York Teaching Hospital NHS Foundation Trust provides a comprehensive range of acute hospital and specialist healthcare services for approximately 800,000 people living in and around York, North Yorkshire, North East Yorkshire and Ryedale - an area covering 3,400 square miles.
The Research & Development Office strive to increase the opportunities for patients and their families to be informed about, and involved in, our research and research processes.
The information on these pages will be relevant to York Hospital staff NHS Foundation Trust staff who are planning their own research study.
This section contains the Standard Operating Procedures (SOPs) and Guidance documents issued by the R&D Unit.
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For Researchers
As the Trust moves to align our research activities with the new Clinical Trials Regulations which take effect from 28th April 2026, we have compiled a list of updates which we will be sharing throughout March 2026. A summary of these updates, including quick reference guides are below.
Please note this information is reference only, and advice should be sought from the Trust Research Advisor or Research Governance manager for research projects relating to the Trust.
As you are aware, the new UK Clinical Trials Regulations come into force at the end of April 2026.
Please read the below for an update on amendments (soon called modifications).
Please take a moment to read the information below - our SOPs will be updated accordingly.
The online Introduction to GCP Training is also being updated nationally to reflect the new regulations and should be finalised by the end of February. As soon as it’s available, we’ll let you know and ask all our staff involved in research delivery to plan time to complete the updated training. Sponsors will also begin asking for evidence of updated GCP, so we want everyone to be prepared as early as possible.
From 28 April 2026:
The HRA confirmed that this terminology change applies to all studies under the new regulations: The approvals process for modifications (amendments) - Health Research Authority
The key reasons for this change are:
Before 28 April 2026
From 28 April 2026
The old vs new rules: Amendments vs Modifications (from 28 April 2026) are summarised below as quick reference guide.
|
|
OLD Rules (Before 28 April 2026) |
NEW Rules (From 28 April 2026) |
|
Terminology |
Amendments |
Modifications |
|
Types |
• Substantial Amendment |
• Substantial Modification |
|
Definition – Major Change |
Substantial Amendment: significant impact on safety, scientific value, or conduct |
Substantial Modification: same principle, updated definition under new regulations |
|
Definition – Middle Category |
Non‑substantial Amendment: smaller change but still needs review/notification |
Modification of an Important Detail: new name; process clarified under new regs |
|
Definition – Small Changes |
Minor Amendment: administrative/typos, implemented immediately |
Minor Modification: same principle; implemented immediately |
|
Submission Tool for study sponsors |
Amendment Tool in IRAS |
Modification Tool (updated version of Amendment Tool) |
|
Approvals Needed |
Some require MHRA, some REC, some both |
Same, but determined by Modification Tool, aligned to new streamlined rules |
|
Submission Route for study sponsors |
Amendment submitted via IRAS combined review (or separate if old processes still used by sponsor) |
All Modifications handled through updated IRAS Modification Tool under the new UK Clinical Trials Regulations |
|
Processing Times |
MHRA: up to 35 days for amendments |
Same timelines but aligned with combined review under revised clinical trials regulations. MHRA and REC now assess modifications together through combined review, so the process is smoother and more streamlined.
|
|
When Changes Can Be Implemented |
Depends on whether substantial or not – site must check approvals |
Must follow rules for Substantial Modifications; REC/MHRA approval needed before implementation |
|
Regulatory Framework |
Based on EU‑derived 2004 Regulations |
Based on UK Clinical Trials Regulations 2026, new definitions, proportionate risk‑based approach |
|
Applies To |
Trials authorised before 28 April 2026 (“old rules trials”) |
Trials authorised on or after 28 April 2026 (“new rules trials”) |
|
Transitional Overlap |
Both systems run in parallel: old‑rule trials follow amendments process, new‑rule trials follow modifications process |
|
As part of the upcoming implementation of the new UK Clinical Trials Regulations at the end of April, we are sharing another key update that will impact how we deliver research across the Trust.
This update focuses on the new simplified consent provisions, which apply to specific lower‑risk CTIMPs.
Under the revised regulations, sponsors of eligible trials may use simplified arrangements for seeking and evidencing informed consent, replacing the default requirement for full written consent. These simplified arrangements are strictly limited to trials that:
Where simplified consent is used, REC approval is still required, and sponsors must provide clear justification in their protocol along with details of how participants will be informed and how consent will be recorded. Evidence of consent may be captured more flexibly (e.g., documentation in clinical notes rather than a signed consent form), but this must be agreed in advance.
SOPs and training materials will be updated to reflect this change.
For now, please familiarise yourselves with the changes summarised below:
|
|
OLD rules (Before April 2026) |
UPDATED rules (From April 2026) |
|
Consent terminology |
Only standard informed consent recognised |
Introduction of simplified arrangements for consent for eligible lower‑risk trials |
|
Who can use simplified consent? |
Not permitted under old rules; full written consent always required except in very narrow emergency exceptions |
Only allowed if ALL criteria met: |
|
Form of consent |
Full written consent form required and signed by participant |
Consent may be simplified (e.g., verbal) if approved by REC and documented appropriately (in clinical notes) |
|
Evidence of consent |
Signed consent form is the default requirement; filed in ISF + medical notes |
Evidence can be proportionate: e.g., clinician’s note, simple tick‑box record, short script, depending on REC approval and protocol detail |
|
Participant information |
Full PIS required |
Concise, proportionate information allowed - shorter leaflets, verbal explanations, digital info etc. |
|
Protocol requirements |
Standard consent description only |
Sponsor MUST justify simplified consent and include: |
|
REC role |
REC checks consent meets set standards |
REC must assess if simplified consent is ethically appropriate; HRA advisory group being established for support |
|
Legal basis |
CT Regulations 2004 (written consent standard) |
New UK Clinical Trials Regulations allow simplified consent for lower‑risk CTIMPs; part of wider regulatory reform |
|
Applicability |
Applies to all CTIMPs equally |
Applies only to eligible lower‑risk trials; standard consent remains unchanged for all others |
Key links:
Simplified arrangements for consent in clinical trials - Health Research Authority
Full MHRA & HRA guidance is still being finalised for this.
1st April 2024 – 31st March 2025
York & Scarborough
86 research studies open to recruitment
5051 patients recruited into clinical trials
