any insurance procured by the
sponsor for this purpose.
Research sites are responsible for making
arrangements for insurance or indemnity to cover potential
liabilities arising from their conduct of the clinical trial.
For Phase 1 trials being conducted outside of the
NHS, research sites, including Clinical
Research Organisations (CROs) or Phase 1 Trial Organisations,
should not rely upon the REC's favourable opinion alone to
understand the details of the insurance or indemnity provided by
the sponsor.
For Phase 1 trials being conducted in NHS
organisations, the UK study-wide review includes a check
of sponsor insurance, to ensure that the insurance is appropriate
to the clinical trial, with no inappropriate exclusions to its
cover (or a statement is received from the sponsor to confirm
that there are no exclusions). Any relevant change to the
insurance arrangements would constitute a substantial and
study-wide reviewable amendment (modification from 28 April 2026)
and be notified to the REC and a study-wide reviewer for review.
NHS organisations should not duplicate these checks.
Ensure you have appropriate cover in place
During recent good clinical practice (GCP) inspections, several
examples have been identified where CROs and Phase 1 Trial
Organisations have not undertaken a suitable check of the
insurance cover for the trial because there has been an
assumption that the REC has reviewed the suitability of the
cover. However, the review by the REC is only to determine
that cover exists.
Non-NHS Phase 1 sites should ensure that sponsor insurance or
indemnity is appropriate to the clinical trial, with no
inappropriate exclusions for each individual trial, and checks
should also be undertaken on annual policy renewals.
The checks for acceptability of cover and impact of any
exclusions should be documented, signed off by a suitably trained
and experienced individual and filed in the Trial Master File
(TMF).
If any exclusions to cover, means that certain individuals would
not be appropriately covered if they participated in the trial,
robust arrangements should be made to ensure that they are not
included (it would usually be expected that this is accounted for
in the clinical trial inclusion/exclusion criteria, but research
sites should be prepared to make additional arrangements where
necessary).
These checks are to demonstrate due diligence by the CRO and
Phase 1 Trial Organisations that the insurance arrangements are
adequate and sufficiently cover the participant population and
IMPs being administered.
Help and guidance
You will find the latest MHRA guidance in the Clinical Trials hub.
Access HRA guidance on changes to
clinical trials regulations.
