Study amendments

A study amendment is a change made to a project after it has received a favourable ethics opinion from UREC. Amendments are appropriate when changes:

  • remain consistent with the original ethical approval
  • do not significantly increase risk to participants or investigators

Please note:
If your proposed changes significantly alter the project or increase risk, you must submit a new ethics application.

Review timeline

Most study amendments are reviewed by the UREC Chair within 3 to 5 working days. If the amendment raises complex ethical issues, it may be referred for routine review at a UREC meeting.

When to submit an amendment

Submit the UREC Study Amendment Form if the changes include:

  • modifications to design, methodology or participant procedures (without increasing risk)
  • changes to participant numbers or recruitment methods
  • inclusion of new participant groups (with no change in vulnerability level)
  • addition of new research locations (with no increased risk)
  • significant updates to study documents (for example information sheets, consent forms)
  • appointment of a new principal investigator or student supervisor
  • extension of the project end date or renewal of a favourable ethics opinion
  • changes to human tissue storage arrangements
  • requests for additional data from existing participants

All amendments must be submitted as one PDF (form plus supporting documents) via the UREC Research Ethics and Governance Submission Tool.

Please note:
If the UREC Chair determines the changes do not meet the criteria for an amendment, you will be asked to submit a new ethics application.

When a new ethics application is required

Submit a new ethics application if changes:

  • involve a major redesign of the project or data collection methods
  • fundamentally alter the nature of the project
  • increase the physical or psychological risk to participants or investigators
  • involve new participant groups with different vulnerability levels
  • affect indemnity or liability arrangements
  • significantly change to the terms of the original favourable ethics opinion

When no amendment is needed

No additional ethical review is required for:

  • minor document edits (for example correcting errors, updating contact points, minor clarifications)
  • changes to investigators (excluding PI or supervisor)
  • changes to funding arrangements
  • internal documentation changes (for example data recording tools)

Phased applications versus amendments

Phased applications are not amendments. They involve submitting separate ethics applications for different stages of a single project – typically when later stages depend on earlier results or where methods vary significantly across phases.

Urgent changes

Do not implement any changes until you receive a favourable opinion from REC – unless the change is urgently required to address immediate hazards. In such cases, notify UREC as soon as possible.

Quick links