Funding

Discipline(s):  All

One very common question researchers ask is when is it appropriate to amend a previously approved IRB protocol and when is it appropriate to renew it.  Fortunately, the Kuali Electronic protocol system allows for amendments and renewals to be done independently of each other and also as one combined submission.

An Amendment should be submitted if you need to change anything about your previously approved protocol. This includes any alteration to the project’s methods or design, extending the end date of the project, adding or removing project investigators, or editing any instruments or consent forms previously approved.

A Renewal should be submitted if the project’s IRB approval is about to expire. This option should rarely be used since it does not allow you to amend/change any of the protocol’s sections, including the end date that you originally provided. It is likely if you are asking for a renewal, you will probably need to extend the end date as well. Check the protocol to make sure there is nothing that will need to be amended before selecting this option.

Kuali also has the option to Renew/Amend as one submission. This option should be selected if you need to renew a project, AND at the same time, amend any of the project’s information.

For more information on human subjects research, please check out the upcoming ORP Monthly Tips Webinar, “Human Subjects Research FAQs and the IRB,” on April 27^th at 12pm.  Registration information for the event can be found here. 

For more information on how to submit a protocol in Kuali Research as well as other related resources, please visit our site.  For any questions, you may also email us at researchcompliance@siue.edu.