Amendments
Making changes after approval
It's not uncommon for a researcher to decide that study procedures need to be changed after IRB approval. Maybe they would like to include additional methods of recruitment or additional participants. Maybe survey or interview questions need to be added or clarified. Maybe additional researchers are joining the team, or other researchers are leaving.
Whatever changes the researcher would like to make, and regardless of the level of review, any change from the approved study procedures must be submitted to the IRB as an amendment application. The amendment application must be approved by the IRB before the new procedures can be used.
Submitting your Amendment Application
There are two aspects to the application you will submit to the IRB. The first is the changes to the approved IRB application. You will need to go through the application and change any relevant sections. For instance, if you add an additional research site and additional participants, you will need to change both the Research Sites section and the Recruitment section to add the new site and increase the anticipated number of participants.
You should read through the rest of the application to make sure that there is no outdated information remaining. Once the amendment application is approved, that new application becomes your IRB approval of record. Only the procedures described in that version are approved.
The second aspect of the amendment application is the summary of the amendment at the bottom of the page. This summary helps your reviewer understand the changes you've made. All changes should be summarized here, no matter how small. However, this will not be part of the final approved protocol, so any changes discussed here must also be made in the body of the application. Changes to the body of the application and the summary must be saved separately, otherwise they will be lost.
If you are submitting a continuing review application, you can make amendments as part of that process.
Once the application has been updated and the changes have been summarized in the amendment application, you will submit to ORS just as you did with the initial application.
Amendment Review Process
Amendments that do not increase the risk of the study are reviewed through an expedited process regardless of the original level of review. The Board has the option to have the convened board review, but this is not typical.
If the amendment does increase the level of risk, or (in the case of exemptions) adds procedures that cannot be exempted, a full review at the new level may take place. If this describes your amendment, plan your timeline accordingly.
None of the new procedures or documents can be used prior to approval of the amendment. All previously approved procedures can continue to take place while the amendment is reviewed.
Making changes without an amendment
If changes to study procedures are made without first receiving approval from the IRB, this is considered non-compliance and an unexpected event report must be filed. This is true even if the non-compliance was the result of an oversight (for example, accidentally enrolling more participants than approved).
Making changes after approval
It's not uncommon for a researcher to decide that study procedures need to be changed after IRB approval. Maybe they would like to include additional methods of recruitment or additional participants. Maybe survey or interview questions need to be added or clarified. Maybe additional researchers are joining the team, or other researchers are leaving.
Whatever changes the researcher would like to make, and regardless of the level of review, any change from the approved study procedures must be submitted to the IRB as an amendment application. The amendment application must be approved by the IRB before the new procedures can be used.
Submitting your Amendment Application
There are two aspects to the application you will submit to the IRB. The first is the changes to the approved IRB application. You will need to go through the application and change any relevant sections. For instance, if you add an additional research site and additional participants, you will need to change both the Research Sites section and the Recruitment section to add the new site and increase the anticipated number of participants.
You should read through the rest of the application to make sure that there is no outdated information remaining. Once the amendment application is approved, that new application becomes your IRB approval of record. Only the procedures described in that version are approved.
The second aspect of the amendment application is the summary of the amendment at the bottom of the page. This summary helps your reviewer understand the changes you've made. All changes should be summarized here, no matter how small. However, this will not be part of the final approved protocol, so any changes discussed here must also be made in the body of the application. Changes to the body of the application and the summary must be saved separately, otherwise they will be lost.
If you are submitting a continuing review application, you can make amendments as part of that process.
Once the application has been updated and the changes have been summarized in the amendment application, you will submit to ORS just as you did with the initial application.
Amendment Review Process
Amendments that do not increase the risk of the study are reviewed through an expedited process regardless of the original level of review. The Board has the option to have the convened board review, but this is not typical.
If the amendment does increase the level of risk, or (in the case of exemptions) adds procedures that cannot be exempted, a full review at the new level may take place. If this describes your amendment, plan your timeline accordingly.
None of the new procedures or documents can be used prior to approval of the amendment. All previously approved procedures can continue to take place while the amendment is reviewed.
Making changes without an amendment
If changes to study procedures are made without first receiving approval from the IRB, this is considered non-compliance and an unexpected event report must be filed. This is true even if the non-compliance was the result of an oversight (for example, accidentally enrolling more participants than approved).