Amendments to research projects after approval has been granted
RGEC approval must be sought for any changes that are made to projects following ethics approval. For example, you will need to apply for an amendment approval if you wish to:
- Change the study design or methodology, participant recruitment process or populations. Example: recruitment of an additional cohort of participants.
- Change any documentation previously reviewed and approved. Example: rewording of any documentation including letters or information sheets.
- Modify the study tools, for example, the addition of a new questionnaire.
- Extend the study end date.
If in doubt whether the change requires further ethics review please contact email@example.com.
If you need to apply for an amendment approval, you will need to submit a ‘Request for Amendment Form’ outlining the changes that are entailed, for consideration of the RGEC Chair in Sussex Direct.
DOWNLOAD THE AMENDMENT FORM here >
In Sussex Direct:
- Select ‘Submit Amendment’ in the approved parent application.
- In the ‘Supporting Documents’ section, upload the Request for Amendment Form together with any new and revised versions of the study documentation.
- The named supervisor will need to authorise and submit the amendment.
Most amendment requests can be considered by the Chair within 10 working days of submission and do not require review at a scheduled RGEC meeting. Occasionally substantial amendments require comprehensive review, and the applicant will be notified.
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