Deferrals

In some cases a sponsor may need to defer these activities, for example, to protect confidential commercial information.

In these cases, a sponsor can request a deferral to the timeframes in which they're expected to register the trial, publish the results or share results with participants.

If a deferral is given, the timeframe in which a sponsor is expected to have completed these activities will be postponed.

Currently, if a deferral is in place for a research study then we’ll not publish a research summary on the HRA website while the deferral is in place. This will continue to be the case when the new regulations come into force.

Phase 1 CTIMPs involving healthy volunteers will be automatically given a deferral due to the commercial sensitivity of this stage of drug development. Please see our deferrals for Phase 1 trials guidance for further information. Other CTIMPs will need to apply for deferrals.

The following sections give you information on deferrals and how to request them.

• requesting a deferral
• requesting an initial deferral for a trial
• when will a deferral be agreed?
• how long deferrals are given for
• requirements once a deferral is agreed
• changes to the end of trial date where a deferral is agreed
• only using the deferral for specific requirements
• once a deferral period ends
• extending the deferral period
• trials with a deferral in place before 28 April 2026

Requesting a deferral

Sponsors of a CTIMP taking place in the United Kingdom (UK) will be able to request a deferral of the transparency requirements in their application for clinical trial authorisation and an ethics committee opinion or after the trial has been approved.

A deferral request must be made before the deadline for the specific transparency requirement. This means the request must be submitted:

• before the first participant is recruited and within 90 calendar days of the trial being approved if the sponsor is planning to defer registration of the trial
  
• within 12 months of the end of the trial if the sponsor is planning to defer publishing a summary of trial results
  
• within 12 months of the end of the trial if the sponsor is planning to defer offering to share results with participants

Requesting an initial deferral for a trial

The way in which a sponsor requests a deferral depends on the status of the application.

If the sponsor knows they’ll need a deferral when preparing their application, they can tell us in their application (in part C of the IRAS study information question set).

In their submission, the sponsor will need to give a reason why they need a deferral for the trial. Confirmation of whether a deferral has been agreed upon will be included in the notification after the favourable opinion is given.

If a sponsor needs to defer the registration requirement after submitting their application, they can request a deferral by contacting deferrals@hra.nhs.uk with the reason for the deferral request.

The HRA will manage the deferral process and will liaise with the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) regarding any deferral requests received.

The sponsor will receive confirmation on whether the deferral has been agreed within 10 days of us receiving the request. The confirmation will also detail the end date for the deferral.

When will a deferral be agreed?

Requests for deferral will normally only be agreed where it is necessary to protect commercially confidential information.

'Commercially confidential information' means any information contained in the data or documents that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the sponsor. Other reasons may be considered, but only where a strong justification is provided.

We expect deferral requests to protect commercially confidential information to only be submitted for early-phase clinical trials.

How long deferrals are given for

Where a deferral is agreed it will be given for up to 30 months from the end of the trial, as defined within the clinical trial protocol.

This initial deferral will cover all transparency requirements (registration, publication of summary results, and offering to share summary results with participants).

Requirements once a deferral is agreed

If a deferral is agreed, the HRA will need the sponsor to carry out some additional activity to make their trial as transparent as possible.

As part of the conditions of the deferral, the sponsor should publish a minimal record on a publicly accessible registry.

The information should include:

• registry number
• IRAS ID
• chief investigator name and site address
• sponsor name and address
• REC decision and date of decision
• nature of clinical trial (for example, bioequivalence in 24 healthy volunteers)
• date of start of trial
• date of end of the trial in the UK, European Union member states (if applicable) and globally (if applicable)
• date of start of recruitment
• date of end of recruitment
• justification of deferral

This should be done within 90 calendar days of the trial receiving combined approval (from both the MHRA and REC) and before the first participant is recruited.

If the minimal record is published with the ISRCTN, they will provide the registration number. Once a sponsor receives it, they should email deferrals@hra.nhs.uk with the registration number.

In addition to publishing a minimal record, it’s still important for sponsors to thank participants or relevant people and provide them with a timeframe for receiving results, even if a deferral has been agreed

Changes to the end of trial date where a deferral is agreed

Deferrals will be given for a set period in relation to the end of trial date. If the sponsor changes the end of trial date, the deferral will remain consistent with the updated end of trial date.

For example, if a trial was initially set to end on 1 June 2027 and had a 30 month deferral agreed, the sponsor would be expected to comply with the transparency regulations on 1 December 2029 (when the deferral expired).

If during the trial the sponsor changed the end of trial date to 1 January 2028, the deferral would still be in place and the end of the deferral period would now be 1 July 2030.

Only using the deferral for specific requirements

If a deferral is agreed, it will initially be given for all transparency requirements, including registering the trial, publishing trial summary results and offering to share results with participants. The sponsor will be able to choose if they use the deferral for all the transparency requirements or if they would be willing to fulfil some of the requirements.

For example, if a sponsor receives a deferral and is only looking to defer publishing summary results and offering to share results but is willing to register the study, they could register the trial at any point during the deferral period.

In this case, if the sponsor did choose to register the trial, it would not impact the deferral in place, or their ability to request an extension to the deferral, for the other transparency requirements.

Once a deferral period ends

When a deferral period is due to end, the sponsor needs to complete the registration of the trial (in the registry where the minimal record was published), publish the summary of trial results and share the results with participants who agreed to receive them before the end of the deferral period.

Extending the deferral period

If the end of the original deferral period is nearing and there is a justifiable reason it needs to be extended, the sponsor will be able to request this.

The process for requesting an extension to a deferral is the same in all cases, regardless of whether the sponsor wants to extend a deferral agreed for the trial registration, publication of summary results, or sharing results with participants.

However, we will not normally agree a further deferral of the registration element 30 months after the end of the study unless the sponsor can provide strong justification for doing so. Deferrals after the initial 30 month period will normally only be agreed for publishing the summary of results and, where necessary, sharing results with participants.

The sponsor will be able to request an extension to a deferral at any time before the expiry of the previous deferral.

To request this, the sponsor will need to email deferrals@hra.nhs.uk at least 10 working days before the end of the deferral period. In their email, the sponsor should include:

• the relevant trial’s IRAS ID
• confirmation of whether the sponsor is looking to extend the deferral for meeting all the relevant research transparency requirements or only specific ones (for example, only publication of a summary of results)
• clear justification for why the sponsor needs to extend the deferral period

The sponsor will be contacted within 10 days of submitting the request to confirm if the deferral has been agreed.

If the extension is agreed, the deferral period will be extended by 30 months.

If, during the 30 month extension, the sponsor determines they need to extend the deferral period further, they can request another extension by following the same process.

Any agreed extensions to the deferral period will extend the previous deferral by another 30 months.

The sponsor will be able to defer up to a maximum of 10 years from the end of the trial.

After 10 years, the sponsor will not be able to defer registration any further and will have to comply with the transparency requirements.

Trials with a deferral in place before 28 April 2026

If a CTIMP is approved, has a deferral in place and the trial is still ongoing by 28 April 2026, the deferral's end date will be extended to 30 months after the end of the trial.

The sponsor does not need to do anything to have this extension applied - it will be updated automatically.

If the sponsor chooses not to use this extension for the deferral period (meaning they decide to register the trial, publish it, or share the results earlier), they can do so. It will be the sponsor's choice as to whether the extended deferral period is used.

If a CTIMP is approved and has a deferral in place by 28 April 2026, but the end of the trial has already been declared, the deferral will not be automatically extended.

However, the sponsor will be able to request an extension if required by following the process outlined in the guidance on extending the deferral period.