Applications for amendments or extensions

You must always submit an amendment application form for any changes to a study which has already obtained ethics approval and a new ethical review application form to renew your approval for another five years. 

If your original application was collaborative, see the guidance on collaborative applications. 

Amendments

Simple amendments

Simple, non-substantial amendments which do not alter or bring any additional ethical considerations should be recorded but do not require ethical review.

If your proposed amendment is for:

• addition or removal of researchers
• addition or removal of research or recruitment sites or locations
• minor changes to study documents such as spelling or grammar, to correct errors or to update contact details to reflect changes in the research team.

And:

• these are the only changes requested
• these changes do not alter or add to the ethical considerations as described in the original application

Then you can use the Ethical amendment application form (simple) (Word) to record your changes – send this to your School ethics committee (SEC) who will acknowledge receipt by email.

Any other amendments

For any other amendments an ethical amendment application form (Word) should be completed and submitted to your School ethics committee. For example, if  you need to modify your original proposal, bring in new elements in a way which would significantly alter any of the responses you originally made, and if your planned changes affect the ethical issues associated with the project.

If your changes amount to essentially a different project to that originally approved, you should submit a new ethical application. For guidance, contact your School ethics committee.

Do not start, or continue, your modified research until you have secured SEC approval for any amendments.

Extensions

Ethical approval is granted for five years.

If you need to extend your approval you can seek a:

• Short discretionary extension - the School ethics committee can grant extensions of up to six months, at their discretion, without the need for an ethical review application. This may be appropriate when the research is nearning completion. A discretionary extension can only be granted once, thereafter a full extension is required. Email your SEC to request a discretionary extension. 
• Renewal of approval -  if you need to extend your approval for a longer period, or if the SEC requests, you must complete a new ethical review application form (Word), noting the original approval code and date. Submit this to your SEC for review and, if approved, approval will be valid for another five years.

Do not start, or continue, your research until you have secured SEC approval for any extension - make sure to submit an application for an extension in advance of your approval expiring (at least four weeks, earlier if possible) to avoid conducting research without the appropriate ethical approval.