Amendments to research projects after approval has been granted
SEM: BSMS 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 SEMFRECBSMS@sussex.ac.uk.
Amendments on Ethics RM
If your original application is on Ethics RM (Infonetica), please unlock your approved application, change Q.2 from ‘New application’ to: ‘Amendment to an already approved application’, edit the form, upload any new documents (with track-changes) and submit as an amendment application.
Amendments on Sussex Direct (old system)
If you need to apply for an amendment approval, you will need to submit a ‘Request for Amendment Form’ unlock your approved application, change your answer to Question 2 and outlining outline the changes that are entailed, for consideration of the RGEC SEM: BSMS 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.
Most amendment requests can be considered by the Chair within 10 working days of submission and do not require review at a scheduled SEM: BSMS meeting. Occasionally substantial amendments require comprehensive review, and the applicant will be notified.
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