Amendment

Changes to the research may invalidate the exempt determination because the research would no longer meet the exempt criteria.

Researcher Responsibility: Consider the impact of a research modification before implementing it. 

Investigators must self-assess whether the proposed changes to their exempt protocol would continue to qualify for exemption. 

Please see FAQ: Amendments for Exempt Protocol for additional information.

The amendment's review path (e.g., full board, expedited, administrative) depends on the nature and level of the change. Substantive changes to a project previously reviewed by the full board most likely will require full board approval.

Minor amendments may be reviewed via an expedited or administrative (i.e., IRB staff) process. Examples of minor amendments include but are not limited to:

• Addition or deletion of study team members
• Addition of procedures that do not increase risk
• Removal of procedures that would reduce risk to subjects
• Addition of non-sensitive survey or interview questions
• Addition of, or changes to, recruitment materials or recruitment strategies
• Changes that do not modify the intent of the content (e.g., typographical error corrections, improvements for clarity)

Adding personnel is a two-step process:

1. Add them to Section 3.0., Assign key study personnel (KSP) access to the study, Once added the submission will show on their personal dashboard.
2. But also do not forget to add them to Section 5.0, IRB New Protocol Application Form, to declare Conflict of Interest for each staff added.
   1. This step will not be able to be completed until they are granted access to the submission in Section 3.0.

If they are not found in the directory, then they do not have an iRIS account.

You can verify the exempt status of your protocol by looking in iRIS at the protocol status. 

If it shows green with the words "Exempt", your study was reviewed and determined to be exempt. 

Then answer "yes" to this question. Then this information applies to your protocol.

If it shows green with the words "Approved", your study was reviewed either under expedited or full board review. Then answer "no" to this question. Then the following information DOES NOT apply to your protocol.

• Changing the funding source.
• Changing the Principal Investigator.
• Adding study personnel.
• New types of subjects. Adding new types of subjects, such as children, prisoners, foreign persons, not previously being recruited.
• New types of records. Adding use of student or medical records when not previously used.
• New procedures. New types of procedures not currently described in the IRB protocol when it means that the research methods no longer fit into the same exempt category.
• Identifiers. Obtaining or recording identifiable data or specimens for studies that previously obtained only de-identified or anonymous data or specimens. Identifiable data may require adding a limited IRB review.
• New risks. Increasing the risk due to any change (For example, adding questions to a survey when the answer to the new questions increases the risk of damage to a subject’s employability or reputation.)
• External collaborators. Adding new external collaborators who do NOT have their own IRB exempt determination.
• Decrease in security measures.
• New intent to submit the research data to the Food and Drug Administration (FDA).

• Adding a subject population that is similar to what is already approved. For example, add graduate students when the application describes undergraduates or add 5^th grade students when the application describes 6^th and 7^th grade students.
• Adding similar survey or interview questions that do not increase risk. Questions must be similar in scope, content, and sensitivity level to what is already described in the IRB Protocol.
• Revising an intervention to something similar. The new intervention must be comparable in nature, duration, and potential for harm, embarrassment, or discomfort as was already described in the IRB Protocol.
• Switching the method of data collection to another method within the same category. For example, from a focus group to an individual interview or an interview to a survey on the same topics.
• Making changes to number of subjects, payment, consent and recruitment materials or methods, survey platform being used, or study instruments so long as the changes do not fall into one of the categories that require a re-determination.
• Increasing data security protections. No additional IRB review is required when a more protective safeguard is put in place.

For all the other changes. If you are unsure whether a modification is needed, consult with IRB staff team or submit the amendment through iRIS.

IF STILL EXEMPT, you do NOT submit an amendment for review. You may implement the change immediately.

Investigators are responsible for documenting in their research records that the changes made to the protocol were self-assessed as continuing to qualify for exemption and that further submission to the IRB was not necessary.

IF UNCERTAIN OR THE CHANGE MEANS THE PROTOCOL IS NO LONGER EXEMPT, submit an amendment in iRIS.

What happens if my study no longer qualifies as exempt?

If the study no longer qualifies for an exemption, the study will require review by the IRB using the expedited or full board review procedures. Your amendment will be routed upon receipt to either an expedited reviewer or full board agenda, depending on the change.

1. Create an amendment in iRIS. 

Find your exempt study in the list of protocols. (You may have to scroll down to the bottom of the screen).

Then under actions, find the Forms button. Click the icon .
This opens a list of submission forms for your protocol.

Click the icon  
to open the amendment form in iRIS.

This opens the amendment submission form.

2. Complete the amendment form.

Answer “yes” to the question on if your protocol is exempt:

Answer the remainder of the questions.

3. Submit the form.

Apply the PI sign-off to complete the amendment process.

If you are not the PI, then hit Submit and Notify PI to alert the PI to complete the sing-off.

4. Review Process

If the amendment is still exempt, IRB (including IRB staff) do NOT review or approve exempt modifications performed through the self-certification process. The submission is acknowledged in iRIS to close out the process.

If the amendment changes the protocol status to expedited or full board, an IRB review is required. The study team will be notified of the review level change in iRIS.