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Amendments to a Research Project

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Having already obtained favourable opinion from the Human Research Ethics Committee (HREC), if something has changed during your research, you may need to make changes to your plans as agreed with HREC. You should apply to HREC to gain support for your plans by submitting an amendment, any revised documents and a marked up copy of your original application. This should be agreed with, and recorded by, HREC so there is an accurate record of your research.

If there are changes which affect the gathering and processing of personal and/or sensitive data, you will also need to get approval from the Data Protection Team for an amended information asset register entry.

Examples of possible amendments include:

Minor amendments

  • Change in the project title
  • Change in the end date of the project
  • Small changes to the number of participants

Major amendments

  • Change in Principal Investigator
  • Any significant change in methodology e.g. reimbursing participants; using an online survey rather than face to face interviews or vice versa; the use of focus groups; the use of observations; audio or audio-visual recording
  • Any significant change in participant type e.g. age range or non-vulnerable to vulnerable participants
  • Change in location
  • Change in research outputs e.g. from a report to a published article
  • Introduction of additional groups of participants. Please note that consent forms used for these groups must be GDPR compliant – use the consent form template as a guide.

Process for obtaining favourable opinion for an amendment to a research project

  • Use the Research Ethics Application System to create an amendment sub-from (see Research Ethics Application System Guide for Applicants).
  • If you submitted your original application using the paper form, you will be unable to create an amendment sub-form in the Research Ethics Application. Please contact the Human Research Ethics team for guidance. Please include your HREC reference number.
  • Amendments will be reviewed by HREC, and you will be notified of the outcome within seven working days.