Faculty of Science

Application and Amendment Forms

Useful forms

For the current application form, and participant information sheet and consent form templates, please download these from the UoP main ethics webpage where the most recent versions will be available.

Notification of a substantial amendment

As projects commence it is not unusual to need to amend or extend the proposal. If an amendment might affect the ethical aspects of a research project then a notification of substantial amendment form, available from the UoP main ethics webpage, should be completed and forward along with an updated application form showing the changes requested. The new proposal should not be adopted until a favourable ethical opinion has been returned. SFEC will endeavour to respond to such notifications within 7 working days of submission, although this can take longer, up to 15 working days, if the changes notified are substantial or introduce significant ethical issues.

It is not possible to give an exact definition of what would merit a substantial amendment or not, but as an example, changes to the method of recruitment of volunteers is likely to require an ethical review, whereas changing the equipment used to measure a variable from one type to another (eg to cope with equipment breakages / advances), would probably not require an ethical review. Of course, there could be extreme examples of each which would have a different need for resubmission response.

Where a study is being amended to improve safety / reduce risk, such changes, of course, should be implemented immediately, but SFEC should be informed of the change(s) to protocol as soon as is practicably possible, ideally no-longer than two weeks of the change being implemented.

Appeal against an ethical opinion

If the PI has difficulties complying with the conditions required following a favourable ethical opinion (with conditions), the PI should in the first instance raise the problem with the Chair through ethics-sci@port.ac.uk to determine whether the issue can be resolved easily.

If the issues cannot be resolved, or more likely the PI wishes to appeal against an unfavourable ethical opinion, the PI should lodge an appeal with the Chair and the University Ethics Advisor (simon.kolstoe@port.ac.uk), which will be managed through the research ethics subcommittee.