Amendments to approved ethics protocols

Amendments to an already approved ethics protocol

If you need to make changes to an ethics protocol that has already been approved, you must edit and then resubmit your protocol. The resubmission will be sent back to a reviewer for approval.

If you are making a minor amendment, you may proceed with the research immediately. If you are making a major amendment, you must wait for the application to be re-approved. See below for a description of minor and major amendments.

Here’s how to edit your ethics submission:

  1. Go to the PPLS Ethics Submission Portal.
  2. Click on ‘Existing Applications’ and find the project you would like to changeScreen Shot 2017-03-07 at 5.23.29 PM
  3. Click the ‘Proj Info’ button.projinfo
  4. Click the ‘View form’ button.viewform
  5. At the top of the page click ‘Edit’.
  6. You will be asked whether you want to edit the existing submission or copy it over to a new one. Choose the “Existing submission” button as shown below.
  7. Make the changes you need.
  8. It helps the review process if you describe the change to the reviewer:
    • Determine whether it is a minor or major change (see below).
    • If the change is major, please be sure you are using up-to-date consent templates for your new submission.
    • Click ‘Uploads’, and upload a document noting the type and specific details of the change. For the “purpose” field, choose “other”. Please also copy this text directly in the optional note text box.
  9. Submit the application. Note that all signatures will again be required.
  10. If it is a minor change, you may proceed with data collection; if it is a major changeplease wait until your project has been re-reviewed and approved.

Major changes

A major change is something which has ethical implications. For example:

  • Substantial changes to the methodology, design, or procedure.
  • Any change relating to study risks (either to participants or researchers).
  • Changes involving the use of deception.
  • Significant changes in study documentation (e.g., consent forms, questionnaires, information sheets, etc.).
  • Changes in the level of consent requested (e.g., added request for general public use of data).
  • Changes in the population tested.
  • If you are not sure whether your amendment is major or minor, please contact

If you are making a major amendment and your information sheet/consent form does not include the GDPR-compliant text now featured in our templates, then you must update your forms!

Minor changes

Minor changes include the following:

  • Minor changes to the protocol or study documentation (correcting errors, updating contact information, minor clarifications, small changes to study design or procedure).
  • Changes to the research team (not the Principal Investigator).
  • Changes in logistical arrangements for secure storage of data.
  • Changes in the locations of studies (unless this involves additional checks and disclosures not already in place).
  • If you are not sure whether your amendment is major or minor, please contact