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What happens if changes are made to the project after receiving ethics approval?


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University of Sunderland in London researcher interviewing participants

What happens if changes are made to the project after ethics approval has been given?

The researcher must think about if the change could affect the welfare, dignity and rights of the participants.
A `significant change´ includes a new research method that, had it been planned at the time, would have been mentioned on the original research ethics approval application.

Examples of this include:

  • Engagement with a different group of participants
  • A different method for recruiting participants
  • A different approach to getting consent, e.g. major changes in the information given to participants or in the consent form
  • A different method of data gathering
  • A different venue for data collection

These are just some of the potential areas to think about. If any potential change is significant, the researcher should contact the Ethics Administrator. They will send the details to the ethics reviewers who looked at the project originally (ideally the leader reviewer). They will then consider the changes and discuss the next steps with the Ethics Administrator. If the changes are significant, you might have to re-apply for full ethics approval at this point. The other possibility os that the reviewer might be happy to approve the changes straight away. The Ethics Administrator will keep a record of proposed changes and the actions taken as a result.

These rules do not apply to the normal, everyday adjustments to data-gathering plans and activities that researchers have to make. It also does not apply to small corrections in the written information you give to your participants, including spelling errors or typos. Discretion, responsibility and common sense are needed to interpret this section. Researchers need to think carefully about what they're doing, how any changes relate to their original ethics approval application, and if any ongoing changes are significant based on the terms explained above.