Applying for an amendment
It may become apparent once you have started your study that it needs to be amended. Changes might include:
- changes to the design or methodology of the study;
- changes to participant recruitment or involvement;
- a change in the number of participants;
- any change relating to the safety or physical or mental integrity of participants, or to the risk/ benefit assessment for the study;
- changes to study documentation such as participant information sheets, consent forms, questionnaires, letters of invitation;
- temporary halt of a study to protect participants from harm;
- changes in funding arrangements;
- any other change that would result in changes to the previously approved application form;
- a change to the research end date*;
- changes to the research team*.
* Notifying the Senior Research Ethics Administrator by email would normally be sufficient for particularly minor changes, for anything else an amendment form must be completed.
What is the procedure? As the changes may present new ethical issues any changes to already approved projects will need to be re-reviewed by the original Ethics Committee. Depending on the nature of the amendment this will either be reviewed by the Chair or by the whole Faculty Research Ethics Committee. Once the changes have been reviewed you will be notified of the Committee's decision. You will need to complete the amendment form and submit it for review via the University's Senior Research Ethics Administrator, Jennifer Blaikie, ResearchEthics@leeds.ac.uk. Please provide copies of any amended or new documentation (eg application form, information sheet, consent form, questionnaires) as these will need to be considered as part of the review.
For informal advice please contact Jennifer Blaikie, email ResearchEthics@leeds.ac.uk, t: 0113 34 34873.
NB There are two exceptions to this procedure:
Applicants from the Faculty of Medicine and Health should contact the Faculty Research Ethics and Governance Administrator as procedures differ in this Faculty.
For amendments to studies which have been approved via the NHS but now come under UoL ethical review